[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Rules and Regulations]
[Pages 28973-29106]
[FR Doc No: 2016-10685]

Vol. 81

Tuesday,

No. 90

May 10, 2016

Part III

Department of Health and Human Services

-----------------------------------------------------------------------

Food and Drug Administration

-----------------------------------------------------------------------

21 CFR Parts 1100, 1140, and 1143

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and
Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco
Control Act; Restrictions on the Sale and Distribution of Tobacco
Products and Required Warning Statements for Tobacco Products; Final
Rule

Federal Register / Vol. 81 , No. 90 / Tuesday, May 10, 2016 / Rules
and Regulations

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1140, and 1143

[Docket No. FDA-2014-N-0189]
RIN 0910-AG38

Deeming Tobacco Products To Be Subject to the Federal Food, Drug,
and Cosmetic Act, as Amended by the Family Smoking Prevention and
Tobacco Control Act; Restrictions on the Sale and Distribution of
Tobacco Products and Required Warning Statements for Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing this final
rule to deem products meeting the statutory definition of ``tobacco
product,'' except accessories of the newly deemed tobacco products, to
be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act),
as amended by the Family Smoking Prevention and Tobacco Control Act
(Tobacco Control Act). The Tobacco Control Act provides FDA authority
to regulate cigarettes, cigarette tobacco, roll-your-own tobacco,
smokeless tobacco, and any other tobacco products that the Agency by
regulation deems to be subject to the law. With this final rule, FDA is
extending the Agency's ``tobacco product'' authorities in the FD&C Act
to all other categories of products that meet the statutory definition
of ``tobacco product'' in the FD&C Act, except accessories of such
newly deemed tobacco products. This final rule also prohibits the sale
of ``covered tobacco products'' to individuals under the age of 18 and
requires the display of health warnings on cigarette tobacco, roll-your
own tobacco, and covered tobacco product packages and in
advertisements. FDA is taking this action to reduce the death and
disease from tobacco products. In accordance with the Tobacco Control
Act, we consider and intend the extension of our authorities over
tobacco products and the various requirements and prohibitions
established by this rule to be severable.

DATES: This rule is effective August 8, 2016. See section IV of this
document regarding compliance dates for certain provisions.

FOR FURTHER INFORMATION CONTACT: Gerie Voss or Katherine Collins,
Office of Regulations, Center for Tobacco Products, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 877-
287-1373<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary
I. Background
II. Legal Authority
    A. Summary of Legal Authority
    B. Responses to Comments Regarding Legal Authority
III. Use of Premarket Pathways for Newly Deemed Products
    A. Background: The Three Pathways To Market a New Tobacco
Product
    B. Interpretation of Substantial Equivalence
    C. Comments on the Grandfather Date
    D. Impact of Premarket Requirements
    E. Clinical Studies and PMTAs
    F. Premarket Pathways and Continuum of Risk
    G. Other Comments
IV. Implementation
    A. Effective Date for Rule
    B. Compliance Periods for Certain Provisions
    C. Policy for Certain Regulatory Requirements for All
Manufacturers of Newly Deemed Products
    D. Compliance Policy Regarding Certain Provisions and Small-
Scale Tobacco Product Manufacturers
V. Premarket Review Requirements and Compliance Policy
    A. Compliance Policy for Premarket Review Requirements
    B. Responses to Comments Regarding Compliance Periods for
Premarket Review Requirements
VI. Components, Parts, and Accessories
    A. Definitions
    B. Discussion of Requirements Associated With Components and
Parts
VII. Regulation of Cigars and Selection of Option 1
    A. Health Risks of Premium Cigars
    B. Youth and Young Adults Use Premium Cigars
    C. Patterns of Use Do Not Preclude Users From Experiencing
Negative Health Effects
    D. Responses to Other Cigar Comments
VIII. Regulation of Electronic Nicotine Delivery Systems (Including
E-Cigarettes) and the Continuum of Nicotine-Delivering Products
    A. Terminology
    B. Prevalence
    C. Toxicity and Nicotine in E-Liquid and Aerosol
    D. Quality Control
    E. Misperceptions
    F. Use as a Cessation Product
    G. Modified Risk Claims
    H. Dual and Polytobacco Use
    I. Applicability of Section 901
    J. Definitions
    K. Sottera Decision
IX. Effect of Deeming Rule on Vape Shop Manufacturers
    A. Premarket Requirements (Sections 910 and 905)
    B. Ingredient Listing and HPHC Requirements (Sections 904 and
915)
    C. Registration and Product Listing (Section 905)
    D. Tobacco Health Document Submissions (Section 904)
    E. Office of Small Business Assistance
X. Regulation of Other Categories of Products
    A. Nicotine in Newly Deemed Products
    B. Dissolvables
    C. Gels
    D. Pipe Tobacco
    E. Waterpipe Tobacco
    F. Additional Novel and Future Tobacco Products
XI. Additional Automatic Provisions Applicable to Newly Deemed
Products
    A. Sections 902 and 903--Adulteration and Misbranding
    B. Sections 904 and 915--Ingredient Listing and Reporting of
HPHCs
    C. Section 905--Registration and Listing
    D. Section 911--Elimination of Low, Light, and Mild, and Other
Unauthorized Modified Risk Claims
    E. Section 919--User Fees
    F. Tobacco Control Act section 102--Prohibition Against Free
Samples
XII. Requests for Additional Regulations Applicable to Newly Deemed
Products
    A. Ban on Flavored Tobacco Products
    B. Additional Access Restrictions
    C. Nicotine Exposure Warnings
XIII. Severability
XIV. Description of the Final Rule--Part 1100
    A. Section 1100.1--Scope
    B. Section 1100.2--Requirements
    C. Section 1100.3--Definitions
XV. Description of the Final Rule--Part 1140
    A. Section 1140.1--Scope
    B. Section 1140.2--Purpose
    C. Section 1140.3--Definitions
    D. Section 1140.10--General Responsibilities of Manufacturers,
Distributors, and Retailers
    E. Section 1140.14--Additional Responsibilities of Retailers
    F. Comments and Responses Regarding Minimum Age and
Identification Requirements
    G. Comments and Responses Regarding Vending Machines
XVI. Description of the Final Rule--Part 1143
    A. Section 1143.1--Definitions
    B. Section 1143.3--Required Warning Statement Regarding
Addictiveness of Nicotine
    C. Section 1143.5--Required Warning Statements for Cigars
    D. Section 1143.7--Language Requirements for Required Warning
Statements
    E. Section 1143.9--Irremovable or Permanent Required Warning
Statements
    F. Section 1143.11--Does Not Apply to Foreign Distribution
    G. Section 1143.13--Effective Date
    H. Comments and Responses Regarding Required Warning Statements
XVII. National Environmental Policy Act
XVIII. Analysis of Impacts
XIX. Paperwork Reduction Act of 1995
    A. Responses to Comments Regarding Proposed Collection of
Information
    B. Existing Burdens Associated With Tobacco Products Currently
Subject to the FD&C Act (i.e., Cigarettes, Cigarette

Tobacco, Roll-Your-Own Tobacco, and Smokeless Tobacco) With Approved
OMB Control Numbers
    C. Burdens Associated With Tobacco Products Currently Subject to
the FD&C Act But Not Yet Approved by OMB
    D. New Collections of Information That Apply Only to Deemed
Products
XX. Executive Order 13132; Federalism
XXI. Executive Order 13175; Tribal Consultation
XXII. References

Executive Summary

Purpose of the Rule

    Cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco were immediately covered by FDA's tobacco product authorities
in chapter IX of the FD&C Act (21 U.S.C. 387 through 387u) when the
Tobacco Control Act went into effect. For other kinds of tobacco
products, the statute authorizes FDA to issue regulations ``deeming''
them to be subject to such authorities. Consistent with the statute,
once a tobacco product is deemed, FDA may put in place ``restrictions
on the sale and distribution of a tobacco product,'' including age-
related access restrictions and advertising and promotion restrictions,
if FDA determines the restrictions are appropriate for the protection
of the public health. This final rule has two purposes: (1) To deem all
products that meet the definition of ``tobacco product'' under the law,
except accessories of a newly deemed tobacco product, and subject them
to the tobacco control authorities in chapter IX of the FD&C Act and
FDA's implementing regulations; and (2) to establish specific
restrictions that are appropriate for the protection of the public
health for the newly deemed tobacco products. In accordance with
section 5 of the Tobacco Control Act, we consider and intend the
extension of our authorities over tobacco products and the various
requirements and prohibitions established by this rule to be severable.
    FDA is taking this action to reduce the death and disease from
tobacco products. Deeming all ``tobacco products'' (including
components and parts but excluding accessories of the newly deemed
products) to be subject to the FD&C Act will result in significant
benefits for the public health. The final rule defines ``component or
part'' and ``accessory'' to provide additional clarity as to which
products are subject to FDA's tobacco product authority. With respect
to these definitions, FDA notes that ``component'' and ``part'' are
separate and distinct terms within chapter IX of the FD&C Act. However,
for purposes of this final rule, FDA is using the terms ``component''
and ``part'' interchangeably and without emphasizing the distinction
between the terms. FDA may clarify the distinctions between `component'
and `part' in the future. Specifically, ``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. The term excludes
anything that is an accessory of a tobacco product.'' Components and
parts of the newly deemed tobacco products, but not their related
accessories, are included in the scope of this final rule. The
following is a nonexhaustive list of examples of components and parts
used with electronic nicotine delivery systems (ENDS) (including e-
cigarettes): E-liquids; atomizers; batteries (with or without variable
voltage); cartomizers (atomizer plus replaceable fluid-filled
cartridge); digital display/lights to adjust settings; clearomisers,
tank systems, flavors, vials that contain e-liquids, and programmable
software. Similarly, the following is a nonexhaustive list of examples
of components and parts used with waterpipe tobacco: Flavor enhancers
and the vials in which they are contained; hose cooling attachments;
water filtration base additives (including those which are flavored);
flavored waterpipe tobacco charcoals and the wrappers or boxes that
contain the charcoals; and bowls, valves, hoses, and heads.
    FDA is defining ``accessory'' to mean ``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.'' Examples of accessories
are ashtrays, spittoons, hookah tongs, cigar clips and stands and pipe
pouches, because they do not contain tobacco, are not derived from
tobacco, and do not affect or alter the performance, composition,
constituents, or characteristics of a tobacco product. Examples of
accessories also include humidors or refrigerators that solely control
the moisture and/or temperature of a stored product and conventional
matches and lighters that solely provide an external heat source to
initiate but not maintain combustion of a tobacco product. An electric
heater or charcoal used for prolonged heating of waterpipe tobacco is
not an accessory because it is maintaining the combustion of the
tobacco. Accessories of newly deemed tobacco products are not included
within the scope of this final rule, although accessories of
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco remain subject to FDA's tobacco product authorities. FDA is not
regulating accessories of newly deemed tobacco products because
accessories, unlike components or parts, are expected to have little
direct impact on the public health.
    This final deeming rule affords FDA additional tools to reduce the
number of illnesses and premature deaths associated with tobacco
product use. For example, FDA will be able to obtain critical
information regarding the health risks of newly deemed tobacco
products, including information derived from ingredient listing
submissions and reporting of harmful and potentially harmful
constituents (HPHCs) required under the FD&C Act. As of the effective
date, persons who own or operate a domestic establishment engaged in
the manufacture, preparation, compounding, or processing of tobacco
products (hereinafter, ``manufacturing establishments'') will be
subject to the registration requirements. FDA will thus receive
information on the location and number of manufacturing establishments,
which will allow the Agency to establish effective compliance programs.
In addition, this rule authorizes FDA to take enforcement action
against manufacturers who sell and distribute products with
unsubstantiated modified risk tobacco product (MRTP) claims, or false
or misleading claims on their labeling or advertising, thus allowing
for better-informed consumers and helping to prevent the use of
misleading campaigns targeted to youth populations. It will also
prevent from entering the market new tobacco products that are not
appropriate for the protection of public health, are not substantially
equivalent to a valid predicate product, or are not exempt from
substantial equivalence (SE). Finally, the newly deemed tobacco
products may be subject to future regulations that FDA determines are

appropriate for the protection of public health.

