
[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Proposed Rules]
[Pages 44484-44485]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17805]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1140

[Docket No. FDA-2013-N-0521]


Menthol in Cigarettes, Tobacco Products; Request for Comments

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 potential regulation of menthol in cigarettes. FDA is also making 
available its preliminary scientific evaluation of public health issues 
related to the use of menthol in cigarettes. The preliminary scientific 
evaluation indicates there is likely a public health impact of menthol 
in cigarettes. This ANPRM is seeking comments, including comments on 
FDA's preliminary evaluation, and data, research, or other information 
that may inform regulatory actions FDA might take with respect to 
menthol in cigarettes.

DATES: Submit either electronic or written comments by September 23, 
2013.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0521, 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:
     Mail/Hand delivery/Courier (for paper 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-2013-N-0521 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 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: Annette L. Marthaler, Center for 
Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 877-287-1373, CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Family Smoking Prevention and 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, section 
907(e) of the FD&C Act (21 U.S.C 387g(e)) requires FDA's Tobacco 
Products Scientific Advisory Committee (TPSAC) to submit a report and 
recommendations to the Secretary of Health and Human Services (the 
Secretary of HHS) on the impact of the use of menthol in cigarettes on 
the public health, including use among children, African Americans, 
Hispanics, and other racial/ethnic minorities.
    TPSAC has submitted the report to HHS, available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM269697.pdf. In addition, 
the nonvoting industry representatives of TPSAC submitted a separate 
document reflecting the industry perspective, available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM249320.pdf. Two cigarette 
manufacturers have challenged FDA's ability to rely on TPSAC's menthol 
report, and that case is currently pending (Lorillard, Inc. v. FDA, No. 
11-440 (D.D.C.)).
    Experts within FDA's Center for Tobacco Products (CTP) also 
initiated an independent evaluation of the available science related to 
the impact of the use of menthol in cigarettes on public health 
including peer-reviewed literature, secondary data analyses, and 
independent CTP analyses of relevant large data sets. This preliminary 
independent evaluation is entitled ``Preliminary Scientific Evaluation 
of the Possible Public Health Effects of Menthol Versus Nonmenthol 
Cigarettes'' (the evaluation) (Ref. 1). The evaluation has been peer 
reviewed, and the peer review report is available on FDA's Web site at 
http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm. FDA is 
also making available an addendum with articles published since the 
evaluation was submitted for peer review in 2011 (Ref. 2).
    As discussed previously, the FD&C Act provides FDA with authority 
to regulate tobacco products. This includes authority to adopt a 
tobacco product standard under section 907 of the FD&C Act if the 
Secretary of HHS finds that a tobacco product standard is appropriate 
for the protection of public health and includes authority to amend an 
existing product standard. In making such a finding, the Secretary of 
HHS must consider scientific evidence concerning: (1) The risks and 
benefits to the population as a whole, including users and nonusers of 
tobacco products, of the product standard; (2) the increased or 
decreased likelihood that existing users of tobacco products will stop 
using such products; and (3) the increased or decreased likelihood that 
those who do not use tobacco products will start using such products. 
The FD&C Act also provides FDA with authority to, by

[[Page 44485]]

regulation, require restrictions on the sale and distribution of a 
tobacco product (section 906(d)(1) of the FD&C Act (21 U.S.C. 
387f(d)(1))). The restrictions on sale and distribution of a tobacco 
product may include restrictions on the access to, and the advertising 
and promotion of, the tobacco product, if the Secretary of HHS 
determines such regulation would be appropriate for the public health.
    FDA intends to use the information submitted in response to this 
Federal Register document, FDA's preliminary independent scientific 
evaluation, and other appropriate information to inform its thinking 
about options for regulating menthol in cigarettes.

