[Federal Register Volume 83, Number 58 (Monday, March 26, 2018)]
[Proposed Rules]
[Pages 12901-12904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06047]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1140, and 1143

[Docket No. FDA-2017-N-6107]
RIN 0910-AH88


Regulation of Premium Cigars

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 premium cigars under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention 
and Tobacco Control Act (Tobacco Control Act), and regulations 
regarding the sale and distribution of tobacco products. Specifically, 
this ANPRM is seeking comments, data, research results, or other 
information that may inform regulatory actions FDA might take with 
respect to premium cigars.

DATES: Submit either electronic or written comments by June 25, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 25, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of June 25, 2018. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

[[Page 12902]]

     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-6107 for ``Regulation of Premium Cigars.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nathan Mease or Deirdre Jurand, Center 
for Tobacco Products, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 1-877-287-1373, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On July 28, 2017, FDA announced a new comprehensive plan for 
tobacco and nicotine regulation that will serve as a multi-year roadmap 
to better protect children and significantly reduce tobacco-related 
disease and death. As part of that announcement, FDA stated that it 
would solicit additional comments and scientific data related to the 
patterns of use and resulting public health impacts from premium cigars 
and consider the appropriate regulatory status of premium cigars. The 
goal is to ensure that FDA has a broad scientific and regulatory 
foundation to efficiently and effectively implement the Tobacco Control 
Act. Moreover, the regulatory considerations with respect to premium 
cigars, their use, and related public health issues continue to be of 
significant interest to some stakeholders, as well as a topic of 
ongoing and emerging research. Given the ongoing interest from many 
parties and sectors, such as industry and Members of Congress, in the 
regulatory status of premium cigars, FDA is issuing this ANPRM to 
request relevant new and different information, data, and analysis not 
submitted in response to FDA's proposed deeming rule (79 FR 23142, 
discussed below) that could inform FDA's regulation of premium cigars.
    The Tobacco Control Act was enacted on June 22, 2009, amending the 
FD&C Act and providing FDA with the authority to regulate tobacco 
products (Pub. L. 111-31). Specifically, section 101(b) of the Tobacco 
Control Act amends the FD&C Act by adding a new chapter that provides 
FDA with authority over tobacco products. Section 901 of the FD&C Act 
(21 U.S.C. 387a), as amended by the Tobacco Control Act, states that 
the new chapter in the FD&C Act (chapter IX--Tobacco Products) (21 
U.S.C. 387 through 387u) \1\ applies to all cigarettes, cigarette 
tobacco, roll-your-own tobacco, smokeless tobacco, and any other 
tobacco products that the Secretary of Health and Human Services by 
regulation deems to be subject to the chapter.
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    \1\ In the U.S. Code, the tobacco control provisions constitute 
a new Subchapter IX of Chapter 9, which constitutes the Federal 
Food, Drug, and Cosmetic Act.
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    In the Federal Register of April 25, 2014 (79 FR 23142), FDA 
published a proposed rule seeking to deem additional products meeting 
the statutory definition of ``tobacco product'' in section 201(rr) of 
the FD&C Act (21 U.S.C. 321(rr)), except accessories to those products, 
to be subject to chapter IX of the FD&C Act (the proposed deeming 
rule). In that proposed rule, FDA proposed two, alternative, options: 
Option 1 proposed to extend the Agency's tobacco product authorities to 
all products that meet the definition of ``tobacco product'' in the 
FD&C Act, except accessories of newly deemed tobacco products, while 
Option 2 proposed to extend the Agency's tobacco product authorities to 
all tobacco products set forth in Option 1, except so-called premium 
cigars (79 FR 23142 at 23150 through 23152). After carefully 
considering the public comments on the rule, the Agency decided to 
adopt Option 1, concluding that there was no appropriate public health 
justification to exclude premium cigars from regulation. Specifically, 
FDA concluded that: (1) All cigars pose serious negative health risks, 
(2) the available evidence does not provide a basis for FDA to conclude 
that the patterns of premium cigar use sufficiently reduce the health 
risks to warrant exclusion, and (3) premium cigars are used by youth 
and young adults. FDA noted that, although some premium cigar smokers 
might smoke these products infrequently or report that they do not 
inhale, these behaviors do not negate the adverse health effects of 
tobacco smoke or demonstrate that cigars do not cause secondhand smoke-
related disease in others. Consequently, premium cigars were included 
in the scope of the final deeming rule published on May 10, 2016 (81 FR 
28974 at 29020) to more effectively protect the public health.
    We received numerous comments on the deeming proposed rule with 
respect to premium cigars, both in favor of and against regulating 
these products. However, the comments against regulation provided 
little data to support the opinions expressed and, where studies were 
submitted, provided little information about the studies cited.
    FDA is seeking comments, evidence, information, data, and analysis 
that were not submitted in response to the proposed deeming rule, or 
that may have become available since then, that could further inform 
FDA's thinking about the regulation of premium cigars. One example of 
the type of information that would be responsive to this request is a 
recent publication that assessed use patterns and related behaviors of 
smokers of ``premium'' and other cigar types (Ref. 1). This paper, the 
PATH

