products currently subject to the FD&C Act and an assumption that
manufacturers would submit applications for the premarket review of
tobacco products.

D. New Collections of Information That Apply Only to Deemed Tobacco
Products

1. Exemption From the Required Warning Statement Requirement
    Description of Respondents: Respondents are manufacturers who, to
obtain an exemption from the required addictiveness warning, certify to
FDA that their product does not contain nicotine and that the
manufacturer has data to support that assertion.
    This rule contains a new information collection that pertains to an
exemption process related to the requirement to include the warning
statement in Sec.  1143.3(a)(1). Section1143.3(c) will provide an
exemption to the manufacturer of a product that otherwise would be
required to include the warning statement in Sec.  1143.3(a)(1) on its
packages and in its advertisements, i.e., ``WARNING: This product
contains nicotine. Nicotine is an addictive chemical.'' This warning
will be required to appear on at least 30 percent of the two principal
display panels of the package and on at least 20 percent of the area of
the advertisement.
    To obtain an exemption from this requirement, a manufacturer would
be required to certify to FDA that its product does not contain
nicotine and that the manufacturer has data to support that assertion.
For any product that obtains this exemption, the section requires that
the product bear the statement: ``This product is made from tobacco.''
The parties that package and label such products will share
responsibility for ensuring that this alternative statement is included
on product packages and in advertisements. The rule will permit
companies to obtain an exemption from this warning requirement in the
event that such tobacco products are developed in the future.
    FDA estimates the annual burden for the information collection as a
result of this rule as follows:

                                 Table 15--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Certification Statement.........               1               1               1              20              20
                                 -------------------------------------------------------------------------------
    Total Exemptions From the     ..............  ..............  ..............  ..............              20
     Required Warning Statement
     Requirement................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimated average burden per response is based on information
collection estimates that apply to tobacco products currently subject
to the FD&C Act. Although very few certifications are expected for
tobacco products that do not contain nicotine, FDA estimates that the
number of certification submissions could rise if the Agency decides in
the future to address not only nicotine, but any other addictive
substances.
    The estimated hours listed in the burden table for certification
submissions reflect the time needed to test the product for nicotine
and to prepare and submit the self-certification request. FDA expects
that these types of certifications will be very rare and estimates that
the Agency will receive on average one submission per year.
    FDA concludes that the labeling statements in Sec. Sec.
1143.3(a)(1) and 1143.5(a)(1) and the alternative statement in Sec.
1143.3(c) (i.e., ``This product is made from tobacco'') are not subject
to review by OMB because they do not constitute a ``collection of
information'' under the PRA (44 U.S.C. 3501-3520). Rather, these
labeling statements are a ``public disclosure'' of information
originally supplied by the Federal Government to the recipient for the
purpose of ``disclosure to the public'' (5 CFR 1320.3(c)(2)).
2. Submitting Warning Plans for Cigar Manufacturers, Importers,
Distributors, and Retailers
    Description of Respondents: The respondents to this collection of
information are manufacturers, importers, distributors, and retailers
of cigar products who will be required to submit warning plans for
cigars to FDA.
    The requirement for submission of warning plans for cigar products,
and the specific requirements relating to the random display and
distribution of required warning statements on cigar

packaging and quarterly rotation of required warning statements in
alternating sequence on cigar product advertising, appear in Sec.
1143.5(c).
    The six warnings for cigars (five specifically for cigars and the
one addictiveness warning) will be required to be randomly displayed in
each 12-month period, in as equal a number of times as is possible on
each brand of cigar sold in product packaging and be randomly
distributed in all areas of the United States in which the product is
marketed accordance with a warning plan submitted to and approved by
FDA. For advertisements, the warning statements must be rotated
quarterly in alternating sequence in each advertisement for each brand
of cigar in accordance with a warning plan submitted to and approved by
FDA.
    For cigar products that are on the market as of the publication
date of the final rule, the effective date for the requirement to
submit warning plans by responsible manufacturers, distributors,
importers, and retailers is 1 year after the date of publication of the
final rule. FDA is establishing this effective date 1 year before the
effective date of the remainder of the part 1143 requirements because
the Agency anticipates that there will be a need for considerable
communication with submitters during its review of the warning plan
submissions. FDA will work with the submitters to ensure that the plans
submitted meet the established criteria for approval under part 1143.
FDA also intends to update the warning plan draft guidance and
information collection, which currently pertains to smokeless tobacco
products, to assist manufacturers, importers, distributors, and
retailers of cigars with the submission of warning plans. The
information collection in this draft guidance is approved under OMB
Control Number 0910-0671. The draft guidance document discusses, among
other things: The statutory requirement to submit a warning plan;
definitions; who submits a warning plan; the scope of a warning plan;
when to submit a warning plan; what information should be submitted in
a warning plan; where to submit a warning plan; and what approval of a
warning plan means.
    The warning statements on cigar packaging must be randomly
displayed in each 12-month period, in as equal a number of times as is
possible on each brand of cigar sold and are required to be randomly
distributed in all areas of the United States in which the product is
marketed in accordance with a warning plan submitted by the responsible
cigar manufacturer, importer, distributor, or retailer to and approved
by FDA.
    To clarify, retailers of cigars sold individually and not in
product packaging are not required to submit a warning plan for
warnings on packages, because the warning signs posted at a retailer's
point-of-sale would include all six warnings applicable to cigars, as
we have noted in Sec.  1143.5(c)(1). Therefore, it is not necessary to
submit a rotational warning plan for them. However, manufacturers,
distributors, and those retailers who are responsible for or direct the
health warning of the advertisements of such products must submit a
warning plan for their advertisements for FDA approval. The rule
requires them to include warnings on advertisements, and the warnings
that must be rotated quarterly in alternating sequence in each
advertisement for each brand of cigar, in accordance with an FDA
approved warning plan.
    FDA is also requiring that the required warning statements be
rotated quarterly in alternating sequence in each advertisement for
each brand of cigar, regardless of whether the cigar is sold in product
packaging. This rotation of warning statements in cigar advertisements
also must be done in accordance with a warning plan submitted by the
responsible cigar manufacturer, importer, distributor, or retailer to
and approved by FDA.
    FDA estimates the annual burden for the information collection as a
result of this rule as follows:

