[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Proposed Rules]
[Pages 17010-17014]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6644]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 2004N-0456]
RIN 0910-AF23


Food Labeling: Serving Sizes of Products That Can Reasonably Be 
Consumed At One Eating Occasion; Updating of Reference Amounts 
Customarily Consumed; Approaches for Recommending Smaller Portion Sizes

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing this advance 
notice of proposed rulemaking (ANPRM) to request comment on whether to 
amend certain provisions of the agency's nutrition labeling regulations 
concerning serving size.

[[Page 17011]]

FDA is issuing this ANPRM in response to recommendations of the Obesity 
Working Group (OWG), which was created by the Commissioner of FDA (the 
Commissioner) to develop an action plan to address the Nation's obesity 
problem. Comments on whether, and if so, how to amend the agency's 
serving size regulations will inform any FDA rulemaking that may result 
from this ANPRM.

DATES: Submit written or electronic comments by June 20, 2005.

ADDRESSES: You may submit comments, identified by Docket No. 2004N-0456 
and/or RIN number 0910-AF23, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
     E-mail: fdadockets@oc.fda.gov. Include Docket No. 2004N-
0456 and/or RIN number 0910-AF23 in the subject line of your e-mail 
message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and Docket No. or Regulatory Information Number (RIN) for this 
rulemaking. All comments received will be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm, including any personal 
information provided. For detailed instructions on submitting comments 
and additional information on the rulemaking process, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lori LeGault, Center for Food Safety 
and Applied Nutrition (HFS-840), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1791.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Serving Size Regulations

    The Federal Food, Drug, and Cosmetic Act (the act), as amended by 
the Nutrition Labeling and Education Act of 1990 (NLEA) (Public Law 
101-535), together with FDA's implementing regulations, established 
mandatory nutrition labeling for packaged foods to enable consumers to 
make more informed and healthier food product choices in the context of 
their daily diet. Section 403(q)(1)(A)(i) of the act (21 U.S.C. 
343(q)(1)(A)(i)) requires that most foods under FDA's jurisdiction bear 
nutrition information based on a serving size that reflects the amount 
of food customarily consumed and is expressed in a common household 
measure appropriate to the food. The NLEA also required that FDA issue 
regulations that establish standards to define serving size.
    To implement the serving size requirements of the NLEA, FDA 
underwent extensive notice-and-comment rulemaking (56 FR 60394, 
November 27, 1991 (the 1991 serving size proposed rule); 58 FR 2229, 
January 6, 1993 (the serving size final rule); and 58 FR 44039, August 
18, 1993 (the serving size technical amendments)). Consistent with the 
act, the serving size regulations established a system to define 
``serving size'' that was composed of two basic elements: (1) Reference 
amounts customarily consumed per eating occasion (reference amounts or 
RACCs) for specific food product categories; and (2) procedures for 
determining serving sizes for use on product labels derived from the 
reference amounts. The second element was necessary because the RACCs 
are provided primarily in metric units (based on data from nationwide 
food consumption surveys that are expressed in grams); however, the act 
requires that serving sizes be expressed in common household measures 
that are appropriate to the particular food.
    In Sec.  101.9(b)(1) (21 CFR 101.9(b)(1)), we defined the term 
``serving'' or ``serving size'' to mean:
    an amount of food customarily consumed per eating occasion by 
persons 4 years of age or older, which is expressed in a common 
household measure that is appropriate to the food. When the food is 
specially formulated or processed for use by infants or by toddlers, 
a serving or serving size means an amount of food customarily 
consumed per eating occasion by infants up to 12 months of age or by 
children 1 through 3 years of age, respectively.
    In Sec.  101.12(b) (21 CFR 101.12(b)), we established RACCs (upon 
which label serving sizes are to be determined) for 129 food product 
categories representing the general food supply and 11 categories for 
infant and toddler foods. The general principles and factors that FDA 
considered in arriving at the RACCs are described in Sec.  101.12(a). 
Among these principles, FDA sought to ensure that foods that have 
similar dietary usage, product characteristics, and customarily 
consumed amounts have a uniform reference amount so that consumers 
could make nutritional comparisons of like products in the marketplace.
    The RACCs represent the amount of food customarily consumed per 
eating occasion for each product category, and were derived primarily 
from data obtained from the 1977-1978 and 1987-1988 Nationwide Food 
Consumption Surveys conducted by the U.S. Department of Agriculture (58 
FR 2229 at 2236-2237). We reviewed food consumption data for the foods 
in each product category and considered three statistical estimates, 
i.e., the mean (average), the median (50th percentile), and the mode 
(most frequent value). Following the procedures detailed in the 1991 
serving size proposed rule (56 FR 60394 at 60403-60406), we determined 
the reference amount that was most likely to represent the amount 
customarily consumed for each product category.
    In Sec.  101.9(b), we established procedures for converting RACCs 
into appropriate label serving sizes. Among these provisions is Sec.  
101.9(b)(6), where we defined the criteria for products to be labeled 
as single-serving containers. (See 58 FR 2229 at 2232-2235 for FDA's 
evaluation of comments.) Most products packaged and sold individually 
that contain less than 200 percent of the applicable RACC must 
currently be labeled as a single serving. An exception to this rule 
occurs for products that contain between 150 percent and 200 percent of 
the RACC and that have a RACC of 100 grams (g) or 100 milliliters (mL) 
or larger. In this case, the product may be labeled as one or two 
servings, at the manufacturer's option.
    For example, the RACC for carbonated beverages is 240 mL (i.e., 8 
fluid (fl) ounces (oz)). Containers of carbonated beverages that weigh 
360 mL (i.e., 12 fl oz, 150 percent of 240 mL) or less must be labeled 
as a single serving. Containers weighing between 360 mL and 480 mL 
(i.e., 16 fl oz, 200 percent of 240 mL) may be labeled as a single 
serving or as ``about 2'' servings per container (Sec.  
101.9(b)(8)(i)).
    For products packaged and sold individually that contain 200 
percent or more of the RACC, it is the manufacturer's option to label 
the product as a single-serving container if