[[Page 12903]]

Study Paper, analyzed findings from the 2013-2014 Population Assessment 
of Tobacco and Health (PATH) Study with a focus on smokers of filtered 
cigars, cigarillos, and traditional cigars, which were further 
classified by study authors as either ``premium'' or ``non-premium.'' 
\2\ With respect to this group of smokers, the PATH Study Paper 
described similarities and differences in user characteristics, tobacco 
use patterns, and purchasing behaviors according to cigar type. Among 
the findings stated in this PATH Study Paper were that those who smoked 
``premium'' cigars tended to report smoking them on fewer days compared 
with smokers of the other cigar types and reported consuming fewer 
cigars per day, on average, compared with smokers of other cigar types. 
In its conclusion, the PATH Study Paper highlighted the importance of 
adequately describing the cigar type studied and, where appropriate, 
differentiating results by cigar type.
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    \2\ While authors of the PATH Study Paper included FDA 
employees, the definition of premium cigars reported in the PATH 
Study Paper was used for research purposes only, and does not 
necessarily reflect FDA's current thinking on regulatory policy.
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    When reviewing the PATH Study Paper and any other studies 
concerning cigars, it should be noted that tobacco research studies 
have not used a single, consistent definition of ``premium'' cigars. As 
demonstrated by FDA's request for definitional information in this 
document, FDA considers it important to understand what definitions of 
premium cigar are used when analyzing and comparing results across 
studies and papers.
    For the purposes of the questions in this ANPRM, ``cigar'' means a 
tobacco product that: (1) Is not a cigarette and (2) is a roll of 
tobacco wrapped in leaf tobacco or any substance containing tobacco 
(see 21 CFR 1143.1).

II. Requests for Comments and Information

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

 Definition of premium cigars
 Use patterns of premium cigars
 Public health considerations associated with premium cigars

    Please provide any evidence or other information supporting your 
comments. Also, provide the definition of ``premium cigar,'' ``youth,'' 
and ``young adult'' used for the studies, information, or views 
provided in your responses.

A. Definition of Premium Cigars

    1. Explain what data may be used to assess (a) the universe of 
cigar products that are currently available to consumers and (b) their 
relevant characteristics, including ``premium'' status. How can 
available sources of information, such as manufacturer registrations 
and/or product listings with FDA, be used in this assessment?
    2. Explain what you believe to be the particular defining 
characteristics of premium cigars. These characteristics could include, 
but not be limited to:
    a. Size (e.g., length, ring gauge, total weight).
    b. Tobacco filler type and minimum required percentages of each 
filler per cigar.
    c. Fermentation type.
    d. Wrapper and binder composition (e.g., whole leaf, reconstituted 
or homogenized tobacco leaf).
    e. Where the tobacco used for premium cigar filler or wrappers is 
grown, and whether differences in growing practices for that tobacco, 
as compared to tobacco used in other cigars, result in different health 
impacts.
    f. Presence or absence of a filter.
    g. Presence or absence of a mouthpiece.
    h. Manufacturing and assembly process (e.g., including any 
production by hand or by machine).
    i. Rate of production (e.g., ``produced at no more than [insert 
number] units per minute'').
    j. Presence or absence of flavor imparting compounds, flavor 
additives, or characterizing flavors other than tobacco.
    k. Presence or absence of any additives other than cigar glue.
    l. Nicotine content.
    m. Tar delivery amounts (and how this should be defined and 
measured).
    n. Carbon monoxide delivery amounts (and how this should be defined 
and measured).
    o. Retail price.
    p. Frequency with which price changes are initiated by particular 
levels in the distribution chain (retailers, manufacturers, importers, 
and/or distributors).
    q. Packaging quantity and size.
    r. Any action directed to consumers, by a retailer or manufacturer, 
such as through labeling, advertising, or marketing, which would 
reasonably be expected to result in consumers believing that the 
tobacco product is a premium cigar.
    3. If available to you, provide annual sales data, including market 
size and volume, for products that you believe should be categorized as 
premium cigars, along with the information's source and the definition 
of ``premium cigar'' used in the data provided.