                                 Table 16--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
       Cigar warning plan           respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Manufacturers, Importers, and                329               1             329             120          39,480
 Retailers......................
                                 -------------------------------------------------------------------------------
    Total Cigar Warning Plan....  ..............  ..............  ..............  ..............          39,480
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimates are based on FDA's experience with smokeless
warning plans and the associated information collection (OMB Control
Number 0910-0671) as well as warning plans for cigarettes submitted to
the FTC prior to the implementation of the Tobacco Control Act on June
22, 2009.
    We estimate 329 entities will submit warning plans, and it will
take an average of 120 hours per respondent to prepare and submit a
warning plan for packaging and advertising for a total of 39,480 hours.
3. Small-Scale Manufacturer Report
    Description of Respondents: The respondents to this collection of
information are manufacturers known as ``small-scale tobacco product
manufacturers.''
    As discussed in section IV, FDA requested comment on the ability of
smaller manufacturers of newly deemed tobacco products to fully comply
with the requirements of the FD&C Act and how FDA might be able to
address those concerns. Considering the comments and FDA's finite
enforcement resources, the Agency's view is that those resources may
not be best used in immediately enforcing the provisions of this rule
against certain manufacturers that are small-scale tobacco product
manufacturers and that fail to comply with certain requirements of the
FD&C Act. FDA retains discretion in all cases to conduct an
individualized inquiry and to consider any and all relevant facts in
determining whether to bring an enforcement action.
    Generally, FDA considers a ``small-scale tobacco product
manufacturer'' to be a manufacturer of any regulated tobacco product
that employs 150 or fewer full-time equivalent employees and has annual
total revenues of $5,000,000 or less. FDA considers a manufacturer to
include each entity that it controls, is controlled by, or is under
common control with such manufacturer. To help make FDA's individual
enforcement decisions more efficient, a manufacturer may voluntarily
submit information regarding employment and revenues. FDA does not
believe a large number of

manufacturers who fit the criteria of a small-scale tobacco product
manufacturer would submit the voluntary information.
    FDA estimates that there are approximately 75 small-scale
manufacturers who will voluntarily submit information. FDA believes it
will take respondents 2 hours to voluntarily submit information
regarding employment and revenues for a total of 150 hours.
    FDA has estimated the burden for submitting the ``small-scale
tobacco product manufacturer'' annual report as follows:

                                 Table 17--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Small-Scale Manufacturer                      75               1              75               2             150
 Reporting......................
                                 -------------------------------------------------------------------------------
    Total Small-Scale             ..............  ..............  ..............  ..............             150
     Manufacturer Report........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The total burden for these new collections of information in this
rulemaking is 1,621,212 reporting hours (121,604 + 1,200 + 9,363 +
158,149 + 5,681 + 15 + 1,285,550 + 20 + 39,480 + 150) and 12,342
recordkeeping hours for a total of 1,633,554 burden hours.
    The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.

XX. Executive Order 13132; Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive Order and, consequently, a
federalism summary impact statement is not required.

