[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Proposed Rules]
[Pages 55835-55837]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23096]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1140

[Docket No. FDA-2011-N-0467]
RIN 0910-AG43


Non-Face-to-Face Sale and Distribution of Tobacco Products and 
Advertising, Promotion, and Marketing of Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this advance 
notice of proposed rulemaking (ANPRM) to obtain information related to 
the regulation of non-face-to-face sale and distribution of tobacco 
products and the advertising, promotion, and marketing of tobacco 
products. FDA is taking this action as part of its implementation of 
the Family Smoking Prevention and Tobacco Control Act (Tobacco Control 
Act). FDA is requesting comments, data, research, or other information 
related to non-face-to-face sale and distribution of tobacco products; 
the advertising, promotion, and marketing of such products; and the 
advertising of tobacco products via the Internet, e-mail, direct mail, 
telephone, smart phones, and other communication technologies that can 
be directed to specific recipients.

DATES: Submit either electronic or written comments by December 8, 
2011.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0467 and/or RIN number 0910-AG43, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2011-N-0467 and Regulatory Information Number (RIN 
0910-AG43) for this rulemaking. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided. For additional information on submitting 
comments, 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.regulations.gov, 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: Beth Buckler, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 877-287-1373, beth.buckler@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The Tobacco Control Act, enacted on June 22, 2009, amends the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) and provides FDA 
with the authority to regulate tobacco products (Pub. L. 111-31, 123 
Stat. 1776). Among other things, the Tobacco Control Act requires FDA 
to issue regulations, by October 1, 2011, regarding the sale and 
distribution of tobacco products that occur through means other than a 
direct, face-to-face exchange between a retailer and a consumer (i.e., 
a non-face-to-face or remote sale) in order to prevent the sale and 
distribution of tobacco products to individuals who have not attained 
the minimum age established by applicable law for the purchase of such 
products, including requirements for age verification (section 
906(d)(4)(A)(i) of the FD&C Act (21 U.S.C. 387f(d)(4)(A)(i))). The 
Tobacco Control Act also requires FDA to issue regulations, by April 1, 
2012, to address the promotion and marketing of tobacco products that 
are sold or distributed through a non-face-to-face exchange in order to 
protect individuals who have not attained the minimum age established 
by applicable law for the purchase of such products (section 
906(d)(4)(A)(ii)). Furthermore, section 906(d)(1) of the FD&C Act 
provides that the Secretary of Health and Human Services (the 
Secretary) may by regulation require restrictions on the sale and 
distribution of a tobacco product, including restrictions on the access 
to, and the advertising and

[[Page 55836]]

