Regulation of Premium Cigars, 12901-12904 [2018-06047]
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Federal Register / Vol. 83, No. 58 / Monday, March 26, 2018 / Proposed Rules
(2) Its one-part rates that include fixed
costs, by
(3) The percentage calculated
consistent with the instructions to FERC
Form No. 501–G prescribed by § 260.402
of this chapter.
(d) Timing. Any natural gas company
filing to reduce its rates pursuant to this
section must do so no later than the date
that it files its FERC Form No. 501–G
pursuant to § 260.402.
(e) Hearing Issues. (1) The only issues
that may be raised by Commission staff
or any intervenor under the procedures
established in this section are:
(i) Whether or not the natural gas
company may file under this section.
(ii) Whether or not the percentage
reduction permitted in § 154.402(c)(iii)
has been properly applied, and
(iii) Whether or not the correct
information was used in that
calculation.
(2) Any other issue raised will be
severed from the proceeding and
dismissed without prejudice.
PART 260—STATEMENTS AND
REPORTS (SCHEDULES)
4. Add § 260.402 to read as follows:
sradovich on DSK3GMQ082PROD with PROPOSALS
§ 260.402 FERC Form No. 501–G. One-time
Report on Rate Effect of the Tax Cuts and
Jobs Act.
(a) Prescription. The form for the Onetime Report on Rate Effect of the Tax
Cuts and Jobs Act of 2017, designated
herein as FERC Form No. 501–G is
prescribed.
(b) Filing requirement. (1) Who must
file. (i) Except as provided in paragraph
(b)(1)(ii) of this section, every natural
gas company that is required under this
part to file a Form No. 2 or 2A for 2017
and has cost-based rates for service
under any rate schedule that were filed
electronically pursuant to part 154 of
this chapter, must prepare and file with
the Commission a FERC Form No. 501–
G pursuant to the definitions and
instructions set forth in that form and
the Implementation Guide.
(ii) A natural gas company whose
rates are being examined in a general
rate case under section 4 of the Natural
Gas Act or in an investigation under
section 5 of the Natural Gas Act need
not file FERC Form No. 501–G. In
addition, a natural gas company that
files an uncontested settlement of its
rates pursuant to § 385.207(a)(5) of this
chapter after March 26, 2018 need not
file FERC Form No. 501–G.
(2) FERC Form No. 501–G must be
filed as prescribed in § 385.2011 of this
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5. The authority citation for part 284
continues to read as follows:
■
Authority: 15 U.S.C. 717–717z, 3301–3432;
42 U.S.C. 7101–7352; 43 U.S.C. 1331–1356.
6. In § 284.123, add paragraph (i) to
read as follows:
■
Rates and charges.
*
Authority: 15 U.S.C. 717–717w, 3301–
3432; 42 U.S.C. 7101–7352.
VerDate Sep<11>2014
PART 284—CERTAIN SALES AND
TRANSPORTATION OF NATURAL GAS
UNDER THE NATURAL GAS POLICY
ACT OF 1978 AND RELATED
AUTHORITIES
§ 284.123
3. The authority citation for part 260
continues to read as follows:
■
■
chapter as indicated in the instructions
set out in the form and Implementation
Guide, and must be properly completed
and verified. Each natural gas company
must file FERC Form No. 501–G
according to the schedule set forth in
the Implementation Guide set out in
that form. Each report must be prepared
in conformance with the Commission’s
form and guidance posted and available
for downloading from the FERC website
(https://www.ferc.gov). One copy of the
report must be retained by the
respondent in its files.
*
*
*
*
(i) If an intrastate pipeline’s rates on
file with the appropriate state regulatory
agency are reduced to reflect the
reduced income tax rates adopted in the
Tax Cuts and Jobs Act of 2017, the
intrastate pipeline must file a new rate
election pursuant to paragraph (b) of
this section not later than 30 days after
the reduced intrastate rate becomes
effective. This requirement applies
regardless of whether the intrastate
pipeline’s existing interstate rates are
based on § 284.123(b)(1) or (2).
[FR Doc. 2018–05669 Filed 3–23–18; 8:45 am]
BILLING CODE 6717–01–P
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.
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 premium cigars
SUMMARY:
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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.
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• 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/201523389.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
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for Tobacco Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 1–877–
287–1373, AskCTP@fda.hhs.gov.
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-yourown 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.
In the Federal Register of April 25,
2014 (79 FR 23142), FDA published a
proposed rule seeking to deem
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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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 smokerelated 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
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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 ‘‘nonpremium.’’ 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.
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:
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• 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.
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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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
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12903
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
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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
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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-cigarsmoking-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
DEPARTMENT OF LABOR
Mine Safety and Health Administration
30 CFR Parts 57, 70, 72, and 75
[Docket No. MSHA–2014–0031]
RIN 1219–AB86
Exposure of Underground Miners to
Diesel Exhaust
Mine Safety and Health
Administration, Labor.
AGENCY:
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Request for information;
reopening of the rulemaking record for
public comments.
ACTION:
In response to requests from
the public, the Mine Safety and Health
Administration (MSHA) is reopening
the rulemaking record for public
comments on the Agency’s request for
information on Exposure of
Underground Miners to Diesel Exhaust.
DATES: The comment period for the
request for information, published on
June 8, 2016 (81 FR 36826), which
closed on January 9, 2018 (82 FR 2284),
is reopened. Comments must be
received on or before midnight Eastern
Standard Time on March 26, 2019.
ADDRESSES: Submit comments and
informational materials for the
rulemaking record, identified by RIN
1219–AB86 or Docket No. MSHA–2014–
0031, by one of the following methods:
• Federal E-Rulemaking Portal:
https://www.regulations.gov. Follow the
on-line instructions for submitting
comments.
• Email: zzMSHA-comments@
dol.gov.
• Mail: MSHA, Office of Standards,
Regulations, and Variances, 201 12th
Street South, Suite 4E401, Arlington,
Virginia 22202–5452.
• Hand Delivery or Courier: 201 12th
Street South, Suite 4E401, Arlington,
Virginia, between 9:00 a.m. and 5:00
p.m. Monday through Friday, except
Federal holidays. Sign in at the
receptionist’s desk on the 4th floor East,
Suite 4E401.
• Fax: 202–693–9441.
Instructions: All submissions must
include ‘‘RIN 1219–AB86’’ or ‘‘Docket
No. MSHA–2014–0031.’’ Do not include
personal information that you do not
want publicly disclosed; MSHA will
post all comments without change to
https://www.regulations.gov and https://
arlweb.msha.gov/currentcomments.asp,
including any personal information
provided.
Docket: For access to the docket to
read comments received, go to https://
www.regulations.gov or https://
arlweb.msha.gov/currentcomments.asp.
To read background documents, go to
https://www.regulations.gov. Review the
docket in person at MSHA, Office of
Standards, Regulations, and Variances,
201 12th Street South, Arlington,
Virginia, between 9:00 a.m. and 5:00
p.m. Monday through Friday, except
Federal Holidays. Sign in at the
receptionist’s desk in Suite 4E401.
Email Notification: To subscribe to
receive an email notification when
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SUMMARY:
E:\FR\FM\26MRP1.SGM
26MRP1
]]>Agencies
[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