XXI. Executive Order 13175; Tribal Consultation

    In accordance with Executive Order 13175, FDA has consulted with
Tribal Government officials. FDA sought comment from Tribal Governments
on April 25, 2014, and conducted a consultation with tribes via Webinar
regarding the NPRM on May 29, 2014. FDA received one comment from a
tribe stating that FDA failed to ensure meaningful and timely input
from tribal officials as required by Executive Order 13175 and
requesting tribal consultation in relation to existing premarket review
activities for cigarettes, roll-your-own tobacco, and smokeless
tobacco. In response, FDA conducted a face-to-face meeting with the
tribe regarding the NPRM on January 21, 2015. FDA has determined that
this final rule does not have tribal implications under Executive Order
13175, because it does not, to our knowledge, have a substantial direct
effect on one or more Indian tribes, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
nor does it impose substantial direct compliance costs.
    (Comment 305) One comment stated that FDA failed to ensure
meaningful and timely input from tribal officials as required by
Executive Order 13175 and the HHS Consultation Policy. The comment
acknowledged FDA's ``Dear Tribal Leader'' letter and Webinar and
requested a face-to-face meeting between FDA and its tribe in relation
to existing premarket review activities for cigarettes, roll-your-own
tobacco, and smokeless tobacco.
    (Response) FDA adheres to Executive Order 13175 and the HHS
Consultation Policy. FDA is committed to meaningful consultation with
federally recognized tribes on FDA's implementation and enforcement of
the Tobacco Control Act. As a result of the tribe's inquiry, FDA
participated in a face-to-face meeting.
    (Comment 306) One comment encouraged FDA to respect tribal
sovereignty in its enforcement of the tobacco regulation. The comment
recommended that FDA provide both training and funding opportunities to
tribal governments to alleviate the economic burdens stemming from
enforcement of the rule. The comment urged FDA to make certain the
regulatory burdens do not limit the economic viability of tribal
operations.
    (Response) FDA recognizes tribal sovereignty and tribal self-
regulation and will work in partnership with tribal leaders to monitor
compliance with this rule. As explained in this rule, FDA is
implementing this rule to protect public health. However, FDA
recognizes that compliance with many of the automatic provisions may be
challenging at first for entities that are new to Federal public health
regulation and as a result, provided compliance policies relating to
provisions such as premarket authorizations and provided additional
time to comply with certain requirements of the FD&C Act for small-
scale tobacco manufacturers. FDA will provide training and other
opportunities to tribal governments after the rule is finalized.

XXII. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m. Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

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278. Environmental Assessment for Regulations (21 CFR 1100, 1140,
and 1143) to deem tobacco products meeting the statutory definition
of ``tobacco product'' to be subject to the Federal Food, Drug, and
Cosmetic Act, to revise existing regulations to include

restrictions on the sale and distribution of covered tobacco
products, and to require the use of health warning statements for
cigarette tobacco, roll-your-own tobacco, and covered tobacco
products.
279. Finding of No Significant Impact for Regulations (21 CFR 1100,
1140, and 1143) to deem tobacco products meeting the statutory
definition of ``tobacco product'' to be subject to the Federal Food,
Drug, and Cosmetic Act, to revise existing regulations to include
restrictions on the sale and distribution of covered tobacco
products, and to require the use of health warning statements for
cigarette tobacco, roll-your-own tobacco, and covered tobacco
products.

List of Subjects

21 CFR Part 1100

    Smoking, Tobacco.

21 CFR Part 1140

    Advertising, Labeling, Smoking, Tobacco.

21 CFR Part 1143

    Advertising, Labeling, Packaging and containers, Smoking, Tobacco.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR
chapter I is amended as follows:

0
1. Add part 1100 to subchapter K to read as follows:

PART 1100--TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY

Sec.
1100.1 Scope.
1100.2 Requirements.
1100.3 Definitions.

    Authority:  21 U.S.C. 387a(b), 387f(d) and Pub. L. 111-31.

Sec.  1100.1  Scope.

    In addition to FDA's authority over cigarettes, cigarette tobacco,
roll-your-own tobacco, and smokeless tobacco, FDA deems all other
products meeting the definition of tobacco product under section
201(rr) of the Federal Food, Drug, and Cosmetic Act, except accessories
of such other tobacco products, to be subject to the Federal Food,
Drug, and Cosmetic Act.

Sec.  1100.2  Requirements.

    Cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless
tobacco are subject to chapter IX of the Federal Food, Drug, and
Cosmetic Act and its implementing regulations. FDA has deemed all other
tobacco products, except accessories of such other tobacco products,
subject to chapter IX of the Federal Food, Drug, and Cosmetic Act and
its implementing regulations.

Sec.  1100.3  Definitions.