[[Page 17012]]

the entire content of the package can reasonably be consumed at a 
single-eating occasion. For example, the RACC for muffins is 55 g. If a 
single large muffin weighs 110 g (200 percent of 55 g), there are two 
options for the serving size declaration: ``1 muffin (110 g)'' or ``1/2 
muffin (55 g).''

B. The Report of the FDA Obesity Working Group

    In August 2003, the Commissioner created the OWG and charged it to 
develop an action plan covering the critical dimensions of the obesity 
problem in America to help consumers lead healthier lives through 
better nutrition. The OWG was composed of professionals across FDA who 
provided a range of expertise in areas such as food labels, 
communication and education efforts, the role of industry and 
restaurants, and therapeutic interventions for obesity. The OWG met 
eight times and received briefings from several invited experts from 
other government agencies. In addition, the OWG held one public 
meeting, one workshop, two round table discussions (one with health 
professionals/academicians, and one with consumer groups), and 
solicited comments on obesity-related issues, directing them to a 
docket established in July 2003 (Docket No. 2003N-0338). The final 
report issued by the OWG centered on the scientific fact that weight 
control is primarily a function of the balance of calories eaten and 
calories expended; and therefore, focused on a ``calories count'' 
emphasis for FDA actions (Ref. 1).
    A principal aspect of the Commissioner's charge was for the OWG to 
``develop an approach for enhancing and improving the food label to 
assist consumers in preventing weight gain and reducing obesity.'' To 
address this issue, among other actions, the OWG recommended that FDA 
reexamine its regulations on serving sizes by soliciting comment on the 
following topics: (1) Whether to require food packages that can 
reasonably be consumed at one eating occasion to declare the whole 
package as a single serving; (2) which, if any, RACCs of food 
categories need to be updated; and (3) whether to provide for 
comparative calorie claims for smaller portions of identical foods.

II. Agency Request for Information

    FDA's research on consumers' use of the Nutrition Facts panel (NFP) 
has indicated that consumers' ability to quickly read and understand 
the NFP is an important factor in determining whether consumers use the 
NFP and whether the NFP is helpful to them. In focus groups, 
participants indicated that they cared about nutrition and reported 
using the NFP, but also said that they did not want to spend a lot of 
time reading labels and did not always consider nutrition when deciding 
what to eat. They were interested in calories, but were also concerned 
about saturated fat, total fat, cholesterol, carbohydrates, and sodium. 
Most participant comments indicated that they incorrectly thought a 
serving size was a recommended portion size, rather than a standardized 
unit of measure. Some participants said that typical serving sizes, as 
a recommended portion, are unrealistic and pointed out that some people 
need to eat different amounts, depending on their age, body type, and 
lifestyle. In the 2002 Health and Diet Survey (Ref. 2), respondents 
were asked how they used the NFP. The most common answers were: (1) To 
see if the product was high or low in a specific nutrient, (2) to 
decide how much to eat, and (3) to help in meal planning. To address 
these issues, we request comments on the following questions:
     How can FDA make serving size information on the NFP 
easier for consumers to use when deciding what foods and how much of 
these foods they should eat?
     Do consumers recognize the differences between serving 
sizes on food labels and servings recommended in dietary guidance? If 
so, what do consumers think the differences are? What information on a 
label would help make this distinction clearer? For example, should the 
serving size and/or servings per container on the food label be made 
more prominent? If so, how?
     Are there some alternative, simpler ways to help consumers 
determine their nutrient intake based on what they eat? If so, please 
describe. What are the advantages and disadvantages of these options?