B. Use Patterns of Premium Cigars

    If available to you, provide the following information related to 
the use patterns of premium cigars generally and among youth and young 
adults specifically:
    1. Studies or information regarding the potential role of premium 
cigars on tobacco initiation and progression to use of other tobacco 
products, especially compared and contrasted against the potential 
roles of other cigars.
    2. Studies or information regarding behavioral data related to dual 
use of premium cigars and other tobacco products, especially compared 
and contrasted against dual use of other cigars.
    3. Studies or information regarding the frequency and intensity 
(e.g., number of cigars smoked per day, depth of smoke inhalation, 
number of days smoking during a particular time period) of premium 
cigar use, especially compared and contrasted against other cigars.
    4. Studies or information regarding the proportion of premium cigar 
smokers showing symptoms of dependence, especially compared and 
contrasted against other cigars.
    5. Studies or information regarding the abuse liability of premium 
cigars compared with other tobacco products, especially compared and 
contrasted against other cigars.
    6. Studies or information regarding the impact of premium cigar 
labeling, advertising, and marketing efforts on patterns of use, 
especially compared and contrasted against other cigars.
    7. Information on the extent to which users of other tobacco 
products might switch to premium cigars if FDA were to exempt premium 
cigars from regulation or to regulate premium cigars differently from 
other cigars, and the measures that could be taken to prevent this from 
occurring. Where you discuss the potential effects of FDA regulating 
premium cigars differently from other cigars, please describe the 
specific different treatment that you envision.

C. Public Health Considerations

    If available to you, provide the following information related to 
public health considerations:
    1. Studies or information on any applicable manufacturing, 
marketing, sale, distribution, advertising, labeling, and/or packaging 
requirements and restrictions in the FD&C Act and its implementing 
regulations, and whether they should be applied differently to

[[Page 12904]]

premium cigars compared to other tobacco products, including other 
cigars.
    2. Studies or information regarding nicotine concentrations for 
premium cigars compared to other tobacco products, including other 
cigars.
    3. Studies or information regarding the risk of oral cancer, 
esophageal cancer, laryngeal cancer, lung cancer, or any other form of 
cancer associated with premium cigars, especially compared and 
contrasted with risks for other cigars.
    4. Studies or information regarding the risk of heart disease 
associated with premium cigars, especially compared and contrasted with 
risks for other cigars.
    5. Studies or information regarding the risk of aortic aneurysm 
associated with premium cigars, especially compared and contrasted with 
risks for other cigars.
    6. Studies or information regarding the risk of periodontal disease 
associated with premium cigars, especially compared and contrasted with 
risks for other cigars.
    7. Studies or information regarding the risk of stroke associated 
with premium cigars, especially compared and contrasted with risks for 
other cigars.
    8. Studies or information regarding the risk of chronic obstructive 
pulmonary disease associated with premium cigars, especially compared 
and contrasted with risks for other cigars.
    9. Studies or information regarding risk of cancers of the mouth 
and throat for premium cigar users who do not inhale or who report that 
they do not inhale, especially compared and contrasted with risks for 
other cigars.
    10. Studies or information on the impact of premium cigar use on 
other public health endpoints, including users and non-users, 
especially compared and contrasted with the impact of other cigars.
    11. Studies or information regarding the addictiveness of premium 
cigars.
    12. Studies or information regarding consumer perceptions of the 
health risks of premium cigars when compared to other tobacco products, 
including other cigars.
    13. Studies or information regarding consumer perceptions of the 
addictiveness of premium cigars, especially compared and contrasted 
with perceptions for other cigars.
    14. Studies or information on the required warning statements, 
shown below and which will be required to appear on cigar packaging and 
advertising in the near future (21 CFR 1143.5(a)(1)). Comment on 
whether any additional or alternative warning statements would be 
appropriate and provide your suggested language and any relevant 
studies or information.
    a. WARNING: Cigar smoking can cause cancers of the mouth and 
throat, even if you do not inhale.
    b. WARNING: Cigar smoking can cause lung cancer and heart disease.
    c. WARNING: Cigars are not a safe alternative to cigarettes.
    d. WARNING: Tobacco smoke increases the risk of lung cancer and 
heart disease, even in nonsmokers.
    e. WARNING: Cigar use while pregnant can harm you and your baby; or 
SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, 
Stillbirth and Low Birth Weight.
    f. WARNING: This product contains nicotine. Nicotine is an 
addictive chemical.

III. Reference

    The following reference is on display in the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the website address, as of the date this document publishes in 
the Federal Register, but websites are subject to change over time.

1. Corey, C.G., E. Holder-Hayes, A.B. Nguyen, et al. ``U.S. Adult 
Cigar Smoking Patterns, Purchasing Behaviors, and Reasons for Use 
According to Cigar Type: Findings From the Population Assessment of 
Tobacco and Health (PATH) Study, 2013-2014'', Nicotine & Tobacco 
Research, September 15, 2017, available at https://academic.oup.com/ntr/article/4159211/U-S-adult-cigar-smoking-patterns-purchasing.

    Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06047 Filed 3-23-18; 8:45 am]
BILLING CODE 4164-01-P