promotion of, the tobacco product, if the Secretary determines that 
such regulation would be appropriate for the protection of the public 
health.
    On March 31, 2010, following the enactment of the Tobacco Control 
Act, and before FDA could issue the regulations required by section 
906(d)(4)(A) of the FD&C Act, the Prevent All Cigarette Trafficking 
(PACT) Act of 2009 (Pub. L. 111-154; 124 Stat. 1087) became law. Among 
other things, the PACT Act makes cigarettes and smokeless tobacco \1\ 
nonmailable matter, with certain exceptions, and requires Internet and 
other remote sellers to comply with all State, local, Tribal, and other 
laws that apply generally to sales of cigarettes or smokeless tobacco 
that occur entirely within the State in which the cigarettes or 
smokeless tobacco products are delivered, including laws imposing 
restrictions on sales to minors (18 U.S.C. 1716E, 15 U.S.C. 
376a(a)(3)). In addition, the PACT Act requires Internet and other 
remote sellers to: (1) Verify the age of their customers prior to the 
sale through the use of commercially-available databases to ensure, 
among other things, that the purchaser is at least the minimum age 
required by law at the place of delivery, and (2) use a method of 
delivery that requires verification of the age and identification of 
the person accepting delivery of the product to ensure that the person 
is at least the minimum age required by law at the place of delivery 
(15 U.S.C. 376a(b)(4)). The PACT Act also directs the Attorney General 
of the United States to create and distribute a list of delivery 
sellers of cigarettes or smokeless tobacco that are not in compliance 
with the PACT Act. This list will be provided to the attorney general 
and tax administrator of every State, common carriers and other persons 
that deliver small packages to consumers in interstate commerce, 
including the U.S. Postal Service, and any other person that can 
promote the effective enforcement of the PACT Act (15 U.S.C. 
376a(e)(1)(A)). The U.S. Postal Service and the Department of Justice's 
Bureau of Alcohol, Tobacco, Firearms and Explosives are responsible for 
implementing the provisions of the PACT Act.
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    \1\ The PACT Act defines the terms ``cigarettes'' and 
``smokeless tobacco'' differently than the FD&C Act (see 15 U.S.C. 
375(a)(2) and (a)(12) of the PACT Act and section 900(3) and (18) of 
the FD&C Act).
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    FDA has determined that additional information is needed about the 
non-face-to-face sale and distribution of tobacco products prior to 
issuing the regulations required by section 906(d)(4)(A)(i) of the FD&C 
Act. Furthermore, because the enactment of the PACT Act affects the 
non-face-to-face sale and distribution of cigarettes and smokeless 
tobacco, FDA is seeking information about how non-face-to-face sale and 
distribution practices for cigarettes and smokeless tobacco have 
changed or will change in light of the PACT Act and its implementing 
regulations (75 FR 29662, May 27, 2010; 75 FR 35302, June 22, 2010). 
FDA also has determined that additional information is needed about the 
advertising, promotion, and marketing of tobacco products prior to 
issuing regulations under sections 906(d)(4)(A)(ii) and 906(d)(1) of 
the FD&C Act. Specifically, FDA is seeking information about the 
advertising, promotion, and marketing of tobacco products sold or 
distributed through a non-face-to-face exchange. In addition, given the 
rapid expansion of the Internet and mobile technologies, FDA is seeking 
information about the advertising of tobacco products via the Internet, 
e-mail, direct mail, telephone, smart phones, and other communication 
technologies that can be directed to specific recipients.
    FDA believes that issuing an ANPRM is the best approach for 
ensuring that the Agency has the information it needs to issue 
effective regulations under that section. FDA intends to use the 
information submitted in response to this document to inform its 
regulation of the sale and distribution of tobacco products through a 
non-face-to-face exchange and the advertising, promotion, and marketing 
of tobacco products.

II. Request for Comments and Information

    FDA is seeking data, research, information, and comments related to 
the following:

A. Non-Face-to-Face Sale and Distribution of Tobacco Products

    1. Other than direct mail, catalog, and Internet sales, what types 
of non-face-to-face sales and distribution methods are used to sell or 
distribute tobacco products to consumers?
    2. Do the non-face-to-face sales and distribution methods differ 
depending on the type of tobacco product being sold (e.g., cigarettes, 
smokeless tobacco, or other products ``made or derived from tobacco'' 
subject to the Tobacco Control Act)? If so, how?
    3. What are the methods used by minors to acquire tobacco products 
through a non-face-to-face exchange?
    a. Which of these methods are minors most successful in using to 
obtain tobacco products?
    b. What are the best data sources (other than Federal Government 
surveys) for information about the extent and character of such 
purchases by minors?
    4. Since the enactment of the PACT Act, have minors found 
alternative methods to purchase and/or acquire cigarettes or smokeless 
tobacco products by a means other than a face-to-face exchange? If so, 
what are they?
    5. What are the current technologies, procedures, or other methods 
used to ensure that the purchaser of a tobacco product through a non-
face-to-face exchange is an adult, including age and ID verification?
    a. How effective are these methods at preventing minors' access to 
tobacco products through a non-face-to-face exchange?
    b. If these methods are not effective, which other technologies, 
procedures, or methods would work more effectively to prevent minors' 
access to tobacco products through a non-face-to-face exchange?
    c. Do these methods differ depending on the type of non-face-to-
face exchange (e.g., Internet, direct mail, catalog, telephone, etc.)? 
If so, how?
    d. Is requiring an adult (whether or not the person who placed an 
order) to sign for the delivery of tobacco products adequate to ensure 
that tobacco products purchased through a non-face-to-face exchange are 
not delivered to minors? Or, is it necessary to require that the 
products be delivered only to the person who ordered them? Are there 
other requirements that could be placed on the delivery of tobacco 
products to prevent their delivery to minors?
    6. What payment methods are used for the sale of tobacco products 
through non-face-to-face exchanges? Do these payment methods differ 
depending on the type of tobacco product purchased? If so, how?
    7. To what extent are tobacco products sold through a non-face-to-
face exchange sold at substantially lower prices than the same types of 
tobacco products sold through a face-to-face exchange? Do the price 
differences vary depending on the type of tobacco product purchased? If 
so, how?
    8. What means are used to deliver tobacco products sold to 
consumers through non-face-to-face exchanges?
    a. Do these means of delivery differ depending on the type of non-
face-to-face exchange (e.g., Internet, direct mail, catalog, etc.)? If 
so, how?
    b. Do these means of delivery differ depending on the type of 
tobacco product sold? If so, how?

