[Federal Register Volume 79, Number 230 (Monday, December 1, 2014)]
[Rules and Regulations]
[Pages 71259-71293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27834]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0171]
RIN 0910-AG56


Food Labeling; Calorie Labeling of Articles of Food in Vending 
Machines

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: To implement the vending machine food labeling provisions of 
the Patient Protection and Affordable Care Act of 2010 (ACA), the Food 
and Drug Administration (FDA or we) is establishing requirements for 
providing calorie declarations for food sold from certain vending 
machines. This final rule will ensure that calorie information is 
available for certain food sold from a vending machine that does not 
permit a prospective purchaser to examine the Nutrition Facts Panel 
before purchasing the article, or does not otherwise provide visible 
nutrition information at the point of purchase. The declaration of 
accurate and clear calorie information for food sold from vending 
machines will make calorie information available to consumers in a 
direct and accessible manner to enable consumers to make informed and 
healthful dietary choices. This final rule applies to certain food from 
vending machines operated by a person engaged in the business of owning 
or operating 20 or more vending machines. Vending machine operators not 
subject to the rules may elect to be subject to the Federal 
requirements by registering with FDA.

DATES: 
    Effective Date: December 1, 2016.
    Compliance Date: Covered vending machine operators must comply with 
the rule by December 1, 2016. See section III.E for more information on 
the effective and compliance dates.
    Comment Date: Submit comments on information collection issues 
under the Paperwork Reduction Act of 1995 by December 31, 2014 (see 
section V, the ``Paperwork Reduction Act of 1995'' section of this 
document).

ADDRESSES: To ensure that comments on the information collection are 
received, the Office of Management and Budget (OMB) recommends that 
written comments be faxed to the Office of Information and Regulatory 
Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to 
oira_submission@omb.eop.gov. All comments should be identified with the 
OMB control number 0910--New and title ``Information Collection 
Provisions of the final rule on Food Labeling: Calorie Labeling of 
Articles of Food in Vending Machines.'' Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Y. Reese, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371, email: 
Daniel.Reese@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary
Purpose and Coverage of the Final Rule
Summary of the Major Provisions of the Final Rule
Costs and Benefits
I. Background
II. Legal Authority
III. Comments on the Proposed Rule, FDA Responses, and Description 
of the Final Rule
    A. Introduction
    B. General Comments
    C. Comments on Specific Provisions and Description of the Final 
Rule
    D. Determination of Calorie Content
    E. Effective Date
    F. Enforcement
IV. Analysis of Impacts--Final Regulatory Impact Analysis
V. Paperwork Reduction Act of 1995
VI. Federalism
VII. Environmental Impact
VIII. References

Executive Summary

Purpose and Coverage of the Final Rule

    To help make calorie information for vending machine foods 
available to prospective purchasers in a direct, accessible, and 
consistent manner to enable them to make informed and healthful dietary 
choices, section 4205 of the ACA and the rule require that vending 
machine operators who own or operate 20 or more vending machines, or 
who voluntarily elect to be covered, must provide calorie declarations 
for those vending machine foods for which the Nutrition Facts label 
cannot be examined prior to purchase or for which visible nutrition 
information is not otherwise provided at the point of purchase.

Summary of the Major Provisions of the Final Rule

     The final rule requires vending machine operators who own 
or operate 20 or more vending machines (or who voluntarily register 
with FDA to be subject to the final rule) to provide calorie 
declarations for certain articles of food sold from vending machines.
    [cir] The final rule defines a vending machine operator as a person 
or entity that controls or directs the function of the vending machine, 
including deciding which articles of food are sold from the machine or 
the placement of the articles of food within the vending machine, and 
is compensated for the control or direction of the function of the 
vending machine.
    [cir] Through biannual registration, vending machine operators who 
are not covered by the final rule can voluntarily elect to become 
subject to it.
     The final rule describes which foods are subject to the 
calorie

[[Page 71260]]

declaration requirement. Vending machine operators do not have to 
declare calorie information for a food if a prospective purchaser can 
view certain calorie information on the front of the package, in the 
Nutrition Facts label on the food, or in a reproduction of the 
Nutrition Facts label on the food subject to certain requirements, or 
if the vending machine operator does not own or operate 20 or more 
vending machines.
     For those foods subject to the calorie declaration 
requirement, the final rule specifies how the calories must be 
declared.
    [cir] Calorie declarations must be clear and conspicuous and placed 
prominently, and may be placed on a sign in, on, or adjacent to the 
vending machine, so long as the sign is in close proximity to the 
article of food or selection button.
    [cir] The final rule establishes type size, color, and contrast 
requirements for calorie declarations in or on the vending machines, 
and for calorie declarations on signs adjacent to the vending machines.
    [cir] The final rule establishes requirements for calorie 
declarations on electronic vending machines, those vending machines 
with only pictures or names of the food items, and those vending 
machines with few choices (e.g., popcorn machines).
     The final rule requires vending machine operator contact 
information to be displayed for enforcement purposes.
     The final rule makes conforming amendments to FDA's 
labeling regulations at Sec.  101.9(j) so that a covered vending 
machine food that is otherwise exempt from nutrition labeling under 
Sec.  101.9 would not lose such exemption by complying with the calorie 
declaration requirements of the final rule.

Costs and Benefits

    The Affordable Care Act requires nutrition labeling for standard 
menu items on menus and menu boards for certain restaurants and similar 
retail food establishments and calorie labeling for food sold from 
certain vending machines. FDA is issuing two separate final rules (one 
for menu labeling and one for vending machine labeling) to implement 
those labeling requirements. For this rule on vending machines alone, 
the expected annualized costs are $37.9 million (over 20 years 
discounted at 7 percent), while the benefits have not been quantified. 
Taken together, the mean estimated benefits of the labeling 
requirements (menu labeling and vending machine labeling rules 
combined) exceed costs by $477.9 million on an annualized basis (over 
20 years discounted at 7 percent; not including net benefits from this 
final rule on vending machine labeling, which are not quantified).

            Summary of Costs and Benefits of Menu Labeling and Vending Machine Rules (in Millions) *
----------------------------------------------------------------------------------------------------------------
                                           Rate
                                         percent)             Benefits                 Costs       Net benefits
----------------------------------------------------------------------------------------------------------------
Total for Labeling (menu and vending             3  $9,221.3....................        $1,697.9        $7,523.4
 rules) over 20 years.                           7  6,752.8.....................         1,333.9         5,418.9
Annualized for Labeling (menu and                3  $601.9......................          $110.8           491.1
 vending rules) over 20 years.                   7  595.5.......................           117.6           477.9
Total for Vending Machine Labeling               3  Not Quantified..............           531.1  ..............
 over 20 years.                                  7  Not Quantified..............           401.1  ..............
Annualized for Vending Machine                   3  Not Quantified..............            34.7  ..............
 Labeling over 20 years.                         7  Not Quantified..............            35.4  ..............
----------------------------------------------------------------------------------------------------------------
* Benefits from this vending machine labeling rule are not quantified and therefore not included.

I. Background

    The Nutrition Labeling and Education Act of 1990 (NLEA) amended the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require, in 
part, nutrition information for food labeling (section 403(q) (21 
U.S.C. 343(q)). Under the NLEA and its implementing regulations (Sec.  
101.9 (21 CFR 101.9)), when a food is in package form, the required 
nutrition information generally must appear on the label of the food. 
The regulations require nutrition information to be provided for a food 
product intended for human consumption and offered for sale unless an 
exemption applies (Sec.  101.9(a)). One of these exemptions applied to 
food products served in a vending machine, provided that the food bore 
no nutrition claims or other nutrition information in any context on 
the label or in the labeling or advertising (Sec.  101.9(j)(2)).
    On March 23, 2010, the President signed the ACA (Public Law 111-
148) into law. Section 4205 of the ACA amended section 403(q) of the 
FD&C Act and section 403A of the FD&C Act (21 U.S.C. 343-1), which 
governs Federal preemption of State and local food labeling 
requirements. Section 4205 of the ACA added section 403(q)(5)(H)(viii) 
to the FD&C Act to require that if an article of food is sold from a 
vending machine that (1) ``does not permit a prospective purchaser to 
examine the Nutrition Facts Panel before purchasing the article or does 
not otherwise provide visible nutrition information at the point of 
purchase;'' and (2) ``is operated by a person who is engaged in the 
business of owning or operating 20 or more vending machines,'' then the 
vending machine operator must ``provide a sign in close proximity to 
each article of food or the selection button that includes a clear and 
conspicuous statement disclosing the number of calories contained in 
the article.''
    Under section 403(q)(5)(H)(ix) of the FD&C Act, vending machine 
operators who are not subject to the new requirements of section 
403(q)(5)(H)(viii) of the FD&C Act can register voluntarily with FDA to 
become subject to the Federal requirements. In the Federal Register of 
July 23, 2010 (75 FR 43182), we published a notice specifying the terms 
and conditions for implementation of voluntary registration, pending 
issuance of regulations.

II. Legal Authority

    Section 4205 of the ACA amended section 403(q)(5) of the FD&C Act, 
in part, by adding a new paragraph (H) to require certain vending 
machine operators to provide calorie declarations for certain articles 
of food sold from vending machines. Under section 403(a)(1) of the FD&C 
Act, such information must be truthful and non-misleading. Under 
section 403(f) of the FD&C Act, any word, statement, or other 
information required by or under the FD&C Act to appear on the label or 
labeling of an article of food must be prominently placed thereon with 
such conspicuousness (as compared with

[[Page 71261]]

other words, statements, designs, or devices, in the labeling) and in 
such terms as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use. 
Food to which these requirements apply is deemed misbranded if these 
requirements are not met. In addition, under section 201(n) of the FD&C 
Act (21 U.S.C. 321(n)), the labeling of food is misleading if it fails 
to reveal facts that are material in light of representations made in 
the labeling or with respect to consequences that may result from use. 
Thus, we are issuing this final rule under sections 201(n), 403(a)(1), 
403(f), and 403(q)(5)(H) of the FD&C Act, as well as under section 
701(a) of the FD&C Act (21 U.S.C. 371(a)), which gives us the authority 
to issue regulations for the efficient enforcement of the FD&C Act.

III. Comments on the Proposed Rule, FDA Responses, and Description of 
the Final Rule

A. Introduction

    In the Federal Register of April 6, 2011 (76 FR 19238), we 
published a proposed rule that would establish requirements for calorie 
declarations for certain articles of food sold from vending machines to 
implement section 403(q)(5)(H)(viii) and (q)(5)(H)(ix) of the FD&C Act. 
We proposed definitions, requirements for calorie labeling for certain 
food sold from vending machines, and requirements for voluntary 
registration by a vending machine operator that is not subject to the 
requirements of section 403(q)(5)(H)(viii) of the FD&C Act to elect to 
be subject to such requirements. We provided a 90-day comment period 
that ended on July 5, 2011.
    We received approximately 250 comments on the proposed rule each 
containing one or more issues. We received comments from consumers; 
consumer groups; trade organizations; the vending machine industry; 
public health organizations; Congress; Federal, State, and local 
government agencies; and other organizations.
    We describe and respond to the comments in sections III.B, C, D, 
and E of this document. To make it easier to identify comments and our 
responses, the word ``Comment,'' in parentheses, will appear before the 
comment's description, and the word ``Response,'' in parentheses, will 
appear before our response. We have also numbered each comment to help 
distinguish between different comments. The number assigned to each 
comment is purely for organizational purposes and does not signify the 
comment's value, importance, or the order in which it was received.

B. General Comments

    Many comments made general remarks supporting or opposing the rule 
and did not focus on a particular section of the rule. Other comments 
addressed FDA's statutory interpretations and general economic issues. 
We address the general comments including general comments relating to 
FDA's statutory interpretations and general economic issues here.
    (Comment 1) The majority of comments supported the proposed rule. 
Some comments stated that the proposed rule strikes the right balance 
between making important nutrition information available to consumers 
and avoiding unnecessary financial burdens on small businesses. Other 
comments said requiring vending machines to display calorie information 
is an integral part of a comprehensive approach to addressing obesity 
by providing consumers with more information to make healthier choices. 
Some comments supported the proposed rule's flexibility regarding how 
covered operators are to declare calories on signs.
    In contrast, other comments opposed the proposed rule. Some 
comments stated that people do not need to be told what to eat. One 
comment stated that labeling responsibilities should be placed on food 
manufacturers, rather than vending machine operators, because food 
manufacturers already have the information and can place it on the food 
label. One comment asserted that calorie declarations on signs in close 
proximity to articles of food sold in vending machines or selections 
buttons are unnecessary because packaged foods already have nutrition 
information on the labels for such foods.
    (Response 1) The final rule does not attempt to tell consumers what 
they should or should not eat. The final rule requires certain vending 
machine operators to provide calorie declarations for certain articles 
of food sold from vending machines on signs in close proximity to such 
articles of food or selection buttons as required by section 
403(q)(5)(H)(viii) of the FD&C Act. The purpose of the final rule is to 
provide accurate and clear calorie information for vending machine 
foods to consumers in a direct and accessible manner to enable 
consumers to make informed and healthful dietary choices.
    As for the comment stating that food manufacturers rather than 
vending machine operators should be responsible for providing calorie 
declarations for vending machine foods, section 403(q)(5)(H)(viii) of 
the FD&C Act expressly applies to certain vending machine operators. 
Therefore, we decline to revise the rule to apply the requirements of 
section 403(q)(5)(H)(viii) of the FD&C Act to food manufacturers.
    We note that some packaged foods may already list nutrition 
information (including calories) on their labels. Such articles of food 
may be exempt from the requirements of section 403(q)(5)(H)(viii) of 
the FD&C Act if they satisfy the criteria set forth in Sec.  101.8(b).
    (Comment 2) Some comments opposed the proposed rule, stating that 
the costs and work to implement the proposed requirements would be 
better spent on other programs. Other comments questioned the value of 
the calorie declaration requirements and asserted that the proposed 
rule would increase the cost of packaged foods sold in vending 
machines. Another comment suggested that the Federal Government provide 
tax incentives to small businesses to offset costs of implementing the 
rule.
    Other comments questioned whether disclosing calorie information 
would have the intended benefits. The comments questioned whether 
vending machine calorie labeling would promote healthier choices and 
the need to educate consumers about the calorie information. The 
comments also questioned whether consumers would ignore the calorie 
information, and whether the calorie information would affect consumer 
behavior.
    (Response 2) With respect to those comments suggesting that Federal 
funds and labor would be better spent on other matters, section 4205 of 
the ACA requires us to issue regulations to implement the vending 
machine labeling requirements, as specified in section 
403(q)(5)(H)(viii) of the FD&C Act.
    The final rule does not require food manufacturers to change the 
labeling of packaged foods, nor does it require vending machine 
manufacturers to change the design of vending machines. Nevertheless, 
it is possible that some costs associated with compliance with this 
rulemaking might pass through to consumers. However, any changes to the 
cost of packaged foods sold in vending machines are likely to be very 
small, because the estimated costs of compliance would be very small 
relative to overall sales from vending machines. The final rule is 
directed at certain vending machine operators, and we discuss the final 
rule's economic impact and its impact on small businesses in a

[[Page 71262]]

full Regulatory Impact Analysis for the final rule (Ref. 1) which is 
available at http://www.regulations.gov (enter Docket No. FDA-2011-F-
0171).
    As for the comments suggesting tax incentives for small businesses, 
we recognize that nearly 97 percent of the covered vending machine 
operators are small businesses, and have provided flexibility in the 
final rule to reduce the burden on small businesses. Specifically, we 
have changed the final rule's effective date from 1 year to 2 years, 
and are allowing covered vending machine operators to choose the method 
for determining calorie content of the food and the materials through 
which the calories are declared, including less expensive means such as 
stickers or signs. We believe this additional flexibility will help 
minimize burdens on and costs for small businesses in complying with 
the requirements of section 403(q)(5)(H)(viii) of the FD&C Act.
    With respect to the comments questioning the rule's potential 
benefits, we note that section 4205 of the ACA requires FDA to 
implement the calorie labeling requirements for vending machines in 
section 403(q)(5)(H)(viii) of the FD&C Act. Further, the declaration of 
accurate and clear calorie information for food sold from vending 
machines will make calorie information available to consumers in a 
direct and accessible manner to enable consumers to make informed and 
healthful dietary choices.
    (Comment 3) The vending machine labeling requirements in section 
403(q)(5)(H)(viii) of the FD&C Act apply to all covered food sold from 
vending machines operated by a person who is engaged in the business of 
owning or operating 20 or more vending machines. The preamble to the 
proposed rule indicates that, as with other vending machine operators, 
vending machine operators who are blind and operate vending machines 
through the Vending Facility Program of the Randolph-Sheppard Act of 
1936, 20 U.S.C. 107 et seq., would be covered by the requirements of 
section 403(q)(5)(H)(viii) of the FD&C Act only if they operate 20 or 
more vending machines that dispense food or if they voluntarily 
register to be covered (76 FR 19238 at 19240-19241).
    Several comments asked that we retain the explanation from the 
preamble to the proposed rule that section 403(q)(5)(H)(viii) of the 
FD&C Act does not apply to vending machine operators who are blind and 
operate vending machines through the Vending Facility Program of the 
Randolph-Sheppard Act if they operate fewer than 20 machines. The 
comments expressed concern that, because State licensing agencies 
responsible for administering the Randolph-Sheppard Act often own the 
vending machines, vending machine operators would be subject to the 
calorie declaration requirements even if they operate fewer than 20 
machines.
    (Response 3) Section 403(q)(5)(H)(viii) of the FD&C Act applies to 
all covered food sold from vending machines ``operated by a person who 
is engaged in the business of owning or operating 20 or more vending 
machines.'' Thus, if a vending machine operator under the Vending 
Facility Program of the Randolph-Sheppard Act does not own or operate 
20 or more vending machines, then the food sold from his or her vending 
machines is outside the scope of the final rule unless the vending 
machine operator voluntarily registers to be covered by the rule under 
Sec.  101.8(d).
    (Comment 4) One comment asked that we clarify that vending machine 
operators, rather than food manufacturers, must comply with this final 
rule.
    (Response 4) Section 403(q)(5)(H)(viii) of the FD&C Act makes it 
clear that the requirements apply to vending machine operators rather 
than food manufacturers.
    Nevertheless, a food manufacturer may provide the number of 
calories for a vending machine food to a vending machine operator to 
help the vending machine operator meet the calorie declaration 
requirements of this rule. In addition, the label for a vending machine 
food may already include calorie information, which the vending machine 
operator may use in providing the calorie declarations required by this 
rule. Further, as food packaging and vending machine technology 
continue to evolve, food manufacturers, vending machine manufacturers, 
and vending machine operators may work together to help vending machine 
operators comply with this rule.
    (Comment 5) One comment asked whether dietary supplements and over-
the-counter drugs (e.g., cough drops), which are sometimes sold in 
vending machines, would be covered by the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act. The comment noted that, in some 
cases, these products bear calorie information, but the information is 
within the context of the Drug or Supplement Facts, and not on the 
front of package (FOP). The comment stated that dietary supplements and 
over-the-counter drugs should not be considered articles of food and 
that we should not apply the calorie labeling requirements to these 
types of items.
    (Response 5) Section 201(f) of the FD&C Act defines ``food'' as: 
``(1) Articles used for food or drink for man or other animals, (2) 
chewing gum, and (3) articles used for components of any such 
article.'' Further, section 201(ff) of the FD&C Act explains that 
dietary supplements are deemed to be foods within the meaning of the 
FD&C Act except for the purposes of sections 201(g) (definition of 
``drug'') and 417 (21 U.S.C. 350f) (reportable food registry) of the 
FD&C Act. The requirements of section 403(q)(5)(H)(viii) of the FD&C 
Act apply ``[i]n the case of an article of food sold from a vending 
machine'' and, therefore, apply to dietary supplements, but do not 
apply to drugs, including over-the-counter drugs.
    (Comment 6) Some comments requested that foods in small packages 
whose total surface area available to bear labeling is less than 12 
square inches, e.g., gum and mints, be exempted from the rule; these 
comments said such an exemption would be consistent with the existing 
exemption from nutrition labeling for foods in small packages (Sec.  
101.9(j)(13)). One comment further reasoned that an exemption for foods 
sold in small packages would be appropriate because such packaged foods 
lack sufficient label space to provide FOP calorie information that 
would be easily readable by the consumer through the vending machine 
window. The comment also speculated that vending machine operators may 
no longer choose to sell gums and mints in most vending machines. Some 
comments also noted that these foods in small packages provide an 
insignificant calorie contribution to the daily diet and requested that 
such foods be exempted from this rule. These comments argued that the 
burden of providing calorie information is not justified for such 
foods.
    Some comments stated that foods exempt from nutrition labeling 
under Sec.  101.9(j) would lose this exemption if they must bear 
calorie information on the front of the package. Similarly, other 
comments asked us to exempt bottled water from this rule because 
bottled water contains insignificant amounts of nutrients and is 
generally exempt from the nutrition labeling requirements of Sec.  
101.9 under the exemption for packaged foods in Sec.  101.9(j)(4). One 
comment expressed concern that, if bottled water products must comply 
with this rule, the bottled water would be required to have a Nutrition 
Facts Panel even though it may be otherwise exempt from the nutrition 
labeling requirements. The comment expressed concern that vending 
machine operators

[[Page 71263]]

may stock less bottled water because they would stock products only 
with nutrition information on the label or FOP labeling so that they 
would not have to post calorie declarations themselves.
    (Response 6) The comments referring to the exemptions are 
describing Sec.  101.9(j)(4) and (j)(13)(i), which FDA issued to 
implement section 403(q)(5)(B) and (C) of the FD&C Act before the 
enactment of the ACA. Section 101.9(j)(13)(i) provides that foods in 
small packages that have a total surface area available to bear 
labeling of less than 12 square inches are exempt from the nutrition 
labeling requirements of Sec.  101.9 provided that the labels for these 
foods bear no nutrition claims or other nutrition information in any 
context on the label or in labeling or advertising. In addition, Sec.  
101.9(j)(4) provides in relevant part that foods containing 
insignificant amounts of all of the nutrients and food components 
required to be included in the declaration of nutrition information 
under Sec.  101.9(c) are exempt from the nutrition labeling 
requirements of Sec.  101.9 provided that these foods bear no nutrition 
claims or other nutrition information in any context on the label or in 
labeling or advertising. However, these exemptions only apply to the 
requirements of section 403(q)(1) and (2) of the FD&C Act, and not the 
vending machine labeling requirements of section 403(q)(5)(H)(viii) of 
the FD&C Act.
    Also, section 403(q)(5)(H)(viii) of the FD&C Act does not include 
an exemption for vending machine foods based on the package size, 
amount of nutrients, or caloric content of such foods. Instead, it 
provides that calorie declarations are not required for food sold from 
a vending machine: (1) That permits a prospective purchaser to examine 
the Nutrition Facts Panel before purchasing the food; or (2) that 
otherwise provides visible nutrition information at the point of 
purchase. If a vending machine food does not fall into either of these 
two categories, a covered vending machine operator must provide calorie 
information for the food.
    We note that this final rule requires a covered vending machine 
operator to post calorie information on a sign in close proximity to a 
vending machine food or its selection button; it does not require that 
such calorie information be included on the label of a vending machine 
food. Further, the final rule provides a number of options for covered 
vending machine operators to post the required calorie information, 
including posting such information on a sign adjacent to a vending 
machine (Sec.  101.8(c)(2)). As a result, the practical limitations 
that may apply to including nutrition information on the labels of 
foods in small packages do not apply to posting calorie information on 
signs for vending machine food. For these reasons, we are not exempting 
vending machine foods that come in small packages (e.g., gum, mints) or 
vending machine foods that contain insignificant nutrient or caloric 
content (e.g., bottled water) from the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act.
    We are also making changes to clarify that a covered vending 
machine food that is exempt from nutrition labeling under an exemption 
provided in Sec.  101.9(j) would not lose such exemption by complying 
with the final rule's calorie labeling requirements. As noted 
previously, Sec.  101.9(j) provides exemptions from the requirements of 
Sec.  101.9, including exemptions that apply to vending machine foods. 
Section 101.9(j)(2)(ii) provides, in relevant part, that food products 
which are served in establishments other than restaurants in which food 
is served for immediate human consumption, including vending machines, 
are exempt from the nutrition labeling requirements of Sec.  101.9 
provided that these foods bear no nutrition claims or other nutrition 
information in any context on the label or in labeling or advertising. 
Similarly, Sec.  101.9(j)(4) and (j)(13)(i) provide exemptions from the 
requirements of Sec.  101.9 provided that the food bears no nutrition 
claims or other nutrition information in any context on the label or in 
labeling or advertising. Because of these provisions, a vending machine 
food that complies with the final rule's calorie labeling requirements 
would not qualify for the exemptions from nutrition labeling in Sec.  
101.9(j)(2)(ii), (j)(4), and (j)(13)(i) because the labeling for such 
food would bear nutrition information.
    To prevent this outcome, we have amended Sec.  101.9(j) so that a 
covered vending machine food that is otherwise exempt from nutrition 
labeling under Sec.  101.9(j) would not lose such exemption by 
complying with the final rule's calorie labeling requirements. We have 
amended Sec.  101.9(j)(2)(ii), (j)(4), and (j)(13)(i) to clarify that 
complying with the vending machine food labeling requirements of Sec.  
101.8(c) will not cause a food product meeting the exemption to lose 
the exemption.
    However, we note that providing visible nutrition information on 
the label of a vending machine food through FOP labeling would 
constitute a nutrient content claim under section 403(r) of the FD&C 
Act. Section 101.13 (21 CFR 101.13), which provides general principles 
for nutrient content claims, states, in relevant part, that information 
that is required or permitted by Sec.  101.9 or Sec.  101.36 (21 CFR 
101.36), as applicable, to be declared in nutrition labeling, and that 
appears as part of the nutrition label, is not considered to be a 
nutrient content claim and is not subject to the requirements of this 
section, unless such information is declared elsewhere on the label or 
in labeling for the food (Sec.  101.13(c)). If nutrition information 
that is required or permitted by Sec.  101.9 or Sec.  101.36, including 
calorie information, appears some place other than the nutrition label 
for a food, such as on the front of the food's package, it is a 
nutrient content claim and is subject to the requirements for nutrient 
content claims (Sec.  101.13(c); 136 Cong. Rec. 20369, at 20419 (1990) 
(``Section 403(r)(1) has been amended to make it clear that the 
information on the nutrition label is not a claim under that provision 
and therefore is not subject to the disclosure requirements in section 
403(r)(2) . . . but the identical information will be subject to 
section 403(r)(2) if it is included in a statement in another portion 
of the label.'')). Accordingly, visible nutrition information provided 
through FOP labeling would be considered a nutrient content claim 
because it is nutrition information that is ``declared elsewhere on the 
label'' for a food. As such, a covered vending machine food that 
provides visible nutrition information at the point of purchase through 
FOP labeling would not qualify for the exemptions from nutrition 
labeling in Sec.  101.9(j)(2)(ii), (j)(4), and (j)(13)(i), and 
therefore would be subject to the nutrition labeling requirements in 
Sec.  101.9.
    (Comment 7) One comment requested that we require vending machine 
operators to provide calorie declarations in a special format for 
visually impaired customers. The comment suggested that this format 
could be large font, Braille, or audio recordings.
    (Response 7) We acknowledge the potential difficulty that visually 
impaired consumers may confront if the calorie declaration exists only 
in visual form, and we would not object if vending machine operators 
wish to develop means, such as large font, Braille, or audio, to help 
provide calorie declarations to visually impaired consumers, so long as 
the vending machine operators otherwise satisfy the requirements of 
section 403(q)(5)(H)(viii) of the FD&C Act. We also would not object if 
vending machine and food manufacturers and designers decide to consider 
the needs of visually impaired consumers when manufacturing and 
designing their