Summary of the Major Provisions of the Regulatory Action

    The final rule has two main sections: (1) Deeming provisions and
(2) additional provisions to protect public health.
    Deeming Provisions--After thorough review of the comments and the
scientific evidence, FDA has concluded that Option 1 (including all
cigars, rather than a subset) more effectively protects the public
health and, therefore, has made that the scope of the final rule.
Accordingly, this final rule deems all products meeting the statutory
definition of ``tobacco product,'' except accessories of the newly
deemed tobacco products, to be subject to FDA's tobacco product
authorities under chapter IX of the FD&C Act. Section 201(rr) of the
FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act,
defines the term ``tobacco product,'' to mean ``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 does not mean ``an article
that is a drug under subsection (g)(1), a device under subsection (b),
or a combination product described in section 353(g) of this title.''
\1\ Products that meet the statutory definition of ``tobacco products''
include currently marketed products such as dissolvables not already
regulated by FDA, gels, waterpipe tobacco, ENDS (including e-
cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal
vaporizers, and electronic pipes), cigars, and pipe tobacco.
---------------------------------------------------------------------------

    \1\ FDA notes that some products falling within the FD&C Act's
definition of ``tobacco product'' may not be considered tobacco
products for Federal excise tax purposes (see 26 U.S.C. 5702(c)).
Taxation of tobacco products, as defined by the Internal Revenue
Code, falls under the jurisdiction of the U.S. Department of the
Treasury/Alcohol and Tobacco Tax and Trade Bureau (TTB). Neither
FDA's act of ``deeming'' nor any other FDA regulations directly
affect the taxation of any tobacco product.
---------------------------------------------------------------------------

    In addition, this final rule deems any additional current and
future tobacco products that meet the statutory definition of ``tobacco
product,'' except accessories of such newly deemed products, to be
subject to FDA's authorities under chapter IX of the FD&C Act. For
example, FDA envisions that there could be tobacco products developed
in the future that provide nicotine delivery through means (e.g., via
dermal absorption or intranasal spray) similar to currently marketed
medicinal nicotine products, but which are not drugs or devices. These
products would be ``tobacco products'' and subject to FDA's chapter IX
authorities in accordance with this final deeming rule.
    Upon the effective date of this final rule (i.e., 90 days from the
date of publication), the newly deemed products will be subject to the
same FD&C Act provisions and relevant regulatory requirements to which
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco are subject, with respect to the following:
    (1) Enforcement action against products determined to be
adulterated or misbranded (other than enforcement actions based on lack
of a marketing authorization during an applicable compliance period);
    (2) Required submission of ingredient listing and reporting of
HPHCs;
    (3) Required registration of tobacco product manufacturing
establishments and product listing;
    (4) Prohibition against sale and distribution of products with
modified risk descriptors (e.g., ``light,'' ``low,'' and ``mild''
descriptors) and claims unless FDA issues an order authorizing their
marketing;
    (5) Prohibition on the distribution of free samples (same as
cigarettes); and
    (6) Premarket review requirements.
    These actions will improve the public health by affording FDA
critical information regarding the health risks of such products;
preventing new products from entering the market unless such marketing
is appropriate for the protection of public health, the products are
found substantially equivalent to a valid predicate product, or the
products are found exempt from the SE requirements; and preventing the
use of unsubstantiated modified risk claims, which may mislead
consumers and lead them to initiate tobacco product use or to continue
using tobacco when they would otherwise quit.
    Additional Provisions--In addition to the provisions in the FD&C
Act and implementing regulations that apply automatically to the newly
deemed products, FDA has the authority to invoke its other authorities
under the Tobacco Control Act in regulating these products. At this
time, under section 906(d) of the FD&C Act (21 U.S.C. 387f(d)), FDA is
establishing three restrictions for covered tobacco products: (1)
Requirement for a minimum age of purchase; (2) requirement for health
warnings for product packages and advertisements (which FDA is also
applying to cigarette tobacco and roll-your-own tobacco); and (3)
prohibition of vending machine sales of such products, unless the
vending machine is located in a facility where the retailer ensures
that individuals under 18 years of age are prohibited from entering at
any time. The term ``covered tobacco products'' is defined as those
products deemed to be subject to the FD&C Act under section 1100.2 of
title 21 of the Code of Federal Regulations (CFR), other than a
component or part that is not made or derived from tobacco. We have
slightly modified the definition of ``covered tobacco products'' from
the notice of proposed rulemaking (NPRM) to clarify that components or
parts that are ``covered tobacco products'' include not only those that
contain tobacco or nicotine, but also those that contain any tobacco
derivative (i.e., we have changed the NPRM definition, which excluded
``any component or part of a tobacco product that does not contain
nicotine or tobacco,'' to exclude ``any component or part of a tobacco
product that is not made or derived from tobacco'' as stated in this
final rule).
    Effective Dates--The deeming provisions (i.e., those provisions
that automatically apply to newly deemed products) and minimum age and
identification and vending machine restrictions are effective 90 days
from the date of publication of the final rule. The health warning
requirements are effective 24 months from the date of publication of
the final rule, with an additional 30-day period in which a
manufacturer may continue to introduce into interstate commerce
existing inventory manufactured before the effective date that does not
contain the required warning statements on packaging.
    This means that:
     After the effective date, no manufacturer, packager,
importer, distributor, or retailer of cigarette tobacco, roll-your-own
tobacco, cigars, or other covered tobacco products may advertise any
such product if the advertisement does not comply with this rule;
     After the effective date, no person may manufacture for
sale or distribution within the United States any such product the
package of which does not comply with this rule;
     Beginning 30 days after the effective date, a manufacturer
may not introduce into domestic commerce, any such product,
irrespective of the date of manufacture, if its package does not comply
with this rule (i.e., non-compliant products manufactured prior to the
effective date may not be

distributed for retail sale after 30 days following the effective
date);
     After the effective date, a distributor or retailer may
not sell, offer to sell, distribute, or import for sale or distribution
within the United States any such product the package of which does not
comply with this regulation, unless the covered tobacco product was
manufactured prior to the effective date; and
     After the effective date, however, a retailer may sell
covered tobacco products in packages that do not have a required
warning if the retailer demonstrates it falls outside the scope of this
rule as described in 21 CFR 1143.3(a)(3) and 1143.5(a)(4).
    Compliance Policy for Premarket Review--Manufacturers of newly
deemed products that are ``new tobacco products'' as defined in section
910(a)(1) of the FD&C Act will be required to obtain premarket
authorization of their products through one of three pathways--SE.,
exemption from SE., or premarket tobacco product applications (sections
905 and 910 of the FD&C Act). As stated in the NPRM, we understand
that, for some newly deemed tobacco products, particularly novel
products, there may not be appropriate predicate products that were on
the market on February 15, 2007, to support a SE claim. Accordingly, in
the NPRM, FDA contemplated a compliance period of 24 months after the
effective date of the final rule for the submission of applications for
all newly deemed, new tobacco products under all three marketing
pathways--premarket tobacco applications (PMTAs), SE reports, and SE
exemption requests.\2\
---------------------------------------------------------------------------

    \2\ Although the NPRM did not explicitly include SE exemption
requests as one of the marketing pathways that applicants could
utilize within a compliance period, FDA did intend for its
contemplated 24-month compliance period to be available for all
marketing pathways.
---------------------------------------------------------------------------

    FDA carefully considered numerous comments regarding the
contemplated compliance period. Many comments expressed concern that
newly deemed, new tobacco products would remain available and could
continue to be marketed indefinitely without scientific review. Other
comments expressed concern, and some submitted data, regarding the
effect that flavors have on youth and young adult use of tobacco
products. FDA also received comments and data regarding the potential
for some net public health benefits that could accrue if flavored ENDS
remain available. After carefully considering all of these comments,
FDA here announces a revised compliance policy as well as the final
rule. (Agency compliance/enforcement policies are not subject to the
requirements that govern notice-and-comment rulemaking. Prof'ls &
Patients for Customized Care v. Shalala, 56 F.3d 592 (5th Cir. 1995) (a
compliance policy guide is not a substantive rule and not subject to
the Administrative Procedure Act's (APA) notice-and-comment
rulemaking); Takhar v. Kessler, 76 F.3d 995, 1002 (9th Cir. 1996) (FDA
compliance policy guides were not required to go through notice-and-
comment procedures). But because the relevant time periods are of
obvious interest, FDA laid out its anticipated compliance policy in the
NPRM, and for similar reasons, is announcing its revised compliance
policy here, rather than in a separate guidance document.) As a result
of FDA's compliance policy, we expect that many manufacturers will keep
their products on the market beyond the effective date of this final
rule. However, if a manufacturer of a product is unable to support an
SE claim for its product (e.g., is unable to identify a valid
predicate, or does not submit an SE report with a valid predicate
within the compliance period, or does not receive authorization within
a continued compliance period) and does not obtain authorization under
one of the other available marketing pathways before the end of an
applicable compliance period, such products remaining on the market
will be subject to enforcement (e.g., seizure, injunction) for failure
to have a marketing authorization under sections 905 and 910 of the
FD&C Act.
    FDA's NPRM included detailed requests for comments on different
possible compliance policy approaches. 79 FR at 23175-77. FDA received
many comments on these compliance-policy issues. For example, comments
jointly submitted by 24 health and medical organizations stated that
the contemplated 24-month compliance period and indefinite period of
continued marketing during FDA review included in the NPRM would
prolong the public's exposure to products that contain nicotine, a
highly addictive substance, and that do not meet the statutory standard
for the grant of a marketing order (Comment No. FDA-2014-N-0189-
79772.). They stated that this approach would allow manufacturers to
market the newly deemed products in ways that appeal to youth and to
manipulate the content of these products in uncontrolled ways for an
indefinite period (id.). Ranking minority members of the Energy and
Commerce Committee, Health Subcommittee, and Oversight and
Investigations Subcommittee, U.S. House of Representatives also called
for a more protective compliance period than the one contemplated in
the NPRM, arguing that the proposed compliance period ``puts the
nation's youth at risk'' (Comment No. FDA-2014-N-0189-80119). Further,
a network of tobacco control policy and legal specialists expressed
concern regarding the effect of continued marketing of tobacco products
that have not been reviewed under the applicable public health
standards of the Tobacco Control Act (Comment No. FDA-2014-N-0189-
81044). FDA also received comments suggesting that the agency should
stagger the compliance periods for different product classes based on
the continuum of risk, with ENDS having a longer compliance period than
other product classes (e.g., Comment No. FDA-2014-N-0189-81859; Comment
No. FDA-2014-N-0189-10852). FDA also received comments and new data
regarding the effect of flavored tobacco products on youth and young
adult use.
    FDA understands that the appeal of flavors and use of flavored
tobacco products have an important role in the initiation and continued
use of tobacco products, and in the health risks associated with use of
these products. Based on all of these comments, we have determined that
exercising enforcement discretion indefinitely could put youth and
young adults at risk for tobacco-related death and disease. However, we
recognize that the availability of alternatives to traditional tobacco
flavors in some products (e.g., ENDS) may potentially help some adult
users who are attempting to transition away from combusted products.
Furthermore, at least some flavored combusted products are likely to be
``grandfathered'' and therefore would remain on the market regardless
of the compliance period provided in the preamble. Taking into
consideration all of the comments on the compliance period and flavors,
we are establishing staggered compliance periods. This approach will
enable FDA to balance concerns regarding the extended availability of
all newly deemed, new tobacco products without scientific review,
concerns regarding flavored tobacco products' appeal to youth, and
emerging evidence that some adults may potentially use certain flavored
tobacco products to transition away from combusted tobacco use. FDA is
establishing staggered initial compliance periods based on the expected
complexity of the applications to be submitted, followed by continued