    For the purposes of this part:
    Accessory means any product that is intended or reasonably expected
to be used with or for the human consumption of a tobacco product; does
not contain tobacco and is not made or derived from tobacco; and meets
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of a tobacco
product; or
    (2) Is intended or reasonably expected to affect or maintain the
performance, composition, constituents, or characteristics of a tobacco
product but
    (i) Solely controls moisture and/or temperature of a stored tobacco
product; or
    (ii) Solely provides an external heat source to initiate but not
maintain combustion of a tobacco product.
    Component or part means any software or assembly of materials
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance,
composition, constituents, or characteristics; or
    (2) To be used with or for the human consumption of a tobacco
product. Component or part excludes anything that is an accessory of a
tobacco product.
    Package or packaging means a pack, box, carton, or container of any
kind or, if no other container, any wrapping (including cellophane), in
which a tobacco product is offered for sale, sold, or otherwise
distributed to consumers.
    Tobacco product. As stated in section 201(rr) of the Federal Food,
Drug, and Cosmetic Act in relevant part, a tobacco product:
    (1) Means any product made or derived from tobacco that is intended
for human consumption, including any component, part, or accessory of a
tobacco product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product);
and
    (2) Does not mean an article that is a drug under section 201(g)(1)
of the Federal Food, Drug, and Cosmetic Act, a device under section
201(h) of the Federal Food, Drug, and Cosmetic Act, or a combination
product described in section 503(g) of the Federal Food, Drug, and
Cosmetic Act.

PART 1140--CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO
PRODUCTS

0
2. The authority citation for 21 CFR part 1140 continues to read as
follows:

    Authority:  21 U.S.C. 301 et seq., Sec. 102, Pub. L. 111-31, 123
Stat. 1776.

0
3. Revise the heading to part 1140 as set forth above.

0
4. Revise Sec.  1140.1 to read as follows:

Sec.  1140.1  Scope.

    (a) This part sets out the restrictions under the Federal Food,
Drug, and Cosmetic Act on the sale, distribution, and use of
cigarettes, smokeless tobacco, and covered tobacco products. Section
1140.16(d) sets out restrictions on the distribution of free samples
for cigarettes, smokeless tobacco, and other tobacco products (as such
term is defined in section 201 of the Federal Food, Drug, and Cosmetic
Act).
    (b) The failure to comply with any applicable provision in this
part in the sale, distribution, and use of cigarettes, smokeless
tobacco, covered tobacco products, or other tobacco products renders
the product misbranded under the Federal Food, Drug, and Cosmetic Act.
    (c) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21, unless otherwise
noted.

0
5. Revise Sec.  1140.2 to read as follows:

Sec.  1140.2  Purpose.

    The purpose of this part is to establish restrictions on the sale,
distribution, and use of cigarettes, smokeless tobacco, and covered
tobacco products in order to reduce the number of children and
adolescents who use these products, and to reduce the life-threatening
consequences associated with tobacco use.

0
6. Revise Sec.  1140.3 to read as follows:

Sec.  1140.3  Definitions.

    For the purposes of this part:
    Accessory means any product that is intended or reasonably expected
to be used with or for the human consumption of a tobacco product; does
not contain tobacco and is not made or derived from tobacco; and meets
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of a tobacco
product; or
    (2) Is intended or reasonably expected to affect or maintain the
performance, composition, constituents, or characteristics of a tobacco
product but
    (i) Solely controls moisture and/or temperature of a stored
product; or
    (ii) Solely provides an external heat source to initiate but not
maintain combustion of a tobacco product.
    Cigarette. (1) Means a product that:

    (i) Is a tobacco product and
    (ii) Meets the definition of the term ``cigarette'' in section 3(1)
of the Federal Cigarette Labeling and Advertising Act; and
    (2) Includes tobacco, in any form, that is functional in the
product, which, because of its appearance, the type of tobacco used in
the filler, or its packaging and labeling, is likely to be offered to,
or purchased by, consumers as a cigarette or as roll-your-own tobacco.
    Cigarette tobacco means any product that consists of loose tobacco
that is intended for use by consumers in a cigarette. Unless otherwise
stated, the requirements applicable to cigarettes under this chapter
also apply to cigarette tobacco.
    Component or part means any software or assembly of materials
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance,
composition, constituents, or characteristics; or
    (2) To be used with or for the human consumption of a tobacco
product. Component or part excludes anything that is an accessory of a
tobacco product.
    Covered tobacco product means any tobacco product deemed to be
subject to the Federal Food, Drug, and Cosmetic Act under Sec.  1100.2
of this chapter, but excludes any component or part that is not made or
derived from tobacco.
    Distributor means any person who furthers the distribution of a
tobacco product, whether domestic or imported, at any point from the
original place of manufacture to the person who sells or distributes
the product to individuals for personal consumption. Common carriers
are not considered distributors for the purposes of this part.
    Importer means any person who imports any tobacco product that is
intended for sale or distribution to consumers in the United States.
    Manufacturer means any person, including any repacker and/or
relabeler, who manufactures, fabricates, assembles, processes, or
labels a finished tobacco product.
    Nicotine means the chemical substance named 3-(1-Methyl-2-
pyrrolidinyl)pyridine or C[10]H[14]N[2], including any salt or complex
of nicotine.
    Package or packaging means a pack, box, carton, or container of any
kind or, if no other container, any wrapping (including cellophane) in
which a tobacco product is offered for sale, sold, or otherwise
distributed to consumers.
    Point of sale means any location at which a consumer can purchase
or otherwise obtain tobacco products for personal consumption.
    Retailer means any person who sells tobacco products to individuals
for personal consumption, or who operates a facility where vending
machines or self-service displays are permitted under this part.
    Roll-your-own tobacco means any tobacco product that, because of
its appearance, type, packaging, or labeling, is suitable for use and
likely to be offered to, or purchased by, consumers as tobacco for
making cigarettes.
    Smokeless tobacco means any tobacco product that consists of cut,
ground, powdered, or leaf tobacco and that is intended to be placed in
the oral or nasal cavity.
    Tobacco product. As stated in section 201(rr) of the Federal Food,
Drug, and Cosmetic Act in relevant part, a tobacco product:
    (1) Means any product made or derived from tobacco that is intended
for human consumption, including any component, part, or accessory of a
tobacco product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product) and
    (2) Does not mean an article that is a drug under section 201(g)(1)
of the Federal Food, Drug, and Cosmetic Act, a device under section
201(h) of the Federal Food, Drug, and Cosmetic Act, or a combination
product described in section 503(g) of the Federal Food, Drug, and
Cosmetic Act.