[[Page 71264]]

products. However, we are not requiring vending machine operators to 
provide calorie declarations in a special format for visually impaired 
consumers at this time.
    (Comment 8) A few comments supporting the proposed rule noted that 
requiring calorie labeling for vending machine foods sold in schools 
would be beneficial. These comments noted that vending machines 
typically are located in schools. Some of these comments asked that we 
require covered vending machine operators to provide separate calorie 
information for children, or list appropriate ``daily calorie ranges or 
percentages'' for children.
    (Response 8) We agree that calorie labeling for vending machine 
foods, including vending machine foods sold in schools, would be 
beneficial.
    Nevertheless, at this time, we decline to require covered vending 
machine operators to provide separate calorie information for children, 
or list appropriate ``daily calorie ranges or percentages'' for 
children as requested by some of the comments. Section 
403(q)(5)(H)(viii) of the FD&C Act requires covered vending machine 
operators to provide a sign ``disclosing the number of calories 
contained in the [covered vending machine food].'' The number of 
calories contained in an article of food does not differ based on the 
population targeted or served by a vending machine.
    Vending machine operators may voluntarily provide additional 
information that puts the calorie declaration for a covered vending 
machine food in the context of a total daily diet, provided that such 
information is truthful and not misleading. However, we decline to 
require such additional information in the final rule because we are 
only establishing regulations for the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act, and certain related provisions of 
section 403 of the FD&C Act, as described in section II, at this time.
    (Comment 9) Some comments addressed issues unrelated to the 
proposed rule's specific calorie labeling requirements for covered 
vending machine food. These comments addressed color-coded package 
labeling, labeling genetically engineered foods, and labeling or 
highlighting other ingredients or nutrients (such as trans fat).
    (Response 9) This rulemaking is intended to implement the vending 
machine calorie labeling requirements of section 403(q)(5)(H)(viii) of 
the FD&C Act. Thus, the issues raised by the comments are beyond the 
scope of this rulemaking.
    (Comment 10) Some comments stated that FDA should not require 
covered vending machine operators to provide FOP calorie labeling or 
calorie declarations on signs in languages other than English, even if 
the label on the article of food is bilingual, but should allow the 
food manufacturer or distributor to voluntarily provide FOP calorie 
labeling or calorie declarations in a second language. One comment 
asked us to confirm that ``Cal'' is an acceptable abbreviation for 
``Calories'' in both French and Spanish.
    (Response 10) We are not requiring covered vending machine 
operators to provide calorie declarations for covered vending machine 
food in languages other than English, even if the label on the article 
of food is bilingual. FDA regulations at Sec.  101.15(c)(1) (21 CFR 
101.15(c)(1)) require that all words, statements, and other information 
required by the FD&C Act to appear on the label or labeling of food 
must appear in English, except that for foods distributed solely in 
Puerto Rico or other territories where the predominant language is not 
English, the predominant language may be substituted for English. 
Therefore, the calorie declarations provided by the covered vending 
machine operator, whether through the Nutrition Facts label or other 
visible nutrition information at the point of purchase (e.g., FOP 
labeling) in accordance with section 403(q)(5)(H)(viii)(I)(aa) of the 
FD&C Act or through a sign in close proximity to each article of food 
or the selection button in accordance with section 403(q)(5)(H)(viii) 
of the FD&C Act, must appear in English, unless the foods are 
distributed solely in Puerto Rico or other territories where the 
predominant language is not English, as provided in Sec.  101.15(c)(1). 
In that context, we would consider ``Cal'' to be an acceptable 
abbreviation for ``Calories'' in French and Spanish.

C. Comments on Specific Provisions and Description of the Final Rule

    Many comments addressed specific provisions in the proposed rule or 
related topics.
1. Section 11.1(h)--Electronic Signatures
    Proposed Sec.  11.1(h) would explain that part 11 (21 CFR part 11) 
regarding electronic signatures does not apply to electronic signatures 
obtained under the voluntary registration provision for vending machine 
operators at proposed Sec.  101.8(d).
    We received no comments on this provision and have finalized it 
without change.
2. Section 101.8(a)--Definitions
    a. Use of statutory definitions. Proposed Sec.  101.8(a) would 
define various terms. It also would explain that the definitions of 
terms in section 201 of the FD&C Act apply to such terms when used in 
proposed Sec.  101.8. We received no comments regarding the use of 
statutory definitions in section 201 of the FD&C Act for the purposes 
of Sec.  101.8, and we have finalized the sentence referring to the use 
of statutory definitions in Sec.  101.8(a) without change.
    b. ``Authorized Official of a Vending Machine Operator''. Proposed 
Sec.  101.8(a) would define ``authorized official of a vending machine 
operator'' as the owner, operator, or agent in charge or any other 
person authorized by the vending machine operator to register the 
vending machine operator, which is not otherwise subject to the 
requirements of section 403(q)(5)(H) of the FD&C Act with FDA for 
purposes of proposed Sec.  101.8(d). (Proposed Sec.  101.8(d) would 
provide for voluntary calorie labeling for foods sold from vending 
machines.)
    We received no comments regarding the proposed definition. However, 
on our own initiative, we have revised the definition to make non-
substantive grammatical and technical changes (such as changing ``the 
vending machine operator'' to ``a vending machine operator'' and 
replacing ``FDA'' with ``the Food and Drug Administration''). We also 
have revised the definition to eliminate potential confusion as to who 
can be the authorized official of a vending machine operator by 
deleting an unnecessary conjunction (``or'') in the list of persons who 
may constitute an authorized official, to specify the provision of the 
FD&C Act covered by the final rule, and to move a descriptive phrase 
closer to the noun that it modifies. The final rule now defines an 
``authorized official of a vending machine operator'' as an owner, 
operator, agent in charge, or any other person authorized by a vending 
machine operator who is not otherwise subject to section 
403(q)(5)(H)(viii) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 343(q)(5)(H)(viii)), to register the vending machine operator 
with the Food and Drug Administration (`FDA') for purposes of paragraph 
(d) of the section.
    c. ``Vending Machine''. Proposed Sec.  101.8(a) would define 
``vending machine'' as a self-service device that, upon insertion of a 
coin, paper currency, token, card, or key, or by optional manual 
operation, dispenses

[[Page 71265]]

servings of food in bulk or in packages, or prepared by the machine, 
without the necessity of replenishing the device between each vending 
operation.
    (Comment 11) One comment argued that ``turret-style'' (also 
referred to as ``turnstile'') refrigerated vending machines do not meet 
the proposed definition of vending machine. According to the comment, 
once a food item in a turnstile vending machine is sold, the space that 
was occupied by the food becomes empty and needs to be restocked. The 
comment stated that a turnstile refrigerated vending machine, 
therefore, does not meet the part of the vending machine definition 
that reads: ``. . . without the necessity of replenishing the device 
between each vending operation.'' The comment also stated that the 
legislative intent of Congress may have been to exclude turnstile 
refrigerated vending machines, which are normally stocked with 
sandwiches, milk, burritos, or refrigerated foods because they are not 
the same as snack vending machines that primarily sell ``junk food.''
    (Response 11) We disagree with the comment's assertion that 
``turret-style'' or turnstile vending machines are outside the 
definition of ``vending machine.'' The definition uses the word 
``replenished'' in relation to the ``device'' rather than the precise 
space the food once occupied. Contrary to the comment's interpretation, 
the final rule's definition of ``vending machine'' considers whether 
the machine, as a whole, needs to be restocked after each vending 
operation and not whether individual space(s) for food are 
``replenished.''
    If we were to accept the comment's interpretation and focus on the 
need to restock a specific space for a food after a vending operation, 
then one could argue that every vending machine would be outside the 
definition because operators do not necessarily restock each space 
after every purchase. It is true that, in turnstile vending machines, 
an empty space is created when a consumer buys an item from a 
particular space. However, the turnstile vending machine has multiple 
spaces within a level or tray, and the next consumer can rotate the 
turret to make another selection. Thus, the vending machine operator 
does not have to replenish the machine after each vending operation.
    Furthermore, the type or nutritional quality of a food carried by 
the vending machine--whether it is a ``meal'' or a ``snack''--makes no 
difference under section 403(q)(5)(H)(viii) of the FD&C Act, nor did 
the proposed rule make such a distinction.
    For these reasons, turret-style or turnstile vending machines are 
``vending machines'' as defined by Sec.  101.8(a). We note that the 
proposed definition used both the words ``device'' and ``machine'' 
interchangeably; for consistency, we have revised the definition of 
``vending machine'' by replacing the term ``device'' with ``machine.''
    d. ``Vending Machine Operator''. Proposed Sec.  101.8(a) would 
define a ``vending machine operator'' as a person(s) or entity that 
controls or directs the function of the vending machine, including 
deciding which articles of food are sold from the machine or the 
placement of the articles of food within the vending machine, and is 
compensated for the control or direction of the function of the vending 
machine.
    We received no comments on the proposed definition and have 
finalized it without change.
3. Section 101.8(b)--Articles of Food Not Covered
    a. Ability to examine the nutrition facts label. Proposed Sec.  
101.8(b) would describe the circumstances under which articles of food 
dispensed from a vending machine are not ``covered vending machine 
food'' such that the requirements of section 403(q)(5)(H)(viii) of the 
FD&C Act do not apply. Proposed Sec.  101.8(b)(1) would provide that an 
article of food dispensed from a vending machine is not ``covered 
vending machine food'' if the prospective purchaser ``can view the 
entire Nutrition Facts Panel on the label of the vended food without an 
obstruction,'' and the Nutrition Facts are the information, and are in 
the format, required in Sec.  101.9(c) and (d), and in a size that 
``permits the prospective purchaser to be able to easily read the 
nutrition information contained in the Nutrition Facts Panel on the 
label of the article of food in the vending machine.'' Proposed Sec.  
101.8(b)(1) also would provide that we would not consider the smaller 
formats allowed for Nutrition Facts for certain food labeling under 
Sec.  101.9 to be a size that a prospective purchaser is able to easily 
read.
    (Comment 12) Most comments supported proposed Sec.  101.8(b)(1). 
One comment suggested that we give additional details as to how the 
food would need to be positioned in the vending machine in order to 
ensure the visibility of the Nutrition Facts Panel.
    One comment objected to the proposed requirement that a prospective 
purchaser be able to view the entire Nutrition Facts Panel without an 
obstruction and said that would be too restrictive. The comment 
conceded that the dispensing coils in a vending machine might partially 
obscure the Nutrition Facts Panel, but said that each coil is only one-
eighth of an inch wide, and virtually the entire Nutrition Facts Panel 
can be visible and readable in the vending machine making additional 
calorie disclosure unnecessary.
    Another comment stated that we should not stipulate that modified 
or smaller formats of the Nutrition Facts Panel would not satisfy the 
requirements of section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act. The 
comment said that it is possible that a product manufacturer or vending 
machine operator could design a clearly visible, readable, and 
conspicuous Nutrition Facts Panel in a modified or smaller format.
    (Response 12) We are revising the rule as suggested by one comment. 
Section 101.8(b) of the final rule provides, in relevant part, that an 
article of food sold from a vending machine is not covered if the 
prospective purchaser can view the calories, serving size, and servings 
per container listed in the Nutrition Facts label (rather than ``the 
entire'' Nutrition Facts label) without any obstruction.
    Under section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act, if the 
Nutrition Facts label on a vending machine food can be examined by a 
prospective purchaser before purchasing the article, a vending machine 
operator is not required to provide the calorie information required by 
section 403(q)(5)(H)(viii) of the FD&C Act for such food. (Although 
section 403(q)(5)(H)(viii) of the FD&C Act uses the term ``Nutrition 
Facts Panel'' and we used the same term in the proposed rule, for the 
purposes of this final rule, we use the term ``Nutrition Facts label'' 
instead of ``Nutrition Facts Panel'' to be consistent with how we 
generally refer to the nutrition information listed under the heading 
``Nutrition Facts'' on the food label.)
    In order for a consumer to examine the Nutrition Facts label to 
determine the amount of calories contained in the article of food, the 
consumer must be able to see the calories, serving size, and servings 
per container listed in the Nutrition Facts label. These pieces of 
information advance the overarching goal of the rule, which is to 
provide consumers with the necessary calorie information in a direct 
and accessible manner to enable consumers to make informed and 
healthful dietary choices. To conclude that the prospective purchaser 
must be able to see additional nutrition information on the Nutrition 
Facts label, beyond the number of calories contained in the article of 
food,

[[Page 71266]]

would mean that even if a prospective purchaser could see the relevant 
calorie information on the Nutrition Facts label, the vending machine 
operator would still be required to post a calorie declaration for the 
food under section 403(q)(5)(H)(viii) of the FD&C Act. Such a 
conclusion seems to provide a redundant or otherwise unnecessary 
outcome.
    Therefore, we have revised Sec.  101.8(b)(1) to indicate that the 
prospective purchaser must be able to view ``the calories, serving 
size, and servings per container listed in the Nutrition Facts label'' 
rather than ``the entire Nutrition Facts label'' itself. These three 
pieces of information must be visible ``without any obstruction.'' 
Regarding the comment suggesting that dispensing coils that are one-
eighth of an inch thick should not be considered an obstruction, we 
disagree. Because there are different types of vending machines, 
different types of food products dispensed from vending machines, as 
well as different ways in which the Nutrition Facts label may be 
presented on a food package, any thickness of a coil could potentially 
obstruct one of the three required pieces of information.
    Regarding the use of smaller formats of the Nutrition Facts label, 
as we noted in the preamble to the proposed rule (76 FR 19238 at 
19243), it is unlikely that a prospective purchaser would be able to 
easily read the nutrition information prior to purchase, as required by 
section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act. We note that certain 
small format Nutrition Facts labels can display calories in as small as 
6 point type size (see Sec.  101.9(j)(13)(i)), and that the information 
in such formats is compressed (e.g., linear or ``string'' format; see 
Sec.  101.9(j)(13)(ii)(A)(2)). Because such formats are more difficult 
to read on vending machine foods prior to purchase, we, therefore, 
decline to consider a modified or smaller format size of the Nutrition 
Facts to be a size that a prospective purchaser could easily read prior 
to purchase. The comment did not provide any data or information (e.g., 
label design) that would suggest that such a format would be readable.
    On our own initiative, we have further revised Sec.  101.8(b) to 
make certain non-substantive and editorial changes. We have replaced 
the term ``dispensed'' with ``sold'' in the first sentence in Sec.  
101.8(b) to better reflect the language of section 403(q)(5)(H)(viii) 
of the FD&C Act. We have moved the words ``the prospective purchaser'' 
in the first sentence of Sec.  101.8(b)(1) to precede the colon that 
introduces Sec.  101.8(b)(1) and (b)(2), inserted the words ``all the 
information in,'' in the first sentence of Sec.  101.8(b)(1), deleted 
the words ``the information'' in the second sentence of Sec.  
101.8(b)(1), and replaced ``Nutrition Facts Panel'' with ``Nutrition 
Facts label'' in Sec.  101.8(b)(1). We have also capitalized one 
instance of ``nutrition facts'' where it was not capitalized in the 
proposal and added the word ``or'' between Sec.  101.8(b)(1) and 
(b)(2).
    (Comment 13) Several comments asserted that any display (e.g., a 
sign or electronic display) of the Nutrition Facts Panel should exempt 
the vending machine operator from the calorie declaration requirements. 
The comments added that a display would not have to be on the package 
of the vending machine food itself, but could be a reproduction of the 
Nutrition Facts Panel. Another comment stated that some electronic 
displays allow the consumer to view the full Nutrition Facts Panel and 
rotate a virtual image of the product, and that FDA should consider 
such displays sufficient in satisfying section 
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act.
    (Response 13) We agree with the comments that certain reproductions 
of a Nutrition Facts label would be sufficient to satisfy section 
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act. Specifically, we conclude 
that a reproduction of a Nutrition Facts label that allows the 
prospective purchaser to view the calories, serving size, and servings 
per container would be sufficient to satisfy section 
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act if the reproduction is a 
reproduction of an actual Nutrition Facts label that complies with 
Sec.  101.9 for a vending machine food, is presented in a size that 
permits the prospective purchaser to be able to easily read the 
nutrition information, and the calories, serving size, and servings per 
container are displayed by the vending machine before the prospective 
purchaser makes his or her purchase. Such reproductions could include 
electronic reproductions of the Nutrition Facts label displayed by a 
vending machine. Therefore, we have revised final Sec.  101.8(b)(1) to 
allow for such reproductions of Nutrition Facts labels.
    b. Visible nutrition information at the point of purchase. Proposed 
Sec.  101.8(b)(2) would provide that an article of food dispensed from 
a vending machine is not covered vending machine food if the article 
provides ``visible nutrition information at the point of purchase,'' 
including the total number of calories for the article of food as 
dispensed.
    Proposed Sec.  101.8(b)(2) also would require that the visible 
nutrition information appear on the food label itself, and that it be 
``clear and conspicuous and easily read on the article of food while in 
the vending machine, in a type size reasonably related to the largest 
printed matter on the label and with sufficient color and contrasting 
background to other print on the label to permit the prospective 
purchaser to clearly distinguish the information.''
    (Comment 14) Because section 403(q)(5)(H)(viii)(I)(aa) of the FD&C 
Act and proposed Sec.  101.8(b)(2) did not define the term ``visible 
nutrition information,'' the preamble to the proposed rule provided two 
possible interpretations for the term ``visible nutrition information'' 
(76 FR 19238 at 19244). We noted that one approach would be to conclude 
that ``nutrition information'' means ``total calories in the article of 
food.'' We noted that an alternative approach would be that ``nutrition 
information'' means ``something more than total calories'' and ``could 
include, in addition to total calories in the food, information such as 
serving size information or information on the nutrients that are 
required to be disclosed in the Nutrition Facts . . . .'' (Id.). The 
preamble to the proposed rule invited comment on ``what other nutrition 
information, if any, should be required if this alternative 
interpretation were adopted'' (Id.).
    Many comments agreed that, in the context of the rule, the term 
``nutrition information'' should mean total calories in the article of 
food. One comment pointed out that ``total calories'' is the 
information that section 403(q)(5)(H)(viii) of the FD&C Act otherwise 
requires covered vending machine operators to provide on a sign for 
foods sold in vending machines. Another comment would revise proposed 
Sec.  101.8(b)(2) to read ``The visible nutrition information at the 
point of purchase may include only the total number of calories in the 
article of food, as dispensed, at the point of purchase'' (emphasis 
added).
    Other comments supported the alternative approach, which interprets 
``nutrition information'' as something more than total calories. These 
comments suggested that, for a vending machine food to be exempt from 
the requirements of section 403(q)(5)(H)(viii) of the FD&C Act, 
``nutrition information'' should mean total calories as well as other 
information such as serving size information, the amount of other 
nutrients (e.g., sodium, fat), and the presence of allergens. Another 
comment

[[Page 71267]]

stated that ``Congress did not depart from its previous definition of 
`nutrition information' and as such it is logical to conclude that 
Congress intended the definition in [section] 343(q)(1) [of the FD&C 
Act] to apply to [section] 343(q)(5)(H)(viii)(I)(aa) [of the FD&C 
Act]--i.e., the entire Nutrition Facts Panel or its equivalent be 
visible.''
    (Response 14) As described previously, we noted in the proposed 
rule that there are two possible ways to interpret ``nutrition 
information'' within the meaning of section 403(q)(5)(H)(viii) of the 
FD&C Act. We noted that ``nutrition information'' could mean ``total 
calories in the article of food'' or ``something more than total 
calories'' (76 FR 19238 at 19244). As to any comments suggesting that 
our proposed interpretation that ``nutrition information'' means 
``total calories'' is not a permissible interpretation, we conclude, as 
described in more detail to follow, that this interpretation is 
permissible in light of the language of section 403(q)(5)(H)(viii) of 
the FD&C Act and other sections of the FD&C Act.
    The comments seem to be raising the question of what Congress 
intended ``nutrition information'' to mean within the context of 
section 403(q)(5)(H)(viii) of the FD&C Act. In construing section 
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act, FDA is confronted with two 
questions. First, has Congress directly spoken to the precise question 
presented (``Chevron step one'')? Chevron, U.S.A., Inc. v. NRDC, Inc., 
467 U.S. 837, 842 (1984). If the ``intent of Congress is clear,'' an 
Agency ``must give effect to the unambiguously expressed intent of 
Congress.'' (Id. at 843.) However, if ``Congress has not directly 
addressed the precise question at issue,'' and the statute is ``silent 
or ambiguous with respect to the specific issue,'' then our 
interpretation of the term ``nutrition information'' will be upheld as 
long as it is based on a ``permissible construction'' of the statute 
(``Chevron step two''). Chevron, 467 U.S. at 842-43; FDA v. Brown & 
Williamson Tobacco Corp, 529 U.S. 120, 132 (2000). To find no 
ambiguity, Congress must have clearly manifested its intention with 
respect to the particular issue. See e.g., Young v. Community Nutrition 
Institute, 476 U.S. 974, 980 (1986).
    We have determined that, in enacting section 
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act, Congress did not speak 
directly and precisely to the meaning of ``nutrition information.'' In 
conducting the Chevron step one analysis, all the traditional tools of 
statutory construction are available, e.g., the statute's text, 
structure, and legislative history. Pharmaceutical Research & 
Manufacturers of America v. Thompson, 251 F.3d 219, 224 (D.C. Cir. 
2001). Since the term is not defined in section 403(q)(5)(H)(viii) or 
elsewhere in the FD&C Act, we have examined the language and design of 
the FD&C Act as a whole to determine that the meaning of ``nutrition 
information'' in section 403(q)(5)(H)(viii) of the FD&C Act is 
ambiguous. See e.g., Davis v. Michigan Department of Treasury, 489 U.S. 
803, 809 (1989) (``It is a fundamental canon of statutory construction 
that the words of a statute must be read in their context and with a 
view to their place in the overall statutory scheme.''); Martini v. 
Federal National Mortgage Association, 178 F.3d 1336, 1345 (D.C. Cir. 
1999). While the term ``nutrition information'' is used in other 
provisions of the FD&C Act, the term is typically accompanied by 
specific nutrients identified within the particular provision. For 
example, section 403(q)(1) of the FD&C Act provides that a food is 
misbranded unless its label or labeling bears certain nutrition 
information. Specifically, sections 403(q)(1)(C) to (E) of the FD&C Act 
identify particular nutrients included within the meaning of 
``nutrition information'' under section 403(q)(1) of the FD&C Act (``A 
food shall be deemed misbranded . . . unless its label or labeling 
bears nutrition information that provides . . . the total number of 
calories . . . [t]otal fat, saturated fat, cholesterol, sodium, total 
carbohydrates, complex carbohydrates, sugars, dietary fiber, and total 
protein . . . any vitamin, mineral or other nutrient required to be 
placed on the label and labeling of food under this Act [under certain 
conditions].'').
    Similarly, section 403(q)(5)(H)(ii)(III) of the FD&C Act, which was 
added to the FD&C Act by section 4205 of the ACA, along with the 
vending machine food labeling requirements of section 
403(q)(5)(H)(viii) of the FD&C Act, explicitly requires restaurants and 
similar retail food establishments to provide ``the nutrition 
information required under clauses (C) and (D) of [section 403(q)(1) of 
the FD&C Act].'' Section 403(q)(5)(H)(viii) of the FD&C Act does not 
expressly identify nutrients other than the number of calories 
contained in a vending machine food. Further, as one comment noted, the 
number of calories contained in a vending machine food is the nutrition 
information that a vending machine operator must provide on a sign 
under section 403(q)(5)(H)(viii) of the FD&C Act if the provisions in 
section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act are not met. Having 
concluded that the meaning of ``nutrition information'' in section 
403(q)(5)(H)(viii) of the FD&C Act is ambiguous, FDA has considered how 
to define the term so as to achieve a ``permissible construction'' 
(Chevron step two). Chevron, 467 U.S. at 842-43. In conducting the 
Chevron step two analysis, the same tools of statutory construction are 
available as those for the step one analysis. Because total calories is 
the nutrition information that a covered vending machine operator would 
otherwise have to provide on a sign for a covered vending machine food, 
we believe that ``nutrition information'' in the context of section 
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act means, at a minimum, the 
number of calories contained in the vending machine food. To conclude 
that ``nutrition information'' means more than the total number of 
calories for an article of food would mean that even if a vending 
machine operator provided such calorie information on the label of the 
food, the operator would still be required to post a calorie 
declaration for the food under section 403(q)(5)(H)(viii) of the FD&C 
Act. Such a reading seems to provide a redundant or otherwise 
unnecessary outcome. For these reasons, we conclude that a vending 
machine that otherwise provides visible nutrition information at the 
point of purchase for an article of food must provide, at a minimum, 
the total calories in the vending machine food, in order for the 
requirements of section 403(q)(5)(H)(viii) of the FD&C Act to not apply 
to such food. As a result, we have revised Sec.  101.8(b)(2) by 
inserting ``at a minimum'' before ``the total number of calories'' to 
specify that the label for a vending machine food may provide other 
nutrition information, including serving size information, in addition 
to the total number of calories.
    In addition, we decline to amend Sec.  101.8(b)(2) to include the 
phrase ``may include only'' the total number of calories in the vending 
machine food because it is not necessary to limit the information to 
calories. We would not object to food manufacturers or vending machine 
operators voluntarily providing information in addition to total 
calories to consumers at the point of purchase, provided that such 
information is truthful and not misleading and otherwise complies with 
the FD&C Act and FDA regulations.
    On our own initiative, we have made non-substantive and editorial 
changes to Sec.  101.8(b)(2) to complement the changes we made to Sec.  
101.8(b)(1), as described in our response to comment 8. We have revised 
the first sentence in Sec.  101.8(b)(2) to state that the prospective 
purchaser can otherwise view visible nutrition information, including, 
at a minimum

