will provide the retailer's responsibilities for the sale of cigarettes
and smokeless tobacco. Section 1140.14(b)(1) through (b)(3) will
provide the retailer's responsibilities for the sale of newly deemed
products.

F. Comments and Responses Regarding Minimum Age and Identification
Requirements

    In the NPRM, FDA sought comment regarding whether to prohibit the
sale of newly deemed products to individuals under 18 years of age and
to require photographic identification for individuals aged 26 and
under (which are the same requirements that currently apply to
cigarettes and smokeless tobacco). FDA discussed the benefits of a
uniform minimum age and identification requirement, including: (1)
Decreasing youth access to tobacco products in another jurisdiction
with less stringent requirements; (2) addressing youth misperceptions
that tobacco products without minimum age or identification
requirements are safer; and (3) increasing the ease with which
retailers can comply with minimum age

and identification requirements for covered tobacco products (79 FR
23142 at 23160 23162). In addition, we expressed our intention to use
an aggressive nationwide enforcement program to increase compliance and
deter youth consumption of tobacco products (79 FR 23142 at 23160).
    Nearly all comments supported a minimum age and identification
requirement for the newly deemed tobacco products. FDA is finalizing
these requirements without change. FDA also intends to update the
current guidance documents for civil money penalties and frequently
asked questions to reflect that violation of these provisions may lead
to the imposition of civil money penalties. A summary of comments
regarding these provisions, and FDA's responses, is included in the
following paragraphs.
    (Comment 223) Many comments supported FDA's proposal due to the
fact that many of the newly deemed products are easily available. For
example, they noted that tobacco industry documents refer to the
increased frequency with which self-service tobacco products are
stolen, and some of the proposed deemed products (e.g., cigars) are
frequently sold in self-service displays (Ref. 243). They expressed
concern that self-service displays increase the likelihood that minors
will have access to tobacco products.
    (Response) FDA agrees that the newly deemed tobacco products are
readily available to consumers. FDA finds that the age and
identification restrictions that are included in this final rule (Sec.
1140.14) will help to limit youth access to the newly deemed tobacco
products. In the event that FDA determines that extending the
prohibition on self-service displays (Sec.  1140.16(c)) to the newly
deemed products is appropriate and meets the applicable standard in
section 906(d), FDA will issue a new NPRM and seek comment.
    (Comment 224) Many comments supported the minimum age and
identification requirements for covered tobacco products based on
increased youth use of newly deemed products and the impact of nicotine
on youth. They noted that, according to the CDC, e-cigarette use among
youth doubled from 2011 to 2012, with 1.78 million high school and
middle school students having ever used e-cigarettes (Ref. 108). Others
noted that the 2012 Surgeon General's report stated that youth are more
sensitive to developing nicotine dependence than adults (Ref. 49). In
addition, other comments stated that because minimum age and
identification requirements for covered tobacco products vary among the
states, a uniform age requirement would help prevent youth from
accessing tobacco products in a neighboring state with less stringent
requirements.
    (Response) FDA agrees with comments supporting the implementation
of minimum age and identification requirements for covered tobacco
products. As we noted in the NPRM, the goal of the minimum age
restriction is to limit youth access to the newly deemed tobacco
products. FDA concludes that the restrictions included with this final
deeming rule are appropriate for the protection of the public health
because they will reduce youth access to and, therefore, likely limit
use of tobacco products.
    (Comment 225) Several comments recommended that FDA raise the
