Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products, 55835-55837 [2011-23096]
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Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Proposed Rules
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Friday, September 16, 2011, from 9 a.m.
until 3 p.m. in room 8E–089. The
tentative meeting agenda includes
introductions, agreement on facilitator
and rules of procedure, presentations
from DOE consultants on the results of
their revised analysis of alternative
candidate standard levels, and
identification of the issues to be
addressed by the negotiations, and any
outstanding data needs.
Public Participation: Members of the
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comments related to the issues being
discussed at appropriate points, when
called on by the moderator. The
facilitator will make every effort to hear
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limits required for the orderly conduct
of business. To attend the meeting and/
or to make oral statements regarding any
of the items on the agenda, e-mail
erac@ee.doe.gov no later than 5 p.m.,
Thursday, September 8, 2011. Please
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erac@ee.doe.gov.
Minutes: The minutes of the meeting
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Issued in Washington, DC, on August 29,
2011.
LaTanya R. Butler,
Acting Deputy Committee Management
Officer.
[FR Doc. 2011–22457 Filed 9–8–11; 8:45 am]
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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.
Advance notice of proposed
rulemaking.
ACTION:
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-toface 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:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
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
PO 00000
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55835
Regulatory Information Number (RIN
0910–AG43) for this rulemaking. All
comments received may be posted
without change to https://
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 https://
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
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55836
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Proposed Rules
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.
FDA has determined that additional
information is needed about the nonface-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.
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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Furthermore, because the enactment of
the PACT Act affects the non-face-toface 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-toface 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?
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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-faceto-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-toface 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?
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Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Proposed Rules
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?
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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
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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 https://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.
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55837
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
DEPARTMENT OF THE INTERIOR
Office of Natural Resources Revenue
30 CFR Parts 1202 and 1206
[Docket No. ONRR–2011–0004]
RIN 1012–AA00
Workshops To Discuss Revisions to
Federal and Indian Coal Valuation
Regulations: Advance Notice of
Proposed Rulemaking
Office of Natural Resources
Revenue, Interior.
ACTION: Notice of Public Workshops.
AGENCY:
The Office of Natural
Resources Revenue (ONRR) announces
three public workshops to discuss
specific issues regarding the existing
royalty valuation regulations at 30 CFR
parts 1202 and 1206 for coal produced
from Federal and Indian leases.
DATES: The public workshop dates and
cities are:
Workshop 1—October 12, 2011
(8:30 a.m.–12 p.m. mountain time) in
Denver, Colorado.
Workshop 2—October 18, 2011
(8:30 a.m.–12 p.m., central time) in
St. Louis, Missouri.
Workshop 3—October 20, 2011
(8:30 a.m.–12 p.m. mountain time) in
Albuquerque, New Mexico.
ADDRESSES: The public workshop
locations are:
Workshop 1—Office of Natural
Resources Revenue, Denver Federal
Center, 6th Avenue and Kipling Street,
Building 85, Auditoriums A–D, Denver,
Colorado 80226, telephone number
(303) 231–3585.
Workshop 2—Marriott St. Louis
Airport, 10700 Pear Tree Lane, St.
Louis, Missouri 63134, telephone
number (314) 423–9700.
Workshop 3—Bureau of Land
Management, Albuquerque District
Office, 435 Montano Road, NW.,
Albuquerque, New Mexico 87102,
telephone number (505) 761–8700.
FOR FURTHER INFORMATION CONTACT: Hyla
Hurst, Regulatory Specialist, Office of
Natural Resources Revenue, P.O. Box
25165, MS 61013C, Denver, Colorado
80225, telephone (303) 231–3495, fax
number (303) 233–2225, e-mail
hyla.hurst@onrr.gov.
SUPPLEMENTARY INFORMATION: The
comment period for the Advance Notice
SUMMARY:
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Agencies
[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.
-----------------------------------------------------------------------
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: https://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 https://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 https://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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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 https://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