[[Page 71268]]

the total number of calories for the article of food as sold at the 
point of purchase. We discuss additional considerations and changes to 
Sec.  101.8(b)(2) in our response to comments 15 and 16 in the 
paragraphs that follow.
    (Comment 15) Because section 403(q)(5)(H)(viii)(I)(aa) of the FD&C 
Act does not specify how a vending machine can provide ``visible 
nutrition information at the point of purchase'' for an article of food 
in accordance with section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act, 
the preamble to the proposed rule noted that the phrase ``at the point 
of purchase'' suggests that ``the information, like the Nutrition Facts 
Panel, should be on the article of food itself'' (76 FR 19238 at 
19244). We tentatively concluded that such information must be 
presented on the label of the food itself (76 FR 19238 at 19244). Under 
proposed Sec.  101.8(b)(2), for nutrition information on the label to 
be considered ``visible,'' it would need, in relevant part, to be clear 
and conspicuous and easily read on the article of food while in the 
vending machine. Further, under proposed Sec.  101.8(b)(2) a vending 
machine food would not be covered by the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act, as long as the food provides 
visible nutrition information ``at the point of purchase,'' and that 
the visible nutrition information ``appear[s] on the food label 
itself.''
    The preamble to the proposed rule also stated that the phrase ``at 
the point of purchase'' could be read to mean that the visible 
nutrition information could be provided in places other than on the 
package of the food in the vending machine, such as on the vending 
machine itself (Id.). We invited comment on this alternative 
interpretation and specifically requested comment on whether, under 
this alternative interpretation, signs (including posters) or booklets 
would be sufficient in providing ``otherwise visible nutrition 
information at the point of purchase'' (Id.). We also requested comment 
on ways to determine if the nutrition information is ``visible'' (Id.).
    Several comments asserted that any display (including a brochure, 
sign, or electronic display) of nutrition information at the point of 
purchase should exempt the vending machine operator from the calorie 
declaration requirements. The comments added that a display would not 
have to be on the package of the vending machine food itself, but could 
be nutrition information through other means, such as booklets.
    One comment recommended that we define ``point of purchase'' as 
``before and after the consumer inserts the required money, token, 
card, or key into the machine or manually operates it and before the 
consumer makes their final item selection.''
    (Response 15) We disagree with the comments asserting that any 
display of nutrition information beyond the package of the food itself 
``should exempt the vending machine operator from the calorie 
declarations requirements.'' As we noted in the proposed rule, in order 
for nutrition information to be ``visible'' at the point of purchase, 
the information must be clear and conspicuous and able to be easily 
read by a prospective purchaser (76 FR 19238 at 19244, 19254). 
Nutrition information in brochures or booklets would not be visible at 
the point of purchase in the same way that such information would be 
visible if presented on the label of a vending machine food, such as 
through FOP labeling. Nutrition information in a brochure or booklet 
would not be clear and conspicuous such that a prospective purchaser 
would be able to easily read the information when making a purchase 
selection as it would if the nutrition information were on the label of 
the food. In addition, brochures and booklets can be easily detached, 
lost, or otherwise absent, from a vending machine. For these reasons, 
we decline to include brochures and booklets within Sec.  101.8(b)(2).
    Regarding electronic displays of nutrition information, we note 
that proposed Sec.  101.8(c)(2)(ii)(E) would provide that electronic 
vending machines (i.e., machines with digital or electronic or liquid 
crystal display (LCD) displays) could be used to comply with the 
calorie declaration requirements in section 403(q)(5)(H)(viii) of the 
FD&C Act. As discussed further in section III.C.4.b.x of this preamble 
in connection with Sec.  101.8(c)(2)(ii)(E), we conclude that 
electronic vending machines can be used to comply with the calorie 
declaration requirements in section 403(q)(5)(H)(viii) of the FD&C Act 
and Sec.  101.8(c). Further, electronic signs otherwise placed in, on, 
or adjacent to the vending machine can be used to provide calorie 
declarations under Sec.  101.8(c), provided that such signs are located 
in close proximity to the article of food or the selection button, and 
otherwise comply with section 403(a)(1), (q)(5)(H)(viii), and (f) of 
the FD&C Act and the requirements of Sec.  101.8(c). Because electronic 
vending machines and signs can be used to provide calorie declarations 
in accordance with Sec.  101.8(c), it would be difficult and perhaps 
unnecessary for FDA to determine whether a vending machine operator is 
using such a method to provide ``visible nutrition information at the 
point of purchase'' in accordance with Sec.  101.8(b) or to provide 
calorie declarations in accordance with Sec.  101.8(c). For these 
reasons, we believe that it is unnecessary to include such electronic 
displays within Sec.  101.8(b)(2).
    Similarly, regarding non-electronic signs providing nutrition 
information, we note that Sec.  101.8(c)(2) allows for the use of signs 
in, on, or adjacent to a vending machine to provide calorie 
declarations for covered vending machine food. Therefore, to the extent 
a vending machine operator provides calorie information for a vending 
machine food on such a sign and otherwise meets the requirements of 
section 403(a)(1), (q)(5)(H)(viii), and (f) of the FD&C Act and Sec.  
101.8(c), the operator would be in compliance with this rule. Because 
such signs can be used to provide calorie declarations in accordance 
with Sec.  101.8(c), it would be difficult and perhaps unnecessary for 
FDA to determine whether a vending machine operator is using such a 
method to provide ``visible nutrition information at the point of 
purchase'' in accordance with Sec.  101.8(b) or to provide calorie 
declarations in accordance with Sec.  101.8(c). For these reasons, we 
believe that it is also unnecessary to include signs within Sec.  
101.8(b)(2).
    As explained in the previous paragraphs, brochures, booklets, 
electronic displays, and non-electronic signs would not satisfy Sec.  
101.8(b)(2). Therefore we conclude, as we did in the proposal, that 
``visible nutrition information at the point of purchase'' for an 
article of food sold from a vending machine must be presented on the 
label of the food itself.
    Regarding the comment that would interpret ``point of purchase'' as 
a moment in time, we agree that ``point of purchase'' can be 
interpreted both with regard to a place (where the prospective 
purchaser buys the vending machine food item) and a time (when the 
prospective purchaser makes the selection). Accordingly, to provide 
visible nutrition information at the point of purchase, such 
information must be on the label of a food sold in a vending machine 
before the prospective purchaser makes a purchase. In order for a 
prospective purchaser to be able to view nutrition information on the 
label of a vending machine food at the point of purchase, the 
prospective purchaser must be able to read the nutrition information 
before purchasing the food, which typically

[[Page 71269]]

means that the vending machine would have to have a clear front so that 
the prospective purchaser would be able to see the information.
    (Comment 16) The preamble to the proposed rule stated that FOP 
labeling could be a way to provide ``visible nutrition information'' so 
long as the criteria for color, font, and type size are met, and the 
total calories contained in the vending machine food are included (76 
FR 19238 at 19244). We tentatively concluded that the visible nutrition 
information must be in a type size reasonably related to the most 
prominent printed matter on the label and in a color that sufficiently 
contrasts with the background, such that a prospective purchaser is 
able to notice and read the information (Id.). The preamble to the 
proposed rule explained that we consider ``reasonably related'' to mean 
a type size that is ``at least 50 percent'' of the size of the largest 
print on the label (Id.). We also noted that if a nutrient content 
claim or health claim is included on the front of the package, the 
claim must comply with relevant FDA regulations authorizing such claims 
(Id.).
    Many comments supported the idea that FOP labeling could provide 
visible nutrition information, stating that FOP labeling is the most 
efficient way to satisfy section 403(q)(5)(H)(viii) of the FD&C Act. 
Other comments stated that vending machine operators are likely to 
prefer food products with FOP labeling because such labeling would 
exempt the operators from having to provide calorie declarations for 
such foods on signs under section 403(q)(5)(H)(viii)(I)(bb) of the FD&C 
Act. These comments added that vending machine operators may pressure 
food manufacturers to provide FOP labeling in exchange for product 
distribution in their vending machines.
    Several comments argued that interpreting ``reasonably related'' to 
mean a type size that is at least 50 percent of the size of the largest 
print on the label would require a type size that is too large. One 
comment would revise the rule to specify a ratio for the size of the 
FOP calorie disclosure relative to other printed material on the label. 
The comment stated that ``reasonably related'' would be hard for 
inspectors to enforce and, therefore, FDA should require the FOP 
calorie disclosure to be at least two-thirds the size of the largest 
font size of any other writing on the package, and a minimum size of 
\1/2\ square inch. Other comments said that the final rule should omit 
requirements for prominence or type size of the FOP calorie disclosure.
    (Response 16) We agree that FOP labeling can be an efficient way to 
provide visible nutrition information within the context of section 
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act, provided that the criteria 
for color and type size are met, and the total calories contained in 
the article of food are included. (We would not consider FOP labeling 
that provides only the calories per serving to count as ``visible 
nutrition information'' within the context of section 
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act). Some manufacturers have 
already been including calories on their FOP labels. With respect to 
the comments concerning possible interactions between food 
manufacturers and vending machine operators, such interactions will 
depend on, and are best left to, vending machine operators and their 
suppliers.
    In response to the comments regarding type size and prominence of 
the visible nutrition information on the label of the food, we have 
revised Sec.  101.8(b)(2)(i) to replace the words ``reasonably 
related'' with ``at least 50 percent of the size of the largest printed 
matter on the label.'' Specifying the minimum type size for calorie 
information on vending machine food labels will provide greater clarity 
for both compliance and enforcement. While we recognize that some 
comments asserted that 50 percent of the size of the largest print on 
the label would result in type sizes that are too large, other comments 
asserted that the resulting type size would be too small, and some 
comments asked FDA to omit any requirements for prominence or type 
size.
    Further, we clarify that section 403(q)(5)(H)(viii)(I)(aa) of the 
FD&C Act describes foods that are not subject to the vending machine 
labeling requirements specified in section 403(q)(5)(H)(viii) of the 
FD&C Act. Therefore, by specifying the type size of the visible 
nutrition information, we are not imposing any additional requirements 
on vending machine food. Instead, we are explaining when articles of 
food sold from vending machines satisfy the language of section 
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act such that such foods are not 
covered by the labeling requirements of section 403(q)(5)(H)(viii) of 
the FD&C Act. In addition, there are other options that vending machine 
operators may choose to satisfy section 403(q)(5)(H)(viii) of the FD&C 
Act, including using a vending machine that provides electronic 
reproductions of Nutrition Facts labels, as provided in Sec.  
101.8(b)(1), or posting signs with calorie declarations, as provided in 
Sec.  101.8(c).
    We disagree with comments asking that we omit requirements for 
prominence or type size of FOP calorie disclosures for the purposes of 
section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act. When a vending 
machine food is in a vending machine, a prospective purchaser cannot 
handle the product to make it easier for the purchaser to read the 
nutrition information. Therefore, ``visible nutrition information'' on 
the front of package must be large enough, and prominent enough, for 
prospective purchasers to see and use the information.
    Furthermore, Sec.  101.8(b)(2) requires the visible nutrition 
information to be ``clear and conspicuous and able to be easily read on 
the article of food while in the vending machine.'' Type size is one 
factor in determining whether the nutrition information on a food label 
is ``clear and conspicuous and easily read,'' and other considerations, 
such as color and contrasting background (which Sec.  101.8(b)(2) also 
addresses), can affect the prospective purchaser's ability to read the 
nutrition information. For example, a prospective purchaser might be 
able to read nutrition information in one vending machine, but not in 
another vending machine if the first vending machine's design enabled 
the prospective purchaser to get close to the food label. In contrast, 
if a vending machine's design results in the food label being several 
inches away from the prospective purchaser, the nutrition information 
might not be as easy to read. The important consideration is to ensure 
that prospective purchasers are able to read and use the nutrition 
information for a vending machine food before purchasing the food.
4. Section 101.8(c)--Requirements for Calorie Labeling for Certain Food 
Sold From Vending Machines
    Proposed Sec.  101.8(c) would establish requirements for calorie 
declarations for foods sold from vending machines, as required by 
section 403(q)(5)(H)(viii) of the FD&C Act. In brief, proposed Sec.  
101.8(c)(1) would define ``covered vending machine food,'' and proposed 
Sec.  101.8(c)(2) would establish requirements for calorie declarations 
on signs in, on, or adjacent to the vending machine.
    a. Covered vending machine food. Proposed Sec.  101.8(c)(1) would 
explain the ``applicability'' of the calorie labeling requirements to 
foods sold from vending machines by defining ``covered vending machine 
food'' as an article of food that is:
     Sold from a vending machine that:
    [cir] Does not permit the consumer to examine the Nutrition Facts 
Panel prior to purchase as provided in paragraph (b) of this section, 
or otherwise provide

[[Page 71270]]

visible nutrition information at the point of purchase as provided in 
paragraph (b);
    [cir] Is operated by a person engaged in the business of owning or 
operating 20 or more vending machines; and
    [cir] Is a vending machine with a selection button; or
     Sold from a vending machine that is operated by a vending 
machine operator that has voluntarily elected to be subject to the 
requirements of this section by registering with FDA under the 
provisions of paragraph (d) of this section.
    (Comment 17) The preamble to the proposed rule explained that the 
requirements of section 403(q)(5)(H)(viii) of the FD&C Act do not apply 
to vending machine operators who own or operate fewer than 20 vending 
machines that sell articles of food (76 FR 19238 at 19241). Thus, even 
if a vending machine operator has 50 vending machines, the operator is 
not subject to the requirements of section 403(q)(5)(H)(viii) of the 
FD&C Act if fewer than 20 of those vending machines sell articles of 
food.
    One comment asked us to clarify that a vending machine that 
dispenses a mix of food and non-food items would be considered a 
vending machine that sells articles of food when determining whether 
the vending machine operator is covered. The comment sought to ensure 
that all vending machines that dispense some articles of food would be 
covered, if applicable.
    (Response 17) In general, Sec.  101.8(a) defines a ``vending 
machine'' as a self-service device that dispenses ``servings of food in 
bulk or in packages, or prepared by the machine.'' This definition 
includes vending machines that sell both food and non-food items. 
However, section 403(q)(5)(H)(viii) of the FD&C Act and Sec.  101.8(c) 
only apply to certain vending machine foods and the operators of 
vending machines that sell such foods. A vending machine that sells an 
article of food will be counted towards the ``20 or more'' threshold 
for determining whether a vending machine operator is covered, even if 
the vending machine also sells non-food items, provided that such a 
vending machine does not dispense those food items as part of a game or 
other non-food related activity, as discussed further in the paragraphs 
that follow.
    We are aware that ``game machines'' sometimes dispense candy or 
other edible items as part of a game or other non-food related 
activity. However, we conclude that ``game machines'' are not covered 
by section 403(q)(5)(H)(viii) of the FD&C Act, and do not count towards 
the ``20 or more'' threshold for determining whether a vending machine 
operator is covered. As we discussed in the preamble to the proposed 
rule (76 FR 19238 at 19241) and explain further in our response to 
comment 18, the primary purpose of a ``game machine'' is to sell a 
chance to play a game or to provide entertainment, and not to sell 
articles of food.
    (Comment 18) In the preamble to the proposed rule, we tentatively 
concluded that vending machines that may dispense food as part of a 
game or other non-food related activity are not covered by section 
403(q)(5)(H)(viii) of the FD&C Act (76 FR 19238 at 19241). For example, 
as we discussed in the preamble to the proposed rule, if a vending 
machine contains small toys and individually wrapped candies that can 
be picked up by maneuvering a large claw arm, we tentatively concluded 
that the vending machine is selling the opportunity to play the game, 
and not selling articles of food (76 FR 19238 at 19241).
    One comment disagreed with our tentative conclusion in the proposed 
rule to not cover vending machines that may dispense food as part of a 
game or other non-food related activity (e.g., claw games with candy 
prizes amongst other prizes). The comment claimed that a consumer 
playing a claw game could still maneuver the claw toward a healthier 
option if the calorie declarations for food prizes were available.
    (Response 18) We decline to apply the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act to vending machines that may 
dispense food as part of a game or other non-food related activity. 
Section 403(q)(5)(H)(viii) of the FD&C Act applies to ``an article of 
food sold from a vending machine.'' FDA concludes that an article of 
food that may be dispensed from a vending machine as part of a game or 
other non-food related activity does not constitute ``an article of 
food sold from a vending machine'' within the context of section 
403(q)(5)(H)(viii) of the FD&C Act. Game machines sell the opportunity 
to play a game or experience entertainment, and not the article of food 
itself. While the comment disagreeing with our conclusion indicated 
that calorie information might motivate an individual to ``maneuver the 
game claw towards a healthier option,'' the comment provided no basis 
to support this assumption. For these reasons, we are not amending the 
final rule to cover game machines, as suggested by the comment.
    (Comment 19) The preamble to the proposed rule noted that section 
403(q)(5)(H)(viii) of the FD&C Act provides that, for covered vending 
machine food, the vending machine operator must provide a sign 
disclosing the number of calories contained in the food ``in close 
proximity to each article of food or the selection button'' (76 FR 
19238 at 19241). We tentatively concluded that the reference to 
``selection button'' can be read to mean that only vending machines 
with selection buttons are subject to the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act. We indicated that we were not aware 
of vending machines without selection buttons other than bulk vending 
machines that dispense, by use of a crank, single types of unpackaged 
articles of food in preselected amounts (e.g., a single piece of gum or 
a handful of candy or nuts). We tentatively concluded that vending 
machines without any type of selection button, including bulk vending 
machines, were not covered by section 403(q)(5)(H)(viii) of the FD&C 
Act, and we invited comment on this subject.
    Some comments agreed with our interpretation of the reference to 
``selection button'' in section 403(q)(5)(H)(viii) of the FD&C Act. The 
comments stated that, for bulk vending machines, a consumer only would 
be choosing whether to buy the bulk product and would not be selecting 
among food items; therefore, the button on such a vending machine would 
not constitute a ``selection button.'' The comments noted that bulk 
foods tend to be lower in calories because of the vended size (such as 
a small handful of nuts or candies) compared to other foods (such as 
candy bars or bags of chips) sold in typical vending machines. One 
comment asked that we exempt ``turret-style'' (turnstile) refrigerated 
food vending machines from the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act because such machines do not have 
selection buttons.
    Other comments disagreed with our interpretation of the reference 
to ``selection button'' in section 403(q)(5)(H)(viii) of the FD&C Act, 
and argued that the lack of a selection button does not justify an 
exemption from the requirements of section 403(q)(5)(H)(viii) of the 
FD&C Act. These comments also asserted that there would be no public 
health rationale for such an exemption. Some comments asserted that the 
mention of a selection button in section 403(q)(5)(H)(viii) of the FD&C 
Act was not intended to differentiate between ``regular'' vending 
machines (i.e., those that have selection buttons) and machines that 
use a device

[[Page 71271]]

other than a selection button. The comments said that the statute's 
mention of a selection button was meant to refer to where the nutrition 
information should be placed. These comments also said that bulk items 
(usually candy and gumballs) are appealing to children, so calorie 
information should be made available. They also urged FDA to maintain 
consistency by requiring calorie labeling for all types of vending 
machines. In addition, one comment pointed out that excluding vending 
machines without a selection button would give bulk vending machines an 
unfair advantage over ``traditional'' (i.e., non-bulk) vending machines 
because the operators of bulk vending machines would not have to incur 
any expenses to implement the calorie declaration requirements.
    Other comments noted that complying with the calorie labeling 
requirements of section 403(q)(5)(H)(viii) of the FD&C Act would not be 
burdensome for a bulk machine vending machine operator because such a 
machine generally only dispenses one product (e.g., nuts, gumballs), 
and consumers do not select between multiple items. Therefore, several 
comments asserted that a vending machine operator for a bulk vending 
machine would only have to affix one sticker or decal displaying the 
calorie declaration on the bulk machine.
    (Response 19) Section 403(q)(5)(H)(viii) of the FD&C Act provides 
that, for covered vending machine food, the vending machine operator 
must provide a sign disclosing the number of calories contained in the 
food ``in close proximity to each article of food or the selection 
button.'' Although in the proposed rule, we tentatively concluded that 
vending machines without selection buttons are not covered, upon 
further consideration and in light of the comments asserting that the 
presence or absence of a selection button should not determine whether 
a vending machine is subject to the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act, this final rule provides that 
covered vending machines also include those without selection buttons.
    In construing whether vending machines without selection buttons 
are within the scope of section 403(q)(5)(H)(viii) of the FD&C Act, we 
are confronted with two questions. First, has Congress directly spoken 
to the precise question presented (``Chevron step one'') Chevron, 
U.S.A., Inc. v. NRDC., 467 U.S. 837, 842 (1984). If Congress has spoken 
directly and plainly, the Agency must implement Congress's 
unambiguously expressed intent. Chevron, 467 U.S. at 842-843. If, 
however, Congress is silent or ambiguous as to the question, our 
interpretation will be upheld as long as it is based on a ``permissible 
construction'' of the statute. (``Chevron step two''). Chevron, 467 
U.S. 843-844; FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 
132 (2000).
    We have determined that, in enacting section 403(q)(5)(H)(viii), 
Congress did not speak directly and plainly to the question of whether 
vending machines without selection buttons are covered. In conducting 
the Chevron step one analysis, all the traditional tools of statutory 
construction are available, e.g., the statute's text, structure, and 
legislative history. Pharmaceutical Research & Manufacturers of America 
v. Thompson, 251 F. 3d 219, 224 (D.C. Cir. 2001). The term ``vending 
machine'' as used in section 403(q)(5)(H)(viii) is not specific as to 
whether it must have a selection button. The scant legislative history 
does not shed any light on whether Congress intended to limit covered 
vending machines only to those with selection buttons by virtue of the 
statutory provision regarding the placement of the calorie declaration 
sign in close proximity to the selection button.
    Having determined that Congress's intent regarding whether vending 
machines without selection buttons are required to have calorie 
declaration signs is ambiguous, we have determined that the final 
rule's interpretation of covered vending machine as any machine 
regardless of whether it has a selection button is a permissible 
construction of the statute. (Chevron step two). In conducting the 
Chevron step two analysis, the same tools of statutory construction are 
available as those for the step one analysis.
    The interpretation in the final rule is consistent with the plain 
meaning of the statute, which is the starting point of statutory 
construction. (See 2A Sutherland Statutory Construction 137 (7th ed. 
2007). Section 403(q)(5)(H)(viii) uses the term ``vending machine'' in 
three instances. It refers to ``an article of food sold from a vending 
machine.'' It refers to ``a person who is engaged in the business of 
owning or operating 20 or more vending machines.'' Finally, the statute 
refers to ``the vending machine operator.'' In the two instances in 
which the statute refers to ``vending machines,'' it does so without 
qualification or limitation on the type of machine.
    Our interpretation is also consistent with the structure of the 
statute which identifies only two limitations that apply to the vending 
machines. Those limitations are set out in section 
403(q)(5)(H)(viii)(I)(aa) and (bb) of the FD&C Act. The provisions 
state that an article of food requires a calorie declaration if it is 
``from a vending machine that (aa) does not permit a prospective 
purchaser to examine the Nutrition Facts Panel before purchasing the 
article or does not otherwise provide visible nutrition information at 
the point of purchase; and (bb) is operated by a person who is engaged 
in the business of owning or operating 20 or more vending machines.'' 
That is, the vending machines not subject to the calorie labeling 
requirements of section 403(q)(5)(H)(viii) of the FD&C Act are those 
that allow the prospective purchaser to examine the Nutrition Facts 
label or does not otherwise provide visible nutrition at the point of 
purchase or those that are operated by a person in the business of 
owning or operating less than 20 vending machines. Although these 
provisions address covered vending machines, they do not address a type 
of vending machine.
    Accordingly, we are interpreting section 403(q)(5)(H)(viii) of the 
FD&C Act to include vending machines with or without selection buttons.
    As for the comments asserting that vending machines without 
selection buttons should not be covered by the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act because articles of food sold from 
bulk vending machines tend to contain fewer calories than foods sold in 
non-bulk vending machines, we clarify that section 403(q)(5)(H)(viii) 
of the FD&C Act does not exclude articles of food that contain low 
levels of calories from the calorie labeling requirements. Consistent 
with section 403(q)(5)(H)(viii) of the FD&C Act's general purpose to 
provide calorie information for foods sold from certain vending 
machines, we interpret section 403(q)(5)(H)(viii) of the FD&C Act to 
apply to vending machines that sell articles of food regardless of the 
food's caloric content and regardless of whether the vending machine 
has a selection button.
    Further, we agree with the comments asserting that excluding 
vending machines without selection buttons from the requirements of 
Sec.  101.8(c) is not supported by a public health rationale. Providing 
such calorie declarations will make calorie information available to 
consumers in a direct and accessible manner to enable consumers to make 
informed and healthful dietary choices. In addition, we agree with the 
comments stating that