minimum age to purchase tobacco products to 21 years old. They claimed
that a higher minimum age would restrict youth access to social sources
of tobacco products because minors tend to have less contact in their
social network with 21-year-olds than with 18-year-olds (Ref. 244).
They also suggested that the minimum age and identification requirement
should mirror the minimum age requirement for alcohol and marijuana
purchases in some States.
    (Response) FDA has determined that minimum age and identification
restrictions, which will apply to all covered tobacco products, are
appropriate for the protection of public health. FDA also will continue
to provide prevention and tobacco product risk awareness campaigns
targeted to youth and young adults. Although section 906(d)(3)(ii)
precludes FDA from raising the minimum age of sale of tobacco products,
section 104 of the Tobacco Control Act required FDA to conduct a study
on the public health implications of raising the minimum age of sale of
tobacco products. This study's report was published (Ref. 245) and can
be found at: http://www.iom.edu/Reports/2015/TobaccoMinimumAgeReport.aspx.
    (Comment 226) Several comments discussed Internet sales of tobacco
products. Some comments favored a ban on Internet sales for all tobacco
products, some supported a ban on only certain tobacco products, and
others opposed a ban on Internet sales of any tobacco products.
    (Response) As explained elsewhere, under this rule, retailers may
not sell covered tobacco products (through any medium, including the
Internet) to individuals under 18 years of age. FDA will continue to
actively enforce the minimum age restriction for Internet sales. FDA
will consider these comments in the future and continue to assess
whether additional access restrictions would be appropriate.
    (Comment 227) Several comments recommended that FDA impose stiff
penalties for noncompliance with minimum age and identification
requirements and institute youth tobacco prevention campaigns and other
actions to effectively reduce youth access to tobacco products.
    (Response) As noted in the NPRM, FDA believes that combining the
minimum age and identification restriction with comprehensive and
consistent enforcement, both at the Federal level and in partnership
with States, will decrease the likelihood of youth smoking initiation
(79 FR 23142 at 23161). In addition, FDA will continue to invest in a
number of public education campaigns to help educate the public--
especially youth--about the dangers of tobacco products.
    (Comment 228) Several comments recommended that FDA prohibit the
sale of tobacco product components, parts, and accessories (not just
covered tobacco products), including ENDS, to minors under 18 years of
age to provide consistency across the country.
    (Response) FDA disagrees. FDA concludes that the application of
minimum age requirements and vending machine requirements to covered
tobacco products, together with its regulation of components and parts
of newly deemed products, will protect the public from the dangers of
tobacco use, discourage initiation, and encourage cessation of use of
such products.
    (Comment 229) A few comments suggested that FDA prohibit cigar
sales to individuals under 18 years of age, except for minors serving
in the U.S. military. They argued that there are greater health hazards
for military personnel than using tobacco products.
    (Response) We disagree with the suggestion that we provide an
exception for minors in the military. Military personnel face the same
risk of tobacco-related death and disease as civilians. As FDA stated
in the preamble, cigars can contain greater levels of nicotine than
cigarettes; cigar smoking is strongly related to certain cancers; and
in certain circumstances, cigars may be as harmful to a person's health
as cigarettes (79 FR 23142 at 23151, 23156).
    (Comment 230) Some comments suggested that retailers record and
retain copies of each purchaser's unexpired driver's license (if the
document includes a photo), an armed forces identification card, or a
valid passport as an acceptable identification to verify a purchaser's
minimum age. Other