[[Page 55837]]

    c. Do these means of delivery differ depending on the location of 
the seller and/or purchaser? If so, how?
    9. What strategies, if any, are used by tobacco product 
manufacturers to ensure that their tobacco products are not sold or 
distributed to minors through non-face-to-face exchanges by parties 
other than the manufacturer?
    a. Do tobacco product manufacturers verify the effectiveness of 
these strategies? If so, how?
    b. Are there any data available to verify the effectiveness of 
these strategies? If so, what are they?
    10. How can FDA most effectively partner with other Federal 
agencies and State, local, territorial, and Tribal governments to 
prevent the sale and distribution of tobacco products to minors through 
non-face-to-face exchanges?

B. Advertising, Promotion, and Marketing of Tobacco Products

    11. What forms of advertising, promotion, and marketing are used to 
promote the sale of tobacco products through non-face-to-face 
exchanges?
    a. What are the current trends in these forms of advertising, 
promotion, and marketing?
    b. Which of these forms of advertising, promotion, and marketing 
are appealing to minors?
    c. Are there themes or techniques used in these forms of 
advertising, promotion, and marketing that are appealing to minors?
    12. How are the Internet, e-mail, direct mail, telephone, 
smartphones, and other communication technologies used to direct 
tobacco product advertising, marketing, and promotion messages to 
specific recipients?
    a. What are the current trends in these forms of advertising, 
promotion, and marketing?
    b. Which of these forms of advertising, promotion, and marketing 
are appealing to minors?
    c. Are there themes or techniques used in these forms of 
advertising, promotion, and marketing that are appealing to minors?
    d. To what extent are databases with individual tobacco user 
information used to direct tobacco product advertising, marketing, and 
promotion messages to specific recipients?
    13. What technologies, procedures or other methods are currently 
used by the tobacco industry (including, but not limited to, 
manufacturers, importers, distributors, and retailers) to restrict or 
minimize a minor's exposure to the forms of advertising, promotion, and 
marketing of tobacco products described in questions 11 and 12 of 
section II.B of this document?
    a. How effective are these methods at restricting or minimizing 
such exposure?
    b. If these methods are not effective, what other technologies, 
procedures, or methods would work more effectively to restrict or 
minimize the exposure of minors to such advertising, promotion, and 
marketing?
    c. Would the technologies, procedures, or other methods described 
in question 13b prevent such tobacco product advertising, promotion, 
and marketing from reaching adult consumers? If so, what alternatives 
are available to minimize minors' exposure while still enabling tobacco 
product information to be communicated to adults?
    d. To the extent that minors' exposure to tobacco product 
advertising, promotion, and marketing cannot be eliminated, what 
restrictions or requirements could be placed on such advertising, 
promotion, and marketing to minimize its appeal to or influence on 
minors who are exposed to it?
    e. Would the technologies, procedures, or other methods described 
in question 13d of section II.B of this document prevent the 
communication of tobacco product information to adult consumers? If so, 
what alternatives are available to minimize minors' exposure while 
still enabling tobacco product information to be communicated to 
adults?
    14. Given the rapid growth of social media (e.g., Facebook, 
Twitter, YouTube, etc.), how can minors' exposure to tobacco product 
advertising, promotion, and marketing through these types of media be 
restricted or minimized?

III. Submission of Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be viewed electronically at http://www.regulations.gov or by visiting the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Authority: The ANPRM is issued under section 906 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 387f) and under the 
authority of the Commissioner of Food and Drugs.

    Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23096 Filed 9-8-11; 8:45 am]
BILLING CODE 4160-01-P