[[Page 71272]]

providing calorie information would not be overly burdensome for bulk 
vending machine operators because such operators can use single 
stickers or decals to provide the required calorie declarations.
    For these reasons, we have revised Sec.  101.8(c)(1) by removing 
the criterion that a food must be sold from a vending machine with a 
selection button to be covered by the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act. Additionally, because the final 
rule covers vending machines regardless of whether they have selection 
buttons, we decline to exempt turret-style or turnstile vending 
machines.
    We also have revised Sec.  101.8(c)(1)(i) and (ii), on our own 
initiative, to clarify the applicability of the rule. Proposed Sec.  
101.8(c)(1)(i) would address vending machines operated by persons who 
must comply with section 403(q)(5)(H)(viii) of the FD&C Act, and 
proposed Sec.  101.8(c)(1)(ii) would address vending machines operated 
by persons who voluntarily register with FDA to become subject to 
section 403(q)(5)(H)(viii) of the FD&C Act. However, the conditions 
under which an article of food would not be covered by the rule (if the 
article of food permits the prospective purchaser to examine the 
Nutrition Facts label before purchase as provided in proposed Sec.  
101.8(b)(1), or otherwise provides visible nutrition information at the 
point of purchase as provided in proposed Sec.  101.8(b)(2)), were 
contained in proposed Sec.  101.8(c)(1)(i)(A) and therefore would not 
have appeared to be applied to persons who voluntarily registered with 
FDA. As a result, we have reorganized and revised Sec.  101.8(c)(1)(i) 
to describe the provisions in Sec.  101.8(b) under which an article of 
food is not covered by the rule. We also have reorganized and revised 
Sec.  101.8(c)(1)(ii) to refer to the two types of vending machine 
operators that may be subject to the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act (those required to comply by law and 
those who may register voluntarily to comply with the requirements). We 
have connected Sec.  101.8(c)(1)(i) and (ii) with the conjunction 
``and'' to specify that the provisions in Sec.  101.8(b) may apply to 
both types of covered vending machine operators.
    On our own initiative, we also have made an editorial change to 
replace ``the FDA'' with ``FDA.'' Also, we have replaced ``consumer'' 
with ``prospective purchaser'' to be consistent with the rest of the 
final rule, and have specified paragraphs ``(b)(1)'' and ``(b)(2)'' 
where these provisions are summarized (rather than referring to them 
both as ``paragraph (b)''), and we have changed ``Nutrition Facts 
Panel'' to ``Nutrition Facts label'' to match terms used in the rest of 
the final rule.
    b. Calorie declaration. Proposed Sec.  101.8(c)(2) would establish 
requirements for calorie declarations for covered vending machine food.
    i. Calorie increments.
    Proposed Sec.  101.8(c)(2)(i)(A) would require the calorie 
declaration to be ``clear and conspicuous'' and declared to the 
``nearest 5-calorie increment up to and including 50 calories and 10-
calorie increment above 50 calories, except that amounts less than 5 
calories may be expressed as zero.''
    In the preamble to the proposed rule, we tentatively decided 
against allowing ranges for declaring calories for vending machine food 
that comes in different varieties and flavors (e.g., coffee or hot 
chocolate) (76 FR 19238 at 19242). We noted in the preamble of the 
proposed rule that a ``vending machine operator could post a calorie 
declaration in close proximity to the selection button for a food that 
comes in different varieties and flavors that is sold in a vending 
machine that has selection buttons corresponding to the different 
options'' (Id.). Therefore, the vending machine operator could provide 
calorie declarations for each variety or option adjacent to selection 
buttons corresponding to each option (Id.). Further, we tentatively 
concluded that calorie ranges are also not necessary within the context 
of vending machines because a vending machine operator would be able to 
disclose calorie information under other options (e.g., use of signs) 
(Id.).
    (Comment 20) Some comments agreed with FDA's tentative conclusion 
in the proposed rule and stated that a range or an average would not be 
necessary. These comments stated that in situations where items are 
displayed such that multiple flavors or varieties exist in the same 
space, different selection buttons provide the opportunity for the 
operator to list separate calorie information for each item, and 
therefore ranges or averages for these vending machines would not be 
necessary.
    A few comments disagreed with FDA's tentative conclusion in the 
proposed rule and recommended that we allow the use of ranges. The 
comments stated that slight variations will occur such as in fresh 
coffee vending machines where different types of creamer or flavoring 
may be used.
    Some comments asked that we exempt self-service, custom order 
vending machines that allow the customer to select size, type of drink, 
type of milk, and additional flavors from the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act. The comments claimed it would not 
be feasible for operators of such vending machines to declare calories 
for all the possible customizations due to lack of space on the vending 
machine. According to one comment, disclosing calories for 
customizations can be inaccurate and misleading. For example, the 
comment asserted that adding syrup to a drink displaces a portion of 
the beverage that would have otherwise been included in the cup, and as 
a result some customizations do not add calories to the finished 
beverage. According to the comment, adding sugar-free syrup actually 
reduces the beverage's calories. Because FDA proposed to not apply the 
nutrition labeling requirements of section 403(q)(5)(H)(i)-(vii) of the 
FD&C Act (relating to standard menu items offered for sale in 
restaurants and similar retail food establishments) to custom orders, 
the comments argued that we should similarly exempt custom beverage 
vending machines from the vending machine labeling requirements of 
section 403(q)(5)(H)(viii) of the FD&C Act. The comments said that if 
we do not exempt such vending machines, we should give vending machine 
operators the flexibility to choose the method of calorie information 
disclosure for highly customizable self-serve products. For example, 
vending machine operators should be permitted to simply disclose 
calorie content for the condiments offered for customization, e.g., 
calories per ounce of milk or per shot of syrup.
    (Response 20) We conclude that calorie ranges are not necessary for 
vending machine foods that come in different varieties and flavors. 
Unlike section 403(q)(5)(H)(v) of the FD&C Act--which pertains to 
nutrition labeling for standard menu items offered for sale in 
restaurants and similar retail food establishments and allows FDA to 
establish standards for disclosing the nutrient content for certain 
standard menu items that come in different flavors, varieties, or 
combinations, through means determined by FDA, including ranges, 
averages, or other methods--section 403(q)(5)(H)(viii) of the FD&C Act 
specifies that, if covered, a vending machine operator must provide a 
sign disclosing the number of calories contained in an article of food 
sold from a vending machine.
    We also decline to permit calorie ranges because, as noted by the 
comments, vending machine operators can declare calories for each 
``option'' offered. For a vending machine that has selection buttons 
corresponding to different options, a vending machine

[[Page 71273]]

operator could post a calorie declaration in close proximity to the 
corresponding selection buttons. In addition, vending machines that 
dispense various flavors or varieties of beverages do so in measurable 
quantities; therefore, it is reasonable to require vending machine 
operators to provide calorie declarations for such options. To give 
vending machine operators flexibility, the final rule allows vending 
machine operators to declare calories per option or for the final 
vended products. For example, if a vending machine dispenses coffee 
products with options for adding skim milk, whole milk, cream, sugar, 
or sugar substitute, the vending machine operator could provide calorie 
declarations for each of those added options individually. If the 
vending machine operator chose to declare calories for the final vended 
products sold from the machine, the calorie declarations would be for 
all final vended coffee products sold from the machine, meaning all 
dispensed combinations of coffee, skim milk, whole milk, cream, sugar, 
and sugar substitute. Note that a vending machine operator could post 
calorie declarations next to each selection button, or on a sign in, 
on, or adjacent to the vending machine, as provided in Sec.  101.8(c).
    We decline to exempt the types of self-service, custom-order 
vending machines described by the comments from the calorie labeling 
requirements for vending machine food of section 403(q)(5)(H)(viii) of 
the FD&C Act. As a preliminary matter, we clarify that while section 
403(q)(5)(H)(vii)(I)(bb) of the FD&C Act, which pertains to restaurants 
and similar retail food establishments, provides that the nutrition 
labeling requirements of sections 403(q)(5)(H)(i) through (vi) of the 
FD&C Act for standard menu items do not apply to ``custom orders'', the 
vending machine food labeling requirements of section 
403(q)(5)(H)(viii) of the FD&C Act do not provide for such an 
exclusion. Furthermore, in the proposed rule for nutrition labeling of 
standard menu items in restaurants and similar retail food 
establishments (76 FR 19192, April 6, 2011), we proposed to define 
``custom order'' as a food order that is prepared in a specific manner 
based on an individual customer's request, which requires the 
restaurant or similar retail food establishment to deviate from its 
usual preparation of a menu item (76 FR 19192 at 19233). The ``custom 
orders'' for purposes of nutrition labeling of standard menu items in 
restaurants and similar retail food establishments are not equivalent 
to vending machine foods that come in different varieties or flavors 
because such vending machine foods are not prepared in a way that 
deviates from a usual preparation of the item. Instead, vending 
machines offering articles of food in different varieties or flavors 
generally are programmed to dispense measurable quantities of 
beverages, flavors, or other varieties at the customer's selection. As 
such, a vending machine operator can declare calories for each variety 
or flavor on a sign in close proximity to the selection buttons for 
such varieties and flavors or on a sign adjacent to the vending 
machine, as provided by Sec.  101.8(c).
    In consideration of the comments asking for flexibility for these 
products, and to provide clarity, we have added a new Sec.  
101.8(c)(2)(i)(D). (We have renumbered proposed Sec.  101.8(c)(2)(i)(D) 
as Sec.  101.8(c)(2)(i)(C) in the final rule, as will be discussed in 
response 23, and removed proposed Sec.  101.8(c)(2)(i)(E) as will be 
discussed in response 24). Section 101.8(c)(2)(i)(D), as finalized, 
provides that if a covered vending machine food is one where the 
prospective purchaser selects among options to produce a final vended 
product (e.g., vended coffee, hot chocolate or tea with options for 
added sugar, sugar substitute, milk, and cream), calories must be 
declared per option or for the final vended products.
    Regarding the comments asserting that it would not be feasible for 
vending machine operators to declare calories for each variety or 
flavor due to lack of space on the vending machine, we note that 
vending machine operators may place a sign declaring calories adjacent 
to the vending machine, as provided in Sec.  101.8(c). We further 
discuss the placement of signs disclosing the number of calories in 
covered vending machine food in our response to comment 28. We also 
note that vending machine operators have flexibility to declare either 
the calories from each option or the calories for final vended 
products.
    Consequently, we have finalized Sec.  101.8(c)(2)(i)(A) without 
change. However, on our own initiative, we have moved the requirement 
in the introductory sentence of proposed Sec.  101.8(c)(2)(i) that the 
number of calories ``must be clear and conspicuous,'' and placed it 
instead in the introductory sentence of Sec.  101.8(c)(2)(ii) of the 
final rule. The ``clear and conspicuous'' standard more appropriately 
reflects the requirements in Sec.  101.8(c)(2)(ii), which focus on the 
placement and appearance of the calorie declarations, rather than the 
requirements of Sec.  101.8(c)(2)(i), which focus on the content of the 
calorie declarations.
    ii. Use of the term ``Calories'' or ``Cal''.
    Proposed Sec.  101.8(c)(2)(i)(B) would require that the term 
``Calories'' or ``Cal'' appear adjacent to the caloric content value 
for each food in the vending machine.
    We received no comments on this provision and have finalized it 
without change.
    iii. Calorie declaration type size, color, and contrast.
    Proposed Sec.  101.8(c)(2)(i)(C) would specify the calorie 
declaration's type size, color, and contrast. For calorie declarations 
in or on the vending machine, the proposal would require the calorie 
declaration to be in a type size no smaller than the name of the food 
on the machine, not the label, selection number, or price of the food 
as displayed on the vending machine, whichever is smallest, with the 
same prominence, i.e., the same color, or in a color at least as 
conspicuous, as the color of the name, if applicable, or price of the 
food or selection number, and the same contrasting background, as the 
item it is in closest proximity to, i.e., name, selection number, or 
price of the food item as displayed on the machine (76 FR 19238 at 
19254).
    (Comment 21) Many comments agreed with the proposed requirements 
for type size, color, and contrast for calorie declarations in or on 
the vending machine. However, some comments argued that the calorie 
declaration should be more prominent. Several comments suggested that 
we revise the rule to state that ``calorie labeling be as large as the 
name of the vended item if it is posted on the machine, selection 
number, or the price, whichever is largest.'' One comment said that the 
font, size, and color of the calorie declaration should be no less 
prominent than the price, label (although the comment did not describe 
what it meant by ``label''), or item name. Another comment said that 
the calorie declaration must be large enough to read from a ``normal 
standing posture.''
    Other comments said the proposed rule was too restrictive and 
wanted greater flexibility for the type size of the calorie 
declaration--whether on the vending machine or on the food itself. 
Several comments claimed that the proposed rule would force vending 
machine operators to make significant changes to the size of product 
brand names on smaller vending buttons or use ``distractingly large'' 
calorie declarations on certain larger vending buttons. (We interpret 
the comment's

[[Page 71274]]

reference to ``vending button'' to be the same as a selection button.)
    Regarding the proposed requirement for contrasting background, one 
comment stated that the calorie declaration should have a contrasting 
background and be in a font color that is at least as visible as, 
rather than the same as, the background and the color of the selection 
number or price.
    (Response 21) The preamble to the proposed rule explained that for 
calorie declarations in or on the vending machine, the calorie 
declaration must be in a type size ``no smaller than the name, 
selection number, or price of the food as displayed on the vending 
machine, whichever is smallest'' (76 FR 19238 at 19243). Proposed Sec.  
101.8(c)(2)(i)(C) would state, in relevant part, that the declaration 
of calories must be in a type size no smaller than the name of the food 
on the machine, not the label, selection number, or price of the food 
as displayed on the vending machine, whichever is smallest. To further 
clarify that the type size of the calorie declarations must be in a 
type size no smaller than the name of the food on the machine, the 
selection number, or the price of the food as displayed on the vending 
machine, whichever is smallest, we have revised the provision that was 
proposed Sec.  101.8(c)(2)(i)(C) (which is moved and consolidated as 
Sec.  101.8(c)(2)(ii)(B) in this final rule, as explained later in this 
response) to place the phrase ``not the label'' in parentheses. We are 
connecting the calorie declaration's type size to the type size of 
other information on the vending machine that a prospective purchaser 
uses to make a selection (i.e., the name of the food on the machine, 
the selection number, the price of the food as displayed), in order to 
ensure that the calorie declaration is clear and conspicuous and 
similarly readable.
    We decline to make the changes requested by the comments to the 
requirements for size and color of the calorie declarations in or on 
the vending machine because the comments did not provide any specific 
information regarding the size or color of the calorie declarations, 
particularly information that would give us a basis to revise the rule. 
For example, the comments asserting that calorie declarations should be 
larger or more prominent did not provide any information to show that 
the proposed requirements would not ensure that the calorie 
declarations are clear and conspicuous and easily readable.
    In addition, with respect to the comment asserting that the calorie 
declaration must be large enough to be seen from a ``normal standing 
posture,'' such a standard would not take into account that there are 
different types of vending machines and that consumers vary in height 
and visual acuity. For example, calorie declarations at the top of a 
vending machine that a tall consumer might see easily could be 
difficult for a comparatively shorter consumer to see.
    As for the comments seeking greater flexibility for vending machine 
operators, the requirements for the type size, color, and contrast of 
calorie declarations in or on the vending machine provide vending 
machine operators with flexibility by linking such requirements to the 
information that prospective purchasers otherwise use to make 
selections. Vending machine operators can therefore use the information 
(i.e., the name of the food, selection number, or price of the food as 
displayed) that is already on their vending machines as a guide to 
comply with the type size, color, and contrast requirements for the 
calorie labeling requirements of section 403(q)(5)(H)(viii) of the FD&C 
Act for calorie declarations in or on the vending machine. This 
flexibility should enable vending machine operators to develop signs 
declaring calories for calorie declarations in or on the vending 
machine regardless of the type of vending machine they have. In 
addition to providing flexibility, the requirements, as finalized, help 
ensure that calorie declarations are clear and conspicuous, as required 
by section 403(q)(5)(H)(viii) of the FD&C Act.
    In consideration of the comment asking that the contrasting 
background be ``at least as visible as'' (rather than ``the same as'') 
the background of the accompanying food item (i.e., its name, selection 
number, or price), we have revised the provision that was proposed 
Sec.  101.8(c)(2)(i)(C) (which is moved and consolidated as Sec.  
101.8(c)(2)(ii)(B) in this final rule, as explained later in this 
response) to require that the calorie declaration have the same 
contrasting background, or a background as least as contrasting as the 
background used for the item it is in the closest proximity to, i.e., 
name, selection number, or price of the food item as displayed on the 
machine. Revising the rule in this manner provides additional 
flexibility related to the prominence requirements, and parallels the 
rule's requirement that the color of the calorie declaration be the 
same or ``at least as conspicuous'' as that of the accompanying food 
item's name, price, or selection number on the vending machine.
    On our own initiative, we are also revising the rule to eliminate a 
duplicate requirement. Proposed Sec.  101.8(c)(2)(i)(C) would describe 
the type size, color and contrast for calorie declarations in or on the 
vending machine, and proposed Sec.  101.8(c)(2)(ii)(B) would describe 
the color and contrast requirement for calorie information in or on the 
vending machine. Organizationally, proposed Sec.  101.8(c)(2)(i) would 
focus on the content of the calorie declarations, and proposed Sec.  
101.8(c)(2)(ii) would focus on the placement and appearance of the 
calorie declarations. Therefore, for clarity, we are moving and 
consolidating proposed Sec.  101.8(c)(2)(i)(C) with proposed Sec.  
101.8(c)(2)(ii)(B) to eliminate the duplicate requirement, and 
renumbering subsequent paragraphs that were proposed Sec.  
101.8(c)(2)(i)(D) and (E) to be Sec.  101.8(c)(2)(i)(C) and (D) in the 
final rule.
    For these reasons, under Sec.  101.8(c)(2)(ii)(B) of the final 
rule, when the calorie declaration is in or on the vending machine, the 
calorie declaration must be in a type size no smaller than the name of 
the food on the machine (not the label), selection number, or price of 
the food as displayed on the vending machine, whichever is smallest, 
with the same prominence, i.e., the same color, or in a color at least 
as conspicuous, as the color of the name, if applicable, or price of 
the food or selection number, and the same contrasting background, or a 
background at least as contrasting as the background used for the item 
it is in closest proximity to, i.e., name, selection number, or price 
of the food item as displayed on the machine.
    iv. Calorie declarations for single-serving packaged food.
    Proposed Sec.  101.8(c)(2)(i)(D) would state that the number of 
calories for single-serving packaged food declared on the sign must be 
identical to the number of calories that are declared in the Nutrition 
Facts, if applicable. Because section 403(q)(5)(H)(viii) of the FD&C 
Act refers to ``an article of food sold from a vending machine,'' the 
preamble to the proposed rule also indicated that calorie information 
must include the total calories present in the covered vending machine 
food as it is vended (76 FR 19238 at 19242). For example, for bundled 
items such as sandwiches that are dispensed with a single serving unit 
of a condiment (e.g., mayonnaise), the calorie declaration must include 
the total calories in the sandwich plus any condiment packets bundled 
with it as a vended article (76 FR 19238 at 19242).
    (Comment 22) One comment stated that calorie ranges are necessary 
with certain foods, such as fresh fruit, cotton

[[Page 71275]]

candy, sandwiches, or pastries because such foods can have slight 
calorie variations. The comment stated that vending machine operators 
need flexibility to declare calories in ranges and that ranges will 
make it easier for vending machine operators to implement the calorie 
labeling requirements.
    (Response 22) We recognize that certain vending machine foods, such 
as fresh fruit, may have naturally occurring variations in calorie 
content depending on the size of the fruit and other factors. This is 
different from the situation of a food with various options that a 
consumer selects (as discussed in comment and response 20), and from 
the situation of a food that comes bundled with various components (as 
discussed in comment and response 23). We conclude that a range is not 
necessary for calorie declarations for vending machine foods that may 
have naturally occurring variations in calorie content depending on the 
size of the fruit or other factors. As discussed further in comment and 
response 34 in section III.D entitled ``Determination of Calorie 
Content,'' a vending machine operator may rely on a number of means to 
determine the calorie content of covered vending machine food. For 
example, a vending machine operator may obtain calorie information from 
nutrient databases, such as the ``USDA National Nutrient Database for 
Standard Reference'' (http://ndb.nal.usda.gov/) and use such 
information in declaring calories, provided that the calorie 
declarations are truthful and not misleading and otherwise in 
compliance with section 403(a)(1), (q)(5)(H)(viii), and (f) of the FD&C 
Act and Sec.  101.8.
    With respect to a potential variation in prepared food such as 
cotton candy, sandwiches, and pastries, we also conclude that a range 
is not necessary for calorie declarations for such foods. As discussed 
further in comment and response 34 in section III.D entitled 
``Determination of Calorie Content,'' vending machine operators may be 
able to use various means to determine the calorie content for vending 
machine foods. For example, if the food is manufactured, the vending 
machine operator may be able to obtain the necessary calorie 
information from the food package's Nutrition Facts label, the 
manufacturer, or nutrient databases. It is the vending machine 
operator's responsibility to ensure that calorie declarations for foods 
are accurate and otherwise in compliance with section 403(a)(1), 
(q)(5)(H)(viii), and (f) of the FD&C Act and Sec.  101.8.
    (Comment 23) For vending machine foods such as sandwiches that 
consist of more than one separately packaged component and are sold as 
one unit in turnstile vending machines, one comment asked us to allow 
the vending machine operator to either: (1) Declare the total calories 
of the food as vended or (2) declare calories for each individual 
component. The comment said this would, for example, allow mayonnaise 
already on the sandwich to be included in the calories for the total 
package and also allow mayonnaise in a separate packet to be excluded 
from the calorie count of a sandwich that does not already have 
mayonnaise on it.
    The comment further stated that allowing vending machine operators 
to declare calories for the components of a covered vending machine 
food separately would give the consumer more information. (The comment 
referred to its suggestion as ``itemized'' calorie declaration.) For 
example, according to the comment, a 428 calorie turkey sandwich with 
two packets of mayonnaise and two packets of mustard derives 250 
calories from the sandwich itself, 86 calories from each packet of 
mayonnaise, and 3 calories from each packet of mustard. The comment 
said that it would be simpler for the vending machine operator to 
declare the calories for the primary item and for each separately 
packaged item that is provided because the operator would not need 
multiple versions of posters, labels, etc. depending on the types and 
quantities of condiments provided. The comment argued that such an 
approach for articles of food with multiple components, like 
sandwiches, would be consistent with FDA's approach to covered vending 
machine foods that come in different varieties and flavors, such as hot 
beverages, which FDA concluded, in the preamble to the proposed rule, 
could be declared per option (e.g., cream for coffee). The comment 
asked that we revise the rule to give turnstile vending machines 
flexibility to declare calories separately for condiments sold with a 
food item.
    (Response 23) We disagree with the comment asking us to allow the 
vending machine operator to either: (1) Declare the total calories of a 
bundled vending machine food as vended, or (2) declare calories for 
each individual component of a bundled vending machine food as vended. 
The requirements of section 403(q)(5)(H)(viii) of the FD&C Act apply, 
in relevant part, ``in the case of an article of food sold from a 
vending machine.'' Regarding a vending machine food that consists of 
more than one separately packaged component and is sold as one unit 
(e.g., sandwich dispensed with a single serving packet of condiment), 
the calorie declaration for the food must include the total calories 
present in the food as it is vended, including the calories present in 
single serving units of condiments. We consider a packaged or plastic-
wrapped sandwich including, if sold along with the sandwich, any 
packet(s) of condiments to be the ``article of food'' for purposes of 
applying the requirements of section 403(q)(5)(H)(viii) of the FD&C 
Act. As such, the vending machine operator must provide a calorie 
declaration for the ``article of food'' as it is vended, which includes 
the calorie content of each component of the ``article of food.''
    We will not object, however, if the vending machine operator 
voluntarily declares the calories for a bundled vending machine food 
that consists of more than one separately packaged component on a per 
packaged component basis, so long as the vending machine operator also 
provides the total calorie declaration for ``the article of food'' as 
it is vended. We note that condiment packets that are not dispensed 
with the sandwich (e.g., those condiments that are stocked in a common 
area near a bank of vending machines) are not part of ``the article of 
food'' for purposes of applying the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act. In such an instance, the vending 
machine operator should not include the condiment packets in the total 
calories of the article of food.
    Further, contrary to the comment's assertion, requiring the calorie 
declaration for a bundled vending machine food to include the total 
calories present in the food as it is vended is not inconsistent with 
the calorie labeling requirements for articles of vending machine food 
that come in different varieties or flavors (e.g., coffee), which we 
discussed in our response to comment 20. When the consumer 
affirmatively can choose the varieties or options dispensed with the 
food by pressing a selection button corresponding to each variety or 
option, the vending machine operator may display the calorie 
declarations for each variety or option in close proximity to the 
corresponding selection buttons for such varieties or options; however, 
when the consumer receives a bundled food item (such as a sandwich with 
a mayonnaise packet accompanying the sandwich), the consumer has 
selected to receive the food item as dispensed, and therefore, it is 
appropriate to label the calories for the entire bundled food item.
    We also disagree with the comment stating that calorie ranges are 
necessary for certain foods, such as sandwiches. In