comments recommended that FDA implement a registration requirement for
mail order sale of tobacco products and require carriers to verify that
the seller sending out packages is registered before accepting the
packages for delivery.
    (Response) The requirements for photo identification are included
in Sec.  1140.14(b)(2). Retailers may choose any method of
identification verification that complies with this provision. FDA
finds that these requirements are appropriate for the protection of the
public health and declines to adopt the recommendations for additional
requirements at this time. However, we will continue to assess whether
additional requirements regarding identification are appropriate.

G. Comments and Responses Regarding Vending Machines

    Consistent with the minimum age and identification provisions, FDA
proposed to ban the sale of covered tobacco products in vending
machines (i.e., requiring face-to-face transactions in retail
facilities) 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. FDA is finalizing this
requirement without change in Sec.  1140.14. Therefore, upon the
effective date of this final rule, covered tobacco products, including
ENDS and cigars, may not be sold in electronic or mechanical devices
such as vending machines unless the device is in an adult-only
facility. This restriction is appropriate for the protection of the
public health because it will eliminate one more method of youth access
to tobacco products.
    A summary of the comments regarding these provisions, and FDA's
responses to them, is included in the following paragraphs.
    (Comment 231) Multiple comments supported restricting vending
machines sales to adult-only facilities. They asserted that FDA's
discussion of this issue demonstrates that the vending machine
restriction serves the stated public health purpose of the regulation.
Other comments stated that FDA's rationale for this restriction for
cigarettes and smokeless tobacco also applies to the newly deemed
tobacco products.
    (Response) FDA agrees that there is a public health benefit to
limiting vending machines to adult-only facilities. As we stated in the
NPRM, studies show that youth are able to access tobacco products in
vending machines (79 FR 23142 at 23162). Therefore, the vending machine
restrictions are important in preventing youth from gaining access to
these products.
    (Comment 232) Several comments suggested that FDA prohibit all
vending machine sales of all tobacco products.
    (Response) FDA disagrees with prohibiting all vending machine sales
of all tobacco products. Sections 1140.14(a)(3) and 1140.14(b)(3)
permit the sale of cigarettes and smokeless tobacco products and
covered tobacco products, respectively, in a non-face-to-face exchange
with the assistance of a mechanical device as long as the retailer
ensures that no person younger than 18 years of age is present, or
permitted to enter, at any time. FDA is permitting adult-only
facilities to sell tobacco products in a vending machine because these
locations employ safeguards to prohibit entry to individuals less than
18 years of age. FDA is not seeking to ban adult access to legally
marketed tobacco products.
    (Comment 233) Several comments recommended that FDA subject tobacco
product components, parts, and accessories (particularly e-cigarettes)
to the proposed vending machine restrictions. These comments expressed
concern regarding exploding tanks and nicotine poisoning due to
accidental e-liquid exposure.
    (Response) FDA agrees that these tobacco product components and
parts can pose public health concerns. At this time, FDA has determined
that it is appropriate for the protection of the public health to
restrict impersonal modes of sale of nicotine-containing components and
parts in vending machines. However, FDA has concluded that it is not
warranted at this time to impose the vending machine restrictions on
components or parts that are not made or derived from tobacco as they
will only be able to deliver nicotine to users by combining them with
covered tobacco products that are subject to the vending machine
restriction (and, therefore, youth cannot access). Accordingly, FDA
believes that the public health will be protected by applying the
vending machine restrictions to components and parts that contain
nicotine or tobacco in order to prevent youth access to these products.
    (Comment 234) Some comments suggested that the deeming rule include
a ban on Internet sales. These comments asserted that manufacturers and
retailers are not enforcing age verification effectively and that youth
are able to purchase tobacco products when they are not in the physical
presence of the seller. Several comments also recommended that FDA
require retailers to verify the age of purchasers of newly deemed
tobacco products using methods similar to those found in the Prevent
All Cigarette Trafficking (PACT) Act of 2009 (which ensures the
collection of Federal, State, and local tobacco taxes on cigarettes and
smokeless tobacco sold via the Internet or mail order sales). Other
comments opined that neither the PACT Act nor State laws have been
effective in preventing youth access to tobacco products.
    (Response) Under this rule, retailers may not sell covered tobacco
products (through any medium) to individuals under 18 years of age. FDA
will continue to actively enforce the minimum age restriction for mail
order sales and Internet sales. FDA will continue to assess whether
additional access restrictions would be appropriate.
    (Comment 235) A few comments stated that because newly deemed
tobacco products are generally not sold in vending machines, there will
be little impact from the proposed vending machine restrictions.
    (Response) FDA disagrees. As discussed in the NPRM (79 FR 23142 at
23162), FDA expects that the vending machine restrictions will have a
positive impact by preventing some youth from accessing tobacco
products. Therefore, FDA concludes that this restriction is appropriate
for the protection of the public health.
    (Comment 236) A few comments stated that FDA should permit tobacco
product sales through vending machines in all locations. They noted
that technological advancements now allow for accurate non-face-to-face
age verification, including electronic age and identity verification
(EAIV) technology and that the PACT Act already requires retailers to
verify a tobacco product purchaser's name, birth date, and address
through an EAIV database prior to accepting a delivery order.
    (Response) FDA disagrees. We explained in the NPRM that other types
of vending machine restrictions, such as electronic locking devices on
vending machines, have not sufficiently limited youth access to tobacco
products (79 FR 23142 at 23162). In addition, vending machines may be
located in facilities that are not as sophisticated as the common
carriers or Internet sellers that are subject to the PACT Act, or these
retailers may not have the financial resources to update their vending
machines to incorporate EAIV technology. Therefore, FDA concludes that
the vending machine restriction is appropriate for the protection of
public health.

XVI. Description of the Final Rule--Part 1143

    In the proposed deeming rule, FDA proposed to add part 1143, which
would mandate the use of ``required warning statements'' for covered
tobacco products, as well as for roll-your-own and cigarette tobacco,
for which health warnings are not already required by Federal statutes
or regulations. As stated throughout this document, FDA has selected
Option 1 with this final rule. Therefore, these requirements apply to
all newly deemed covered tobacco products, including premium and other
types of cigars. 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.