compliance periods for FDA review such that our exercise of enforcement
discretion will end twelve months after each initial compliance period.
In other words, manufacturers of all newly deemed, new tobacco products
will have a 12-, 18- or 24-month initial compliance period in which to
prepare applications for marketing authorization, as well as a 12-month
continued compliance period after those dates in which to obtain
authorization from FDA (resulting in total compliance periods of 24,
30, or 36 months). After the close of the continued compliance period,
products will be subject to enforcement unless they are grandfathered
or are the subject of a marketing authorization order. FDA's revised
compliance policy for premarket review--resulting in products remaining
on the market while manufacturers seek review but also contemplating an
end to the continued compliance policy--will balance the public health
concerns raised in the comments, allow the Agency to more efficiently
manage the flow of incoming applications, and encourage high-quality
premarket submissions from applicants.
    According to this revised compliance policy, for newly deemed
products that are on the market on the effective date of this final
rule and were not on the market on February 15, 2007, FDA is providing
a 12-month initial compliance period for manufacturers to submit (and
FDA to receive) an SE exemption request, an 18-month initial compliance
period for manufacturers to submit (and FDA to receive) SE
applications, and a 24-month initial compliance period for
manufacturers to submit (and FDA to receive) a PMTA.
    If manufacturers submit (and FDA receives) the applications during
their respective compliance periods, FDA, for a certain period of time
as discussed in the following paragraph, intends to continue the
compliance policy and does not intend to initiate enforcement action
for these products remaining on the market without FDA authorization.
    For newly deemed tobacco products using the SE Exemption pathway,
this continued compliance period (i.e., the time during which FDA does
not intend to enforce the premarket review requirements) will close 24
months after the effective date of part 1100 of this final deeming rule
(i.e.,12 months after the 12-month initial compliance period closes for
submission and receipt of SE exemption requests). The earlier
submission period for the SE exemption pathway is intended to allow the
manufacturer time to consider other pathways if the exemption request
is denied or if FDA refuses to accept the request if, for example, the
application is incomplete. For newly deemed tobacco products using the
SE pathway, this continued compliance period will close 30 months after
the effective date of part 1100 of this final deeming rule (i.e., 12
months after the 18-month initial compliance period closes for
submission and receipt of SE Reports). For newly deemed tobacco
products using the PMTA pathway, this continued compliance period will
close 36 months after the effective date (i.e., 12 months after the 24-
month compliance period closes for submission and receipt of PMTAs).
Any such newly deemed tobacco product for which an application under
one of the three marketing pathways has not been submitted within 24
months from the effective date of part 1100 of this final deeming rule
will not benefit from this continued compliance policy and will be
subject to enforcement as of that date. In addition, once the
respective continued compliance period ends for products with
applications submitted according to this policy, products remaining on
the market without premarket authorizations in effect, even if the
product has a pending application that was originally submitted by its
respective initial compliance deadline set forth previously in this
document, will be subject to enforcement. However, if at the time of
the conclusion of the continued compliance period, the applicant has
provided the needed information and review of a pending marketing
application has made substantial progress toward completion, FDA may
consider, on a case-by-case basis, whether to defer enforcement of the
premarket authorization requirements for a reasonable time period.
    Regarding concerns as to the inability to use the SE pathway for
certain products, FDA notes that an applicant may use as a predicate
any tobacco product commercially marketed in the United States as of
February 15, 2007, or previously found substantially equivalent (note
that we interpret the phrase ``as of'' February 15, 2007, as meaning
that the tobacco product was commercially marketed (other than
exclusively in test markets) in the United States on February 15, 2007.
If your tobacco product had been commercially marketed in the United
States before February 15, 2007, but was not commercially marketed on
that date, it is not a grandfathered product and may not be
commercially marketed unless you obtain a marketing authorization under
section 910 of the FD&C Act).\3\ This may possibly include a predicate
that is in a different category or subcategory than the new product
that is the subject of the SE report. While FDA currently does not have
a policy that limits comparisons to the same category, we do see cross-
category comparisons as more challenging for an applicant and we may
express limitations on such comparisons in the future, if they become
warranted as we gain experience regulating newly deemed products. FDA
also is continuing to research e-cigarettes, other ENDS, and heated
cigarette products that likely were on the market ``as of'' (i.e., on)
February 15, 2007. Additionally, FDA has determined that some e-
cigarettes and other ENDS were manufactured in 2006 and commercially
marketed in the United States in early 2007. In particular, we have
identified an ENDS product that may have been on the market on February
15, 2007. This product may possibly be able to serve as a valid
predicate for purposes of the SE pathway. The burden of demonstrating
that a valid predicate exists rests with the manufacturer submitting a
SE report. To facilitate the determination that a product is eligible
to serve as a valid predicate, any individual who has evidence that an
e-cigarette or other ENDS was commercially marketed in the United
States on February 15, 2007, may submit a stand-alone grandfather
submission to FDA (See final guidance, ``Establishing That a Tobacco
Product Was Commercially Marketed in the United States as of February
15, 2007'' (79 FR 58358, September 29, 2014)). (Based on FDA's
experiences to date, and since stand-alone grandfather submissions are
purely voluntary, FDA does not anticipate that many manufacturers will
make such submissions, but this option is available.) Regardless of the
predicate selected for comparison, manufacturers are responsible for
providing scientific data adequate to demonstrate that, in the case of
an SE report, the characteristics of the new product are the same as
the predicate or, if the characteristics are different, that these
differences do not cause the new product to raise different questions
of public health. We encourage interested parties to review the
applications FDA

posts on http://www.fda.gov for examples of products that do not raise
different questions of public health when compared with the specified
predicate product.
---------------------------------------------------------------------------

    \3\ FDA Guidance states that ``[i]f you cannot provide
documentation specifically dated on February 15, 2007, FDA suggests
you provide documentation of commercial marketing for a reasonable
period of time before and after February 15, 2007.'' Guidance for
Industry entitled ``Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007
(79 FR 58358, Sept. 29, 2014), The guidance also provides examples
of sources of evidence, e.g., bills of lading.
---------------------------------------------------------------------------

    Vape Establishments Acting as Manufacturers--Several comments asked
FDA to clarify whether e-cigarette retail stores and vape
establishments are considered ``tobacco product manufacturers'' under
the FD&C Act. In response, FDA has explained that establishments that
mix or prepare e-liquids or create or modify aerosolizing apparatus for
direct sale to consumers are tobacco product manufacturers under the
definition set forth in the FD&C Act and, accordingly, are subject to
the same legal requirements that apply to other tobacco product
manufacturers.
    Revisions to Health Warning Requirements--FDA is finalizing this
deeming rule with a few changes to the proposed health warning
requirements for newly deemed products. For example, FDA has slightly
revised the nicotine warning statement to read: ``WARNING: This product
contains nicotine. Nicotine is an addictive chemical.'' The alternative
warning statement for products that do not contain nicotine (i.e., no
nicotine at detectable levels) is revised to read: ``This product is
made from tobacco.'' We have also provided additional language
explaining the process for self-certifying that the product does not
contain nicotine, which must be submitted to FDA, and the recordkeeping
recommendations for this self-certification. E-liquids that do not
contain tobacco or nicotine or are not derived from tobacco or nicotine
do not meet the definition of ``covered tobacco product,'' as described
throughout this final rule, and will not be required to carry an
addiction warning or to submit a self-certification. In addition, we
have added language to clarify that the warning statements on packages
must be printed in at least 12-point font size to be conspicuous and
legible.
    Further, we have added a provision to indicate that a product
package too small or otherwise unable to accommodate a label with
sufficient space to bear such information will be exempt from the
requirements to place the warning statement directly on packages (as
required in Sec.  1143.3(a)(1)), as long as the warning requirements
enumerated in Sec.  1143.3(a)(2) and (d) are met. For instance, for
small packages, the warning statement must appear on the two principal
display panels on the outer carton or other outer container or wrapper
or on a tag otherwise permanently affixed to the tobacco product
package. This required warning must be printed using the same
specifications in Sec.  1143.3(a)(1) and (2) (which provide the
specifications for the addiction warning). In such cases, the carton,
outer container, wrapper, or tag would serve as one of the principal
display panels.
    Reproductive Health Warning for Cigars--In the proposed deeming
rule, FDA proposed to require four of the five warnings already
included on most cigar packages and in most cigar advertisements as a
result of settlement agreements between the Federal Trade Commission
(FTC) and the seven largest U.S. cigar manufacturers (hereinafter,
``FTC consent decrees''). (See, e.g., In re Swisher International,
Inc., Docket No. C-3964.) FDA did not propose to require the fifth
warning (SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of
Infertility, Stillbirth and Low Birth Weight), but asked for comments
regarding this decision. Upon further consideration, FDA has decided to
require a fifth warning regarding reproductive health effects and cigar
use specifically, which reads ``WARNING: Cigar use while pregnant can
harm you and your baby.'' This requirement is supported by existing
scientific evidence and is appropriate for the protection of the public
health. However, because the general statement ``Tobacco smoke
increases the risk of infertility, stillbirth and low birth weight'' is
also a true statement, and because scientific evidence demonstrates
that cigar smoke is similar in content and effects to cigarette smoke,
FDA is allowing the use of the reproductive health warning required by
the FTC consent decrees as an optional alternative to the fifth FDA
warning. FDA expects that providing the optional alternative will
benefit entities bound by the FTC consent decrees.
    Nicotine Exposure Warning and Child-Resistant Packaging--After
reviewing the comments, FDA recognizes the importance of alerting
consumers to, and protecting children from, the hazards from ingestion
of, and eye and skin exposure to, e-liquids containing nicotine. Toward
that end, FDA issued an advance NPRM (ANPRM) prior to this deeming rule
(80 FR 51146 (2015)), seeking comments, data, research, or other
information that may inform regulatory actions FDA may take with
respect to a nicotine exposure warning and child-resistant packaging.
In addition, elsewhere in this issue of the Federal Register, FDA has
made available draft guidance, which when final will describe FDA's
current thinking regarding some appropriate means of addressing the
premarket authorization requirements for newly deemed ENDS products,
including recommendations for exposure warnings and child-resistant
packaging that would help to support a showing that the marketing of a
product is appropriate for the protection of public health.
    Requests for Additional Regulations Applicable to Newly Deemed
Products--In the NPRM, FDA noted that, once the products were deemed,
the Agency could issue additional regulations applicable to newly
deemed products, including product standards under section 907 of the
FD&C Act (21 U.S.C. 387g). FDA received many suggestions for additional
regulations that should apply to the newly deemed products. FDA is
taking these comments under advisement and considering whether to issue
NPRMs for such provisions.
    Compliance Policy Regarding Certain Provisions and Small-Scale
Tobacco Product Manufacturers--In the NPRM, FDA requested comment on
the ability of small 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 certain provisions of
this rule against certain manufacturers that are small-scale tobacco
product manufacturers and that may need additional time to comply with
certain requirements of the FD&C Act. Generally, for purposes of this
new compliance policy in which FDA is specifying additional periods of
time for such manufacturers to comply with certain provisions (i.e.,
additional time to respond to SE deficiency letters, an additional six-
month compliance period for the tobacco health document submission
requirements, and additional time to submit ingredient listings, as
discussed in Section IV.D). As with manufacturers generally, these
small-scale tobacco manufacturers will also benefit from additional
assistance with their marketing applications, including: a Regulatory
Health Project Manager so that they have a single point of contact in
FDA's Center for Tobacco Products (CTP's) Office of Science (OS) for
questions about their marketing applications; an appeals process for
denial of marketing applications (of which one small business has
already taken advantage); and staff from CTP's Office of Compliance and
Enforcement (OCE), who assist such businesses in helping them to
identify documents that may be used to establish that their

predicate products were on the market on February 15, 2007. Further,
CTP's OCE will continue to assist small-scale tobacco product
manufacturers in their submission of rotational warning plans for FDA
approval and to provide a system to assist such businesses in
navigating the regulatory requirements of FDA. 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. In formulating our thinking on what a small-scale tobacco product
manufacturer is for purposes of this policy, FDA has considered all
available data on employment, revenues, production volume and other
details of operation for current manufacturers of newly deemed
products. FDA considers a manufacturer to include each entity that it
controls, is controlled by, or is under common control with. To help
make FDA's individual enforcement decisions more efficient, a
manufacturer may voluntarily submit information regarding employment
and revenues.\4\
---------------------------------------------------------------------------

    \4\ FDA notes that our current thinking regarding ``small-scale
tobacco product manufacturer'' for purposes of this compliance
policy differs from definitions of ``small manufacturer'' or ``small
tobacco product manufacturer'' that pertain in several other
contexts, including definitions established by the Small Business
Administration or the Tobacco Control Act's definition of a ``small
tobacco product manufacturer.'' FDA notes that its current thinking
reflects an evaluation of all available data regarding manufacturers
of newly deemed tobacco products, as well as careful review of the
potentially unique interests of the smallest tobacco product
manufacturers as considered in light of the Agency's statutory
obligations regarding the protection of public health.
---------------------------------------------------------------------------

    Policy for Certain Regulatory Requirements for All Manufacturers of
Newly Deemed Products--Although FDA maintains that all of the automatic
provisions are important given that all tobacco products have inherent
risks, 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. In addition, FDA expects that it will
obtain necessary information from its regulation of finished tobacco
products. As a result, FDA has established a compliance policy for
premarket submission and for obtaining authorization with respect to
certain components and parts of newly deemed tobacco products. We note
that FDA also intends to issue a guidance regarding HPHC reporting
under section 904(a)(3), and later a testing and reporting regulation
as required by section 915, with enough time for manufacturers to
report given the 3-year compliance period for HPHC reporting. Section
904(a)(3) requires the submission of a report listing all constituents,
including smoke constituents identified as harmful or potentially
harmful (HPHC) by the Secretary. Section 915 requires the testing and
reporting of the constituents, ingredients, and additives the Secretary
determines should be tested to protect the public health. The section
915 testing and reporting requirements apply only after FDA issues a
regulation implementing that section, which it has not yet done. Until
these testing and reporting requirements have been established, newly
deemed tobacco products (and currently regulated tobacco products) are
not subject to the testing and reporting provisions found under section
915. As noted elsewhere in this document, FDA does not intend to
enforce the reporting requirements under section 904(a)(3) for newly
deemed products before the close of the 3-year compliance period, even
if the HPHC guidance and the section 915 regulation are issued well in
advance of that time.
    Severability--In accordance with section 5 of the Tobacco Control
Act, FDA considers and intends the extension of its authorities over
all tobacco products and the various requirements and prohibitions
established by this rule to be severable. It is FDA's interpretation
and position that the invalidity of any provision of this rule shall
not affect the validity of any other part of this rule. In the event
any court or other lawful authority were to temporarily or permanently
invalidate, restrain, enjoin, or suspend any provision of this final
rule, FDA would conclude that the remaining parts continue to be valid.
As stated in section 5 of the Tobacco Control Act, if certain
applications of this rule to persons or circumstances (discussed in the
preamble or otherwise) are held to be invalid, application of such
provisions to any other person or circumstance will not be affected and
will continue to be enforced. Each provision of the rule is
independently supported by data and analysis as described or referenced
in this preamble and, if issued separately, would remain a proper
exercise of FDA authority.