A. Updating RACCs

    The serving size is critical to nutrition labeling since all of the 
information on nutrient levels depends on the amount of the product 
represented. Because there is evidence that the U.S. population is 
eating larger portion sizes than they did in the 1970s and 1980s (Refs. 
3 through 6), the OWG recommends that FDA determine whether to update 
the RACCs, and if so, how to update the RACCs. Changes to the RACCs, in 
most instances, would require changes to the serving size on products, 
which in turn would require changes to the nutrient values listed on 
the nutrition label.
    Newer food consumption data are available from the 1999-2000 and 
the 2001-2002 National Health and Nutrition Examination Surveys 
(NHANES) (Ref. 7), and these data provide a more current indication of 
the amount of food being consumed by individuals. However, we do not 
want consumers to confuse the serving size on the food label (which is 
required by the act to be based on the amount customarily consumed) 
with an amount that is recommended for consumption. For example, if 
data show that consumers are drinking larger amounts of carbonated 
beverages and FDA increases the RACC, which will likely increase the 
serving size on the food label, additional educational efforts may be 
required to reinforce to consumers that a larger serving size on the 
container is not a ``recommended'' serving size.
    We request comments on these issues and specifically on the 
following questions:
     How do recent food consumption data, such as data from the 
1999-2000 and 2001-2002 NHANES, factor into the determination of which, 
if any, RACCs need to be updated? Are there other food consumption data 
sources that are available or that could be provided to the agency for 
our consideration?
     If we revise the RACCs, what criteria should be used as 
the basis for change? For example, would a percentage (e.g., 20 
percent, 25 percent, or 30 percent) increase or decrease from current 
RACCs be a valid rationale for change?
     Would consumers think that an increase in serving size on 
food labels means more of the food should be eaten? What additional 
education efforts should be provided to consumers to avoid such a 
conclusion?
     We previously stated in the preamble to the serving size 
final rule under part 101 (21 CFR part 101) (58 FR 2229 at 2235): 
``Section 403(q)(1)(A)(i) of the act, which states that a serving size 
is the amount customarily consumed, effectively requires the use of 
food consumption data as the primary basis for determining serving 
sizes.'' However, considering the issues raised previously in this 
document, should the agency reconsider its definition of ``serving'' 
and ``serving size'' or how the agency interprets ``customarily 
consumed''?

B. Single-Serving Containers

    Several comments to the OWG docket strongly opposed the practice of 
individually packaged foods that appear to be single-serving 
containers, declaring two or more servings on the

[[Page 17013]]