A. Section 1143.1--Definitions

    In the NPRM, FDA sought comment on definitions for the following
terms: Cigar, covered cigar, covered tobacco product, package, required
warning statement, and roll-your-own tobacco. As stated throughout this
document, FDA has selected Option 1 as the scope of this rule.
Therefore, the definition of covered cigar is unnecessary and has been
removed from this section. We also added definitions of point-of-sale,
retailer, and tobacco product. These terms are used in part 1143 and
were already included in parts 1100 and 1140.
    FDA received many comments regarding the need to define components,
parts, and accessories, which resulted in the addition of definitions
of ``component or part'' and ``accessory'' in Sec.  1140.3. The
discussion of this language in included in section VI.A. In addition,
we included a definition of ``cigarette tobacco'' given that the health
warning requirements apply to covered tobacco products, roll-your-own
tobacco, and cigarette tobacco. We also have added a definition of
``principal display panels'' to address comments suggesting that a
definition was necessary to comply with this part. The term ``principal
display panels'' is defined as the panels of a package that are most
likely to be displayed, presented, shown, or examined by the consumer.

B. Section 1143.3--Required Warning Statement Regarding Addictiveness
of Nicotine

    Proposed Sec.  1143.3 included a requirement that any person who
manufactures, sells, offers to sell, distributes, or imports for sale
or distribution within the United States, cigarette tobacco, roll-your-
own tobacco and covered tobacco products other than cigars must include
the following warning statement on each product package and in each
advertisement: ``WARNING: This product contains nicotine derived from
tobacco. Nicotine is an addictive chemical.'' The NPRM provided that a
manufacturer could submit a certification that its tobacco product does
not contain nicotine and notify FDA that it intends to use the
alternative warning statement: ``This product is derived from
tobacco.'' FDA also proposed size and placement requirements for the
use of this warning statement on packages and in advertisements.
    Upon review of the comments, FDA is revising the language of this
warning to read: ``WARNING: This product contains nicotine. Nicotine is
an addictive chemical.'' The alternative warning statement is also
revised to read: ``This product is made from tobacco.'' This warning
will be required 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
the advertisement. We also added language to Sec.  1143.3(a) to clarify
that the warning statement must be printed in at least 12-point font
size in order to be clear and legible.
    Further, we added language to Sec.  1143.3(a)(3)(ii) to clarify
when a retailer of any tobacco product covered by paragraphs (a)(1) and
(2) of this section will not be in violation of this section for
packaging that does not comply with these requirements. This final rule
provides that a retailer will not be in violation if the package: (1)
Contains a health warning; (2) is supplied to the retailer by a tobacco
product manufacturer, importer, or distributor, who has the required
state, local, or TTB-issued license or permit, if applicable
(consistent with the language in Sec.  1143.5(a)(4)(ii)); and (3) is
not altered by the retailer in a way that is material to the
requirements of this section.
    In addition, in response to comments regarding minimum font size
for advertisements, we have revised Sec.  1143.3(b)(2)(ii) to include a
12-point minimum font size for the warnings on advertisements. We note
that the warning also needs to occupy ``the greatest possible portion
of the warning area set aside for the required text.'' Therefore, a
print advertisement would require a much larger font size in order to
comply with this requirement.
    Given that comments expressed uncertainty as to how the self-
certification process in Sec.  1143.3(c) would work, we also included
language in this section to further clarify this process. This section
now provides that the certification statement can be submitted by the
tobacco product manufacturer to FDA. FDA recommends that all data used
to support the self-certification, or copies of the data, be maintained
at the manufacturing facility or another location that is reasonably
accessible to the manufacturer and to any officers or employees duly
designated by the Secretary, which includes FDA employees. These data,
including data not stored at the inspected facility, should be made
readily available for copying or inspection by an officer or employee
duly designated by the Secretary. Manufacturers interested in
submitting a certification statement may contact CTP at 1-877-CTP-1373
for more information regarding this submission.
    Further, in response to comments, we added Sec.  1143.3(d), which
states that, if a product package is too small or otherwise unable to
accommodate a label with sufficient space to bear such information, it
will be exempt from the requirement to place the warning statement
directly on the product package if the warning appears on the outer
carton or other outer container or wrapper or on a tag otherwise
permanently affixed to the tobacco product package. Under this
provision, the warning statement must be printed using the
specifications required in Sec.  1143.3(a)(1) and (a)(2). In these
cases, the outer carton, outer container, wrapper, or tag would serve
as the location for the principal display panels. If a tag is used for
the principal display panels, both sides of the tag must be visible to
the consumer. The warning statements must be printed on both sides of
the tag to comply with Sec.  1143.3(a)(2).
    We also note that this requirement in Sec.  1143.3 applies to
cigarette tobacco, roll-your-own tobacco, and covered tobacco products
other than cigars. Both cigarette tobacco and roll-your-own tobacco are
defined in Sec.  1143.1. This warning requirement does not apply to
smokeless tobacco products. Smokeless tobacco products must meet the
warnings requirements in CSTHEA (15 U.S.C. 4401 et seq.).