Costs and Benefits

    This final rule deems all products meeting the statutory definition
of ``tobacco product,'' except accessories of a newly deemed tobacco
product, to be subject to chapter IX of the FD&C Act. This final rule
also finalizes additional provisions that would apply to certain newly
deemed products as well as to certain other tobacco products. Once
deemed, tobacco products become subject to the FD&C Act and its
implementing regulations. The FD&C Act requirements that will apply to
newly deemed products include establishment registration and product
listing, ingredient listing, HPHC testing and reporting, premarket
submissions prior to the introduction of new products, and labeling
requirements. Free samples of newly deemed tobacco products will also
be prohibited. The additional provisions of this final rule include
minimum age and identification requirements, vending machine
restrictions, and required warning statements for packages and
advertisements.

                                                   Table 1--Summary of Quantified Costs Over 20 Years
                                                                       [$ million]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Lower bound                     Upper bound     Lower bound                     Upper bound
                                                               (3%)        Primary  (3%)       (3%)            (7%)        Primary  (7%)       (7%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Private Sector Costs...................           517.7           783.7         1,109.8           450.4           670.9           939.8
Present Value of Government Costs \1\...................           204.6           204.6           204.6           145.7           145.7           145.7
Present Value of Total Costs............................           722.3           988.2         1,314.4           596.1           816.5         1,085.4
Annualized Value of Private Sector Costs................            34.8            52.7            74.6            42.5            63.3            88.7
Annualized Value of Government Costs \1\................            13.8            13.8            13.8            13.8            13.8            13.8
Annualized Value of Total Costs.........................            48.5            66.4            88.3            56.3            77.1           102.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ FDA costs represent an opportunity cost, but this rule will not result in changes to overall FDA accounting costs, the size of the Federal budget,
  or the total amount of tobacco industry user fees.

    The direct benefits of making each of the newly deemed tobacco
products subject to the requirements of chapter IX of the FD&C Act are
difficult to quantify, and we cannot predict the size of these benefits
at this time. Table 1 summarizes the quantified costs of this final
rule over 20 years. For the reasons provided in the preamble and
analysis of impacts, FDA has concluded that the benefits of the final
rule justify the costs. Among other effects, new products will be
subject to an evaluation to ensure they meet the appropriate public
health standard for the pathway before they can be marketed, labeling
cannot contain misleading statements, and FDA will be made aware of the
ingredients in newly deemed tobacco products. If, without the final
rule, new products would pose substantially greater health risks than
those already on the market, the premarket requirements made effective
by this final rule would keep such products from appearing on the
market and worsening the health effects of tobacco product use. The
warning statements required by this final rule will help consumers
better understand and appreciate the risks and characteristics of
tobacco products.

I. Background

    Cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco were immediately covered by FDA's tobacco product authorities
in chapter IX of the FD&C when the Tobacco Control Act went into
effect. For other tobacco products, the statute authorized FDA to issue
regulations ``deeming'' them to be subject to such authorities.
Consistent with the statute, once a tobacco product is deemed, FDA may
put in place ``restrictions on the sale and distribution of a tobacco
product,'' if FDA determines the restrictions are appropriate for the
protection of the public health (21 U.S.C. 387f(d)(1)).
    The Surgeon General has long recognized that the addictive nature
of tobacco products is due to the presence of highly addictive nicotine
that can be absorbed into the bloodstream (see, e.g., Ref. 1 at 6-9).
While the amount of nicotine delivered and the means through which it
is delivered can either reduce or enhance nicotine's potential for
abuse and physiological effects (Ref. 2 at 113), nicotine is addictive.
In general, the quicker the delivery, rate of absorption, and
attainment of peak concentrations of nicotine, the greater the
potential for addiction (id.).
    The Surgeon General reported that ``most people begin to smoke in
adolescence and develop characteristic patterns of nicotine dependence
before adulthood'' (Ref. 3). These youth develop physical dependence
and experience withdrawal symptoms when they try to quit smoking (id.).
As a result, addiction to nicotine is often lifelong (Ref. 4), and
youth and young adults generally ``underestimate the tenacity of
nicotine addiction and overestimate their ability to stop smoking when
they choose'' (Ref. 5). For example, in a study of over 1,200 sixth
grade students who inhaled tobacco products, 58.5 percent had lost
autonomy over their tobacco use (i.e., had difficulty trying to quit)
(Ref. 6). One survey also revealed that ``nearly 60 percent of
adolescents believed that they could smoke for a few years and then
quit'' (Ref. 7). Research conducted in animal models has indicated that
exposure to substances such as nicotine can disrupt prenatal brain
development and may have long-term consequences on executive cognitive
function and on the risk of developing a substance abuse disorder and
various mental health problems as an adult (Ref. 8), and this exposure
to nicotine can also have long-term results on decreasing attention
performance and increasing impulsivity which could promote the
maintenance of nicotine use behavior (id.).
    The Surgeon General also emphasizes that ``nicotine addiction
develops as a neurobiologic adaptation to chronic nicotine exposure,''
suggesting that the pattern of tobacco product use (e.g., frequency of
using the product) is a factor in the facilitation of nicotine
addiction (Ref. 9 at 112). The Surgeon General also noted ``all forms
of nicotine delivery do not pose an equal risk in establishing and
maintaining addiction'' and this may be because the pharmacokinetics of
various nicotine containing products differ (id.). The FDA-approved
nicotine patch is an example of slow absorption and once-a-day dosing
which results in minimal potential for addiction (Ref. 2 at 113). In
1988, the Surgeon General recognized that the ultimate levels of
nicotine absorbed into the blood from tobacco products on the market at
that time can be similar in magnitude regardless of the product forms
used to deliver nicotine (Ref. 1). For example, research has shown that
oral use of smokeless tobacco products that do not emit smoke results
in ``high venous concentrations of nicotine equal to those for use of
cigarettes'' (Ref. 2 at 113).
    FDA believes that the inhalation of nicotine (i.e., nicotine
without the products of combustion) is of less risk to the user than
the inhalation of nicotine delivered by smoke from combusted tobacco
products. However, limited data suggest that the pharmacokinetic
properties of inhaled nicotine can be similar to nicotine delivered by
combusted tobacco products. Thus, inhaled nicotine from a non-
combustible product may be as addictive as inhaled nicotine delivered
by combusted tobacco products. Researchers recognize that the effects
from nicotine exposure by inhalation without combustion are likely not
responsible for the high prevalence of tobacco-related death and
disease in this country (Refs. 10, 11). Although nicotine itself has
not been shown to cause the chronic disease associated with tobacco
use, the 2014 Surgeon General's report noted that there are still risks
associated with nicotine (Ref. 9 at 111). For example, nicotine at high
enough doses has acute toxicity (id.). Research in animal models have
demonstrated that nicotine exposure during fetal development may have
lasting adverse consequences for brain development (id.). Nicotine also
adversely affects maternal and fetal health during pregnancy,
contributing to multiple adverse outcomes such as preterm delivery and
stillbirth (id.; citing Refs. 12, 13). Further, data from studies of
mice also suggest that nicotine exposure during adolescence may have
lasting adverse consequences for brain development (id.). Some studies
in animal models also have found that nicotine can have detrimental
effects on the cardiovascular system and potentially disrupt the
central nervous system (Refs. 14, 15).
    ``Since the 1964 Surgeon General's report, comprehensive tobacco
control programs and policies have been proven effective for
controlling tobacco use'' (Ref. 9 at 36). Accordingly, FDA is issuing
this final rule to serve two purposes: (1) To deem products that meet
the definition of ``tobacco product'' under the law, except accessories
of newly deemed tobacco products, and subject them to the tobacco
control authorities in the FD&C Act; and (2) to establish specific
restrictions that are appropriate for the protection of the public
health for the newly deemed tobacco products. To satisfy these
purposes, FDA proposed two options (Option 1 and Option 2), which
provided two alternatives for the scope of the deeming provisions and,
consequently, the application of the additional specific provisions.
Under Option 1, all products meeting the definition of a ``tobacco
product,'' except accessories of newly deemed tobacco products, would
be deemed. Option 2 was the same as Option 1,

except a subset of cigars known as ``premium cigars'' would be
excluded.
    Currently, tobacco products unregulated by FDA are widely available
and come in many forms, including cigars, pipe tobacco, waterpipe
tobacco, liquids (e-liquids) for ENDS (the most popular of which are
electronic cigarettes, but also include e-hookah, e-cigars, vape pens,
personal vaporizers, and electronic pipes), liquid nicotine that is
made or derived from tobacco, nicotine gels, and certain dissolvable
tobacco products (i.e., dissolvable products that do not currently meet
the definition of ``smokeless tobacco'' in section 900(18) of the FD&C
Act (21 U.S.C. 387(18)) because they do not contain cut, ground,
powdered, or leaf tobacco and instead contain nicotine extracted from
tobacco). Upon implementation of this final rule, currently unregulated
tobacco products and future products meeting the definition of
``tobacco product'' under section 201(rr) (except accessories of newly
deemed tobacco products) will be subject to chapter IX of the FD&C Act.
    FDA issued a proposed deeming rule on April 25, 2014 (79 FR 23142).
We received over 135,000 comments on the NPRM. Comments were received
from tobacco product manufacturers, retailers, academia, medical
professionals, local governments, advocacy groups, and consumers. To
make it easier to identify comments and our responses, the word
``Comment,'' in parentheses, will appear before each comment, and the
word ``Response,'' in parentheses, will appear before each response. We
have numbered the comments to make it easier to distinguish between
comments; the numbers are for organizational purposes only and do not
reflect the order in which we received the comments or any value
associated with them. We have combined similar comments under one
numbered comment. In addition to the comments specific to this
rulemaking that we address in the following paragraphs, we received
many general comments expressing support or opposition to the rule and
separate provisions within the rule. These comments express broad
policy views and do not address specific points related to this
rulemaking. Therefore, these general comments do not require a
response. Other comments outside the scope of this rulemaking also have
not been addressed here. The remaining comments, as well as FDA's
responses, are included in this document.