label--such as sodas and snack packs. In addition, as noted in the OWG 
report, FDA initiated eight focus groups around the country and, among 
other questions, asked consumers about serving size information on 
small packages. Examples of food labels were presented for a 20 fl oz 
soda and an individually packaged large muffin. In general, focus group 
participants thought that having multiple servings listed on the label 
for these products was misleading and confusing. Many participants did 
realize that if the entire package of food is eaten, the number of 
servings should be multiplied by the amount of the nutrient of 
interest; though some participants were confused and made mistakes when 
trying to calculate the total amount in their heads.
    To address this issue, we ask for comments on the following 
questions:
     Should FDA initiate rulemaking to require packages that 
can reasonably be consumed at one eating occasion to provide the 
nutrition information for the entire package? If so, what criteria 
should FDA use to determine which multiserving products would require 
nutrition information for the entire package? Should it be based on the 
total amount in the container, the type of food, or something else?
     Should such products be required to include an additional 
column within the NFP to list the quantitative amounts and % Daily 
Value for the entire package, as well as the preexisting columns 
listing the quantitative amounts and % Daily Value for a serving that 
is less than the entire package (i.e., the serving size derived from 
the RACC)? Alternatively, should the nutrition information only be 
declared for the entire package as a single serving?
     If the nutrient amount per serving size (derived from the 
RACC) and per package were listed side-by-side in separate columns, how 
would this affect consumers' ability to understand the label?
    The current cutoff criteria for single serving containers (200 
percent of the RACC (or 150 percent for products that have a RACC of 
100 g or 100 mL or larger)) does not appear to be appropriate across 
the board for all food categories. As previously noted in this 
document, participants in focus groups said they thought that having 
multiple servings listed on the label of a 20 fl oz soda (250 percent 
of the RACC) was misleading and confusing.
     Should the current cutoff criteria to define single-
serving containers be changed? Should criteria vary for different types 
of products? Explain why or why not. What criteria should be used to 
designate which package sizes should be required to list nutrition 
information for the entire package?
    In addition to the three statistical estimates previously mentioned 
in this document (i.e., the mean, median, and mode), food consumption 
surveys allow calculation of intake estimates for individuals who eat a 
greater amount of food than average (e.g., those in the 90th and 95th 
percentiles). Should package sizes falling at these amounts (e.g., 90th 
or 95th percentile), as reported from nationwide food consumption 
surveys, be used as cut points at or below which nutrition information 
should be included for the entire package? If so, the RACC tables in 
Sec.  101.12(b) would have to be modified to include a column for the 
amount specific to each product category as a cut point for when a 
product must be labeled as a single-serving container. Is this a viable 
option? If not, how can single-serving containers be defined?
    New regulations can have indirect effects, such as the repackaging 
of a product by the manufacturer.
     If FDA requires that manufacturers list the nutrient 
content for the entire package for packages up to specified sizes, are 
manufacturers likely to repackage products in larger sizes to avoid 
this requirement? If so, what are the likely impacts of this 
repackaging?
     Conversely, manufacturers may have an incentive to lower 
the size, and therefore the total calories, of single serving packages. 
Would this be an option that manufacturers would consider? If so, what 
would be the likely consequences of this repackaging?

C. Comparison of Calories in Foods of Different Portion Sizes

    As noted in the OWG Report, the Federal Trade Commission has 
suggested that FDA consider ``allowing food marketers to make truthful, 
non-misleading label claims comparing foods of different portion 
sizes.'' Our current regulations for comparative nutrient content 
claims, including calorie claims, require that all such comparisons be 
based on a uniform amount of food, i.e., per RACC for individual foods 
or per 100 g for meals and main dishes. Consequently, the current 
regulations (Sec.  101.60(b)) require that comparisons reflect actual 
nutrient differences in the same quantity of similar foods (e.g., 
``Reduced calorie chocolate ice cream, 25% fewer calories than the 
leading brand of chocolate ice cream. The leading brand contains 150 
calories per 1/2 cup serving. Our ice cream contains 100 calories per 
1/2 cup serving''). The current regulations do not permit claims that 
compare the amount of calories based on different sized portions of the 
same food.
    Nevertheless, as noted in the OWG report, ``using the food label to 
promote consumption of smaller portions may have merit [particularly] 
if consumers understand that (1) the calorie reduction is solely a 
function of the reduction in portion size and (2) the smaller portion 
size is actually less than what they usually consume.'' Thus, we 
solicit comments regarding the appropriateness of label claims based on 
the amount of calories in a specified portion of a product (i.e., the 
amount of food specified by the claim, e.g., one 15 g cookie) vs. 
claims based on the RACC and specified in the labeled serving size of a 
product (i.e., the amount specified in the Nutrition Facts panel, e.g., 
two 15 g cookies). We ask for specific comments on the following 
questions:
     Because all currently approved comparative claims are 
based on the difference in the amount of the nutrient in a uniform 
amount of food such as per RACC, or per 100 g, will it be confusing to 
consumers to have claims made only on the basis of the difference in 
the amount of calories in two different labeled servings (i.e., the 
serving size specified in two different Nutrition Facts panels, e.g., 
an 8 fl oz can vs. a 12 fl oz can of soda) or two different portions 
(i.e., amounts specified by the claim, e.g., one 15 g cookie vs. two 15 
g cookies) of the same food? Explain why or why not.
     If a claim is made based only on the difference in the 
amount of calories in two different serving sizes or portions of the 
same food, what words should be used to ensure that consumers 
understand that comparisons are made only on this basis (i.e., the 
difference in the amount of product) and that there is not a difference 
based on product reformulation, e.g., ``the caloric savings is based on 
a smaller than normal portion?''
     Should the size of the compared servings, portions, or 
packages be part of the claim (e.g., ``this 8 fl oz bottle of juice has 
33 percent fewer calories than our 12 fl oz bottle'')? Explain why or 
why not.
     Should these types of claims be limited to products that 
are identical except for the specified serving or portion size?
     Will such claims be misleading if the claim is based on 
the number of calories that are in an amount of food other than what is 
specified in the Nutrition Facts panel (e.g., claims based on half a 
``labeled serving''--one cookie, compared to the amount specified in 
the Nutrition Facts panel--two cookies)?