C. Section 1143.5--Required Warning Statements for Cigars

    In Sec.  1143.5, FDA proposed warnings for the cigars that would be
covered under this final rule. In addition to the addictiveness
warning, FDA proposed that all cigars (except those sold individually
and not in product packages) would be required to include

the following warnings on packages and in advertisements:
     WARNING: Cigar smoking can cause cancers of the mouth and
throat, even if you do not inhale.
     WARNING: Cigar smoking can cause lung cancer and heart
disease.
     WARNING: Cigars are not a safe alternative to cigarettes.
     WARNING: Tobacco smoke increases the risk of lung cancer
and heart disease, even in nonsmokers.

FDA also proposed size and placement requirements for the warning
statements on packages and in advertisements. FDA is finalizing these
warning requirements in accordance with Option 1 deeming all cigars
(rather than a subset). Further, FDA is adding an additional warning
statement (WARNING: Cigar use while pregnant can harm you and your
baby.) with an optional alternative statement (SURGEON GENERAL WARNING:
Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth
Weight) as discussed in section XVI.H.16.
    Therefore, the full list of required warnings for use on cigar
packages and in cigar advertisements is as follows:
     WARNING: This product contains nicotine. Nicotine is an
addictive chemical.
     WARNING: Cigar smoking can cause cancers of the mouth and
throat, even if you do not inhale.
     WARNING: Cigar smoking can cause lung cancer and heart
disease.
     WARNING: Cigars are not a safe alternative to cigarettes.
     WARNING: Tobacco smoke increases the risk of lung cancer
and heart disease, even in nonsmokers.
     WARNING: Cigar use while pregnant can harm you and your
baby. (Or, as an optional alternative statement: SURGEON GENERAL
WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and
Low Birth Weight.)

The health warnings are required to appear on at least 30 percent of
each of the two principal display panels of the package and on at least
20 percent of the area of the print advertisements and other
advertisements with a visual component. As we did for Sec.
1143.3(a)(2)(ii) and (b)(2)(ii), we added language to Sec.
1143.5(a)(2)(ii) and (b)(2)(ii) to clarify that the font used for
warnings on packaging and advertisements must be at least 12-point font
size in order to be clear and legible. We note that the warning also
must occupy ``the greatest possible portion of the warning area set
aside for the required text.'' Therefore, a print advertisement would
require a much larger font size in order to comply with this
requirement.
    For packages, the six warnings for cigars (five specifically for
cigars and the one addictiveness warning) will be required to be
randomly displayed in each 12-month period, in as equal a number of
times as is possible on each brand of cigar sold in product packaging
and randomly distributed in all areas of the United States. This random
display and distribution must be done in accordance with a warning plan
submitted to, and approved by, FDA. For advertisements, the warnings
must be rotated quarterly in alternating sequence in each advertisement
for each brand of cigar in accordance with a warning plan submitted to,
and approved by, FDA. Warning plans must be submitted for FDA review
and approval by responsible manufacturers, distributors, importers, and
retailers by 1 year after the date of publication of the final rule
(however, all other part 1143 requirements shall take effect 2 years
after the publication date of this final rule).
    In the NPRM, FDA did not have a separate section (with its own
effective date) explicitly requiring the submission of warning plans
with its own effective date. Rather, the sections of part 1143
requiring random display and distribution of warning statements for
packaging and quarterly rotation of warning statements for
advertisements (for which FDA proposed a 2-year effective date) stated
that such random display and distribution and quarterly rotation be
done in accordance with a warning plan submitted to and approved by
FDA. Thus, those provisions implicitly required that submission of the
warning plan and approval by FDA be done prior to the 2-year effective
date by which manufacturers must comply with the plan. FDA has added
Sec.  1143.5(c)(3) to specifically include the requirement to submit a
proposed warning plan. (See section XVI.H.17 for additional information
regarding the warning plan requirement and timeframe for submission.)
    The same warning statement requirements will apply to cigars sold
individually and not in product packages.\15\ However, instead of being
required to place warnings directly on these product packages,
retailers will be required to post signage at the point of sale listing
the six warnings (five specifically for cigars and one addictiveness
warning) on a minimum of 8.5 x 11 inch sign. The rule requires that the
sign be placed on or within 3 inches of each cash register where
payment is made and the sign is unobstructed in its entirety and can be
easily read by each consumer making a purchase.
---------------------------------------------------------------------------