[[Page 71276]]

the case of bundled items, the consumer is unable to customize the item 
that is vended until after it is dispensed, and, therefore, a 
declaration of total calories is appropriate rather than a range. In 
the case of bundled items, as we have indicated, we would not object to 
additional calorie declarations for each component of a bundled item, 
as long as the vending machine operator also provides the total calorie 
declaration for the bundled item, as it is vended.
    As discussed in response 21, we have moved what had been proposed 
as Sec.  101.8(c)(2)(i)(C) and therefore we are renumbering proposed 
Sec.  101.8(c)(2)(i)(D) as Sec.  101.8(c)(2)(i)(C). Also, as discussed 
further in section III.C.4.b.v, we have made changes to renumbered 
Sec.  101.8(c)(2)(i)(C) to further clarify that a calorie declaration 
for a covered vending machine food must include the total number of 
calories for the food, whether the food is a single-serving or multiple 
serving food. Section 101.8(c)(2)(i)(C) of this final rule provides 
that the number of calories for a covered vending machine food must 
include the total calories present in the food. As discussed in section 
III.D, a vending machine operator may determine the total calories 
contained in a covered vending machine food through a variety of 
methods, including obtaining the calorie information from the food 
package's Nutrition Facts label, the manufacturer or supplier of the 
food, nutrient databases, cookbooks or laboratory analyses. Covered 
vending operators must ensure that the calorie declarations are 
truthful and not misleading, as required by section 403(a)(1) of the 
FD&C Act, and otherwise comply with section 403(q)(5)(H)(viii) and (f) 
of the FD&C Act and Sec.  101.8.
    v. Calorie declarations for packaged food having multiple servings.
    Proposed Sec.  101.8(c)(2)(i)(E) would require that the calorie 
declaration for a covered vending machine food that contains multiple 
servings include the total number of calories present in the vending 
machine food. Proposed Sec.  101.8(c)(2)(i)(E) would also allow vending 
machine operators to voluntarily disclose the calories per serving in 
addition to the total calories for the food.
    (Comment 24) Many comments stated that vending machine food, 
regardless of its serving size, is typically consumed in one occasion. 
The comments agreed with proposed Sec.  101.8(c)(2)(i)(E) and said that 
section 403(q)(5)(H)(viii) of the FD&C Act's reference to an ``article 
of food sold from a vending machine'' and disclosure of calories 
contained in the article indicates that a vending machine operator must 
declare the total calories contained in a vending machine food as it is 
packaged for sale, or otherwise sold from a vending machine, even if 
the food's Nutrition Facts label states that the food contains more 
than one serving. Similarly, because vending machine food is typically 
consumed in one occasion, a few comments noted that declaring calories 
per serving could be potentially confusing to consumers. The comments 
stated that it would be deceptive, for example, to label a bag of chips 
as 160 calories (per one-ounce serving) on the vending machine, only to 
have people discover that the whole bag of chips contained 1.5 servings 
and 240 calories.
    Other comments disagreed with proposed Sec.  101.8(c)(2)(i)(E). The 
comments would base calorie declarations on the serving size listed on 
the Nutrition Facts label and said that doing so would be consistent 
with current nutrition labeling requirements. The comments pointed out 
that some commonly vended foods contain more than one serving and that, 
for those foods, the calories as listed per serving in the Nutrition 
Facts label would not be identical to the calorie declaration 
disclosing the number of calories contained in the entire article of 
food.
    In contrast to the comments asserting that vending machine foods 
typically are consumed in their entirety in one occasion, regardless of 
listed servings on the package, a few comments stated that labeling 
total calories for foods such as gum would be misleading because 
typically, people do not chew the entire pack of gum in one occasion 
and that calories should be allowed to be displayed per serving.
    Several comments supporting calorie declarations per serving noted 
that Congress used the term ``item'' for the nutrition labeling 
requirements for standard menu items offered for sale in restaurants 
and similar retail food establishments of section 4205 of the ACA, but 
used the term ``article'' for the vending machine food labeling 
requirements. One comment stated that because Congress used different 
words to express the two requirements, the words should have different 
meanings. The comment contended that ``article,'' which is used in the 
vending machine labeling requirements of section 4205 of the ACA, 
suggests that the number of calories per serving, and not the total 
number of calories contained in the food, must be declared. The comment 
also noted that the nutrition labeling requirements for packaged foods 
is per serving. According to the comment, if FDA thinks per serving 
calorie declarations are not sufficient, we should address the issue 
directly through our serving size regulations and not indirectly 
through the vending machine calorie declaration requirements.
    (Response 24) We decline to revise the rule to require the calorie 
declarations for covered vending machine food to be based on the 
serving size listed on the Nutrition Facts label. We agree with the 
comments asserting that many vending machine foods are typically 
consumed in one occasion. Further, we note that the requirements of 
section 403(q)(5)(H)(viii) of the FD&C Act apply to an ``article of 
food sold from a vending machine,'' and section 403(q)(5)(H)(viii) of 
the FD&C Act requires a vending machine operator to disclose the 
``number of calories contained in the article [of food].'' Thus, we 
conclude that section 403(q)(5)(H)(viii) of the FD&C Act requires that 
the calorie declaration for an article of food sold from a vending 
machine, including foods that contains multiple servings, be equal to 
the total ``number of calories contained in the article [of food]'' as 
dispensed, rather than the number of calories contained in the serving 
size, if applicable, for the food. The total number of calories can be 
determined by multiplying the number of calories per serving by the 
number of servings in the package. For example, if the Nutrition Facts 
for an article of food states 80 calories per serving and 3 servings 
per container, the total number of calories in the entire package would 
be 240 calories.
    Further, regarding the comments supporting calorie declarations per 
serving because Congress used the term ``item'' for the nutrition 
labeling requirements for standard menu items offered for sale in 
restaurants and similar retail food establishments of section 4205 of 
the ACA, but used the term ``article'' for the vending machine food 
labeling requirements, we disagree with the comments. First, the 
language of section 403(q)(5)(H)(viii) of the FD&C Act generally 
provides, in relevant part, that ``[i]n the case of an article of food 
sold from a vending machine . . . the vending machine operator shall 
provide a sign in close proximity to each article of food or the 
selection button that includes . . . the number of calories contained 
in the article [of food].'' (Emphasis added.) Therefore, the calorie 
declaration must include the number of calories contained in the 
article of food, and not the number of calories per serving of the 
food.
    Second, the fact that Congress used the term ``menu item'' in 
section 403(q)(5)(H)(i)-(vii) of the FD&C Act does not indicate that 
``article of food''

[[Page 71277]]

should be interpreted to mean ``per serving'' within the meaning of 
section 403(q)(5)(H)(viii) of the FD&C Act. If Congress intended to 
require calories to be declared in serving size amounts, Congress could 
have used specific language to indicate this intent, as demonstrated 
elsewhere in section 403(q) of the FD&C Act (``serving size,'' ``number 
of servings,'' and ``per serving'' in section 403(q)(1)(A) and 
(q)(5)(H)(iii) of the FD&C Act). Such an omission indicates that 
declaring calories in serving size amounts was not the intent of 
Congress. E.g., Russello v. U.S., 464 U.S. 16, 23 (1983) (``[W]here 
Congress includes particular language in one section of a statute but 
omits it in another section of the same Act, it is generally presumed 
that Congress acts intentionally and purposely in the disparate 
inclusion or exclusion'') (citation omitted).
    We reiterate, however, that proposed Sec.  101.8(c)(2)(i)(E) (which 
has been consolidated with proposed Sec.  101.8(c)(2)(i)(D) and 
renumbered as Sec.  101.8(c)(2)(i)(C) in the final rule, as explained 
further in the paragraphs that follow) would allow for the voluntary 
declaration of calories per serving for covered vending machine foods. 
Regarding the comment suggesting that we revise our serving size 
regulations, we clarify that this rule implements the requirements of 
section 403(q)(5)(H)(viii) of the FD&C Act for foods sold in vending 
machines. For the purposes of this rule, calorie declarations for 
covered vending machine foods must be provided for the total number of 
calories contained in the article of food.
    As discussed in response 21 of this preamble, we have moved 
proposed Sec.  101.8(c)(2)(i)(C) and therefore have renumbered proposed 
Sec.  101.8(c)(2)(i)(D) as Sec.  101.8(c)(2)(i)(C). Additionally, for 
the reasons noted in the previous paragraphs, and as discussed in 
section III.C.4.b.iv, we have made changes to renumbered Sec.  
101.8(c)(2)(i)(C) to further clarify that a calorie declaration for a 
covered vending machine food must include the total number of calories 
for the food, whether the food is a single serving or multiple serving 
food. In addition, we have added a sentence to Sec.  101.8(c)(2)(i)(C) 
explaining that for a covered vending machine food with multiple 
servings a vending machine operator may voluntarily disclose calories 
per serving in addition to the total calories for the covered vending 
machine food. This sentence was originally included in Sec.  
101.8(c)(2)(i)(E). Because we have moved the sentence to Sec.  
101.8(c)(2)(i)(C) and Sec.  101.8(c)(2)(i)(C) now applies to both 
single- and multiple-serving covered vending machine foods, we have 
removed proposed Sec.  101.8(c)(2)(i)(E).
    vi. Calorie declarations on signs in close proximity to the article 
of food or selection button.
    Proposed Sec.  101.8(c)(2)(ii) would establish requirements 
pertaining to the placement of calorie declarations. Proposed Sec.  
101.8(c)(2)(ii)(A) would require the calorie declarations to be placed 
on a sign in close proximity to the article of food or selection 
button, i.e., in, on, or adjacent to the vending machine, but not 
necessarily attached to the vending machine, so long as the sign is 
visible at the same time as the food, its name, price, or selection 
button or selection number is visible.
    The preamble to the proposed rule explained that ``a sign that is a 
poster may be an appropriate medium to convey the required calorie 
declarations, so long as the sign is in close proximity to the covered 
vending machine food or selection button'' (76 FR 19238 at 19243). We 
also tentatively concluded that for certain types of vending machines 
with a limited number of selections (e.g., popcorn with or without 
added butter), the sign with the statement of calories may appear 
anywhere on the front (or face) of the vending machine, and that ``a 
sign may consist of a handwritten sticker in permanent marking that is 
affixed to the machine'' (76 FR 19238 at 19243).
    (Comment 25) One comment asked that we permit a ``static cling'' 
type label (e.g., a plastic decal that sticks to a surface because of 
static electricity) to be placed on the outside of ``closed-front'' 
vending machines (i.e., vending machines that do not have transparent 
glass fronts).
    (Response 25) Section 403(q)(5)(H)(viii) of the FD&C Act does not 
specify how a sign declaring calories is to be affixed to a vending 
machine or what materials are to be used for the sign. To give vending 
machine operators the greatest flexibility, the final rule also does 
not specify the type of material to be used as a sign or the manner in 
which the sign must be affixed to a vending machine. However, 
regardless of the material used for the sign, compliance with the 
calorie labeling requirements is contingent on the sign being in close 
proximity to each article of food or selection button and otherwise 
satisfying the requirements of section 403(a)(1), (f), and 
(q)(5)(H)(viii) of the FD&C Act and Sec.  101.8.
    (Comment 26) Many comments supported proposed Sec.  
101.8(c)(2)(ii)(A), which would allow a vending machine operator to 
provide a sign in close proximity to each article of food or selection 
button that displays calorie declarations for multiple vending machine 
foods. These comments stated that allowing vending machine operators to 
provide a sign with calorie declarations in this manner would be the 
least expensive and least burdensome way for vending machine operators 
to comply with section 403(q)(5)(H)(viii) of the FD&C Act. Some 
comments stated that a sign or poster could cost as little as $5 per 
vending machine and would be the ``least burdensome'' on small 
businesses. Other comments stated that allowing a vending machine 
operator to provide calorie declarations on a sign adjacent to or on 
the vending machine would reduce stocking errors by blind vending 
machine operators.
    Conversely, some comments claimed that section 403(q)(5)(H)(viii) 
of the FD&C Act requires calorie declarations to be on individual 
``signs'' for each article of food and that posting calorie 
declarations for multiple foods on a single sign that is not adjacent 
to the corresponding article of food would not meet the statute's 
requirements. One comment argued that if FDA permits calorie 
declarations for multiple vending machine foods on a single sign, we 
should at least prohibit such single signs from being placed adjacent 
to the vending machine, and ensure the close proximity of the single 
sign to each article of food or the selection button by revising the 
rule to read as follows: ``This calorie information must be placed on a 
sign next to the article of food or its selection button, or on a sign 
appended to the front of the vending machine at a similar height as the 
machine's selection buttons.''
    (Response 26) Section 403(q)(5)(H)(viii) of the FD&C Act expressly 
states, in relevant part, that a vending machine operator must provide 
``a sign in close proximity to each article of food or the selection 
button that includes the number of calories contained in the article.'' 
Section 403(q)(5)(H)(viii) of the FD&C Act does not specify whether 
vending machine operators must use a single sign with calorie 
declarations for multiple articles of food, or multiple signs 
corresponding to each article of food or selection button. To give 
vending machine operators the greatest amount of flexibility and to 
take into consideration different types of vending machines, we 
interpret section 403(q)(5)(H)(viii) of the FD&C Act to allow vending 
machine operators to use one sign with calorie declarations for all of 
the covered vending machine food sold from the vending machine or a 
sign for each covered vending machine food sold

[[Page 71278]]

from the vending machine, or a combination of the two, as long as the 
sign or signs are in close proximity to the covered vending machine 
food or selection button, as provided in Sec.  101.8(c)(2), and 
otherwise satisfies the requirements of section 403(a)(1), (f), and 
(q)(5)(H)(viii) of the FD&C Act and Sec.  101.8.
    (Comment 27) Some comments asked us to clarify whether the rule 
would permit a vending machine operator to provide a sign adjacent to 
the vending machine that lists calorie declarations for all possible 
products that could be sold from the machine. The comments stated that 
such signs would be permanent in nature and would reduce the need to 
print new signs when different products are added to the vending 
machine.
    Other comments suggested that grouping vending machine food items 
on a sign by category will allow consumers to better compare products.
    (Response 27) We decline to revise Sec.  101.8(c)(2)(ii)(A) to 
allow a vending machine operator to provide a sign adjacent to the 
vending machine that lists all possible articles of food that could be 
sold from the machine. However, we would not object to a vending 
machine operator providing calorie declarations for articles of food 
that are typically offered for sale in the specific vending machine but 
may not be offered for sale at all times (for example, in cases where 
the article sells out, or is temporarily replaced by another item), 
provided that the calorie declarations are clear and conspicuous and 
placed prominently. The calorie labeling requirements of section 
403(q)(5)(H)(viii) of the FD&C Act apply ``[i]n the case of an article 
of food sold from a vending machine'' (emphasis added). Accordingly, 
whether a vending machine operator provides individual signs for each 
article of food or selection button, or a sign with calorie 
declarations for multiple articles of food, section 403(q)(5)(H)(viii) 
of the FD&C Act requires vending machine operators to provide clear and 
conspicuous calorie declarations for those articles of food that are 
sold from the machine. Vending machine operators must also ensure that 
such calorie declarations are not false or misleading as required by 
section 403(a)(1) of the FD&C Act and are prominently placed on signs 
with such conspicuousness and in such terms as to render the calorie 
declarations likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use as required 
by section 403(f) of the FD&C Act. A long listing of food items, some 
of which are not available for sale in a vending machine, might make it 
more difficult for a prospective purchaser to locate the relevant 
calorie declarations for articles of food actually sold from the 
vending machine. In other words, depending on the number of foods 
listed on the sign and other factors, inclusion of calorie declarations 
for covered vending machine foods that are not sold from the particular 
vending machine, could result in the calorie declarations for covered 
vending machine foods actually sold from the vending machine no longer 
being clear and conspicuous, non-misleading, prominently placed and 
likely to be read and understood by the ordinary individual under 
customary conditions of purchase and use.
    Therefore, we have revised Sec.  101.8(c)(2)(ii)(A) to state that 
the list of covered vending machine food items on a sign must give 
calorie declarations for those articles of food that are sold from that 
particular vending machine.
    At the same time, we recognize that calorie declarations could, in 
some cases, be displayed for vending machine foods that are not 
available for sale in the machine at a given time. For example, the 
food may have been offered for sale in the vending machine but the 
vending machine may have sold out of that item at some point in time. 
As another example, a food that is typically stocked in a vending 
machine might be temporarily replaced by another item. Nevertheless, 
vending machine operators must continue to ensure that calorie 
declarations on such a sign are tailored to articles of food currently 
or typically sold from that particular vending machine and otherwise 
satisfy the requirements of section 403(a)(1), (f), and (q)(5)(H)(viii) 
of the FD&C Act and Sec.  101.8.
    As for the comments suggesting that signs adjacent to the vending 
machines should group food items together, the final rule does not 
prescribe the manner in which articles of food and their associated 
calories are listed on a sign. Therefore, vending machine operators 
have the flexibility to organize the information on the signs as they 
wish, provided that the sign and the information on the sign comply 
with section 403(a)(1), (f), and (q)(5)(H)(viii) of the FD&C Act and 
Sec.  101.8.
    (Comment 28) Many comments opposed allowing vending machine 
operators to declare calories on a sign adjacent to the vending 
machine. Some comments contended that consumers are unlikely to see 
calorie declarations on a sign adjacent to a vending machine, 
particularly compared to calorie declarations posted directly next to 
each vending machine food, but did not provide any data to support this 
contention. One comment suggested that we require a statement on the 
vending machine directing the consumer to the location of the sign 
adjacent to the machine.
    (Response 28) We disagree with those comments stating that we 
should not allow signs adjacent to the vending machine. Section 
403(q)(5)(H)(viii) of the FD&C Act expressly states that ``a vending 
machine operator shall provide a sign in close proximity to each 
article of food or the selection button . . . .'' We have determined 
that a sign that is adjacent to the vending machine is ``in close 
proximity,'' to the covered vending machine food or selection button, 
so long as the calorie declaration on the sign is visible at the same 
time as the food, its name, or its selection button or selection number 
is visible.
    We also note that Sec.  101.8(c)(2)(ii) requires that the sign be 
``placed prominently.'' To help ensure that calorie declarations on a 
sign placed adjacent to the vending machine are clear and conspicuous, 
and placed prominently, Sec.  101.8(c)(2)(ii)(C) requires that the 
calorie declaration must be in type that is all black or one color 
printed on a white or other neutral background that contrasts with the 
type color. Further, Sec.  101.8(c)(2)(ii)(C) also helps to ensure that 
such calorie declarations are prominently placed on signs with such 
conspicuousness and in such terms as to render them likely to be read 
and understood by the prospective purchaser under customary conditions 
of purchase and use, consistent with section 403(f) of the FD&C Act. 
Considering our interpretation of ``close proximity'' and the 
requirement of Sec.  101.8(c)(2)(ii), we conclude that an additional 
statement directing the consumer to the sign is not necessary. 
Therefore, we decline to amend the rule to require a statement on the 
vending machine that directs the consumer to the location of a sign 
adjacent to the vending machine. However, to further address the 
comments' concern regarding the visibility of the calorie declarations 
on a sign adjacent to a vending machine, we have modified Sec.  
101.8(c)(2)(ii)(A) to specify that the calorie declaration must be 
visible at the same time as the food, its name, price, selection 
button, or selection number is visible (emphasis added). In addition, 
on our own initiative, we have replaced the reference to ``[t]his 
calorie information'' at the beginning of Sec.  101.8(c)(2)(ii)(A) with 
``the calorie declarations'' to be consistent with the rest of the 
final rule.

[[Page 71279]]

    As discussed in response 20, we have also moved the requirement in 
the introductory sentence of proposed Sec.  101.8(c)(2)(i) that the 
number of calories ``must be clear and conspicuous,'' and placed it 
instead in the introductory sentence of Sec.  101.8(c)(2)(ii) for this 
final rule. The ``clear and conspicuous'' standard more appropriately 
reflects the requirements in Sec.  101.8(c)(2)(ii), which focus on the 
placement and appearance of the calorie declarations, rather than the 
requirements of Sec.  101.8(c)(2)(i), which focus on the content of the 
calorie declarations.
    (Comment 29) One comment, opposed to allowing calorie declarations 
on signs adjacent to vending machines, compared such signs to 
stanchions at drive-through restaurants. The comment stated that, in 
the context of drive-through restaurants, FDA has already taken the 
position in its proposed rule for nutrition labeling of standard menu 
items in restaurants and similar retail food establishments (76 FR 
19192) that requiring consumers to look to one place (i.e., a menu 
board) for important food-selection information such as price and then 
to another (e.g., a stanchion) for calories, ``is likely to be more 
difficult for customers attempting to use the declared calorie 
information at the point of selection'' (76 FR 19192 at 19206). The 
comment contended that it would be similarly difficult for consumers to 
use calorie information if consumers had to look at the food in the 
vending machine and at an adjacent sign for calorie declarations.
    (Response 29) We disagree with the comment. Section 
403(q)(5)(H)(ii)(II)(aa) of the FD&C Act requires, in relevant part, 
that a covered restaurant or similar retail food establishment disclose 
the number of calories in a standard menu item ``adjacent to the name 
of the standard menu item . . . on the menu board, including a drive-
through menu board . . . .'' (emphasis added). Section 
403(q)(5)(H)(viii) of the FD&C Act, in contrast, requires a covered 
vending machine operator to ``provide a sign in close proximity to each 
article of food or the selection button . . . .'' Thus, the placement 
of calorie declarations for covered vending machine food under section 
403(q)(5)(H)(viii) of the FD&C Act is not directly analogous to the 
placement of calorie information for standard menu items under section 
403(q)(5)(H)(ii)(II)(aa) of the FD&C Act.
    Further, we do not consider vending machines to present a situation 
that is analogous to menu boards at drive-through restaurants or 
similar retail food establishments. A menu board at a drive-through is 
distinguishable because, as we discussed in the proposed rule for 
nutrition labeling of standard menu items in restaurants and similar 
retail food establishments (76 FR 19192 at 19206), customers have a 
restricted field of vision from their car windows while in a drive-
through, and they may have a relatively short time to consider and 
review the menu board before ordering (76 FR 19192 at 19206). Vending 
machine consumers generally are not faced with similar restrictions. 
Accordingly, we interpret ``a sign in close proximity to each article 
of food or the selection button'' within the context of section 
403(q)(5)(H)(viii) of the FD&C Act to mean adjacent to the vending 
machine in addition to in or on the vending machine.
    (Comment 30) Another comment noted that some localities prohibit 
the use of signs without permits and described certain jurisdictions 
that would levy a $25 fine for not obtaining a permit. According to the 
comment, such ordinances could be problematic for vending machine 
operators who would prefer to use signs adjacent to the vending machine 
to meet the calorie declaration requirements of section 
403(q)(5)(H)(viii) of the FD&C Act.
    (Response 30) This final rule gives vending machine operators the 
flexibility to comply with the calorie labeling requirements for 
vending machine foods in a way that minimizes burdens and that does not 
conflict with local requirements described by the comment. For example, 
where a State or local requirement regulates use of particular types of 
signs (e.g., large signs, free-standing signs), a vending machine 
operator could still comply with the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act by providing a sign in or on the 
vending machine (e.g., using small individual signs or stickers). 
Alternatively, a vending machine operator could stock foods in a 
vending machine that permits a prospective purchaser to view the 
calories, serving size, and servings per container listed in the 
Nutrition Facts label on the foods, or in a reproduction of the 
Nutrition Facts label; or that otherwise provides visible nutrition 
information at the point of purchase, as provided in Sec.  101.8(b).
    vii. Color and contrast for calorie declarations in or on the 
vending machine.
    Proposed Sec.  101.8(c)(2)(ii)(B) would specify that when the 
calorie information is in or on the vending machine, the calorie 
declaration must be in the same color or a color at least as 
conspicuous as the color of the name or the price of the food or 
selection number.
    We received no comments on this provision. However, on our own 
initiative, as discussed in response 21, we have moved what was 
proposed as Sec.  101.8(c)(2)(i)(C) to Sec.  101.8(c)(2)(ii)(B) of this 
final rule to eliminate a duplicate requirement on color and contrast 
for calorie declarations in or on the vending machine. Section 
101.8(c)(2)(ii)(B) now specifies that when the calorie declaration is 
in or on the vending machine, the calorie declaration must be in a type 
size no smaller than the name of the food on the machine (not the 
label), selection number, or price of the food as displayed on the 
vending machine, whichever is smallest, with the same prominence, i.e., 
the same color, or in a color at least as conspicuous, as the color of 
the name, if applicable, or price of the food or selection number, and 
the same contrasting background, or a background at least as 
contrasting as the background used for the item it is in closest 
proximity to, i.e., name, selection number, or price of the food item 
as displayed on the machine.
    viii. Type size, color, and contrast for calorie declarations 
adjacent to the vending machine.
    When the calorie declaration is on a sign adjacent to the vending 
machine, proposed Sec.  101.8(c)(2)(ii)(C) would require the calorie 
declaration to be in type that is ``all black or one color printed on a 
white or other neutral background that contrasts with the type color'' 
(76 FR 19238 at 19254). The preamble to the proposed rule explained 
that we were not proposing a minimum type size for the calorie 
declaration when it is on a sign adjacent to the vending machine (76 FR 
19238 at 19243), and we invited comment on this issue.
    (Comment 31) One comment asked that we establish additional 
requirements for size, type face, and color for the calorie 
declarations on the signs adjacent to the vending machine but the 
comment did not provide any specific suggestions.
    (Response 31) Unlike calorie declarations in or on the vending 
machine, calorie declarations on signs adjacent to a vending machine 
are not accompanied, or otherwise surrounded by, pre-existing text or 
colors to which we could link the requirements. We note however that 
section 403(q)(5)(H)(viii) of the FD&C Act requires that calorie 
declarations be clear and conspicuous, and the requirement that the 
calorie declarations be clear and conspicuous also is codified in Sec.  
101.8(c)(2)(i). Further, section 403(f) of the FD&C Act requires, in 
relevant part, that any word,