[[Page 17014]]

     Should this claim be limited to single-serving containers, 
or is it appropriate on multi-serving packages? Explain why or why not.
     If claims are permitted on multi-serving packages, should 
these claims be limited to products that have portioned pieces, such as 
cookies or slices of bread, or should they be allowed on products that 
are not portion controlled, such as pies or bulk sodas? For example, 
might this claim be extended to ``bulk'' products such as pizza 
suggesting that if you cut a smaller slice, you will get a caloric 
savings?
     What comparative terms are appropriate? Because 
``reduced'' has always been used to signal some type of reformulation 
(i.e., special processing, alteration, formulation, or reformulation to 
lower the nutrient content), is it appropriate to use the term 
``reduced'' on products that have not been so altered? Is ``less 
than,'' which has been used more broadly to signal differences in 
nutrient levels derived through a variety of means, a more appropriate 
term?
     Currently all comparative calorie claims are limited to 
reductions of at least 25 percent. Should these comparisons (e.g., 
reduced or fewer calories) continue to be limited to reductions of at 
least 25 percent, and if not, what justification is there that a 
smaller reduction of calories would be meaningful and significant? 
Please provide data.
     What other requirements may be necessary to ensure that 
the claim is not confusing or misleading to consumers?
     If manufacturers are permitted to make such label 
comparisons of different portion sizes of food, what is the likely 
change in the distribution of package sizes that will become available 
to consumers?
     What other labeling changes, if any, would encourage a 
broader range of package sizes?

III. Future Analysis of Benefits and Costs

    If the agency proposes regulatory changes based on the initiatives 
outlined in this ANPRM, we will estimate the costs of labeling changes 
and other potential costs (such as the costs of reformulating products) 
should the regulations create incentives for new products. The comments 
on this ANPRM may identify other costs as well. The benefits of the 
regulatory options depend on how consumers respond to the changes in 
label serving sizes or package sizes. We will use the information from 
comments to help determine ways to estimate the possible consumer 
responses to various changes. The comments will also contribute to our 
estimates of the effects of regulatory options on small entities.

IV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
FDA has verified the Web site addresses but is not responsible for 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.
    1. Report of the Working Group on Obesity, ``Calories Count'' 
(Internet address: http://www.cfsan.fda.gov/dms/owg-toc.html), March 
12, 2004.
    2. Food and Drug Administration, Center for Food Safety and 
Applied Nutrition, ``2002 Health and Diet Survey--Preliminary 
Topline Frequencies (Weighted),'' March 2004.
    3. U.S. Department of Health and Human Services, National 
Institutes of Health, National Heart, Lung, and Blood Institute, 
``Portion Distortion! Do You Know How Food Portions Have Changed in 
20 Years?'' (Internet address: http://hin.nhlbi.nih.gov/portion/
index.htm).
    4. Young, L. R. and M. Nestle, ``Expanding Portion Sizes in the 
U.S. Marketplace: Implications for Nutrition Counseling,'' Journal 
of the American Dietetic Association, Vol. 103, No. 2, pp. 231-234, 
February 2003.
    5. Smiciklas-Wright, H., D. C. Mitchell, S. J. Mickle, J. D. 
Goldman, A. Cook, ``Foods Commonly Eaten in the United States, 1989-
1991 and 1994-1996, Are Portion Sizes Changing?'' Journal of the 
American Dietetic Association, Vol. 103, No. 1, pp. 41-47, January 
2003.
    6. Nielsen, S. J. and B. M. Popkin, ``Patterns and Trends in 
Food Portion Sizes, 1977-1998,'' Journal of the American Medical 
Association, Vol. 289, No. 4, pp. 450-453, January 22/29, 2003.
    7. U.S. Department of Health and Human Services, National Center 
for Health Statistics, NHANES 1999-2000 Data Files (Internet 
address: http://www.cdc.gov/nchs/about/major/nhanes/NHANES99_
00.htm) and NHANES 2001-2002 Data Files (Internet address: http://
www.cdc.gov/nchs/about/major/nhanes/nhanes01-02.htm).

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: March 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-6644 Filed 4-1-05; 8:45 am]
BILLING CODE 4160-01-S