    \15\ In general, pursuant to the Internal Revenue Code at 26
U.S.C. 5751, a tobacco product cannot be sold at retail unless it is
in the package in which the product is removed, upon payment of
Federal excise tax, from the factory or from customs custody.
Section 5751(a)(3) and TTB regulations at 27 CFR 46.166(a) state
that tobacco products may be sold, or offered for sale, at retail
from such packages, provided the products remain in the packages
until removed by the customer or in the presence of the customer.
---------------------------------------------------------------------------

D. Section 1143.7--Language Requirements for Required Warning
Statements

    Consistent with section 3(b) of CSTHEA (15 U.S.C. 4402(b)), FDA
proposed in Sec.  1143.7 that the warning statement appear in the
English language, with two exceptions. First, under Sec.  1143.7(a), if
an advertisement appears in a non-English language publication, the
required warning statement would be required to appear in the
predominant language (i.e., the primary language used in the
nonsponsored content) of the publication. Second, under Sec.
1143.7(b), if an advertisement is in an English language publication
but the advertisement is presented in a language other than English,
the required warning statement would be required to appear in the same
foreign language as that principally used in the advertisement. FDA is
finalizing this section as proposed in the NPRM with one change; given
that FDA has noted throughout this document that the health warning
requirements apply to advertisements in any medium, we have changed the
references from ``publication'' to ``medium'' in this section.

E. Section 1143.9--Irremovable or Permanent Required Warning Statements

    FDA proposed that the warning statements for covered tobacco
products be indelibly printed on or permanently affixed to packages and
advertisements. FDA is finalizing this requirement without change.

F. Section 1143.11--Does Not Apply to Foreign Distribution

    FDA proposed to limit the applicability of the health warning
requirements by clarifying that they would not apply to manufacturers
or distributors of tobacco products that do not manufacture, package,
or import the products for sale or distribution within the United
States. FDA is finalizing this requirement.

G. Section 1143.13--Effective Date

    In the NPRM, FDA sought comment regarding the effective date of the
health warning requirements. FDA proposed that these requirements would
take effect 24 months after the date that the final rule publishes in
the Federal Register and all products manufactured on or after the
effective date must include the required warning statements on their
labels.
    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;
     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 of which do not have a required
warning if the retailer demonstrates it falls outside the scope of this
rule as described in Sec. Sec.  1143.3(a)(3) and 1143.5(a)(4).
    In addition to proposed Sec.  1143.13, we added paragraph (b)
indicating that the requirement to submit a warning plan pursuant to
Sec.  1143.5(c)(3), describing the random display and distribution of
warning statements on cigar packages and the quarterly rotation of
warning statements in cigar advertisements, will take effect 12 months
after the date of publication of this final rule. FDA is establishing
this effective date at 12 months before the effective date of the
required warnings for cigars described under part 1143 (24 months after
the publication of the final rule) because the Agency anticipates that
there will be a need for communication with submitters during its
review of the warning plan submissions. This submission deadline also
helps FDA to ensure that its surveillance program for compliance with
the warning label requirements under section 1143 is implemented as of
the effective date of 24 months after the publication of the final
rule. FDA intends to work with manufacturers, importers, distributors,
and retailers to get an approved warning plan in place. Cigar entities
may wish to contact FDA to discuss the submission of their warning
plans in order to make the subsequent approval process more orderly and
efficient. See section XVI.H.17 for additional information regarding
the warning plan requirement.