II. Request for Comments and Information

    FDA is seeking comments, including comments on its preliminary 
evaluation, and data, research (e.g., published or unpublished studies, 
case studies), and any other information related to the following 
questions. Please explain your responses and provide any evidence or 
other information supporting your responses to the following questions:

A. Tobacco Product Standards

    1. Should FDA consider establishing a tobacco product standard for 
menthol in menthol cigarettes? If so, what allowable level of menthol 
(e.g., maximum or minimum) would be appropriate for the protection of 
the public health?
    2. Rather than a tobacco product standard for menthol in menthol 
cigarettes, should FDA consider a tobacco product standard for any 
additive, constituent, artificial or natural flavor, or other 
ingredient that produces a characterizing flavor of menthol in the 
tobacco product or its smoke?
    3. If a tobacco product standard for menthol in menthol cigarettes 
were to be established, should FDA consider issuing regulations to 
address menthol in other tobacco products besides cigarettes? If so, 
what other tobacco products with menthol should be regulated: All 
tobacco products, just all combusted tobacco products, or some other 
category or group of tobacco products? If not, what distinctions should 
be made between products?
    4. If a product standard prohibiting or limiting menthol were to be 
established, what length of time should manufacturers be provided to 
achieve compliance with the standard? If a product standard prohibiting 
or limiting menthol were to be established, would a stepped approach in 
which the level of menthol was gradually reduced be appropriate for the 
protection of the public health?
    5. If a product standard limiting menthol were to be established, 
are there alternatives that could be substituted by manufacturers to 
maintain the effect or appeal of menthol to menthol cigarette smokers 
and potential initiators? If so, what are these substitutes? Should 
they be regulated if menthol is regulated; and if so, how should they 
be regulated? If not, what distinctions should be made between menthol 
and potential substitutes?

B. Sale and Distribution Restrictions

    1. Should FDA consider establishing restrictions on the sale and/or 
distribution of menthol cigarettes? If so, what restrictions would be 
appropriate and what would be the impact on youth or adult smoking 
behavior, initiation, and cessation?
    2. Should FDA consider establishing restrictions on the advertising 
and promotion of menthol cigarettes? If so, what restrictions would be 
appropriate and what would be the impact on youth or adult smoking 
behavior, initiation, and cessation?

C. Other Actions and Considerations

    1. Are there other tobacco product standards, regulatory, or other 
actions that FDA could implement that would more effectively reduce the 
harms caused by menthol cigarette smoking and better protect the public 
health than the tobacco product standards or regulatory actions 
discussed in the preceding questions?
    2. To the extent that you have identified a tobacco product 
standard or other regulatory action in response to the prior questions, 
please provide additional information and comments on:
    2.1 Is compliance with the tobacco product standard or other 
regulatory action you identified technically achievable?
    2.2 How FDA would structure a corresponding rule to maximize 
compliance, facilitate enforcement, and otherwise maximize public 
health benefits?
    3. If menthol cigarettes could no longer be legally sold, is there 
evidence that illicit trade in menthol cigarettes would become a 
significant problem? If so what would be the impact of any such illicit 
trade on public health? How would any such illicit trade compare to the 
existing illicit trade in cigarettes?
    4. What additional information and research beyond that described 
in the evaluation is there on the potential impact of sale and 
distribution restrictions of menthol cigarettes on specific 
subpopulations, such as those based on racial, ethnic, socioeconomic 
status, and sexuality/gender identity?
    5. To what extent are you aware of current (within the past 5 
years) advertising and/or promotion of menthol cigarettes that have 
targeted specific communities, subpopulations, and locations, beyond 
that described in the evaluation?
    6. Might any current advertising or other marketing or public 
statements concerning menthol cigarettes, or menthol in other tobacco 
products, constitute reduced risk claims?

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

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, 
and are available electronically at http://www.regulations.gov.
1. CTP, Preliminary Scientific Evaluation of the Possible Public 
Health Effects of Menthol Versus Nonmenthol Cigarettes.
2. CTP, Reference Addendum to the ``Preliminary Scientific 
Evaluation of the Possible Public Health Effects of Menthol versus 
Nonmenthol Cigarettes, 2013.''

    Dated: July 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17805 Filed 7-23-13; 8:45 am]
BILLING CODE 4160-01-P