[[Page 71280]]

statement, or other information required by or under the FD&C Act to 
appear in the labeling of food be prominently placed thereon with such 
conspicuousness and in such terms as to render it likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use. Thus, we conclude that a calorie declaration on a 
sign adjacent to a vending machine must be in a type size large enough 
to render it likely to be read and understood by the prospective 
purchaser under customary conditions of purchase and use, and we have 
revised Sec.  101.8(c)(2)(ii)(C) accordingly. In addition, as discussed 
in response 28, we have modified Sec.  101.8(c)(2)(ii)(A) to specify 
that calorie declarations on signs adjacent to vending machines must be 
visible at the same time as the food, its name, price, selection 
button, or selection number is visible.
    On our own initiative, we have revised Sec.  101.8(c)(2)(ii)(C) to 
replace the reference to calorie ``information'' with calorie 
``declaration'' to be consistent with the rest of the final rule.
    ix. Vending machines displaying a picture or other representation 
of food.
    Proposed Sec.  101.8(c)(2)(ii)(D) would require that, where the 
vending machine only displays a vignette or name of the food item, the 
calorie information must be in close proximity to the vignette or name 
or in close proximity to the selection button (76 FR 19238 at 19254).
    We received no comments on this provision. However, on our own 
initiative, we have revised Sec.  101.8(c)(2)(ii)(D) by inserting the 
words ``picture or other representation'' in place of ``vignette'' for 
plain language purposes, and by replacing the reference to calorie 
``information'' with calorie ``declaration'' to be consistent with the 
rest of the final rule.
    x. Electronic vending machines.
    Proposed Sec.  101.8(c)(2)(ii)(E) would require that, for 
electronic vending machines (e.g., machines with digital or electronic 
or liquid crystal display (LCD) displays), the calorie information may 
be displayed when the selection numbers are entered but before the 
selection is confirmed.
    (Comment 32) Some comments supported proposed Sec.  
101.8(c)(2)(ii)(E) and stated that such electronic or LCD displays meet 
the requirements of section 403(q)(5)(H)(viii) of the FD&C Act. One 
comment stated that some electronic displays allow the consumer to view 
the full Nutrition Facts Panel and rotate a virtual image of the 
product, or otherwise allow consumers to compare the Nutrition Facts of 
two products side by side.
    Many comments opposed or would delete proposed Sec.  
101.8(c)(2)(ii)(E). Several comments noted that electronic displays 
would show calorie declarations for just one food item at a time. A few 
comments said that calorie declarations for all food items must be 
available to consumers at the same time before selection of an item so 
that consumers can compare calorie declarations for items 
simultaneously. Otherwise, the comments argued, consumers would have to 
keep track of the calorie declarations for each item until they made a 
final selection.
    One comment said that care should be taken in using the term 
``purchaser,'' which the comment considered to be the person paying for 
the item. The comment said that the purchaser could be at a different 
location from the ``user'' of the vending machine. For example, some 
vending machines allow a ``purchaser'' to pay for a vended item in one 
location while a ``user'' obtains the vended item in another location. 
This comment also suggested adding a new provision for clarity to read 
as follows: ``For vending machines retrofitted with digital or 
electronic or liquid crystal display (LCD) displays, the calorie 
information may be displayed at the user's request before the purchase 
is confirmed by entering a selection ID, selecting a product image, 
searching by name, or filtering product based on specific criteria.'' 
The comment did not explain why the new provision would focus on 
retrofitted vending machines.
    (Response 32) We disagree with the comments asserting that 
electronic vending machines cannot meet the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act because electronic vending machines 
might be able to display calorie information for only one food item at 
a time. First, we note that electronic vending machines that provide 
calorie declarations in close proximity to vending machine foods or 
their selection buttons would comply with the calorie declaration 
requirements in section 403(q)(5)(H)(viii) of the FD&C Act, provided 
that such calorie declarations otherwise comply with section 403(a)(1) 
and (f) of the FD&C Act and Sec.  101.8. Second, we understand that 
electronic vending machines have varying capabilities, and so to 
provide flexibility for vending machine operators to satisfy the 
requirements of section 403(q)(5)(H)(viii) of the FD&C Act, we are not 
requiring calorie declarations for electronic vending machines to be 
rendered simultaneously, although some electronic vending machines may 
have this capability. An electronic display that provides calorie 
declarations for one food at a time, allowing the prospective purchaser 
to cancel his or her initial selection, and then select other items in 
order to obtain the calorie declaration for each of them would 
constitute ``a sign in close proximity to each article of food or the 
selection button . . . disclosing the number of calories contained in 
the article,'' as required by section 403(q)(5)(H)(viii) of the FD&C 
Act. We therefore conclude that electronic vending machines may satisfy 
the calorie labeling requirements of section 403(q)(5)(H)(viii) of the 
FD&C Act.
    However, to further ensure that the prospective purchaser is able 
to view the calorie declaration before making a purchase, we have 
revised Sec.  101.8(c)(2)(ii)(E) on our own initiative to replace the 
proposed language with language stating that the calorie declaration 
must be displayed before the prospective purchaser makes his or her 
purchase.
    As discussed in response 13, we also note that an electronic 
reproduction of the Nutrition Facts label could be one way that a 
vending machine could permit a prospective purchaser to examine the 
Nutrition Facts Panel for an article of food to satisfy section 
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act. Therefore, we have revised 
Sec.  101.8(b)(2) by adding a new paragraph (b)(2)(ii) pertaining to 
electronic reproductions of the Nutrition Facts label.
    We decline to adopt the comment's suggestion that we revise the 
final rule to distinguish between a vending machine ``user'' and 
``purchaser.'' Section 403(q)(5)(H)(viii) of the FD&C Act uses the term 
``prospective purchaser'' and does not make a distinction between a 
``prospective purchaser'' and a vending machine ``user.'' Accordingly, 
we decline to make such a distinction in the final rule.
    We also decline to adopt the comment's suggested language regarding 
``retrofitted'' vending machines and the manner in which calorie 
information may be displayed. Section 403(q)(5)(H)(viii) of the FD&C 
Act does not address retrofitting of vending machines with digital, 
electronic, or other displays, and does not distinguish between 
retrofitted vending machines with such displays and other vending 
machines. We also note that the comment's suggested language, ``may be 
displayed at the user's request,'' would make the display of calorie 
information discretionary, and such a result would be inconsistent with 
the statutory requirement of section 403(q)(5)(H)(viii) of the FD&C Act 
that a covered vending machine operator provide a sign

[[Page 71281]]

disclosing the number of calories contained in a covered vending 
machine food.
    xi. Vending machines with limited choices.
    Proposed Sec.  101.8(c)(2)(ii)(F) would provide that for vending 
machines with limited choices, such as vending machines that dispense 
only popcorn, the declaration of calories may appear on the face of the 
machine so long as the declaration is prominent, not crowded by other 
labeling on the machine, and the type size is reasonably related to the 
largest print on the vending machine.
    We received no comments on this provision. However, as described in 
response 16 of this preamble, we revised Sec.  101.8(b)(2)(i), in 
response to comments regarding type size and prominence of the visible 
nutrition information on the label of the food, to replace the words 
``reasonably related'' with ``at least 50 percent of the size of the 
largest print on the label.'' For consistency with our edit to Sec.  
101.8(b)(2)(i) and to provide additional clarity, we are revising Sec.  
101.8(c)(2)(ii)(F). We considered whether to replace ``reasonably 
related to the largest print on the vending machine'' with ``at least 
50 percent of the size of the largest print on the vending machine.'' 
However, we note that unlike Sec.  101.8(b)(2)(i), where we are 
establishing a type size requirement based on other printed material on 
the label of a package of food, here we are establishing a type size 
requirement based on other printed material on the vending machine 
itself. Given the comparatively large surface area of vending machines, 
we are not requiring that the calorie declaration be 50 percent of the 
size of the largest print on the face of the vending machine, as the 
largest print could potentially be very large. Instead, Sec.  
101.8(c)(2)(ii)(F), as finalized, provides that for vending machines 
with limited choices, the declaration of calories may appear on the 
face of the machine so long as the declaration is prominent, not 
crowded by other labeling on the machine, and the type size is no 
smaller than the name of the food on the machine (not the label), 
selection number, or price of the food as displayed on the vending 
machine, whichever is smallest.
5. Voluntary Registration To Provide Calorie Labeling for Foods Sold 
From Vending Machines
    Proposed Sec.  101.8(d) would provide that a vending machine 
operator that is not subject to section 403(q)(5)(H)(viii) of the FD&C 
Act may voluntarily register with FDA to be subject to the calorie 
labeling requirements established in Sec.  101.8(c)(2). Proposed Sec.  
101.8(d)(1) and (d)(2) would describe the applicability of the 
voluntary registration provision and who may register. Proposed Sec.  
101.8(d)(3)(i) through (d)(3)(iv) would list the information that a 
vending machine operator would be required to provide to FDA (i.e., 
contact information for the vending machine operator, address of the 
location of each vending machine, preferred mailing address, 
certification of the information submitted) in order to register 
voluntarily. Proposed Sec.  101.8(d)(3)(v) and (d)(3)(vi) also would 
describe the mechanism for submission of the information by email, fax, 
mail, or online form. Finally, proposed Sec.  101.8(d)(3)(vii) would 
require re-registration every other year within 60 days prior to the 
expiration of the vending machine operator's current registration with 
FDA.
    We received comments asking us to expand the voluntary database to 
require registration of all operators of covered vending machines, and 
we will address those comments in section III.C.6 of this preamble. We 
received no other comments on proposed Sec.  101.8(d). However, on our 
own initiative, we have revised Sec.  101.8(d) to clarify that the 
vending machine operator, rather than its authorized official, becomes 
subject to the requirements of section 403(q)(5)(H)(viii) of the FD&C 
Act through voluntary registration, even if the authorized official 
voluntarily registered on the vending machine operator's behalf. Also, 
for completeness, we have added ``.gov'' to the end of the email 
address provided for voluntary registration under Sec.  101.8(d). The 
complete email address now reads ``menulawregistration@fda.hhs.gov.''
6. Vending Machine Operator Contact Information
    (Comment 33) Some comments said we should develop a database of 
covered vending machine operators and those who have elected to comply 
voluntarily with section 403(q)(5)(H)(viii) of the FD&C Act. The 
comments stated that the database could enable state and local 
inspectors to determine which vending machines are subject to the 
calorie declaration requirements of section 403(q)(5)(H)(viii) of the 
FD&C Act.
    Another comment suggested that, to help with enforcement, we could 
expand the voluntary registry in Sec.  101.8(d) to require all 
operators of covered vending machines to provide FDA with their names, 
contact information, and number and location of vending machines. The 
comment stated that we could share this information with States and 
localities that enforce local calorie labeling laws. As an alternative, 
the comment suggested that we require vending machine operators to post 
this information (name, contact information, etc.) on the front of each 
vending machine.
    (Response 33) The final rule, at Sec.  101.8(e)(1) and (e)(2), adds 
a requirement for vending machine operators to post their contact 
information for vending machines selling covered vending machine food. 
(We have renumbered proposed Sec.  101.8(e), which dealt with the topic 
of signatures, as Sec.  101.8(f) in the final rule). As indicated by a 
comment, such a requirement is necessary for efficient enforcement of 
section 403(q)(5)(H)(viii) of the FD&C Act because it enables FDA to 
contact vending machine operators for enforcement purposes. Without 
such a requirement, we would not be able to contact vending machine 
operators subject to the requirements of section 403(q)(5)(H)(viii) of 
the FD&C Act because such contact information would not always be 
readily available to the Agency. Section 101.8(e)(1) specifies that the 
contact information must list the vending machine operator's name, 
telephone number, and mailing address or email address.
    Section 101.8(e)(2) specifies that the contact information must be 
readable and may be placed on the face of the vending machine, or 
otherwise must be placed with the calorie declarations described in 
Sec.  101.8(c)(2)(ii) (i.e., on the sign in, on, or adjacent to the 
vending machine). We are providing flexibility to vending machine 
operators regarding where they can display the contact information. We 
note that some States have licensing requirements for vending machine 
operators, and some of these licensing requirements already require the 
vending machine operator's license or contact information to be 
displayed on the vending machine. If the contact information displayed 
on a vending machine due to State or local requirements includes some 
but not all of the contact information required under Sec.  
101.8(e)(1), the vending machine operator must display the remaining 
contact information required under Sec.  101.8(e)(1) in the manner 
specified under Sec.  101.8(e)(2). In other words, rather than 
requiring the vending machine operator to display contact information 
twice, we are providing flexibility by allowing vending machine 
operators to display the remaining contact information in a manner 
permitted in Sec.  101.8(e)(2). For example, if a vending machine 
operator is required to display its name and address

[[Page 71282]]

on the face of a vending machine under an applicable State or local 
requirement and the operator complied with such requirement, the 
operator could display the remaining contact information required under 
Sec.  101.8(e)(1) (i.e., its phone number) on the face of the vending 
machine or on the sign listing calorie declarations in, on, or adjacent 
to the vending machine in order to comply with Sec.  101.8(e). 
Regardless of the method that vending machine operators select to 
satisfy the requirements of Sec.  101.8(e), they should ensure that the 
information being provided is their contact information.
    As for the comments requesting that all vending machine operators 
(including those who are subject to section 403(q)(5)(H)(viii) of the 
FD&C Act and those who voluntarily register to be subject to section 
403(q)(5)(H)(viii) of the FD&C Act) register with FDA, we decline to 
establish such a database at this time. We believe it would be more 
practical to wait until we and vending machine operators have been able 
to implement the vending machine labeling requirements and see what 
issues arise as part of that implementation.
7. Signatures
    Proposed Sec.  101.8(e) would provide that signatures obtained 
under the voluntary registration provisions that meet the definition of 
electronic signatures in Sec.  11.3(b)(7) are exempt from the 
requirements of part 11.
    The preamble to the proposed rule indicated that we expect this 
exemption for signatures to facilitate the voluntary registration 
process (76 FR 19238 at 19245).
    We received no comments on this provision, however because we have 
added a new Sec.  101.8(e) (contact information of vending machine 
operators for vending machines selling covered vending machine food), 
we have renumbered this provision as Sec.  101.8(f).

D. Determination of Calorie Content

    Section 403(q)(5)(H)(viii) of the FD&C Act does not prescribe where 
or how covered vending machine operators must obtain the necessary 
calorie information to meet the calorie declaration requirements for 
covered vending machine foods. If a covered vending machine food does 
not bear Nutrition Facts, we anticipated in the preamble to the 
proposed rule, that the vending machine operator could obtain the 
calorie information from food manufacturers or suppliers (76 FR 19238 
at 19242). We invited comment on whether ``a vending machine operator 
may use nutrient databases, cookbooks, laboratory analyses, and other 
reasonable means'' if calorie information is not available from the 
food manufacturer or supplier (Id.). We also invited comment on 
``whether vending machine operators should be required to provide FDA 
the information on which they relied to determine the total calories 
posted for the vending machine food'' (76 FR 19238 at 19242).
    (Comment 34) One comment supported allowing covered vending machine 
operators to use nutrient databases and cookbooks as tools for 
determining calorie information if calorie information is not available 
from the food manufacturer or supplier. The comment also suggested 
allowing menus as a tool for determining calorie information. Further, 
the comment said that we should not require vending machine operators 
to give FDA the method or information on which the vending machine 
operators relied to determine the total calories posted for the vending 
machine food. The comment said that such a requirement would be an 
economic burden both for the vending machine operator to provide such 
information and for FDA to collect, record, and store such information. 
Another comment suggested that FDA require covered vending machine 
operators to have a reasonable basis for calorie declarations for 
vending machine foods, in accordance with the reasonable basis 
provision for nutrition labeling for standard menu items offered for 
sale in restaurants and similar retail food establishments in section 
403(q)(5)(H)(iv) of the FD&C Act.
    (Response 34) We agree with the comments supporting the use of 
nutrient databases and cookbooks to determine the total calories 
contained in a covered vending machine food. A vending machine operator 
may obtain the necessary calorie information from the food package's 
Nutrition Facts label, the manufacturer or supplier of the food, 
nutrient databases, cookbooks, or laboratory analyses. We anticipate 
that, for most packaged foods, the vending machine operator will use 
the food package's Nutrition Facts label to determine calorie 
information for the food.
    Menus likely would not be a reliable means of determining the 
calorie information for a vending machine food, because the 
ingredients, portion size, and method of preparing a food listed on a 
menu may differ from those used for a food sold from a vending machine. 
Such differences may result in a calorie declaration for a food listed 
on a menu that does not accurately reflect the calorie content of the 
same food sold from a vending machine. We recognize, however, that 
compliance ultimately is based on the accuracy of the declaration 
rather than just the method used to determine the calorie information.
    We anticipate that vending machine operators are likely to generate 
and maintain a record of the information on which they relied to 
determine the total calories posted for the vending machine food. We 
encourage vending machine operators to be prepared to share it with FDA 
upon our request during an inspection if we need to determine whether 
the calories declarations, posted by a vending machine operator under 
Sec.  101.8(c), are truthful and not misleading.
    We disagree with the comment suggesting that we apply the 
reasonable basis provision in section 403(q)(5)(H)(vi) of the FD&C Act 
to covered vending machine food. The reasonable basis requirement in 
section 403(q)(5)(H)(vi) of the FD&C Act applies only to restaurants 
and similar retail food establishments covered by the requirements of 
section 403(q)(5)(H) of the FD&C Act, and does not apply to covered 
vending machine food. We note that covered vending machine operators 
must ensure that calorie declarations are truthful and not misleading 
under section 403(a)(1) of the FD&C Act, and otherwise comply with 
section 403(q)(5)(H)(viii) and (f) of the FD&C Act and Sec.  101.8.

E. Effective Date

    The preamble to the proposed rule indicated that a final rule would 
become effective 1 year from the date of publication of the final rule 
in the Federal Register (76 FR 19238 at 19245).
    (Comment 35) Many comments suggested that FDA make the final rule 
effective 6 months after its publication. Noting that we proposed a 6-
month effective date in the proposed rule pertaining to nutrition 
labeling of standard menu items in restaurants and similar retail food 
establishments, the comments argued that labeling foods sold in vending 
machines with calorie information would be even less burdensome than 
restaurant menu labeling because a vending machine operator could 
simply post stickers listing calories to meet the requirements. The 
comments asserted that vending machine operators should be able to 
comply with the calorie labeling requirements within the same timeframe 
that we proposed in the proposed rule for nutrition labeling of 
standard menu items in restaurants and

[[Page 71283]]

similar retail food establishments (76 FR 19192).
    Other comments--many from vending machine trade associations--
requested a minimum of 2 years to come into compliance. The comments 
claimed that 1 year was not sufficient time to come into compliance 
because more than 70 percent of vending machine operators have three or 
fewer employees. Some comments said that because vending machine 
operators may have few employees, placing calorie declarations for all 
of their vending machines would be costly and time-consuming.
    A few comments asserted that a 2-year effective date is needed due 
to a lengthy design and test process for new vending machines, and to 
establish a relationship between vending machine operators and food 
manufacturers in order to develop ``verification procedures'' which 
typically do not exist at the present time. The comments did not 
explain what they meant by ``verification procedures.''
    Another comment suggested a phased-in implementation period to give 
vending machine operators a longer time to meet the calorie declaration 
requirements. The comment did not state how long the phased-in 
implementation period should be.
    A few comments said we should follow the same approach that we have 
taken historically for other food labeling changes and cited FDA's 
uniform compliance date policy for food labeling regulations. The 
comments stated that the uniform compliance date for food labeling 
regulations issued between January 1, 2011, and December 31, 2012, is 
January 1, 2014 (75 FR 78155 (December 15, 2010)), and we should, 
therefore, impose an effective date of January 1, 2014, assuming the 
final rule publishes before December 31, 2012.
    (Response 35) We recognize that vending machine operators may have 
few employees and resources. We also understand that vending machine 
manufacturers and food manufacturers are continuing to design new 
products, and that vending machine operators may wish to work with 
vending machine manufacturers and food manufacturers to develop ways to 
comply with section 403(q)(5)(H)(viii) of the FD&C Act. We are also 
taking into consideration FDA's 2012 final rule (77 FR 70885, November 
28, 2012), which establishes January 1, 2016, as the next uniform 
compliance date for food labeling changes required by food labeling 
regulations that are issued between January 1, 2013, and December 31, 
2014. Because vending machine operators may display the Nutrition Facts 
label or other visible nutrition information in order to satisfy Sec.  
101.8(b), it would be helpful for vending machine operators to see any 
changes that manufacturers may make to the labels of packaged foods 
which may be timed in accordance with the next uniform compliance date. 
For these reasons, we are revising the effective date of the final rule 
to 2 years from the date of its publication in the Federal Register, 
which will be after the January 1, 2016 uniform compliance date. All 
covered vending machine operators must come into compliance with the 
requirements of this rule no later than 2 years after the date of its 
publication.

F. Enforcement

    (Comment 36) Some comments said we should devise a reporting 
mechanism for individuals to report possible violations of section 
403(q)(5)(H)(viii) of the FD&C Act and a regime of penalties for 
confirmed violations. These comments also suggested that we develop a 
protocol for checking the accuracy of the calorie information provided 
by covered vending machine operators.
    (Response 36) We decline to establish a reporting mechanism for 
individuals to report possible violations of section 403(q)(5)(H)(viii) 
of the FD&C Act or the final rule. FDA's regulations already provide 
individuals with mechanisms to communicate with the Agency. If an 
individual finds that the calorie declaration for an article of food 
sold from a vending machine is incorrect, he or she can contact FDA by 
calling the FDA complaint coordinator for their region (http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm).
    As for the comments' suggestion regarding penalties, penalties are 
already set forth in the FD&C Act. We are establishing these 
regulations under sections 201(n), 403(a)(1), (f), (q)(5)(H), and 
701(a) of the FD&C Act. Therefore, we note that failure to comply with 
the regulations will render the covered vending machine food misbranded 
under section 403(a), (f), or (q) of the FD&C Act. Violations of Sec.  
101.8 may result in enforcement action. For example, introducing, 
delivering for introduction, or receiving a misbranded food in or into 
interstate commerce, or misbranding a food while it is in interstate 
commerce or being held for sale after shipment in interstate commerce, 
are prohibited acts under section 301 of the FD&C Act (21 U.S.C. 331), 
carrying criminal penalties under section 303 of the FD&C Act (21 
U.S.C. 333). In addition, under section 302 of the FD&C Act (21 U.S.C. 
332), the United States can bring a civil action in Federal court to 
enjoin a person who commits a prohibited act. Under section 304(a)(1) 
of the FD&C Act (21 U.S.C. 334(a)(1)), food that is misbranded when 
introduced into or while in interstate commerce or while held for sale 
after shipment in interstate commerce may be seized by order of a 
Federal court.
    With respect to the comments suggesting that we develop a protocol 
to check the accuracy of calorie information, we intend to develop an 
enforcement strategy as we gain more experience with the final rule. 
For example, we could first check to ensure that the calorie 
declaration provided by a covered vending machine operator matches the 
calorie information on the article of food from the food manufacturer 
or supplier, such as on the Nutrition Facts label. We could also use 
lab analyses to determine whether the calorie declaration for a given 
vending machine food is accurate.
    (Comment 37) Another comment asked us to provide training, 
guidance, and funding to State and local inspectors to facilitate 
enforcement.
    (Response 37) The final rule does not become effective until 
December 1, 2016. During that period we will assess resources and 
consider conducting training or further outreach as necessary.

IV. Analysis of Impacts--Final Regulatory Impact Analysis

    FDA has examined the impacts of this final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public 
Law 104-4). Executive Orders 12866 and 13563 direct Agencies to assess 
all costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). We have developed a detailed Regulatory Impact Analysis (RIA) 
that presents the benefits and costs of this final rule (Ref. 1) which 
is available at http://www.regulations.gov (enter Docket No. FDA-2011-
F-0171). The full economic impact analyses of FDA regulations are no 
longer (as of April 2012) published in the Federal Register but are 
submitted to the docket and are available at http://www.regulations.gov. We also post the full economic impact analyses of 
FDA regulations at the following Web site: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

[[Page 71284]]

We believe that the final rule is an economically significant 
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. According to our analysis, we believe that the final 
rule will have a significant economic impact on a substantial number of 
small entities, and we have accordingly analyzed regulatory options 
that would minimize the economic impact of the rule on small entities 
consistent with statutory objectives. We have crafted the final rule to 
provide flexibility for compliance.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $141 million, using the most current (2013) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    The analyses that we have performed to examine the impacts of this 
final rule under Executive Order 12866, Executive Order 13563, the 
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of 
1995 are included in the RIA (Ref. 1).
    We had prepared a ``Preliminary Regulatory Impact Analysis'' (Ref. 
2) in connection with the proposed rule. We also included sections 
titled ``Summary Preliminary Regulatory Impact Analysis'' and ``Initial 
Regulatory Flexibility Analysis'' in the preamble to the proposed rule 
(76 FR 19238 at 19245-19249). We received comments on our analysis of 
the impacts presented in those sections, and the RIA (Ref. 1) contains 
our responses to those comments.

V. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by OMB under the Paperwork Reduction Act of 1995 (the 
PRA) (44 U.S.C. 3501-3520). A description of these provisions is given 
in this section of the document with estimates of the annual reporting 
and third-party disclosure burden. Included in each burden estimate is 
the time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    We had included a section entitled ``Paperwork Reduction Act'' in 
the preamble to the proposed rule (76 FR 19238 at 19249-19251). We 
received the following comments on our analysis of the burdens 
presented in the proposed rule.
    (Comment 38) One comment stated that we did not calculate the 
burdens to the suppliers of vending machine food. The comment stated 
that these suppliers will bear the larger burden from the requirements 
of the final rule.
    (Response 38) Neither section 403(q)(5)(H)(viii) of the FD&C Act 
nor the final rule applies to suppliers of vending machine food; 
instead, section 403(q)(5)(H)(viii) of the FD&C Act and the final rule 
establish requirements for certain vending machine operators. We 
recognize that a supplier of covered vending machine food may provide 
calorie information on front-of-package labeling and such calorie 
information may constitute visible nutrition information in accordance 
with section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act provided that 
the applicable requirements of Sec.  101.8(b) are satisfied. However, 
neither section 403(q)(5)(H)(viii) of the FD&C Act nor the final rule 
requires suppliers to provide such information. As such, the final rule 
does not impose burdens on suppliers of vending machine food.
    (Comment 39) One comment stated that posting calories would not be 
burdensome, as most foods sold in vending machines already provide 
calorie information on their Nutrition Facts labels, and for foods that 
do not already have calorie information, labeling to disclose calories 
can be accomplished easily by using stickers. Another comment stated 
that, in light of the major beverage companies' prior commitment to 
putting calorie information on selection buttons, we should reduce our 
burden estimate.
    (Response 39) To the extent that foods sold from covered vending 
machines permit a prospective purchaser to examine the Nutrition Facts 
label before purchasing the food or otherwise provide visible nutrition 
information at the point of purchase in accordance with section 
403(q)(5)(H)(viii) of the FD&C Act and Sec.  101.8(b), the vending 
machine operator would not be required to provide calorie declarations 
for such foods. In addition, we recognize that the ``Clear on 
Calories'' commitment by the American Beverage Association, which 
includes a pledge that calories will be displayed on selection buttons 
of ``company-controlled vending machines,'' may be consistent with the 
calorie declaration requirements of section 403(q)(5)(H)(viii) of the 
FD&C Act. Our estimates of the burdens already account for the fact 
that many vending machine foods will not require additional nutrition 
analysis under this final rule. For example, we estimate in the RIA 
that only 723 to 963 covered vending machine operators will need to 
acquire nutrition information for at least some of their vending 
machine food (Ref. 1).
    Our estimate of the burdens and cost of nutrition analysis also 
takes into consideration that vending machine operators can comply with 
the requirements of the final rule by providing calorie declarations 
through less burdensome and less expensive means (e.g., a poster 
affixed to the front of the machine could cost, on average, $20 per 
machine per year) (Ref. 1). The final rule does not prescribe the types 
of materials through which calories must be declared, and a sticker, 
for example, could be an appropriate medium to convey a required 
calorie declaration.
    (Comment 40) One comment stated that our estimate on how frequently 
labeling would need to change is too low. The comment stated that in 
almost all cases, machines are restocked and serviced every 5 weeks, 
with busier locations stocked once or more per week. The comment stated 
that the restocking will require labeling changes because restocking 
may result in the substitution of certain products for other products 
or the addition of new products. The comment stated that relabeling 
would need to occur between 10 and 17 times per year for each machine, 
with some machines requiring partial relabeling at least 50 times per 
year.
    (Response 40) In the preliminary RIA, we estimated an average 
recurring burden of between 5 and 15 minutes per vending machine per 
year to install or refresh the calorie displays. We said that signs 
would not always need to be updated every time a machine's product mix 
(i.e., the assortment of vending machine foods offered for sale in a 
vending machine at a particular time) changed.
    We recognize that the product mix in a particular vending machine 
may change with each restocking. For each machine, the rule requires 
operators to declare the calorie information for those articles of food 
that are sold from that particular vending machine. However, we would 
not object to a vending machine operator providing calorie

[[Page 71285]]

declarations for articles of food that are typically offered for sale 
in a vending machine but may not be offered for sale at all times (for 
example, in cases where the article sells out, or is temporarily 
replaced by another item), provided that the calorie declarations are 
clear and conspicuous and placed prominently. Thus, signs would not 
always need to be updated every time a machine's product mix changed, 
so long as the sign declares the calories for each article of food sold 
from the covered vending machine. For example, if a particular article 
of food is sold out, the vending machine operator would not need to 
design and print a new sign to remove the calorie declaration for such 
food. In addition, to the extent that foods sold from covered vending 
machines permit a prospective purchaser to examine the Nutrition Facts 
label before purchasing the food or otherwise provide visible nutrition 
information at the point of purchase in accordance with section 
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act and Sec.  101.8(b), the 
vending machine operator would not be required to provide calorie 
declarations for such foods. Therefore, restocking of covered vending 
machines that sell such foods would not require the vending machine 
operator to update signs. Furthermore, in order to accommodate the 
occasional trial or experimental product, the sign template could, for 
example, be designed with blank space, on which the operator could 
handwrite the experimental product's name and caloric value, or place a 
declarative sticker next to the new product within the machine (should 
it have a glass/plexiglass front). The comment provided an estimate of 
the number of times a vending machine's sign would likely need to be 
replaced, or 10 to 17 times. We estimate that in accordance to the 
factors described in the earlier paragraphs of this response, calorie 
declaration signs would only need to be replaced between 1 and 4 times 
per year (or even zero for some products). This estimate also takes 
into consideration that vending machine operators have the flexibility 
to choose a medium (e.g., stickers, posters) and a format (e.g., 
individual signs per covered vending machine food; sign(s) in, on, or 
adjacent to the vending machine) for the calorie declaration that will 
make the most sense for a particular vending machine operator depending 
on the variability of products that the operator carries and the 
frequency of restocking.
    We invite comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Title: Information Collection Provisions of the Final Rule on Food 
Labeling; Calorie Labeling of Articles of Food in Vending Machines

A. Reporting Requirements

Description of Respondents
    The likely respondents to this information collection are vending 
machine operators that voluntarily elect to be subject to the Federal 
requirements of this rule by registering with FDA.
Description
    Vending machine operators not subject to the requirements of the 
ACA may elect to be subject to the Federal requirements by registering 
with FDA. Vending machine operators that voluntarily register must 
provide FDA with their contact information, the address of the location 
of each vending machine owned or operated by the vending machine 
operator that is being registered, the preferred mailing address (if 
different from the vending machine operator address) for purposes of 
receiving correspondence, and certification that the information 
submitted is true and accurate, that the person or firm submitting it 
is authorized to do so, and that each registered vending machine will 
be subject to the requirements of Sec.  101.8. In the proposed rule, 
the total reporting burden included both the reporting burden for menu 
labeling and vending machine operator voluntary registration (see 76 FR 
19238 and 19251). For the final rule, these burdens are estimated 
separately for each rule. To keep the establishment's registration 
active, the authorized official of the vending machine operator must 
register every other year within 60 days prior to the expiration of the 
vending machine operator's current registration with FDA. Registration 
will automatically expire if not renewed.
    Vending machine operators that have voluntarily registered to 
become subject to the Federal requirements must satisfy the calorie 
labeling requirements of section 403(q)(5)(H)(viii) of the FD&C Act and 
Sec.  101.8(c). We further note that an article of food sold from a 
vending machine operator who has voluntarily registered with FDA to be 
subject to the requirements of section 403(q)(5)(H)(viii) of the FD&C 
Act is not required to provide calorie declarations for articles of 
food sold from a vending machine that permits the prospective purchaser 
to examine the Nutrition Facts label before purchasing the article as 
provided in Sec.  101.8(b)(1), or otherwise provides visible nutrition 
information at the point of purchase as provided in Sec.  101.8(b)(2).

                     Table 1--Estimated Annual Reporting Burden: Voluntary Registration \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
        21 CFR part 101            Number of     responses per   Total annual     per response     Total hours
                                  respondents     respondent       responses       (in hours)
----------------------------------------------------------------------------------------------------------------
Initial Burden (annualized
 over 3 years):
    Sec.   101.8(d) Initial                 13               1              13              2               26
     Registration.............
Annual Burden:
    Sec.   101.8(d)                         19               1              19          \2\ 0.5              9.5
     Registration Renewal.....
                               ---------------------------------------------------------------------------------
        Total Burden Hours....  ..............  ..............  ..............  ...............             35.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ 30 minutes.


[[Page 71286]]

    We lack data on the number of vending machine operators with fewer 
than 20 machines that might voluntarily register to comply with this 
final rule. We do not expect the net benefit for voluntary registration 
by any non-covered vending machine operators to be positive and in the 
RIA (Ref. 1) we indicate that as of the conducting of this analysis, no 
vending machine operators have voluntarily registered with FDA. 
Therefore we did not estimate a significant burden in the RIA (Ref. 1). 
However, in the event that a few will register anyway, or find some 
positive incentive to do so, for the purposes of this PRA analysis, we 
estimate the burden such operators will face. We estimate there are 
approximately 757 vending machine operators with fewer than 20 
machines; this number is based on the mean estimate of the low and high 
counts of firms with less than $50,000 in annual revenue from the RIA 
(Ref. 1). We estimate that 5 percent of vending machine operators with 
fewer than 20 machines may voluntarily register to become subject to 
the final requirements, or 38 operators. We estimate a burden of 
approximately 2 hours per initial registration, which yields a total 
burden of 76 hours (38 total operators x 2 hours per response). 
Annualizing this number over 3 years yields a rounded 13 respondents 
per year (5 percent x 757 operators/3 years). With an annualized 
estimate of 13 vending machine operators and one registration per 
vending machine operator at 2 hours per registration, we estimate the 
initial hourly burden for these operators is 26 hours.
    We expect that renewal registrations after the first year will 
require substantially less time because operators are expected to be 
able to affirm or update the existing information in an online account 
in a way similar to other FDA firm registration systems. Therefore, we 
estimate that re-registration will take 0.5 hours for each registrant. 
This would indicate that biennial registration would impose a burden of 
19 hours (38 operators x 0.5 hours) every 2 years, or 9.5 hours every 
year (18 operators every year x 0.5 hours).

B. Recordkeeping Requirements

    The preamble to the proposed rule (76 FR 19238 at 19249-19251) 
provided an estimate of the recordkeeping burden, which consisted of 
the burden associated with calorie analysis and the burden associated 
with generating, providing, or maintaining records. Upon further 
consideration, we have omitted the burden estimate associated with 
generating, providing, or maintaining records previously provided in 
table 3 of the proposed rule because the rule does not require vending 
machine operators to generate, provide, or maintain records. Further, 
as discussed in section C of this analysis, we have included a burden 
estimate for calorie analysis as part of the third party disclosure 
burden, since the ``total time, effort, or financial resources expended 
by [covered vending machine operators]'' (5 CFR 1320.3(b)) to declare 
calories for covered vending machine food likely includes time, effort, 
or financial resources to determine the calorie content of such food.

C. Third-Party Disclosure Requirements

Description of Respondents
    The likely respondents to this information collection are vending 
machine operators that are subject to the ACA's requirements and those 
that choose to voluntarily register to comply with the disclosure 
requirements.
Description
    We calculate two types of third party disclosure burdens under the 
rule. The first burden is the time and effort expended by vending 
machine operators to determine the calorie content of covered vending 
machine food for the required calorie declarations, which we refer to 
as ``Calorie Analysis.''
    Vending machine operators must also provide calorie declarations 
for covered vending machine foods on signs in, on, or adjacent to 
vending machines. The second burden is the cost of materials and the 
time expended by vending machine operators to physically produce and 
install the signs for the calorie declarations, which we refer to as 
``Calorie Declaration Signs.'' We estimate the burden of signage for 
non-bulk and bulk vending machines separately. We provide our estimates 
of the third party disclosure burdens in table 2.

                                                         Table 2--Third Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Number of
            21 CFR part 101                Number of      disclosures    Total annual    Average burden per  disclosure     Total hours    Capital costs
                                          respondents   per respondent    disclosures              (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i), Calorie                     282              11           3,102  1...............................           3,102  ..............
 Analysis.
Sec.   101.8(c)(2)(ii), Template                 3,279               5          16,395  2...............................          32,790  ..............
 Design.
Sec.   101.8(c)(2)(ii), Sign Creation.           3,279             125         409,875  0.475 (28.5 min.)...............         194,710      $4,671,047
Sec.   101.8(e)(1), Contact                      3,279             125         409,875  0.025 (1.5 min.)................          10,248  ..............
 Information.
Sec.   101.8(c)(2)(ii), Sign                 1,868,419               1       1,868,419  0.083 (5 min.)..................         155,079  ..............
 Installation.
Sec.   101.8(c)(2)(ii), Sign                   511,576               2       1,023,152  0.5 (30 min.)...................         511,576  ..............
 Information Update.
Sec.   101.8(c)(2)(ii), Sign                 1,755,986               2       3,511,972  0.17 (10 min.)..................         597,035  ..............
 Replacement.
Sec.   101.8(c)(2)(ii), Bulk Machine           128,533               1         128,533  0.025 (1.5 min.)................           3,213  ..............
 Signage.
                                       ------------------------------------------------                                  -------------------------------
    Total Burden......................  ..............  ..............  ..............  ................................       1,507,753       4,671,047
--------------------------------------------------------------------------------------------------------------------------------------------------------

Third-Party Disclosure Requirements: Calorie Analysis
    A calorie analysis entails the burden of determining calorie 
content for covered vending machine food. Most foods sold from vending 
machines provide the nutrition labeling required by section 403(q) of 
the FD&C Act and Sec.  101.9, including calorie content information, 
which means that calorie content for many covered vending machine foods 
is already available on the Nutrition Facts labels for such foods. In 
that case, vending machine operators will not need to determine the 
calorie content of such foods because they can simply declare the 
calorie information they find on the Nutrition Facts label. 
Nevertheless, some operators may need to determine calorie information 
for those vending machine foods that may not bear Nutrition Facts 
labels or otherwise provide visible nutrition information at the point 
of purchase in

[[Page 71287]]

accordance with section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act and 
Sec.  101.8(b). An operator may obtain the necessary calorie 
information from nutrient databases, cookbooks, or laboratory analyses. 
Calorie analysis will most likely only be needed for vended food items 
such as refrigerated, frozen, can/bowl, or other shelf-stable main meal 
items, hot cup beverages, and cold cup beverages. We anticipate that 
vending machine operators are likely to generate and maintain a record 
of the information on which they relied to determine the total calories 
posted for the vending machine food.
    As stated in the RIA (Ref. 1), we estimate the mean number of 
vending machine operators that need calorie analysis to be 847. 
Annualizing this estimate over 3 years yields 282 operators. We also 
estimate the range of products available in a typical machine for each 
of the three most commonly sold product categories that are likely to 
require a calorie analysis, or 3 percent of food items, 5 percent of 
hot beverages, and 1 percent of cold cup beverages. We estimate that 
food machines typically offer between 10 and 25 different items, and 
both hot beverage and cold cup beverage machines typically offer 
between 5 and 10 items. From this, we estimate each vending machine 
operator will require a calorie analysis for 11 items, on average. 
These estimates were based upon conversations with vending machine 
operators (Ref. 3) and our survey of various vending machine models 
that vend these types of food and beverage (Ref. 4). Based on data from 
FDA's Recordkeeping Cost Model (Ref. 5), we estimate the time needed to 
determine the calorie content of each covered vending machine food to 
be approximately 1 hour. Our estimate for the burden hours that would 
be required for new calorie analysis is then 9,317 hours (847 operators 
x 11 products needing analysis x 1 hour per analysis). Annualizing this 
value over 3 years yields 3,102 hours (847 operators/3 years x 11 
products needing analysis x 4 hours per analysis). (847 operators/3 
years = 282 operators per year.) There will not be capital costs 
associated with a calorie analysis.
Third-Party Disclosure Requirements: Calorie Declaration Signs
    Under this rule, covered vending machine operators with 20 or more 
vending machines and vending machine operators that voluntarily 
register to become subject to the Federal requirements, must disclose 
calorie information by providing calorie declaration signs in, on, or 
adjacent to their vending machines to a third party who will most often 
be the prospective purchaser or consumer. Our burden estimate for the 
calorie declaration signs is based on the total time it takes for 
vending machine operators to produce and install the calorie 
declaration signs. We separately estimate the burden for two kinds of 
vending machines, non-bulk and bulk machines. For non-bulk vending 
machines, we estimate the burden to operators as the initial time it 
takes them to develop the calorie disclosure signage, which includes 
the time for the sign template design (i.e. the creation of generalized 
sign templates), sign creation (i.e. using templates to design machine-
specific signs), and installation; and then the time for the recurring 
burden, which includes the time to update or change calorie information 
and the physical replacement of the disclosure signage when the product 
mix of the machine changes. For bulk machines, we estimate the burden 
to operators for the cost of individual calorie labels. (We assume that 
individual calorie declaration stickers will be placed on the face of 
each individual bulk vending machine, since each machine only vends a 
single product.) Recurring updates to signage will only likely be 
required for non-bulk, non-beverage machines since the product mixes of 
these machines are changed regularly, while the product mix for bulk 
machines is unlikely to change.
    We estimate there is an average of 9,838 (9,800 covered non-bulk + 
38 voluntary) vending machine operators subject to the rule. (9,838/3 = 
3,279 annualized). Our estimate for the average number of non-bulk 
vending machines that will require declaration signage is based upon 
data obtained from the Vending Times Survey and National Automatic 
Merchandising Association (NAMA) and the Economic Census, and as 
summarized in table 8 of the final RIA (Refs. 1, 6 to 8). We estimate 
there is an average of 5.61 million non-bulk vending machines. Digital 
signage is an emerging technology, and according to NAMA approximately 
0.1 percent of all vending machines in operation currently have 
electronic video displays capable of providing calorie information, or 
approximately 4,014 to 5,670 vending machines (Ref. 3). Subtracting the 
number of vending machines with the electronic video from the total 
machine count yields an average of 5.611 million vending machines that 
will need signage. We expect the number of vending machines that will 
require signage to decline over time as manufacturers continue to add 
the required calorie information to the principal display panel of the 
package as part of ``front of package labeling,'' and because we 
anticipate greater use of electronic video displays on vending 
machines. In addition, to the extent that covered vending machines sell 
foods that permit prospective purchasers to examine the Nutrition Facts 
label before purchase or otherwise provide visible nutrition 
information at the point of purchase in accordance with section 
403(q)(5)(H)(viii)(I)(aa) of the FD&C Act and Sec.  101.8(b), this 
analysis may overestimate the burden estimate for calorie declaration 
signs.
    We estimate the time it takes for the one-time design of a calorie 
disclosure sign template to be 2 hours. The number of templates a given 
firm would need to design to produce signs that comply with the rule 
may vary based upon the number of different types of products the firm 
purveys. We estimate a range of one to ten templates would be 
necessary. We base this range on the eight general food and beverage 
vending categories monitored by the Vending Times Census, plus two 
additional templates to account for the existence of combination 
machines, which vend more than one general product type (e.g. snacks 
and cold canned beverages)--see table 4 of the final RIA (Refs. 1, 6). 
Since not all firms will sell items from each of the general food 
categories, we estimate that on average, firms will sell items from 
approximately four general food categories and operate one set of 
combination machines, requiring the need to develop (on average) five 
templates. At 2 hours per template, the total initial burden for 
designing templates comes to an estimated 98,380 hours (9,838 operators 
x 5 templates x 2 hours per template). Annualizing this value over 3 
years yields a burden of 32,790 hours (9,838 operators/3 years x 5 
templates x 2 hours per template). There are no capital costs 
associated with template design.
    We estimate the time it takes to enter calorie information into a 
single sign template and prepare it for printing to be 0.475 hours. 
Again, we estimate the number of machine configurations to be 125. The 
count of machine configurations is a general estimate of the number of 
different types of machines an operator uses to sell its products, and 
takes into account that fact that a machine's specific product mix will 
depend on locational characteristics (e.g. office vs. hotel) and the 
type of machine (e.g. beverage vs. snack). We estimate the total 
initial burden for sign creation using the predesigned templates to be 
584,131

[[Page 71288]]

hours (9,838 operators x 125 sign formats x 0.475 hours per sign). 
Annualized over 3 years, this burden becomes 194,710 hours (9,838 
operators/3 years x 125 signs x 0.475 hours per sign). Capital costs 
associated with sign creation correspond to the cost of paper and ink 
for printing the signs. As estimated in the RIA (Ref. 1), the capital 
costs are $2.50 per sign, which results in a total capital cost of 
$14,013,143 [(5,604,914 covered non-bulk machines + 343 voluntarily 
registered machines) x $2.50 per machine]. Annualized over 3 years, 
this value becomes $4,671,048 (5,605,257 machines/3 years x $2.50 per 
machine).
    Vending machine operators must also provide their contact 
information on each vending machine selling covered vending machine 
food as required under Sec.  101.8(e)(1). We assume that venders that 
do not already have a sign or label with their contact information will 
add their contact information into the initial sign design. We estimate 
the time it takes to include contact information is 1.5 minutes (0.025 
hours) for each sign. We estimate the total initial burden for 
including contact information on the predesigned templates to be 30,744 
hours (9,838 operators x 125 sign formats x 0.025 hours per sign). 
Annualized over 3 years, this burden becomes 10,248 hours (9,838 
operators/3 years x 125 signs x 0.025 hours per sign). There are no 
capital costs associated with adding contact information. (Some States 
have licensing requirements for vending machine operators, and some of 
these licensing requirements already require the vending machine 
operator's license or contact information to be displayed on the 
vending machine. If the contact information displayed on a vending 
machine due to State or local requirements includes some but not all of 
the contact information required under Sec.  101.8(e)(1), the vending 
machine operator is required to display the remaining contact 
information required under Sec.  101.8(e)(1) in a manner specified 
under Sec.  101.8(e)(1). We do not have an estimate of the number of 
machines already in compliance; to the extent that some operators are 
already in compliance, we overestimate the burden of third-party 
disclosure.)
    We estimate the time it takes to install a sign onto a single 
machine to be 5 minutes (0.083 hours) for each sign. With 5,605,257 
machines (5,604,914 covered machines + 343 voluntarily registered 
machines), we estimate the annual burden for initial sign installation 
to be 465,236 hours (5,605,257 machines x 1 sign per machine x 0.083 
hours installation). Annualized over 3 years, this burden becomes 
155,079 hours (5,605,257 machines/3 years x 1 sign per machine x 0.083 
hours installation). (5,605,257 machines/3 years = 1,868,419 machines 
per year.) There are no capital costs associated with sign 
installation.
    We divide the estimates for the recurring burden of non-bulk third-
party disclosure into two parts: Updating calorie sign information for 
changes in the product mix (which involves updating the digital format) 
and physical sign replacement (which involves printing and 
installation). We estimate the average number of product configurations 
for machines that will experience regular changes to their product mix 
to be 52. This value is lower than the overall average of 125 since 
some machines (such as beverage machines) do not experience regular 
changes to the product mix. We estimate the average number of times 
that calorie signs will need to be updated to be twice per year. 
Finally, we estimate the time it takes to update a single sign using 
the predesigned template to be 0.5 hours. Thus, the total burden for 
updating sign information is 511,576 hours [511,576 records (made up of 
9,838 operators x 52 product configurations) x 2 updates per year x 0.5 
hours per update].
    We estimate the annual number of covered machines that will need 
regular sign replacement to be 1,755,986 machines (1,755,879 covered 
machines + 107 voluntarily registered machines). We estimate the time 
it takes to remove and replace old signs with new signs to be 0.17 
hours (10 minutes). Thus, the total annual burden for replacing signs 
is 597,035 hours (1,755,986 machines x 2 replacements per year x 0.17 
hours per replacement). There are no capital costs associated with 
updating sign information or physical sign replacement.
    We estimate there is an average of 385,600 covered bulk vending 
machines, based on data obtained from the Vending Times Census and NAMA 
(Refs. 6, 8). We assume each bulk machine vends a single bulk product, 
and we further assume they will choose the most economical signage, 
which means they are likely to use a small sticker on the face of each 
machine. We estimate the time to print and apply each sticker is 1.5 
minutes (0.025 hours). Thus, the total burden for bulk machine signage 
is 9,640 hours (385,600 bulk machines x 0.025 hours per machine). 
Annualized over 3 years, this value becomes 3,213 hours (385,600/3 
years x 0.025 hours per machine). (385,600/3 years) = 128,533 machines 
per year.)
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, 
or emailed to oira_submission@omb.eop.gov. All comments should be 
identified with the title ``Information Collection Provisions of the 
Final Rule on Food Labeling; Calorie Labeling of Articles of Food in 
Vending Machines.''
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3507(d)), we have resubmitted the information collection provisions of 
this final rule to OMB for review, because the final rule provides an 
additional modification to Sec.  101.8. These requirements will not be 
effective until we obtain OMB approval. Interested persons are 
requested to submit comments regarding information collection to OMB 
(see DATES and ADDRESSES).
    Prior to the effective and compliance date of this final rule, we 
will publish a notice in the Federal Register announcing OMB's decision 
to approve, modify, or disapprove the information collection provisions 
in this final rule. An Agency may not conduct or sponsor, and a person 
is not required to respond to, a collection of information unless it 
displays a currently valid OMB control number.