II. Legal Authority

A. Summary of Legal Authority

    As set forth in the preamble to the NPRM (79 FR 23142 at 23145),
the Tobacco Control Act provided FDA with the authority to regulate
tobacco products by, among other things, adding chapter IX to the FD&C
Act. Section 901 of the FD&C Act (21 U.S.C. 387a) provides that this
new chapter (Chapter IX--Tobacco Products) applies to all cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to
any other tobacco products that the Secretary of Health and Human
Services by regulation deems to be subject to this chapter. In
accordance with section 901 of the FD&C Act, FDA issued a NPRM to
extend FDA's ``tobacco product'' authorities to products that meet the
statutory definition of ``tobacco product'' in section 201(rr) of the
FD&C Act,\5\ except the accessories of these tobacco products, and
provided two separate options as to the scope of cigar products that
would be deemed subject to FDA's tobacco authorities. FDA is selecting
Option 1 deeming all tobacco products, including premium cigars, except
the accessories of the newly deemed products, with this final rule.
---------------------------------------------------------------------------

    \5\ Section 201(rr) of the FD&C Act defines ``tobacco product,''
in relevant part, as 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). 21 U.S.C. 321(rr).
---------------------------------------------------------------------------

    In addition, section 906(d)(1) of the FD&C Act authorizes FDA to
require restrictions on the sale and distribution of a tobacco product,
if the Agency determines that ``such regulation would be appropriate
for the protection of the public health.'' FDA has determined that the
additional restrictions included with this final rule (i.e., minimum
age and identification requirements, vending machine restrictions, and
health warning statements) are ``appropriate for the protection of the
public health.''
    These authorities are supplemented by section 903 of the FD&C Act
(21 U.S.C. 387c), which provides, among other things, that a tobacco
product is misbranded unless the manufacturer, packer, or distributor
thereof includes in all advertisements and other descriptive printed
matter issued or caused to be issued by the manufacturer, packer, or
distributor with respect to that tobacco product a brief statement of
the uses of the tobacco product and relevant warnings, precautions,
side effects, and contraindications (section 903(a)(8)(B)(i) of the
FD&C Act). Section 903(a)(7)(B) of the FD&C Act also provides that a
tobacco product is misbranded if it is sold or distributed in violation
of a regulation prescribed under section 906(d) of the FD&C Act.
    In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a))
provides FDA with authority to issue regulations for the efficient
enforcement of the FD&C Act.

B. Responses to Comments Regarding Legal Authority

    FDA received comments on a wide range of legal issues, including
FDA's authority to deem tobacco products subject to the FD&C Act and
constitutional issues that may be implicated by the NPRM. FDA carefully
considered these comments and concludes that the Agency has authority
to deem the tobacco products covered under this final rule. FDA is not
aware of other legal concerns from comments that prevent the Agency
from taking the actions included in this final rule. A summary of
comments regarding legal authority, and FDA's responses, follows.
1. Section 901 Authority
    (Comment 1) Generally, the comments did not challenge FDA's
authority under section 901 of the FD&C Act, but at least one comment
argued that section 901 does not grant FDA the authority to deem, ``in
a sweeping manner,'' all products (excluding accessories) that meet the
statutory definition of ``tobacco product.'' The comment argued that
Congress intended to grant FDA discretion to deem products only on a
product-by-product basis, or at best, a category-by-category basis, and
that FDA lacks authority to ``simply swallow all extant and future
tobacco products up in its authority[.]''
    (Response) FDA disagrees. Section 901 grants FDA the authority to
deem ``any . . . tobacco products that the Secretary by regulation
deems to be subject to [chapter IX of the FD&C Act].'' There is no
provision in the statute that restricts FDA's authority to deem all
tobacco products that meet the statutory definition or requires FDA to
deem products on an individual or product category basis.
    The comment did not provide a basis for the claim that Congress
intended to restrict FDA's deeming authority to piecemeal deeming of
specific categories of products and no such restrictions exist. FDA
believes that deeming tobacco products on a product or category basis
would create regulatory loopholes, substantial delay (at the risk to
public health), and significantly impede FDA's ability to

create a comprehensive regulatory scheme.
    Even if there was ambiguity in the wording of section 901, which
FDA does not believe there is, FDA would be entitled to deference on
this interpretation of the statute (Chevron U.S.A., Inc. v. Natural
Res. Def. Council, Inc., 467 U.S. 837, 842-45 (1984), quoting Morton v.
Ruiz, 415 U.S. 199, 231 (1974) (``We have long recognized that
considerable weight should be accorded to an executive department's
construction of a statutory scheme it is entrusted to administer, and
the principle of deference to administrative interpretations . . .'')).
    (Comment 2) At least one comment questioned whether section 901 of
the FD&C Act provides authority to deem future tobacco products under
the new rule. Specifically, the comment argued that a ``tobacco
product'' must exist at the time the rule takes effect for it to be
subject to ``deeming'' under the rule.
    (Response) FDA disagrees. The term ``tobacco product'' is defined
in section 201(rr) of the FD&C Act, 21 U.S.C. 321(rr), to mean ``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 excluding drugs, devices, and combination products as defined under
the FD&C Act. The definition has no temporal element, and nothing in
the statute limits FDA's deeming authority to products or categories of
products that are currently marketed. Contrary to Congress's intention
in enacting the statute, the proposed interpretation would
substantially impede FDA's ability to protect the public health.
Indeed, FDA's ability to regulate new products would be further delayed
by months or even years after the introduction of each new product, as
the Agency would have to initiate a rulemaking to deem each new product
before existing regulations would apply. Such an interpretation would
frustrate the intent underlying the Tobacco Control Act and endanger
the public health.
    Moreover, we note that the Agency is not simply creating a rule to
apply to theoretical products with completely unknown risks that will
be developed in the future. Instead, FDA is finalizing this rule to
include all ``tobacco products'' within the scope of its regulatory
authority based on the potential harm posed by existing products and
the Agency's experience with the regulation of such products (which
have all been made or derived from tobacco). This experience has shown
us that it would be easier for manufacturers and more protective for
public health for a company to know (prior to development and
marketing) that its product must be reviewed and authorized by FDA in
order to be offered for sale in the United States.
    (Comment 3) A number of comments contended that section 901(g) of
the FD&C Act requires FDA to consult with other Federal Agencies before
promulgating a new rule under chapter IX of the FD&C Act.
    (Response) FDA agrees that section 901(g) requires FDA to
``endeavor to consult with other Federal Agencies, as appropriate.''
FDA consulted with other Federal Agencies during the Federal Agency
review process required by Executive Order 12866, satisfying its
requirement under section 901(g).
2. FDA's Exercise of Authority
    (Comment 4) Some comments, largely from the ENDS industry, argued
that FDA is required to establish that deeming will benefit public
health, and that insufficient evidence exists to do so. Specifically,
they argued that FDA is unable to quantify the health risks of certain
products (namely, e-cigarettes) \6\ without multiple long-term studies,
and that currently such studies do not exist. A few comments cited the
public health standard in section 906(d) of the FD&C Act as authority
for these claims.
---------------------------------------------------------------------------

    \6\ FDA notes that most comments referred to ``e-cigarettes''
when discussing ENDS products. Therefore, FDA refers to ``e-
cigarette'' in the comment summaries. Because FDA's responses
generally apply to all ENDS products (the most popular of which are
electronic cigarettes, but also includes e-hookah, e-cigars, vape
pens, personal vaporizers, and electronic pipes), FDA's responses to
the comments generally use the term ``ENDS.''
---------------------------------------------------------------------------

    (Response) FDA disagrees. These comments attempted to impose a
standard for the application of FDA's deeming authority that is not
created by statute or otherwise. Under section 901(b), chapter IX of
the FD&C Act shall apply to all cigarettes, cigarette tobacco, roll-
your-own tobacco, and smokeless tobacco and to any other tobacco
products that the Secretary by regulation deems to be subject to this
chapter (emphasis added). The only pertinent limitations on the scope
of FDA's deeming authority are the definition of ``tobacco product''
set forth in section 201(rr) of the FD&C Act and a provision regarding
tobacco growers and similar entities and tobacco leaf that is not in
the possession of a manufacturer of tobacco products in section
901(c)(2) of the FD&C Act.
    FDA disagrees with the comments that argued that the standard set
forth in section 906(d) of the FD&C Act applies to the act of deeming
tobacco products. Sections 901 and 906(d)(1) provide FDA with separate
authorities. Section 901 gives FDA the authority to deem additional
products to be subject to chapter IX. Once products are subject to
chapter IX, FDA can use other authorities in chapter IX, such as
section 906(d), to take regulatory action with respect to such
products. By its own language, section 906(d) applies to regulations
FDA issues requiring restrictions on the sale and distribution,
including restrictions on the access to, and the advertising and
promotion of, a tobacco product; therefore, the standard in section
906(d)(1) applies only to the additional regulations issued by FDA
under section 906(d) (such as the minimum age and identification
requirements and vending machine restrictions this rule is promulgating
in Sec.  1140.14, and the health warning requirements in Sec. Sec.
1143.3 and 1143.5) and not to deeming itself or the provisions in the
statute that apply automatically to newly deemed products.
    Although FDA is not required to meet a particular public health
standard to deem tobacco products, regulation of the newly deemed
products will be beneficial to public health. The Agency has concluded,
based on scientific data, that the newly deemed products should be
regulated due to their potential for public harm (e.g., 79 FR at 23154-
23158) and regulation is necessary to learn more about that potential.
Greater regulatory certainty created by premarket authorizations should
help companies to invest in creating novel products, with greater
confidence that improved products will enter the market without having
to compete against equally novel, but more dangerous products. For
example, a company wishing to invest the additional resources needed to
ensure that its e-cigarette is designed and manufactured with
appropriate methods and controls will be more likely to do so if the
product is not competing against products that are more cheaply and
crudely made, yet appear to be identical to the consumer. Over time,
since the ``appropriate for the protection of the public health''
standard involves comparison to the general tobacco product market, FDA
believes the employment of the premarket authorities could create
incentives for producers to develop products that are less dangerous
when consumed, less likely to lead to initiation of tobacco use, and/or
easier to quit.
    Further, FDA's premarket review of the newly deemed products will

increase product consistency. For example, FDA's oversight of the
constituents of e-cigarettes cartridges will help to ensure quality
control relative to the chemicals and their quantities being
aerosolized and inhaled. At present, there is significant variability
in the concentration of chemicals amongst products--including
variability between labeled content and concentration and actual
content and concentration (e.g., Refs. 16, 17, 18, 19, 20). Without a
regulatory framework, users who expect consistency in these products
may instead be subject to significant variability in nicotine content
among products, raising potential public health and safety issues.
Implementation of the premarket review requirements also will allow FDA
to monitor product development and changes and to prevent more harmful
or addictive products from reaching the market.
    In addition, as FDA discussed in the NPRM, deeming all tobacco
products will provide FDA with critical information regarding the
health risks of the products including information derived from
ingredient listing submissions and reporting of HPHCs required under
the FD&C Act (79 FR 23142 at 23148). Obtaining this information is
particularly important given the addictiveness of nicotine and the
toxicity associated with tobacco products. Given that ``[e]xposure to
secondhand tobacco smoke has been causally linked to cancer,
respiratory, and cardiovascular diseases, and to adverse effects on the
health of infants and children,'' this information will be helpful in
further assessing the toxicity of the newly deemed tobacco products
(Ref. 9 at 7).\7\
---------------------------------------------------------------------------

    \7\ As stated in the 2014 Surgeon General's Report, ``the burden
of death and disease from tobacco use in the United States is
overwhelmingly caused by cigarettes and other combusted tobacco
products'' (Ref. 9 at 7).
---------------------------------------------------------------------------