0
7. Revise Sec.  1140.10 to read as follows:

Sec.  1140.10  General responsibilities of manufacturers, distributors,
and retailers.

    Each manufacturer, distributor, importer, and retailer is
responsible for ensuring that the cigarettes, smokeless tobacco, or
covered tobacco products it manufactures, labels, advertises, packages,
distributes, imports, sells, or otherwise holds for sale comply with
all applicable requirements under this part.

0
8. Revise Sec.  1140.14 to read as follows:

Sec.  1140.14  Additional responsibilities of retailers.

    (a) In addition to the other requirements under this part, each
cigarette and smokeless tobacco retailer is responsible for ensuring
that all sales of cigarettes or smokeless tobacco to any person comply
with the following requirements:
    (1) No retailer may sell cigarettes or smokeless tobacco to any
person younger than 18 years of age;
    (2)(i) Except as otherwise provided in paragraph (a)(2)(ii) of this
section and in Sec.  1140.16(c)(2)(i), each retailer must verify by
means of photographic identification containing the bearer's date of
birth that no person purchasing the product is younger than 18 years of
age;
    (ii) No such verification is required for any person over the age
of 26;
    (3) Except as otherwise provided in Sec.  1140.16(c)(2)(ii), a
retailer may sell cigarettes or smokeless tobacco only in a direct,
face-to-face exchange without the assistance of any electronic or
mechanical device (such as a vending machine);
    (4) No retailer may break or otherwise open any cigarette or
smokeless tobacco package to sell or distribute individual cigarettes
or a number of unpackaged cigarettes that is smaller than the quantity
in the minimum cigarette package size defined in Sec.  1140.16(b), or
any quantity of cigarette tobacco or smokeless tobacco that is smaller
than the smallest package distributed by the manufacturer for
individual consumer use; and
    (5) Each retailer must ensure that all self-service displays,
advertising, labeling, and other items, that are located in the
retailer's establishment and that do not comply with the requirements
of this part, are removed or are brought into compliance with the
requirements under this part.
    (b) Notwithstanding the requirements in paragraph (a) of this
section and in addition to the other requirements under this part, each
retailer of covered tobacco products is responsible for ensuring that
all sales of such covered tobacco products to any person comply with
the following requirements:
    (1) No retailer may sell covered tobacco products to any person
younger than 18 years of age;
    (2)(i) Except as otherwise provided in paragraph (a)(2)(ii) of this
section and in Sec.  1140.16(c)(2)(i), each retailer must verify by
means of photographic identification containing the bearer's date of
birth that no person purchasing the product is younger than 18 years of
age;
    (ii) No such verification is required for any person over the age
of 26; and
    (3) A retailer may not sell covered tobacco products with the
assistance of any electronic or mechanical device (such as a vending
machine), except in facilities where the retailer ensures that no
person younger than 18 years of age is present, or permitted to enter,
at any time.

0
9. Add part 1143 to subchapter K to read as follows:

PART 1143--MINIMUM REQUIRED WARNING STATEMENTS

Sec.

1143.1 Definitions.
1143.3 Required warning statement regarding addictiveness of
nicotine.
1143.5 Required warning statements for cigars.
1143.7 Language requirements for required warning statements.
1143.9 Irremovable or permanent required warning statements.
1143.11 Does not apply to foreign distribution.
1143.13 Effective date.

    Authority:  21 U.S.C. 387a(b), 387f(d).

Sec.  1143.1  Definitions.