VI. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. Section 4(a) of the Executive Order 
requires Agencies to ``construe . . . a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Federal law includes an express preemption provision 
that preempts ``any requirement for nutrition labeling of food that is 
not identical to the requirement of section 403(q) [of the FD&C Act [21 
U.S.C. 343(q)]]'', except that this provision does not apply ``to food 
that is offered for sale in a restaurant or similar retail food 
establishment that is not part of a chain with 20 or more locations 
doing business under the same name (regardless of the type of ownership 
of the locations) and offering for sale substantially the same menu 
items unless such restaurant or similar retail food establishment 
complies with the

[[Page 71289]]

voluntary provision of nutrition information requirements under section 
403(q)(5)(H)(ix) [of the FD&C Act]'' (21 U.S.C. 343(q)(5)(H)(ix)). The 
final rule creates requirements for nutrition labeling of food under 
section 403(q) of the FD&C Act that would preempt certain non-identical 
State and local nutrition labeling requirements.
    Section 4205 of the ACA also included a Rule of Construction 
providing that nothing in the amendments made by [section 4205] shall 
be construed--(1) to preempt any provision of State or local law, 
unless such provision establishes or continues into effect nutrient 
content disclosures of the type required under section 403(q)(5)(H) of 
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)] (as 
added by subsection(b)) and is expressly preempted under subsection 
(a)(4) of such section; (2) to apply to any State or local requirement 
respecting a statement in the labeling of food that provides for a 
warning concerning the safety of the food or component of the food; or 
(3) except as provided in section 403(q)(5)(H)(ix) of the Federal Food, 
Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)(ix)] (as added by 
subsection (b)), to apply to any restaurant or similar retail food 
establishment other than a restaurant or similar retail food 
establishment described in section 403(q)(5)(H)(i) of such Act [21 
U.S.C. 343(q)(5)(H)(i)]. (See Public Law 111-148, Sec. 4205(d), 124 
Stat. 119, 576 (2010).)
    We interpret the provisions of section 4205 of the ACA related to 
preemption to mean that States and local governments may not impose 
nutrition labeling requirements for food sold from vending machines 
that must comply with the Federal requirements of section 403(q)(5)(H) 
of the FD&C Act, unless the State or local requirements are identical 
to the Federal requirements. In other words, States and localities 
cannot have additional or different nutrition labeling requirements for 
food sold either: (1) From vending machines that are operated by a 
person engaged in the business of owning or operating 20 or more 
vending machines subject to the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act or (2) from vending machines 
operated by a person not subject to the requirements of section 
403(q)(5)(H)(viii) of the FD&C Act who voluntarily elects to be subject 
to those requirements by registering biannually under section 
403(q)(5)(H)(ix) of the FD&C Act.
    Otherwise, for food sold from vending machines not subject to the 
nutrition labeling requirements of section 403(q)(5)(H)(viii) of the 
FD&C Act, States and localities may impose nutrition labeling 
requirements. Under our interpretation of the Rule of Construction in 
section 4205(d)(1) of the ACA, nutrition labeling for food sold from 
these vending machines would not be ``nutrient content disclosures of 
the type required under section 403(q)(5)(H)(viii) [of the FD&C Act]'' 
and, therefore, would not be preempted. Under this interpretation, 
States and localities would be able to continue to require nutrition 
labeling for food sold from vending machines which are exempt from 
nutrition labeling under section 403(q)(5) of the FD&C Act. This 
interpretation is consistent with the fact that Congress included 
vending machine operators in the voluntary registration provision of 
section 403(q)(5)(H)(ix) of the FD&C Act. There would have been no need 
to include vending machine operators in the provision that allows 
opting into the Federal requirements if States and localities could not 
otherwise require non-identical nutrition labeling for food sold from 
any vending machines.
    The preamble to the proposed rule (76 FR 19238 at 19252) described 
an alternative interpretation of section 4205 of the ACA that could 
leave less room for States and localities to require nutrition labeling 
for food sold from vending machines. Under this alternative 
interpretation, State or local nutrition labeling requirements for food 
sold from vending machines would be preempted because such nutrition 
labeling requirements would be ``nutrition content disclosures of the 
type required under section 403(q)(5)(H) [of the FD&C Act ]'' and would 
not fall within the exception to preemption in section 403A(a)(4) of 
the FD&C Act (``except that this paragraph does not apply to food that 
is offered for sale in a restaurant or similar retail food 
establishment that is not part of a chain with 20 or more locations . . 
.'').
    Under this alternative interpretation, States and localities could 
not have nutrition labeling requirements for food sold in vending 
machines that were not identical to the Federal requirements, unless 
they successfully petitioned FDA. The position that no State or 
locality may have a vending machine food nutrition labeling requirement 
not identical to the Federal requirements, regardless of how many 
vending machines the operator owns or operates, was the position in the 
guidance we issued (entitled ``Guidance for Industry: Questions and 
Answers Regarding the Effect of Section 4205 of the Patient Protection 
and Affordable Care Act of 2010 on State and Local Menu and Vending 
Machine Labeling Laws'' (75 FR 52427, August 25, 2010)). Federal law 
provides that, upon petition, we may exempt State or local requirements 
from the express preemption provisions of section 403A(a) of the FD&C 
Act under certain conditions (21 U.S.C. 343-1(b)). We have issued 
regulations at Sec.  100.1 (21 CFR 100.1) describing the petition 
process that is available to State and local governments to request 
such exemptions from preemption. Under our proposed interpretation, for 
food sold from vending machines that is not subject to the nutrition 
labeling requirements of section 403(q)(5)(H) of the FD&C Act, States 
and localities may establish or continue to impose nutrition labeling 
requirements. Under the alternative interpretation, there would be food 
sold in vending machines for which the Federal Government has not 
required nutrition labeling and for which States and localities would 
be precluded from establishing such labeling requirements unless they 
successfully petitioned FDA and a rulemaking was completed. This 
approach would risk creating a regulatory gap that would be 
inconsistent with the purposes of section 4205 of the ACA. It would 
also impose a restriction and burden on the States and localities that 
is inconsistent with the Federalism principles expressed in Executive 
Order 13132, as well as a substantial administrative burden on FDA if 
States petition for exemption.
    We invited comments on our interpretation of section 4205 of the 
ACA related to preemption, as well as on the alternative interpretation 
described in the Federalism section. We also requested comments on the 
use of the petition process in this context and on other potential 
interpretations that interested persons identify as appropriate given 
both the preemption-related language of section 4205 of the ACA and the 
statutory goals.
    (Comment 41) Several comments supported the preemptive scope being 
limited to State and local requirements imposing additional or 
different nutritional labeling requirements for food sold from covered 
vending machines, including food sold from machines operated by a 
person who has elected to be subject to the requirements of section 
403(q)(5)(H) of the FD&C Act (76 FR 19238 at 19251-19252). Some 
comments stated that the alternative interpretation, that no State or 
locality may have a vending machine food nutrition labeling requirement 
that is not identical to the Federal requirements regardless of how 
many vending machines the operator owns or operates, would restrict 
State and local

[[Page 71290]]

authorities and create a ``regulatory vacuum'' because the Federal 
system exempts vending machine operators with fewer than 20 machines. A 
few comments stated that the alternative interpretation, which would 
create a gap in coverage of vending machines, would be inconsistent 
with the purposes and language of section 4205 of the ACA. These 
comments also stated that imposing a restriction on States and 
localities is inconsistent with Federalism principles expressed in 
Executive Order 13132. Another comment stated that section 4205 of the 
ACA intends that States and localities have authority to regulate 
nutritional information for machines that do not come under the purview 
of the Federal law.
    Several comments would have us revise the rule to clarify that 
``identical'' does not mean verbatim in wording rather in effect. One 
comment suggested the following language: ``The specific words of the 
State or local requirements need not be the same. State or local 
requirements that are worded differently from the Federal requirements 
and/or provide for different enforcement schemes may still be 
`identical' under [section 4205 of the ACA].''
    Other comments noted that the savings clause for warnings about the 
safety of food is included in the Rule of Construction in section 
4205(d) of the ACA. A few comments suggested that we codify the Rule of 
Construction because its omission from the rule may lead to confusion 
over how the statute should be interpreted. The comments noted that the 
lack of a codified statement for a similar rule of construction in the 
NLEA has led to confusion and to court decisions that did not take that 
rule of construction into account. One comment stated that we should 
include a savings clause that expressly identifies that nutrition 
labeling for less than 20 machines is not preempted in the absence of 
voluntary compliance by non-covered vending machine operators.
    (Response 41) We agree with the comments asserting that the 
preemptive effect of the Federal nutrition labeling requirements of 
section 4205 of the ACA for food sold from vending machines is limited 
to State and local requirements that impose additional or different 
nutrition labeling requirements for food sold from vending machines 
that are covered by the Federal requirements of section 403(q)(5)(H) of 
the FD&C Act and Sec.  101.8. We also agree that the alternative 
interpretation described in the proposed rule (76 FR 19238 at 19251 
through 19252), that no State or locality may have a nutrition labeling 
requirement for food sold from vending machines that is not identical 
to the Federal requirements regardless of how many vending machines the 
operator owns or operates, would restrict State and local authorities 
and create a regulatory gap that would be inconsistent with the 
purposes and language of section 4205 of the ACA and the Federalism 
principles expressed in Executive Order 13132. In addition, as we noted 
in the preamble to the proposed rule (76 FR 19238 at 19251 through 
19252), there would be no reason for Congress to include vending 
machine operators in the voluntary registration provision of section 
403(q)(5)(H)(ix) of the FD&C Act, which allows vending machine 
operators not subject to the requirements of section 403(q)(5)(H) of 
the FD&C Act to opt into the Federal requirements if State and local 
governments could not otherwise require non-identical nutrition 
labeling for food sold from any vending machines.
    For these reasons, we interpret the provisions of section 4205 of 
the ACA related to preemption to mean that States and local governments 
may not establish or continue into effect nutrition labeling 
requirements for food sold from vending machines covered by the Federal 
requirements of section 403(q)(5)(H) of the FD&C Act and Sec.  101.8, 
unless the State or local requirements are identical to the Federal 
requirements of section 403(q)(5)(H) of the FD&C Act and Sec.  101.8. 
In other words, States and localities cannot have additional or 
different nutrition labeling requirements for food sold either from: 
(1) Vending machines that are operated by a person engaged in the 
business of owning or operating 20 or more vending machines subject to 
the requirements of section 403(q)(5)(H)(viii) of the FD&C Act and 
Sec.  101.8; or (2) vending machines operated by a person not otherwise 
subject to the requirements of section 403(q)(5)(H)(viii) of the FD&C 
Act and Sec.  101.8 who voluntarily elects to be subject to those 
requirements by registering biannually with FDA in accordance with 
section 403(q)(5)(H)(ix) of the FD&C Act and Sec.  101.8(d). For food 
sold from vending machines not subject to the nutrition labeling 
requirements of section 403(q)(5)(H)(viii) of the FD&C Act, States and 
localities may impose nutrition labeling requirements.
    In response to the comments asserting that we revise the rule to 
clarify the meaning of ``identical'' within the context of section 
403A(a)(4) of the FD&C Act, we note that we have already issued a 
regulation at Sec.  100.1 that explains the meaning of ``not identical 
to'' in the context of section 403A of the FD&C Act in describing the 
petition process available to State and local governments to request an 
exemption from the express preemption provisions of section 403A of the 
FD&C Act under section 403A(b) of the FD&C Act. FDA regulations, at 
Sec.  100.1(c)(4), provide, in relevant part, that, within the context 
of section 403A of FD&C Act, ``not identical to'' does not refer to the 
specific words in the State or local requirement but instead means that 
the State or local requirement directly or indirectly imposes 
obligations or contains provisions concerning the labeling of food 
that: (1) Are not imposed by or contained in the applicable provision 
(including any implementing regulation) of section 403 of the FD&C Act 
or (2) differ from those specifically imposed by or contained in the 
applicable provision (including any implementing regulation) of section 
403 of the FD&C Act. Accordingly, a State or local nutrition labeling 
requirement for food sold from vending machines covered by the 
requirements of section 403(q)(5)(H)(viii) of the FD&C Act and Sec.  
101.8 that directly or indirectly imposes obligations or contains 
labeling provisions that: (1) Are not imposed by or contained in 
section 403(q) of the FD&C Act and Sec.  101.8; or (2) differ from 
those specifically imposed by or contained in section 403(q) of the 
FD&C Act and Sec.  101.8 would be ``not identical to'' the Federal 
requirements and therefore would be preempted under section 403A(a)(4) 
of the FD&C Act. Because the meaning of the phrase ``not identical 
to,'' within the context of section 403A of the FD&C Act, is already 
described in Sec.  100.1 and is further clarified here in the context 
of vending machines, we decline to revise the rule to clarify the 
meaning of ``identical'' as suggested by the comments.
    We decline to amend Sec.  101.8 to restate the Rule of Construction 
at section 4205(d) of the ACA or to add a savings clause that expressly 
provides that nutrition labeling for fewer than 20 vending machines is 
not preempted in the absence of voluntary compliance. As discussed in 
section III.C.4.a of this preamble, and specified in Sec.  101.8(c)(1), 
Sec.  101.8 only applies to food sold from a vending machine that: (1) 
Is operated by a person engaged in the business of owning or operating 
20 or more machines; or (2) is operated by a vending machine operator 
that has voluntarily elected to be subject to Sec.  101.8 by 
registering with FDA in accordance with Sec.  101.8(d). In addition, we 
explain our interpretation of the provisions of section 4205 of the ACA

[[Page 71291]]

related to preemption mentioned previously, including our 
interpretation that State and local governments may impose nutrition 
labeling requirements for food sold from vending machines not subject 
to the requirements of section 403(q)(5)(H) of the FD&C Act, which 
would include vending machines operated by a person engaged in the 
business of owning or operating fewer than 20 vending machines. Because 
Sec.  101.8(c)(1) specifies what foods and vending machines are covered 
by the requirements of section 403(q)(5)(H) and Sec.  101.8, and we 
have described the Rule of Construction at section 4205(d) of the ACA 
and explained our interpretation of the provisions of section 4205 of 
the ACA related to preemption mentioned previously, we decline to 
revise Sec.  101.8 as suggested by the comments.

VII. Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov.

1. FDA/CFSAN, ``Food Labeling: Calorie Labeling of Articles of Food 
in Vending Machines, Regulatory Impact Analysis,'' 2014.
2. FDA/CFSAN, ``Food Labeling: Calorie Labeling of Articles of Food 
in Vending Machines NPRM, Preliminary Regulatory Impact Analysis,'' 
2011.
3. Memo to File. Correspondence with Eric Dell of the National 
Automatic Merchandising Association. April 10, 2013.
4. Memo to File. Correspondence with Eric Dell of the National 
Automatic Merchandising Association. April 13, 2013.
5. Eastern Research Group I. ``Evaluation of Recordkeeping Costs for 
Food Manufacturers, Final Report,'' A. Sertkaya, A. Berlind, and S. 
Erdem, Eds. Contract No. 223-01-2461, Task Order Number 5. 2007.
6. ``2012 Census of the Industry,'' Vending Times, 2012; 52(12).
7. 2012 State of the Vending Industry Report, 2013,'' Automatic 
Merchandiser.
8. National Automatic Merchandising Association. Comments of: The 
National Automatic Merchandising Association. Docket No. FDA-2010-N-
0298. 2010.

List of Subjects

21 CFR Part 11

    Administrative practice and procedure, Computer technology, 
Reporting and recordkeeping requirements.

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
11 and 101 are amended as follows:

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
1. The authority citation for 21 CFR part 11 continues to read as 
follows:

    Authority:  21 U.S.C. 321-393; 42 U.S.C. 262.


0
2. Section 11.1 is amended by adding paragraph (h) to read as follows:


Sec.  11.1  Scope.

* * * * *
    (h) This part does not apply to electronic signatures obtained 
under Sec.  101.8(d) of this chapter.

PART 101--FOOD LABELING

0
3. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.


0
4. Section 101.8 is added to subpart A to read as follows:


Sec.  101.8  Vending machines.

    (a) Definitions. The definitions of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this section. In addition, for the purposes of this section:
    Authorized official of a vending machine operator means an owner, 
operator, agent in charge, or any other person authorized by a vending 
machine operator who is not otherwise subject to section 
403(q)(5)(H)(viii) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 343(q)(5)(H)(viii)), to register the vending machine operator 
with the Food and Drug Administration (``FDA'') for purposes of 
paragraph (d) of this section.
    Vending machine means a self-service machine that, upon insertion 
of a coin, paper currency, token, card, or key, or by optional manual 
operation, dispenses servings of food in bulk or in packages, or 
prepared by the machine, without the necessity of replenishing the 
machine between each vending operation.
    Vending machine operator means a person(s) or entity that controls 
or directs the function of the vending machine, including deciding 
which articles of food are sold from the machine or the placement of 
the articles of food within the vending machine, and is compensated for 
the control or direction of the function of the vending machine.
    (b) Articles of food not covered. Articles of food sold from a 
vending machine are not covered vending machine food if:
    (1) The prospective purchaser can view:
    (i) The calories, serving size, and servings per container listed 
in the Nutrition Facts label on the vending machine food without any 
obstruction. The Nutrition Facts label must be in the format required 
in Sec.  101.9(c) and (d). The Nutrition Facts label must be in a size 
that permits the prospective purchaser to be able to easily read the 
nutrition information contained in the Nutrition Facts label on the 
article of food in the vending machine. Smaller formats allowed for 
Nutrition Facts for certain food labeling under FDA regulation at Sec.  
101.9 are not considered to be a size that a prospective purchaser is 
able to easily read; or
    (ii) The calories, serving size, and servings per container listed 
in a reproduction of the Nutrition Facts label on the vending machine 
food, provided that the reproduction is a reproduction of an actual 
Nutrition Facts label that complies with Sec.  101.9 for a vending 
machine food, is presented in a size that permits the prospective 
purchaser to be able to easily read the nutrition information, and the 
calories, serving size, and servings per container are displayed by the 
vending machine before the prospective purchaser makes his or her 
purchase; or
    (2) The prospective purchaser can otherwise view visible nutrition 
information, including, at a minimum the total number of calories for 
the article of food as sold at the point of purchase. This visible 
nutrition information must appear on the food label itself. The visible 
nutrition information must be clear and conspicuous and able to be 
easily read on the article of food while in the vending machine, in a 
type size at least 50 percent of the size of the largest printed matter 
on the label and with sufficient color and contrasting background to 
other print on the label

[[Page 71292]]

to permit the perspective purchaser to clearly distinguish the 
information.
    (c) Requirements for calorie labeling for certain food sold from 
vending machines--(1) Applicability; covered vending machine food. For 
the purposes of this section, the term ``covered vending machine food'' 
means an article of food that is:
    (i) Sold from a vending machine that does not permit the 
prospective purchaser to examine the Nutrition Facts label prior to 
purchase as provided in paragraph (b)(1) of this section or otherwise 
provide visible nutrition information at the point of purchase as 
provided in paragraph (b)(2) of this section; and
    (ii) Sold from a vending machine that:
    (A) Is operated by a person engaged in the business of owning or 
operating 20 or more vending machines; or
    (B) Is operated by a vending machine operator that has voluntarily 
elected to be subject to the requirements of this section by 
registering with FDA under paragraph (d) of this section.
    (2) Calorie declaration. (i) The number of calories for a covered 
vending machine food must be declared in the following manner:
    (A) To the nearest 5-calorie increment up to and including 50 
calories and 10-calorie increment above 50 calories, except that 
amounts less than 5 calories may be expressed as zero.
    (B) The term ``Calories'' or ``Cal'' must appear adjacent to the 
caloric content value for each food in the vending machine.
    (C) The calorie declaration for a packaged food must include the 
total calories present in the packaged food, regardless of whether the 
packaged food contains a single serving or multiple servings. The 
vending machine operator may voluntarily disclose calories per serving 
in addition to the total calories for the food.
    (D) If a covered vending machine food is one where the prospective 
purchaser selects among options to produce a final vended product 
(e.g., vended coffee, hot chocolate or tea with options for added 
sugar, sugar substitute, milk, and cream), calories must be declared 
per option or for the final vended products.
    (ii) Calorie declarations for covered vending machine food must be 
clear and conspicuous and placed prominently in the following manner:
    (A) The calorie declarations may be placed on a sign in close 
proximity to the article of food or selection button, i.e., in, on, or 
adjacent to the vending machine, but not necessarily attached to the 
vending machine, so long as the calorie declaration is visible at the 
same time as the food, its name, price, selection button, or selection 
number is visible. The sign must give calorie declarations for those 
articles of food that are sold from that particular vending machine.
    (B) When the calorie declaration is in or on the vending machine, 
the calorie declaration must be in a type size no smaller than the name 
of the food on the machine (not the label), selection number, or price 
of the food as displayed on the vending machine, whichever is smallest, 
with the same prominence, i.e., the same color, or in a color at least 
as conspicuous, as the color of the name, if applicable, or price of 
the food or selection number, and the same contrasting background, or a 
background at least as contrasting as the background used for the item 
it is in closest proximity to, i.e., name, selection number, or price 
of the food item as displayed on the machine.
    (C) When the calorie declaration is on a sign adjacent to the 
vending machine, the calorie declaration must be in a type size large 
enough to render it likely to be read and understood by the prospective 
purchaser under customary conditions of purchase and use, and in a type 
that is all black or one color on a white or other neutral background 
that contrasts with the type color.
    (D) Where the vending machine only displays a picture or other 
representation or name of the food item, the calorie declaration must 
be in close proximity to the picture or other representation or name, 
or in close proximity to the selection button.
    (E) For electronic vending machines (e.g., machines with digital or 
electronic or liquid crystal display (LCD) displays), the calorie 
declaration must be displayed before the prospective purchaser makes 
his or her purchase.
    (F) For vending machines with few choices, e.g., popcorn, the 
calorie declaration may appear on the face of the machine so long as 
the declaration is prominent, not crowded by other labeling on the 
machine, and the type size is no smaller than the name of the food on 
the machine (not the label), selection number, or price of the food as 
displayed on the vending machine, whichever is smallest.
    (d) Voluntary provision of calorie labeling for foods sold from 
vending machines--(1) Applicability. A vending machine operator that is 
not subject to the requirements of section 403(q)(5)(H)(viii) of the 
Federal Food, Drug, and Cosmetic Act may, through its authorized 
official, voluntarily register with FDA to be subject to the 
requirements established in paragraph (c)(2) of this section. An 
authorized official of a vending machine operator that voluntarily 
registers cannot be subject to any State or local nutrition labeling 
requirements that are not identical to the requirements in 403(q)(5)(H) 
of the Federal Food, Drug, and Cosmetic Act.
    (2) Who may register? A vending machine operator that is not 
otherwise subject to the requirements of section 403(q)(5)(H) of the 
Federal Food, Drug, and Cosmetic Act may register with FDA.
    (3) What information is required? The vending machine operator must 
provide FDA with the following information:
    (i) The contact information (including name, address, phone number, 
email address), for the vending machine operator;
    (ii) The address of the location of each vending machine owned or 
operated by the vending machine operator that is being registered;
    (iii) Preferred mailing address (if different from the vending 
machine operator address), for purposes of receiving correspondence; 
and
    (iv) Certification that the information submitted is true and 
accurate, that the person or firm submitting it is authorized to do so, 
and that each registered vending machine will be subject to the 
requirements of this section.
    (v) Information should be submitted by email by typing complete 
information into the portable document format (PDF) form, saving it on 
the registrant's computer, and sending it by email to 
menulawregistration@fda.hhs.gov. If email is not available, the 
registrant can either fill in the PDF form and print it out (or print 
out the blank PDF and fill in the information by hand or typewriter), 
and either fax the completed form to 301-436-2804 or mail it to FDA, 
CFSAN Menu and Vending Machine Labeling Registration, White Oak 
Building 22, rm. 0209, 10903 New Hampshire Ave., Silver Spring, MD 
20993.
    (vi) Authorized officials of a vending machine operator who elect 
to be subject to the Federal requirements can register by visiting 
http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm217762.htm. FDA has created a form that contains fields requesting 
the information in paragraph (d) of this section and made the form 
available at this Web site. Registrants must use this form to ensure 
that complete information is submitted.
    (vii) To keep the establishment's registration active, the 
authorized official of the vending machine operator must register every 
other year within 60 days prior to the expiration of the vending 
machine operator's current

[[Page 71293]]

registration with FDA. Registration will automatically expire if not 
renewed.
    (e) Vending machine operator contact information. (1) A vending 
machine operator that is subject to section 403(q)(5)(H)(viii) of the 
Federal Food, Drug, and Cosmetic Act or a vending machine operator that 
voluntarily registers to be subject to the requirements under paragraph 
(d) of this section must provide its contact information for vending 
machines selling covered vending machine food. The contact information 
must list the vending machine operator's name, telephone number, and 
mailing address or email address.
    (2) The contact information must be readable and may be placed on 
the face of the vending machine, or otherwise must be placed with the 
calorie declarations as described in paragraph (c)(2)(ii) of this 
section (i.e., on the sign in, on, or adjacent to the vending machine).
    (f) Signatures. Signatures obtained under paragraph (d) of this 
section that meet the definition of electronic signatures in Sec.  
11.3(b)(7) of this chapter are exempt from the requirements of part 11 
of this chapter.

0
5. In Sec.  101.9, revise paragraphs (j)(2)(ii) and (j)(4) and the 
introductory text of paragraph (j)(13)(i) to read as follows:


Sec.  101.9  Nutrition labeling of food.

* * * * *
    (j) * * *
    (2) * * *
    (ii) Served in other establishments in which food is served for 
immediate human consumption (e.g., institutional food service 
establishments, such as schools, hospitals, and cafeterias; 
transportation carriers, such as trains and airplanes; bakeries, 
delicatessens, and retail confectionery stores where there are 
facilities for immediate consumption on the premises; food service 
vendors, such as lunch wagons, ice cream shops, mall cookie counters, 
vending machines, and sidewalk carts where foods are generally consumed 
immediately where purchased or while the consumer is walking away, 
including similar foods sold from convenience stores; and food delivery 
systems or establishments where ready-to-eat foods are delivered to 
homes or offices), Provided, That the food bears no nutrition claims or 
other nutrition information in any context on the label or in labeling 
or advertising, except as provided in Sec.  101.8(c). Claims or other 
nutrition information, except as provided in Sec.  101.8(c), subject 
the food to the provisions of this section;
* * * * *
    (4) Foods that contain insignificant amounts of all of the 
nutrients and food components required to be included in the 
declaration of nutrition information under paragraph (c) of this 
section, Provided, That the food bears no nutrition claims or other 
nutrition information in any context on the label or in labeling or 
advertising, except as provided in Sec.  101.8(c). Claims or other 
nutrition information, except as provided in Sec.  101.8(c), subject 
the food to the provisions of this section. An insignificant amount of 
a nutrient or food component shall be that amount that allows a 
declaration of zero in nutrition labeling, except that for total 
carbohydrate, dietary fiber, and protein, it shall be an amount that 
allows a declaration of ``less than 1 gram.'' Examples of foods that 
are exempt under this paragraph include coffee beans (whole or ground), 
tea leaves, plain unsweetened instant coffee and tea, condiment-type 
dehydrated vegetables, flavor extracts, and food colors.
* * * * *
    (13)(i) Foods in small packages that have a total surface area 
available to bear labeling of less than 12 square inches, Provided, 
That the labels for these foods bear no nutrition claims or other 
nutrition information in any context on the label or in labeling or 
advertising, except as provided in Sec.  101.8(c). Claims or other 
nutrition information, except as provided in Sec.  101.8(c), subject 
the food to the provisions of this section.
* * * * *

    Dated: November 19, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27834 Filed 11-25-14; 8:45 am]
BILLING CODE 4164-01-P