    Many of these comments also argued that FDA's acknowledgment that
it does ``not currently have sufficient data . . . to determine what
effects e-cigarettes have on the public health'' is an admission that
FDA does not know, and cannot determine, whether regulation of these
products will benefit public health. FDA disagrees. That language
follows the statement, ``some have advanced views that certain new
tobacco products that are noncombustible . . . may be less hazardous,
at least in certain respects, than combustible products . . . ,'' and
refers to the lack of evidence supporting such asserted benefits (79 FR
23142 at 23144). Whether ENDS generally may eventually be shown to have
a net benefit on or harm to public health at the population level--and
there have not yet been long-term studies conducted to support either
claim at this time--regulation of ENDS will still benefit public
health. The 2014 Surgeon General's Report also notes that ``[f]urther
research with attention to their individual and population-level
consequences will be helpful to fully address these questions. However,
the promotion of noncombustible products is much more likely to provide
public health benefits only in an environment where the appeal,
accessibility, promotion, and use of cigarettes and other combusted
tobacco products are being rapidly reduced'' (Ref. 9 at 874).
    FDA noted in the NPRM that many public health benefits will flow
from deeming tobacco products (including e-cigarettes and other ENDS).
Even if a category of products were to prove generally beneficial,
individual products within that category may raise concerns. For
example, some products may be particularly attractive to youth or
deliver unexpected high levels of toxicants. In addition, once all
tobacco products are deemed, any manufacturer seeking to market its
product as a modified risk tobacco product (MRTP) will be required to
provide substantiation and obtain an order from FDA before making such
claims, where it is currently not subject to such requirements under
the FD&C Act. More generally, regulation and product review allows the
Agency to help ensure the public health is protected. FDA's regulatory
tools, including the adulteration and misbranding provisions in
sections 902 (21 U.S.C. 387b) and 903 of the FD&C Act as applied to
newly deemed products, will help to protect consumers by subjecting all
tobacco products to certain basic requirements, such as that their
labeling and advertising not be false or misleading. FDA will be able
to take enforcement action against any tobacco products that do not
meet these requirements. Further, implementation of the requirements
regarding premarket applications, SE reports, and exemption requests
(sections 905 and 910 of the FD&C Act (21 U.S.C. 387e and 387j,
respectively)) will increase product consistency and help protect the
public health from adverse impacts. For example, although there is
currently variability in the concentrations of chemicals in e-liquids,
FDA oversight of the constituents in e-liquids and ENDS will help to
ensure quality control over the types and quantities of chemicals being
aerosolized and inhaled (79 FR 23142 at 23149). Once deemed, the
Tobacco Control Act authorizes FDA to impose certain types of
restrictions that it has determined are appropriate to the protection
of public health. Under this authority, FDA is imposing certain
restrictions for ENDS and other products, such as minimum age
requirements.
    The need for deeming is further confirmed by the continued dramatic
rise in youth and young adult use of tobacco products such as e-
cigarettes and waterpipe tobacco, and continued youth and young adult
use of cigars (mainly cigarillos). As discussed in the NPRM, e-
cigarettes are widely available in retail outlets such as kiosks in
shopping malls and on the Internet and their online popularity has
surpassed that of snus which has been on the market far longer than e-
cigarettes (Ref. 21).
    Recent studies show a dramatic rise in the use of ENDS products.
The Centers for Disease Control and Prevention (CDC) and FDA analyzed
data from the 2011-2014 National Youth Tobacco Surveys (NYTS) and found
that current (past 30 day) e-cigarette use among high school students
increased nearly 800 percent from 1.5 percent in 2011 to 13.4 percent
in 2014 (Ref. 22). In 2014, a total of 24.6 percent of high school
students reported current use of a tobacco product (id.). Among all
high school students, e-cigarettes (13.4 percent) were the most common
tobacco products used (id.). This increase was not limited to any one
demographic group; e-cigarettes were the most commonly used product
among high school non-Hispanic whites, Hispanics, and persons of non-
Hispanic other races (id.). E-cigarettes (3.9 percent) were also the
tobacco product used most commonly by middle school students (id.).
From 2011 to 2014, statistically significant nonlinear increases were
observed among high school students for current e-cigarette use (1.5
percent to 13.4 percent) (id.). Among middle school students,
statistically significant increases were observed from 2011 to 2014
(id.). In 2014, an estimated 4.6 million middle and high school
students currently used any tobacco product (i.e., cigarettes, cigars,
smokeless tobacco, e-cigarettes, hookahs, tobacco pipes, snus,
dissolvable tobacco, and bidis), of which an estimated 2.2 million
students currently used two or more tobacco products. Overall, in 2014,
2.4 million middle and high school students reported current use of e-
cigarettes (id.). The data also demonstrated that when use of all
tobacco products was considered in aggregate, there was no

change in overall current tobacco use among middle and high school
students.
    Another recently published study found that ninth grade students
who reported having ever used e-cigarettes at the baseline assessment
were approximately 2.7 times more likely than non-e-cigarette users to
have started smoking combusted tobacco products (cigarettes, cigars,
waterpipe tobacco) and 1.7 times more likely to have started smoking
conventional cigarettes 6 to 12 months later (Ref. 23). While this
study indicates that e-cigarette users are more likely than non-e-
cigarette users to also use combusted tobacco products 12 months later,
it cannot be determined by the research findings if such users would
have used combusted tobacco products regardless of e-cigarette use.
Researchers noted that some teens are more likely to use e-cigarettes
prior to combustible tobacco products for several reasons including the
availability of e-cigarettes in flavors attractive to youth (id.).
    In terms of young adult and adult use of e-cigarettes, evidence
from the most recent studies on ENDS use among young adults and adults
indicates that among adults who had never smoked cigarettes, prevalence
of ever e-cigarette use was highest among young adults aged 18 to 24
and decreased with increasing age (Ref. 24). However, current cigarette
smokers and recent former smokers (i.e., those who quit smoking within
the past year) were more likely to use e-cigarettes than long-term
former smokers (i.e., those who quit smoking more than 1 year ago) and
adults who had never smoked. Current cigarette smokers who had tried to
quit in the past year were also more likely to use e-cigarettes than
those who had not tried to quit (id.). It is noted that it cannot be
determined by the research findings: (1) Whether former cigarette
smokers who now exclusively use e-cigarettes would not have ceased
smoking cigarettes regardless of e-cigarette use; and (2) whether the
e-cigarette use preceded quitting or the quitting occurred first and
then was followed by later e-cigarette use.
    The data from the 2011 through 2014 NYTS also show that high school
students' use of waterpipe tobacco more than doubled during this time
period. In fact, researchers observed substantial increases in
waterpipe tobacco use among both middle and high school students from
2011 through 2014 culminating in an estimated 1.6 million waterpipe
tobacco youth users in 2014 (Ref. 22). From 2013 to 2014, prevalence
almost doubled for high school students from 5.2 percent (770,000) to
9.4 percent (1.3 million) and more than doubled for middle school
students from 1.1 percent (120,000) to 2.5 percent (280,000) (id.).
These findings are consistent with earlier research on older youths and
young adults discussed in the comments stating that waterpipe tobacco
use continues to increase in popularity, particularly among college
students, with as many as 40 percent reporting ever using waterpipe
tobacco and 20 percent reporting current use (i.e., use within the past
30 days) on some college campuses (Refs. 25, 26).
    Likewise, youth continue to use cigars. Data from the 2014 NYTS
indicate that 8.2 percent (1,200,000) of high school students and 1.9
percent (220,000) of middle school students had smoked cigars
(including cigars, cigarillos, or little cigars) in the past 30 days
(Ref. 22). Nineteen percent of students in 8th, 10th, and 12th grades
participating in the Monitoring the Future study in 2014 also reported
smoking small or little cigars (which represents a decrease from 23.1
percent in 2010, but it is unclear if subjects misidentified cigars as
cigarettes during the study) (Ref. 27). In addition, the 2014 National
Survey on Drug Use and Health (NSDUH) found that more than 2,500 youth
under the age of 18 smoke their first cigar each day, nearly as many as
those who smoke their first cigarette each day (more than 2,600) (Ref.
28). Nevertheless, data on youth cigar use from the Youth Risk Behavior
Surveillance System (YRBSS) shows that current cigar use among youth
(i.e., use of a cigar, cigarillo, or little cigar on at least one day
during the last 30 days) has declined between 1997 and 2013 (22 percent
to 12.6 percent); however, no statistically significant change was
observed between 2011 (13.1 percent) and 2013 (12.6 percent) (Ref. 29).
    (Comment 5) At least one comment argued that the rule violates the
APA, 5 U.S.C. 706, saying that it requires FDA to provide ``the
specific basis for [its] conclusion and the data on which each of [its]
critical assumptions is based'' (quoting Ranchers Cattlemen Action
Legal Fund United Stockgrowers of America, No. 04-cv-51, 2004 WL
1047837 at *7 (D. Mont. Apr. 26, 2004), and FDA failed to do so.
    (Response) FDA disagrees. The unpublished district court case
quoted in the comment was reversed by the Ninth Circuit on exactly this
point (415 F.3d 1078 (9th Cir. 2005)). The Ninth Circuit stated the
correct standard: ``All that is required is that the agency have
`considered the relevant facts and articulated a rational connection
between the facts found and the choices made' '' (id. at 1093). See
Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416
(1971); Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mut.
Auto. Ins. Co., 463 U.S. 29, 42-43 (1983).
    In any event, the NPRM contains substantial explanation of FDA's
reasoning in proposing this rule, including over 190 citations to
scientific literature, and the NPRM and the final rule's supplementary
information contain many pages explaining the data and comments
considered, the conclusions drawn from the literature, and FDA's
rationale for the final rule, fully satisfying the Administrative
Procedure Act (APA).
    (Comment 6) A few comments objected that FDA did not discuss the
possibility of illicit markets in the proposed deeming rule, stating
that FDA is required to consider the consequences of illicit markets
under section 907(b)(2) of the FD&C Act.
    (Response) FDA disagrees. Section 907(b)(2) does not apply to
deeming, but rather applies only to the promulgation of regulations
establishing tobacco product standards under section 907 of the FD&C
Act. In any event, the Agency cannot refuse to act in furtherance of
the public health because some individuals might violate the law.
Nevertheless, FDA authority over the newly deemed tobacco products will
give it means to determine which products are legally on the market and
which are counterfeit or otherwise illegally marketed and to take
enforcement action against manufacturers who sell and distribute
illegal products. The Tobacco Control Act gives the Agency these and
other authorities, such as section 920 of the FD&C Act (21 U.S.C.
387t), to help address illicit tobacco products.
3. Constitutional Issues
    The Tobacco Control Act includes provisions restricting tobacco
product marketing. As discussed in this document, some of these
provisions apply to all products covered by the statute--including the
newly deemed products--and others authorize FDA to impose additional
restrictions. We received comments that argue that some of the
restrictions this final rule imposes on newly deemed products violate
the First Amendment.
a. Free Samples of Tobacco Products
    (Comment 7) A few comments questioned the constitutionality of the
ban on the distribution of free samples of tobacco products. (See Sec.
1140.16(d)(1)).) First, the comments argued that distributing free
samples is a form of commercial speech that is protected by the First
Amendment and that the ban is unconstitutional as

applied to the newly deemed products. Citing Central Hudson Gas and
Electric Corp. v. Public Services Commission, 447 U.S. 557, 566 (1980),
the comments argued that, accordingly, FDA must show that the ban is
narrowly tailored to directly and materially advance a substantial
State interest and that FDA failed to do so. The comments stated that
while the court in Discount Tobacco City & Lottery v. United States,
674 F.3d 509 (6th Cir. 2012), cert. denied sub nom. Am. Snuff Co., LLC
v. United States, 133 S. Ct. 1996 (2013) (``Discount Tobacco''), upheld
the Tobacco Control Act's sampling ban on cigarettes, the evidence the
court used to uphold that ban does not support the same ban for the
newly deemed tobacco products. They argued that FDA has presented no
evidence that samples of these products lead to youth initiation and,
therefore, the Agency would not be advancing a legitimate government
interest with this ban. Additionally, they suggested that even if the
ban did advance a legitimate government interest, FDA could achieve the
same results through less restrictive means, such as by allowing
samples in qualified adult-only facilities, as FDA does with smokeless
tobacco.
    (Response) FDA disagrees that the ban on free samples is
unconstitutional. First, although FDA acknowledges that in Discount
Tobacco, 674 F.3d at 538-39, the Sixth Circuit treated the distribution
of free samples as a form of commercial speech, FDA continues to
believe that distribution of free samples is conduct not speech.
Provisions that regulate conduct without a significant expressive
element do not implicate the First Amendment. See Arcara v. Cloud
Books, Inc., 478 U.S. 697, 706-07 (1986). Additionally, a free sample
ban is akin to a price restriction (i.e., tobacco products cannot be
free)--a ``form[ ] of regulation that would not involve any restriction
on speech.'' 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 507
(1996) (opinion of Stevens, J.). Therefore, the free sample provision
regulates the distribution of a product, and there is no First
Amendment right to distribute free samples of a tobacco product.
    Second, even if the distribution of free samples does implicate the
First Amendment, as the Sixth Circuit concluded, the court went on to
uphold the constitutionality of the restriction on free samples of
tobacco products. Discount Tobacco, 674 F.3d at 541. In Discount
Tobacco, as here, the manufacturers of tobacco products argued that the
government failed to show that the ban would directly and materially
advance the government interest of decreasing use of tobacco products
by youth. The manufacturers further argued that even if the sampling
ban were effective, there are less restrictive methods of preventing
youth tobacco use (id. at 538, 541). The Sixth Circuit rejected both
arguments, and held that the government ``presented extensive
documentation that free samples of tobacco products are [an] `easily
accessible source of these products to young people,' . . . and freely
obtainable, even with the tobacco industry's `voluntary codes that
supposedly restrict distribution of free samples to underage persons'''
id. at 541 (quoting 61 FR 44396 at 44460, 45244-45 & nn. 1206-08
(August 28, 1996)). The Court further held that free samples ``may
serve as the best advertisement of all for a product that is
physiologically addictive, and socially attractive to youth'' (id.).
    The comments do not attempt to distinguish Discount Tobacco. Here,
where there is a substantial government interest in preventing youth
access to all tobacco products, and the newly deemed products, like the
products considered by the Sixth Circuit Court of Appeals, are also
``physiologically addictive, and socially attractive to youth,''
Discount Tobacco is directly on point. As we stated in the NPRM, the
prohibition against free samples will eliminate a pathway for youth to
access tobacco products, which can help in reducing youth initiation
and therefore short-term and long-term morbidity and mortality
resulting from these products.
    Youth are uniquely susceptible to biological, social, and
environmental influences to use and become addicted to tobacco
products. See section X.A. As FDA recognized as early as 1995, ``[f]ree
samples give young people a `risk-free and cost-free way to satisfy
their curiosity' about tobacco products, and, when distributed at
cultural or social events, may increase social pressure on young people
to accept and to use the free samples'' (60 FR 41314 at 41326 (quoting
Ref. 30). For these reasons, we believe it is critical to prohibit the
distribution of free samples of newly deemed tobacco products, which
are highly addictive and can lead to a lifetime of tobacco use, with
attendant adverse health consequences.
    FDA received comments noting extensive sampling of some newly
deemed products in venues that may attract youth, including:
     The major sellers of e-cigarettes distribute free samples
in venues likely to attract large audiences.
     At least eight e-cigarette companies promote their
products through sponsored or sampling events, many of which appear to
be youth-oriented (Ref. 31).
     In 2012 and 2013 alone, 6 e-cigarette companies sponsored
or provided free samples at 348 events, many of which were music
festivals and motorsport events geared toward young people--including
Grand Prix auto racing events (id.).
     Field research in Oregon found that e-cigarette retailers
include the opportunity to sample the wide variety of flavored nicotine
cartridges in their sales pitches with test stations for free sampling
(Comments of Oregon Health Authority, FDA-2014-N-0189-76358).
    As described above and in the NPRM, the free sample provision will
address distribution of newly deemed tobacco products at venues such as
these. Contrary to the assertions in the comments, FDA does not believe
that it could achieve the same results by allowing samples of newly
deemed products in qualified adult-only facilities, as FDA does with
smokeless tobacco. In section 102(a)(2)(G) of the Tobacco Control Act
(21 U.S.C. 387a-1(a)(2)(G)), Congress required FDA to reissue the final
1996 rule (published in the Federal Register of August 28, 1996, 61 FR
44396), with several changes, including the addition of a narrow
exception to the free sample ban to allow for distribution of smokeless
tobacco products in qualified, adult-only facilities (QAOFs). This
exception is very prescriptive and operates only in very limited
instances (e.g., where the product is distributed in a specific type of
temporary enclosed structure with age verification by a law enforcement
officer or a security guard licensed by a governmental entity, and with
the amount of smokeless tobacco per adult consumer subject to specific
portion requirements). If FDA were to extend this exception, in whole
or in part, to other tobacco products (when Congress explicitly
extended the free sample ban to cigarettes and all ``other tobacco
products,'' which would include all future deemed tobacco products and
laid out the qualified adult-only facility exception only for
smokeless), FDA would have to justify such an exception in light of the
potential adverse public health impact of allowing free samples and
determine the particular parameters of the exception as appropriate for
newly deemed tobacco products. This would include, at a minimum,
parameters relating to type of facility, means of access, type(s) of
tobacco products distributed, and portion sizes for each type of
tobacco product for which FDA is creating an exception. Newly deemed
products have been largely unregulated and their markets,