    For purposes of this part:
    Accessory means any product that is intended or reasonably expected
to be used with or for the human consumption of a tobacco product; does
not contain tobacco and is not made or derived from tobacco; and meets
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of a tobacco
product; or
    (2) Is intended or reasonably expected to affect or maintain the
performance, composition, constituents, or characteristics of a tobacco
product but
    (i) Solely controls moisture and/or temperature of a stored tobacco
product; or
    (ii) Solely provides an external heat source to initiate but not
maintain combustion of a tobacco product
    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.
    Cigarette tobacco means any product that consists of loose tobacco
that is intended for use by consumers in a cigarette. Unless otherwise
stated, the requirements applicable to cigarettes under this chapter
also apply to cigarette tobacco.
    Component or part means any software or assembly of materials
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance,
composition, constituents, or characteristics; or
    (2) to be used with or for the human consumption of a tobacco
product. Component or part excludes anything that is an accessory of a
tobacco product.
    Covered tobacco product means any tobacco product deemed to be
subject to the Federal Food, Drug, and Cosmetic Act pursuant to Sec.
1100.2 of this chapter, but excludes any component or part that is not
made or derived from tobacco.
    Package or packaging means a pack, box, carton, or container of any
kind or, if no other container, any wrapping (including cellophane), in
which a tobacco product is offered for sale, sold, or otherwise
distributed to consumers.
    Principal display panels means the panels of a package that are
most likely to be displayed, presented, shown, or examined by the
consumer.
    Point of sale means any location at which a consumer can purchase
or otherwise obtain tobacco products for personal consumption.
    Retailer means any person who sells tobacco products to individuals
for personal consumption, or who operates a facility where vending
machines or self-service displays are permitted under this part.
    Required warning statement means a textual warning statement
required to be on packaging and in advertisements for cigarette
tobacco, roll-your-own tobacco, cigars, and other covered tobacco
products.
    Roll-your-own tobacco means any tobacco product that, because of
its appearance, type, packaging, or labeling, is suitable for use and
likely to be offered to, or purchased by, consumers as tobacco for
making cigarettes.
    Tobacco product. As stated in section 201(rr) of the Federal Food,
Drug, and Cosmetic Act in relevant part, a tobacco product:
    (1) Means any product made or derived from tobacco that is intended
for human consumption, including any component, part, or accessory of a
tobacco product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product) and
    (2) Does not mean an article that is a drug under section 201(g)(1)
of the Federal Food, Drug, and Cosmetic Act, a device under section
201(h) of the Federal Food, Drug, and Cosmetic Act, or a combination
product described in section 503(g) of the Federal Food, Drug, and
Cosmetic Act.

Sec.  1143.3  Required warning statement regarding addictiveness of
nicotine.

    (a) Packages. (1) For cigarette tobacco, roll-your-own tobacco, and
covered tobacco products other than cigars, it is unlawful for any
person to manufacture, package, sell, offer to sell, distribute, or
import for sale or distribution within the United States such product
unless the tobacco product package bears the following required warning
statement on the package label: ``WARNING: This product contains
nicotine. Nicotine is an addictive chemical.''
    (2) The required warning statement must appear directly on the
package and must be clearly visible underneath any cellophane or other
clear wrapping as follows:
    (i) Be located in a conspicuous and prominent place on the two
principal display panels of the package and the warning area must
comprise at least 30 percent of each of the principal display panels;
    (ii) Be printed in at least 12-point font size and ensures that the
required warning statement occupies the greatest possible proportion of
the warning area set aside for the required text;
    (iii) Be printed in conspicuous and legible Helvetica bold or Arial
bold type (or other sans serif fonts) and in black text on a white
background or white text on a black background in a manner that
contrasts by typography, layout, or color, with all other printed
material on the package;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section; and
    (v) Be centered in the warning area in which the text is required
to be printed and positioned such that the text of the required warning
statement and the other information on the principal display panel have
the same orientation.
    (3) A retailer of any tobacco product covered by paragraphs (a)(1)
and (2) of this section will not be in violation of this section for
packaging that:
    (i) Contains a health warning;
    (ii) Is supplied to the retailer by the tobacco product
manufacturer, importer, or distributor, who has the required state,
local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license
or permit, if applicable, and
    (iii) Is not altered by the retailer in a way that is material to
the requirements of this section.
    (b) Advertisements. (1) For cigarette tobacco, roll-your-own
tobacco, and covered tobacco products other than cigars, it is unlawful
for any such tobacco product manufacturer, packager, importer,
distributor, or retailer of the tobacco product to advertise or cause
to be advertised within the United States any tobacco product unless
each advertisement bears the required warning statement specified in
paragraph (a)(1) of this section.
    (2) For print advertisements and other advertisements with a visual
component (including, for example, advertisements on signs, shelf-
talkers, Internet Web pages, and electronic mail correspondence), the
required warning statement must appear in the upper portion of the area
of the advertisement within the trim area as follows:
    (i) Occupy at least 20 percent of the area of the advertisement;
    (ii) Appear in at least 12-point font size and ensures that the
required warning statement occupies the greatest