H. Comments and Responses Regarding Required Warning Statements

1. General
    (Comment 237) Several comments urged FDA to clearly define
``advertisement'' in the final rule as it is unclear what constitutes
an advertisement that must contain the required warning statements. At
least one comment suggested that the final rule contain language
explaining that any statement regarding the availability of tobacco
products in a store does not by itself constitute an advertisement.
    (Response) FDA does not believe it is necessary to include a
definition of ``advertisement'' in this final rule, but notes that for
purposes of this rule, the term ``advertisement'' should be interpreted
broadly and should be interpreted to include statements regarding the
availability of tobacco products.
    In addition, advertisements subject to this final rule may appear
in or on, for example, promotional materials (point-of-sale or non-
point-of-sale), billboards, posters, placards, published journals,
newspapers, magazines, other periodicals, catalogues, leaflets,
brochures, direct mail, shelf-talkers, display racks, Internet Web
pages, television, electronic mail correspondence, and also include
those communicated via mobile telephone, smartphone, microblog, social
media Web site, or other communication tool; Web sites, applications,
or other programs that allow for the sharing of audio, video, or
photography files; video and audio promotions; and items not subject to
the sale or distribution ban in Sec.  1140.34. FDA intends to provide
guidance on how to comply with the health warning requirements on
unique types of media.
    (Comment 238) Several comments noted that the proposed cigar
warnings are appropriate for the protection of public health. The
comments noted that the rule would enhance public health by extending
the labeling requirements beyond the seven manufacturers currently
required to use them under the FTC consent decrees, by providing for
random display on cigar packages and rotation in advertisements, and by
requiring point-of-sale warnings for cigars sold individually that are
not packaged. The comment also noted that the substance of each warning
is strongly supported by the available scientific evidence. However,
several comments took issue with the proposed warnings for premium
cigars, claiming that they lack a sound scientific basis.
    (Response) FDA finds there is a strong scientific basis to require
health warnings on cigar packages and in cigar advertisements (as well
as on signs for unpackaged cigars), which was extensively discussed in
the NPRM (79 FR 23142 at 23167 through 23170).
    (Comment 239) Several comments stated that the NPRM is unclear
regarding the requirement to develop and submit rotation plans for
warnings signs required where cigars are sold individually and not in a
product package. One comment stated that the final rule should make
clear that this obligation falls on cigar manufacturers and not on
retailers that sell cigars. Another comment stated that retailers
should be responsible for creating and posting the point of sale signs.
    (Response) To clarify, retailers of cigars sold individually and
not in product packaging are not required to submit a warning plan for
warnings on packages, because the warning signs posted at a retailer's
point-of-sale would include all six warnings applicable to cigars, as
we have noted above in our discussion of Sec.  1143.5(c)(1). Cigar
retailers would be responsible for creating and posting these signs in
accordance with Sec.  1143.5(a)(3)(i)-(iv). Therefore, there is no need
to rotate these health warnings, nor is it necessary to submit a
rotational warning plan for them. However, manufacturers must submit a
warning plan for advertisements, as the rule requires manufacturers of
all cigars to include warnings in advertisements that must be rotated
quarterly in alternating sequence in each advertisement for each brand
of cigar. Similarly, retailers who are responsible for or direct their
own cigar advertising must submit a warning plan for those
advertisements.
    (Comment 240) One comment suggested that FDA adopt labeling rules,
similar to those proposed for premium cigars, for e-cigarette products
that are sold without packaging (i.e., require signage at the point of
sale for stores selling e-cigarettes rather than require labels on
their packages).
    (Response) Unlike cigars sold individually and not in product