particularly for novel noncombustible products such as ENDS, are
dynamic. Comments did not provide evidence demonstrating that the
distribution of free samples of newly deemed tobacco products would be
consistent with protecting public health. While there is evidence
suggesting that distribution of tobacco products is harmful (e.g.,
courts have expressed concern that free samples can provide young
people with easy access to tobacco products), FDA has not yet obtained
product-specific evidence and, therefore, cannot set limits for the
quantities or portion sizes of products taken away from a QAOF that are
commensurate with the current exception for smokeless tobacco products.
Therefore, QAOFs could still allow for access to tobacco products in a
manner that will have a negative public health impact.
    Prohibiting free samples is a minor restriction on distribution,
and tobacco product manufacturers, distributors, and retailers remain
free to inform consumers about their products. The free sample
prohibition does not interfere with the ability of a manufacturer,
distributor or retailer to communicate truthful and nonmisleading
information to adult consumers. We further address this prohibition and
respond to additional comments in section XI.F.
    (Comment 8) Some comments recommended that FDA exempt e-cigarettes
from the prohibition on free samples. In the alternative, the comments
recommended that FDA restrict the circumstances in which free samples
may be given to adult consumers. For example, comments suggested that
FDA require age verification for each recipient of a free sample and
limit the amount of free products that recipients may take away from an
event in which samples are distributed.
    (Response) We disagree for the reasons discussed in the response to
the previous comment. As stated in the NPRM, prohibiting free samples
eliminates a pathway to tobacco products for youth, which can help to
reduce initiation and thus decrease morbidity caused by use of tobacco
products (79 FR 23142 at 23149). In addition, the United States Court
of Appeals for the Sixth Circuit previously recognized that FDA has
provided ``extensive'' evidence that free tobacco samples constitute an
``easily accessible source'' for youth (Discount Tobacco City &
Lottery, Inc. v. United States, 674 F.3d 509, 541 (6th Cir. 2012)
(citing 61 FR 44396 at 44460, August 28, 1996), cert. denied sub nom.
Am. Snuff Co., LLC v. United States, 133 S. Ct. 1966 (2013)). With the
growth in the use of ENDS, particularly by youth (see section VIII.B),
a free sample prohibition is necessary to reduce youth access to ENDS
and possibly a transition to combusted tobacco products (see Ref. 23).
b. Modified Risk Tobacco Products
    Section 911 of the FD&C Act (21 U.S.C. 387k) prohibits the
introduction or delivery for introduction into interstate commerce of
any MRTP without an FDA order in effect under section 911(g). An MRTP
is a tobacco product that is sold or distributed for use to reduce harm
or the risk of tobacco-related disease associated with commercially
marketed tobacco products; this includes tobacco products, the product
label, labeling, or advertising of which represents that it is less
harmful or presents a lower risk of disease than other tobacco
products.
    (Comment 9) A comment from one tobacco company argued that section
911 is unconstitutional on its face. This comment argued, at length,
that FDA's oversight of claims that a particular tobacco product is
safer than others violates the First Amendment--even as applied to
currently regulated products, such as cigarettes.
    (Response) Comments addressed to the facial constitutionality of a
statute are generally outside the scope of an agency's rulemaking
authority. Am. Meat Inst. v. U.S. Dep't of Agric., 760 F.3d 18, 25
(D.C. Cir. 2014) (en banc) (``We do not think the constitutionality of
a statute should bobble up and down at an administration's
discretion.''). That said, FDA disagrees with the challenges against
section 911's constitutionality. The Sixth Circuit considered and
unanimously rejected the same argument in Discount Tobacco, 674 F.3d at
531-37, and the Supreme Court denied the manufacturers' petition for a
writ of certiorari (133 S. Ct. 1966 (2013)). As the Sixth Circuit
explained, section 911 requires that a manufacturer establish health
claims for particular tobacco products to FDA before marketing, rather
than allow only post-market review of such claims (674 F.3d at 537
(``it would be a virtual impossibility to unring the bell of
misinformation after it has been rung'')). This provision does not
``infringe significantly on noncommercial speech'' since it leaves
``untouched'' manufacturers' ``ability to make `direct comments on
public issues' '' (id. at 533 (citation omitted)). Instead, the court
held, what section 911 restricts is commercial speech, since it applies
to consumer-directed claims regarding a manufacturer's specific
products (id.). That restriction on commercial speech, the court held,
is constitutional under Central Hudson Gas & Electric Corp. v. Public
Service Commission, 447 U.S. 557 (1980): It advances a substantial
government interest in preventing inaccurate and harmful health claims
about tobacco products of the sort that the industry has made for many
decades, and it is sufficiently tailored because it concerns only
consumer-targeted speech about tobacco products' health effects or
contents and is no more extensive than warranted. Discount Tobacco, 674
F.3d at 534-37. FDA observes that this comment did not address Discount
Tobacco's holding or the Sixth Circuit's analysis.
    (Comment 10) A few comments argued that section 911 may violate the
First Amendment if it is applied to ban descriptions of e-cigarettes
and other noncombustible products as ``smokeless'' or ``smoke-free.''
    (Response) FDA has carefully considered the comments that argued
that noncombusted products, including ENDS, should be permitted to use
the terms ``smokeless'' and smoke-free'' to describe their products. We
note that section 911 provides that ``No smokeless tobacco product
shall be considered to be [an MRTP] solely because its label, labeling,
or advertising uses the following phrases to describe such product and
its use: `smokeless tobacco,' `smokeless tobacco product,' `not
consumed by smoking,' `does not produce smoke,' `smokefree' [and four
more similar terms].'' However, this provision only applies to
``smokeless tobacco,'' which is explicitly defined in the FD&C Act as
``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''
(section 900(18) of the FD&C Act). ENDS do not fall within that
definition. Moreover, in contrast to ENDS, consumption of ``smokeless
tobacco products,'' as defined, does not require the use of heat,
inhalation of the product into the lungs, or exhalation of constituents
into the close environment. FDA is also aware that some e-cigarettes
are heated to a high enough level to cause combustion of the e-liquid.
For these reasons, and until FDA obtains product-specific evidence, the
Agency will evaluate an ENDS manufacturer's use of ``smokeless'' or
``smoke-free'' (and similar descriptive terms) on a case-by-case basis,
and the Agency will continue to apply the MRTP provisions in a manner
consistent with the statute and Constitution. This case-by-case
approach to ``smokeless,'' ``smoke-free,'' and similar terms is
appropriate as