possible proportion of the warning area set aside for the required
text;
    (iii) Appear in conspicuous and legible Helvetica bold or Arial
bold type (or other similar sans serif fonts) and in black text on a
white background or white text on a black background in a manner that
contrasts by typography, layout, or color, with all other material on
the advertisement;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section;
    (v) Be centered in the warning area in which the text is required
to appear and positioned such that the text of the required warning
statement and the other textual information in the advertisement have
the same orientation; and
    (vi) Be surrounded by a rectangular border that is the same color
as the text of the required warning statement and that is not less than
3 millimeters (mm) or more than 4 mm.
    (3) This paragraph (b) applies to a retailer only if that retailer
is responsible for or directs the health warning required under the
paragraph. However, this paragraph does not relieve a retailer of
liability if the retailer displays, in a location open to the public,
an advertisement that does not contain a health warning or contains a
health warning that has been altered by the retailer in a way that is
material to the requirements of this section.
    (c) Self-certification. A tobacco product that would otherwise be
required to bear the warning in paragraph (a)(1) of this section but
does not contain nicotine is not required to bear the warning in
paragraph (a)(1) of this section on packages or advertisements if the
tobacco product manufacturer has submitted to FDA a confirmation
statement certifying to be true and accurate that the product does not
contain nicotine and that the tobacco product manufacturer has data to
support that assertion. Any product not required to bear the warning in
paragraph (a)(1) of this section must include the statement ``This
product is made from tobacco.'' on all packages and advertisements in
accordance with the requirements of this part.
    (d) Small packages. A tobacco product that would otherwise be
required to bear the warning in paragraph (a)(1) of this section but is
too small or otherwise unable to accommodate a label with sufficient
space to bear such information is exempt from compliance with the
requirement provided that the information and specifications required
under paragraphs (a)(1) and (2) of this section appear on the carton or
other outer container or wrapper if the carton, outer container, or
wrapper has sufficient space to bear the information, or appear on a
tag otherwise firmly and permanently affixed to the tobacco product
package. In such cases, the carton, outer container, wrapper, or tag
will serve as the location of the principal display panels.

Sec.  1143.5  Required warning statements for cigars.

    (a) Packages. (1) It is unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale or
distribution within the United States any cigar product unless the
product package bears one of the following required warning statements
on the package label:
    (i) WARNING: Cigar smoking can cause cancers of the mouth and
throat, even if you do not inhale.
    (ii) WARNING: Cigar smoking can cause lung cancer and heart
disease.
    (iii) WARNING: Cigars are not a safe alternative to cigarettes.
    (iv) WARNING: Tobacco smoke increases the risk of lung cancer and
heart disease, even in nonsmokers.
    (v)(A) WARNING: Cigar use while pregnant can harm you and your
baby.; or
    (B) SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of
Infertility, Stillbirth and Low Birth Weight.
    (vi) WARNING: This product contains nicotine. Nicotine is an
addictive chemical.
    (2) Each required warning statement must appear directly on the
package and must be clearly visible underneath any cellophane or other
clear wrapping as follows:
    (i) Be located in a conspicuous and prominent place on the two
principal display panels of the package and the warning area must
comprise at least 30 percent of each of the principal display panels;
    (ii) Appear in at least 12-point font size and ensure that the
required warning statement occupies the greatest possible proportion of
the warning area set aside for the required text;
    (iii) Be printed in conspicuous and legible Helvetica bold or Arial
bold type (or other similar sans serif fonts) and in black text on a
white background or white text on a black background in a manner that
contrasts by typography, layout, or color, with all other printed
material on the package;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section; and
    (v) Be centered in the warning area in which the text is required
to be printed and positioned such that the text of the required warning
statement and the other information on that principal display panel
have the same orientation.
    (3) No person may manufacture, package, sell, offer to sell,
distribute, or import for sale or distribution within the United States
any cigar without a required warning statement, except for cigars that
are sold individually and not in a product package. For cigars that are
sold individually and not in a product package, the required warning
statements must be posted at the retailer's point-of-sale in accordance
with the following:
    (i) All of the warnings in paragraph (a) of this section must be
placed on a sign that is a minimum of 8.5 x 11 inches, posted on or
within 3 inches of each cash register where payment may be made so that
the sign(s) are unobstructed in their entirety and can be read easily
by each consumer making a purchase;
    (ii) The sign must be clear, legible, and conspicuous and be
printed in black Helvetica bold or Arial bold type (or other similar
sans serif fonts) against a solid white background in at least 17 point
type with appropriate space between the warning statements;
    (iii) Be printed in a manner that contrasts by typography, layout,
or color, with all other printed material; and
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section.
    (4) A retailer of any cigar covered by paragraphs (a)(1) and (2) of
this section will not be in violation of this section for packaging
that:
    (i) Contains a health warning;
    (ii) Is supplied to the retailer by the tobacco product
manufacturer, importer, or distributor who has the required state,
local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license
or permit, if applicable, and
    (iii) Is not altered by the retailer in a way that is material to
the requirements of this section.
    (b) Advertisements. (1) It is unlawful for any tobacco product
manufacturer, packager, importer, distributor, or retailer of cigars to
advertise or cause to be advertised within the United States any cigar
unless each advertisement bears one of the required warning statements
specified in paragraph (a)(1) of this section.
    (2) For print advertisements and other advertisements with a visual
component (including, for example, advertisements on signs, shelf-
talkers, Internet Web pages, and electronic mail correspondence), each
required warning statement must appear in the upper