applied to ENDS, which encompasses a broad, heterogeneous, and evolving
category of products.
4. Required Warning Labels
    This final rule requires advertising and packaging warnings for
newly deemed covered tobacco products and for cigarette tobacco and
roll-your-own tobacco, as authorized by Section 906(d) of the FD&C Act,
21 U.S.C. 387f (d). Packaging and advertising for all newly deemed
products other than cigars must display an addictiveness warning that
states: ``WARNING: This product contains nicotine. Nicotine is an
addictive chemical.'' (Subject to certain requirements, the
manufacturer of a product that does not contain nicotine may use an
alternative warning that states: ``This product is made from
tobacco.'') Packaging and advertising for cigars must display either
the addictiveness warning, or one of five others specified in the rule.
    The final rule requires the warnings to appear on at least 30
percent of the two principal display panels of the package, and at
least 20 percent of the area of advertisements. These are the same
warning sizes Congress established for smokeless tobacco in the Tobacco
Control Act: At least 30 percent of smokeless-tobacco packaging's two
principal panels, and at least 20 percent of the area of each
advertisement. 15 U.S.C. 4402(a)(2)(A), (b)(2)(B). In the same Act,
Congress prescribed an even larger size for cigarette warnings: 50
percent of the front and rear panels of cigarette packaging (and the
same 20 percent size for cigarette advertisements) (15 U.S.C.
1333(a)(2), (b)(2)). (The larger warning sizes required for cigarettes
have not yet been implemented, because FDA's initial regulations
implementing a graphics component for cigarette warnings were vacated
by the DC Circuit Court of Appeals in R.J. Reynolds Tobacco Co. v. FDA,
696 F.3d 1205 (D.C. Cir. 2012), overruled on other grounds by Am. Meat
Inst., 760 F.3d at 22-23.)
    A detailed discussion of the warning requirements appears in
section XVI.
a. First Amendment Challenges
    The required warnings are a form of compelled disclosure, and are
thus subject to First Amendment scrutiny. Milavetz, Gallop & Milavetz,
P.A. v. United States, 559 U.S. 229, 249 (2010); Riley v. Nat'l Fed'n
of the Blind of N.C., Inc., 487 U.S. 781, 797-98 (1988).
    (Comment 11) Although the comments generally did not dispute the
need for warning labels, some commenters questioned the accuracy of the
addictiveness warning as applied to cigars, contending that cigar users
do not always inhale.
    (Response) Nicotine is ``one of the most addictive substances used
by humans'' (Ref. 7). ``Because the extension of First Amendment
protection to commercial speech is justified principally by the value
to consumers of the information such speech provides,'' the
manufacturers' ``constitutionally protected interest in not providing
any particular factual information in his advertising is minimal.'' Am.
Meat Inst., 760 F.3d at 26 (quoting Zauderer v. Office of Disciplinary
Counsel, 471 U.S. 626, 651 (1985)).
    Cigar packaging and advertisements are required to display one of
six warnings, one of which is the addictiveness warning. Research
indicates that most cigar smokers do inhale some amount of smoke, even
when they do not intend to inhale, and are not aware of doing so (Refs.
32, 33). Even when cigar smokers do not breathe smoke into their lungs,
they are still subject to the addictive effects of nicotine through
nicotine absorption (Refs. 32, 34). This is because cigar smoke
dissolves in saliva, allowing the smoker to absorb sufficient nicotine
to create dependence, even if the smoke is not inhaled (Refs. 34, 35).
    (Comment 12) A few comments argued that the First Amendment
prohibits a requirement for covered tobacco products to carry warning
labels that cover 30 percent of the two principal display panels of the
packaging. These comments argued that manufacturers have limited space
on packaging to communicate information to consumers, including
branding and marketing information, and that requiring manufacturers to
dedicate 30 percent of that space for a warning is unduly burdensome,
because it prevents manufacturers from using that space to convey their
own messages. The comments argued that the warning label presents a
simple message that could be relayed in a smaller space.
    (Response) FDA disagrees. In Discount Tobacco, the Sixth Circuit
considered and rejected the same First Amendment arguments against the
size required by the Tobacco Control Act for cigarette and smokeless
tobacco warnings. Discount Tobacco, 674 F.3d at 567. The court found
ample evidence supporting the size requirements, and held that the
manufacturers failed to show ``that the remaining portions of their
packaging [were] insufficient for them to market their products'' (id.
at 564-66, 567). The comments argued that the requirement that the
warning cover 30 percent of the two principal display panels is unduly
burdensome and would prevent manufacturers of newly deemed products
from communicating information about their products. As in Discount
Tobacco, the comments failed to substantiate that claim with evidence.
Nor did the comments provide evidence that the same size requirements
for smokeless tobacco--which have been in force since 2010--have unduly
burdened the speech of smokeless tobacco manufacturers.
    As the court explained in Discount Tobacco, Congress required
larger warnings for smokeless tobacco and cigarettes in the wake of the
Surgeon General's conclusion that existing warnings were ```given
little attention or consideration by viewers''' and IOM's analysis
showing that those warnings ```fail[ed] to convey relevant information
in an effective way.''' Discount Tobacco, 674 F.3d at 562 (quoting
Refs. 3, 7).
    The comments contending that the warning label size is burdensome
or unjustified are misplaced for the same reasons identified by the
Discount Tobacco court. After emphasizing that the relevant First
Amendment standard looks only to whether mandatory warnings are
reasonably related to the government's interest, Discount Tobacco, 674
F.3d at 567 (citing Zauderer v. Office of Disciplinary Counsel, 471
U.S. 626, 651 (1985)), the Sixth Circuit held that the required
cigarette warning labels, which were to cover 50 percent of the two
primary panels of cigarette packs (far more than the 30 percent
required here), did not violate the First Amendment because ``[a]mple
evidence supports the size requirement for the new warnings . . . and
Plaintiffs have not shown that the remaining portions of their
packaging are insufficient for them to market their products.'' (674
F.3d at 567; see also id. at 530-31 (Clay, J., concurring in result)
(finding that the government demonstrated that the Tobacco Control
Act's size and placement requirements satisfied Zauderer scrutiny).)
    Article 11 of the Framework Convention on Tobacco Control (FCTC),
evidence of a strong worldwide consensus regarding a regulatory
strategy for addressing the serious negative impacts of tobacco
products,\8\ recognized the importance of having warnings cover at
least 30 percent of the area of the two principal display panels. The
European Union (EU) requires that health warnings comprise 30 percent
of the area on the front of the package and 40 percent on the back of
the package

(2001/37/EC). Users are more likely to recall warnings that are in a
larger size and that appear on the front/major surfaces of the tobacco
product package. (Ref. 7). Before a warning label can help a consumer
better understand and appreciate the risks against which it warns, the
consumer must notice and pay attention to the warning. The likelihood
that a consumer will do so depends upon warning's size and position.
(Refs. 36, 37, 38, 39, 40).
---------------------------------------------------------------------------

    \8\ There are 180 parties to the WHO's FCTC as of November 2015.
At this time, the United States is a signatory but has not ratified
this treaty.
---------------------------------------------------------------------------

    Some comments sought to support their First Amendment arguments
against the warning label sizes by citing the D.C. Circuit's decision
in R.J. Reynolds v. FDA, 696 F.3d 1205 (D.C. Cir. 2012), which vacated
specific cigarette warnings previously issued by FDA. However, the
decision in Reynolds was based on the graphics components of the
cigarette warnings, not their size. Moreover, the reasoning of the
Reynolds panel decision was overtaken by the D.C. Circuit's more recent
en banc decision in American Meat Institute, 760 F.3d at 22-23.
    FDA recognizes that the warning size requirement for covered
tobacco products may present special difficulties for products in
particularly small packages. To address this concern, FDA has added
subsection (d) to Sec.  1143.4. Under Sec.  1143.4(d), a product that
is too small or otherwise unable to accommodate a label with sufficient
space to bear the required warning, printed in the required font size,
may instead carry the warning on the carton or other outer container or
wrapper. In cases where there is no carton or other outer container or
wrapper that is large enough to carry the warning, the product may
carry the warning on a tag firmly and permanently affixed to the
package.
    FDA agrees that other warnings on tobacco product packages, such as
a warning regarding the risk of nicotine poisoning (as suggested by one
particular comment), may also provide consumers with important health
risk information. Therefore, elsewhere in this issue of the Federal
Register, FDA has made available draft guidance, which when final will
describe FDA's current thinking regarding some appropriate means of
addressing the premarket authorization requirements for newly deemed
ENDS products, including recommendations for exposure warnings that
would help to support a showing that a product is appropriate for the
protection of public health. FDA also has issued an ANPRM seeking
comments, data, research, or other information that may inform
regulatory actions FDA might take with respect to nicotine exposure
warnings and child-resistant packaging for certain tobacco products. If
FDA determines that it is appropriate for the protection of the public
health to require such a warning (in addition to the addiction
warning), FDA will consider at that time whether it is necessary to
change the formatting requirements for the addiction warning to ensure
that all warnings are clear and conspicuous.
b. Preemption of State Law Warning Requirements
    (Comment 13) A number of comments sought an affirmative statement
from FDA that the NPRM preempts State and local warning requirements. A
few of the comments directly referenced California's reproductive
health warning requirements for products containing nicotine (a notice
mandated by Proposition 65). Many cited the explicit preemption
provisions that apply to cigarettes and smokeless tobacco (see 15
U.S.C. 1334(b) and 4406(b)). One manufacturer argued that it would be
arbitrary and capricious to subject the newly deemed products to a
patchwork of Federal, State, and municipal requirements, while
cigarettes and smokeless tobacco warning requirements are uniform
across States and potentially less stringent. The comment further
argued that it would be particularly unreasonable to subject
noncombusted products to State and local labeling requirements because
(according to the comment) noncombusted products are ``safer than
cigarettes.''
    Taking the other side of the issue were comments from public health
groups and a joint comment from 29 State Attorneys General who
advocated for an explicit statement that the NPRM does not preempt
State and local warning requirements, including California's
Proposition 65. At a minimum, they suggested that FDA change the
heading of part 1143 from ``Required Warning Statement'' to ``Minimum
Required Warning Statement'' to indicate that the deeming rule does not
preclude other health warnings.
    (Response) Section 916(a)(1) of the FD&C Act (21 U.S.C. 387p)
expressly preserves the authority of State and local governments to,
among other things, enact and enforce laws regarding tobacco products
that are in addition to, or more stringent than, requirements
established under chapter IX of the FD&C Act. The preservation of State
and local governmental authority over tobacco products is limited by
section 916(a)(2) of the FD&C Act, which expressly preempts any State
or local requirement that is different from, or in addition to, any
requirement under chapter IX of the FD&C Act relating to tobacco
product standards, premarket review, adulteration, misbranding,
labeling, registration, good manufacturing practices, or MRTPs.\9\
However, section 916(a)(2)(B) of the FD&C Act states that the express
preemption provision in section 916(a)(2)(A) does not apply to
requirements relating to, among other things, the sale, distribution,
possession, information reporting to the State, exposure to, access to,
the advertising and promotion of, or use of, tobacco products by
individuals of any age. A State or local statute is facially preempted
only if no set of circumstances exists under which the statute would be
valid. (See Comm. of Dental Amalgam Mfrs. & Distribs. v. Stratton, 92
F.3d 807, 810 (9th Cir. 1996).) FDA notified State and local
jurisdictions about the potential impact this rule could have on their
requirements. No State or local laws in effect at the close of the
public comment period were identified that FDA determined would be
preempted by this final rule.
---------------------------------------------------------------------------

    \9\ We note that while section 906(e) of the FD&C Act refers to
``good manufacturing practices,'' FDA refers to any regulations that
could be issued under section 906(e) as tobacco product
manufacturing practices.
---------------------------------------------------------------------------

    With respect to the argument that it would be arbitrary and
capricious to allow States and localities to subject newly deemed
products to different warning requirements than cigarettes and
smokeless tobacco products, we note that the preemptive effect depends
on the relevant statutes. The preemption provisions of the Federal
Cigarette Labeling and Advertising Act of 1965 (FCLAA) (15 U.S.C. 1334)
and the Comprehensive Smokeless Tobacco Health Education Act of 1986
(CSTHEA) (15 U.S.C. 4406), which apply to cigarettes and smokeless
products, respectively, are significantly different from section 916 of
the FD&C Act. For example, the FCLAA and CSTHEA provisions expressly
preempt State and local regulation of the content of cigarette and
smokeless product advertisements, while section 916(a)(2)(B) of the
FD&C Act exempts State and local advertising restrictions from
preemption.
    Separate and apart from the issue of preemption, elsewhere in this
issue of the Federal Register, FDA has made available draft guidance,
which when final will describe FDA's current thinking regarding some
appropriate means of addressing the premarket authorization
requirements for newly deemed ENDS products, including

recommendations for exposure warnings that would help support a showing
that a product is appropriate for the protection of public health.
Additionally, FDA notes that some ENDS product manufacturers have
voluntarily included exposure warnings on their products. Accordingly,
FDA has changed the heading of part 1143 from ``Required Warning
Statements'' to ``Minimum Required Warning Statements'' in order to
clarify that part 1143 is not intended to prevent tobacco product
manufacturers from including truthful, non-misleading warnings on their
products' packaging or advertisements voluntarily or as a result of FDA
guidance.

III. Use of Premarket Pathways for Newly Deemed Products

    As stated in the proposed deeming rule, manufacturers of newly
deemed products that are ``new tobacco products'' as defined in section
910(a)(1) of the FD&C Act will be required to obtain premarket
authorization of their products through one of three pathways--SE.,
exemption from SE., or premarket tobacco product application (PMTAs)
(sections 905 and 910 of the FD&C Act). The substantive requirements of
these provisions are set by statute and, thus, have not changed from
the NPRM. However, FDA has revised the compliance periods for
submitting premarket applications, as discussed in section V.A.
    As an initial matter, with this final rule, we are also clarifying
when FDA will consider a document to have been submitted for purposes
of the compliance periods for submission of documents and data required
by the automatic provisions of the statute. In the NPRM, we noted that
the automatic provisions require companies to submit information to
FDA, and we proposed various compliance periods to provide industry
with time to make such submissions (e.g., ``the manufacturer submits a
905(j) report for the product by [effective date of part 1100 plus 24
months]''). As previously discussed publically (see http://www.fda.gov/tobaccoproducts/newsevents/ucm393894.htm), FDA generally relies on the
date of receipt of a submission by FDA's Document Control Center (DCC)
as the date that the document was submitted (not the date that the
submitter sent it). The DCC has been and will continue to be fully
equipped to receive tobacco product submissions (including the number
of submissions expected at the close of compliance periods). Therefore,
regulated entities should ensure that FDA's DCC receives any submission
by the due date or end of compliance period. The time it takes to
review a premarket application is dependent upon the type of
application and the complexity of the product. FDA has taken many steps
to reduce the previous backlog and prevent further backlogs of
marketing applications pending FDA review. FDA intends to act as
expeditiously as possible with respect to all new applications, while
ensuring that statutory standards are met. If an applicant wishes to
discuss a product application, the applicant may request a meeting as
set forth in FDA's final guidance entitled ``Meetings with Industry and
Investigators on the Research and Development of Tobacco Products''
(announced May 25, 2012, 77 FR 31368).
    In addition, we are clarifying that FDA distinguishes between a
marketing application that has been ``filed,'' one that ``has been
accepted,'' and one that has been ``submitted'' to FDA. A marketing
application has been ``submitted'' when a complete application is
delivered and received electronically, through the mail, or through a
courier to CTP's Document Control Center (DCC). Once a complete PMTA
application is submitted and received by CTP's DCC, FDA will have 180