portion of the area of the advertisement within the trim area as
follows:
    (i) Occupy at least 20 percent of the area of the advertisement;
    (ii) Appear in at least 12-point font size that ensures that the
required warning statement occupies the greatest possible proportion of
the warning area set aside for the text required;
    (iii) Appear in conspicuous and legible Helvetica bold or Arial
bold type (or other similar sans serif fonts) and in black text on a
white background or white text on a black background in a manner that
contrasts by typography, layout, or color, with all other material on
the advertisement;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1)
of this section;
    (v) Be centered in the warning area in which the text is required
to appear and positioned such that the text of the required warning
statement and the other textual information in the advertisement have
the same orientation; and
    (vi) Be surrounded by a rectangular border that is the same color
as the text of the required warning statement and that is not less than
3 mm or more than 4 mm.
    (3) This paragraph (b) applies to a retailer only if that retailer
is responsible for or directs the warning statements required under the
paragraph. However, this paragraph does not relieve a retailer of
liability if the retailer displays, in a location open to the public,
an advertisement that does not contain a health warning or contains a
health warning that has been altered by the retailer in a way that is
material to the requirements of this section.
    (c) Marketing requirements. (1) Except for cigars sold individually
and not in a product package, the warning statements required for
packages in paragraph (a)(1) of this section must be randomly displayed
in each 12-month period, in as equal a number of times as is possible
on each brand of cigar sold in product packaging and be randomly
distributed in all areas of the United States in which the product is
marketed in accordance with a plan submitted by the cigar manufacturer,
importer, distributor, or retailer to, and approved by, the Food and
Drug Administration.
    (2) The warning statements required for advertisements in paragraph
(a)(1) of this section must be rotated quarterly in alternating
sequence in each advertisement for each brand of cigar in accordance
with a plan submitted by the cigar manufacturer, importer, distributor,
or retailer to, and approved by, the Food and Drug Administration.
    (3) Each person required to randomly display and distribute or
rotate warnings in accordance with an FDA-approved plan under this part
shall submit a proposed warning plan to FDA no later than either 12
months after May 10, 2016, or 12 months before advertising or
commercially marketing a product that is subject to such requirement,
whichever is later.

Sec.  1143.7  Language requirements for required warning statements.

    The text in each warning statement required in Sec.  1143.3 or
Sec.  1143.5 must be in the English language, except as follows:
    (a) In the case of an advertisement that appears in a non-English
medium, the text in the required warning statement must appear in the
predominant language of the medium whether or not the advertisement is
in English, and;
    (b) In the case of an advertisement that appears in an English
language medium but that is not in English, the text in the required
warning statement must appear in the same language as that principally
used in the advertisement.

Sec.  1143.9  Irremovable or permanent required warning statements.

    The warning statements required by this section must be indelibly
printed on or permanently affixed to the package or advertisement.
These warnings, for example, must not be printed or placed on a product
label affixed to a clear outer wrapper that is likely to be removed to
access the product within the package.

Sec.  1143.11  Does not apply to foreign distribution.

    The provisions of this part do not apply to a manufacturer or
distributor of tobacco products that does not manufacture, package, or
import tobacco products for sale or distribution within the United
States.

Sec.  1143.13  Effective date.

    (a) Except as stated in paragraph (b) of this section, this part
will take effect 24 months after May 10, 2016. The effective date will
be with respect to the date of manufacture, provided that, in any case,
beginning 30 days after the effective date, a manufacturer may not
introduce into the domestic commerce of the United States any product,
irrespective of the date of manufacture, that is not in conformance
with this part.
    (b) The requirement to submit a warning plan to FDA under Sec.
1143.5(c)(3) will take effect 12 months after May 10, 2016.

    Dated: May 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10685 Filed 5-5-16; 8:45 am]
 BILLING CODE 4164-01-P