packages, ENDS and any e-liquids containing nicotine that are sold
separately are sold in some sort of packaging on which the
addictiveness warning can be provided. Therefore, it is not necessary
at this time to instead require warnings at the point-of-sale. The
warning requirements in this final rule are appropriate for the
protection of the public health because they provide information to the
consumers each time they use the product.
2. Continuum of Risk
    (Comment 241) Several comments asserted that different product
categories should carry different health warnings relative to the
health risk the products present to adult consumers. They also thought
that, in view of the continuum of risk, the size of the proposed
addictiveness warning on e-cigarettes and other noncombusted products
is too large and the location too prominent. For example, one comment
suggested that FDA require that this warning be smaller for these
products than for smokeless tobacco products (i.e., 20 percent of the
principal display panel) and it should appear only on one of the
principal display panels of the package. Another comment noted that,
because of its relative size and placement, the proposed e-cigarette
warning could deter combusted cigarette smokers from switching to a
noncombusted product based on a misunderstanding of the relative risks
of smoking versus electronic and noncombusted products. This comment
suggested that the warning on e-cigarettes should be no larger or more
prominently located than the currently required cigarette warnings.
    (Response) FDA disagrees. As discussed in section VIII, though FDA
recognizes the existence of a continuum of nicotine-delivering
products, all tobacco products are addictive and potentially dangerous.
There is a public health benefit to warning consumers regarding the
addictiveness of nicotine, regardless of how it is delivered. Numerous
studies show that the likelihood that warnings are seen and noticed
depends upon their size and position. (Refs. 36, 37, 38, 39; see
section II.B.4). In addition, as mentioned in section VIII.C, study
results have been inconclusive about the effects of ENDS products on
the population. FDA does not believe, at this time, that it has
sufficient evidence about the risks of ENDS products to justify the use
of different warnings sizes and to determine the appropriate size for
each product category. FDA will continue to monitor research regarding
the health effects of different types of ENDS.
    As to the comment that e-cigarette warnings should be no larger or
more prominently located than currently required for cigarettes, 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
that Congress established for smokeless tobacco in the Tobacco Control
Act. 15 U.S.C. 4402(a)(2)(A), (b)(2)(A). In the same Act, Congress
prescribed an even larger size for cigarette warnings: 50 percent on
the front and rear panels of cigarette packaging (and the same 20
percent size for cigarette advertisements) (id. Sec.  1333(a)(2),
(b)(2)). However, the larger warning sizes required for cigarettes have
not yet been implemented because the final rule was challenged in
court, and on August 24, 2012, the United States Court of Appeals for
the District of Columbia Circuit vacated the rule and remanded the
matter to the Agency. R.J. Reynolds Tobacco Co., v. Food & Drug
Administration, 696 F.3d 1205 (D.C. Circuit 2012), overruled on other
grounds by Am. Meat Inst. v. U.S. Dep't of Agric., 760 F.3d 18, 25
(D.C. Cir. 2014) (en banc). On December 5, 2012, the Court denied the
government's petition for panel rehearing and rehearing en banc, and
FDA decided not to seek further review of the Court's ruling. FDA is
conducting research that aims to support a new rulemaking consistent
with the Tobacco Control Act (see Generic Clearance for the Collection
of Qualitative Data on Tobacco Products and Communications (OMB Control
Number 0910-0796) and Pretesting of Tobacco Communications (OMB Control
Number 0910-0674)). For smokeless tobacco packaging, the warning labels
must be located on the two principal display panels and cover at least
30 percent of each panel (15 U.S.C. 4402(a)(2)(A)), which is consistent
with the warning labels required for newly deemed tobacco products.
    (Comment 242) Several comments stated that informing consumers that
tobacco products are addictive by requiring an addictiveness warning
does not fulfill any useful public health goal. These comments believed
that it is misleading to describe all nicotine-containing products as
addictive without describing the relative risk of the products.
    (Response) FDA disagrees. The addictive nature of tobacco products
has been well documented. The Surgeon General has long recognized the
addictive nature of tobacco products due to the presence of nicotine,
which is highly addictive and can be absorbed into the bloodstream
(Ref. 1). Congress also expressed concern about the addictiveness of
these ``inherently dangerous products'' (section 2(2) of the Tobacco
Control Act). Because the covered tobacco products are made or derived
from tobacco and most (if not all) contain nicotine, they are likely
addictive (Refs. 14, 246, 247, 248, 249). For products that do not
contain nicotine (i.e., no nicotine at detectable levels), the rule
provides for an alternative warning statement, ``This product is made
from tobacco.''
    Consumers, especially youth and young adults, wrongly believe that
many tobacco products covered by this rule are less addictive than
cigarettes; systematically underestimate their vulnerability to
becoming addicted to nicotine and the use of tobacco products; and
overestimate their ability to stop using tobacco products when they
choose (79 FR at 23158-59, 23166). The addictiveness warning will help
consumers understand and appreciate the consequences of using tobacco
products. The addictiveness warning will help ensure that youth and
young adults, who may be more susceptible to the addictiveness of
nicotine, have a greater awareness of the presence of nicotine and the
addictiveness of these products before they might become addicted.
    Additionally, any manufacturer that wishes can submit an MRTP
application to FDA to show that its product is less hazardous than
another tobacco product. When the Tobacco Control Act was passed,
Congress found that unless tobacco products that purport to reduce the
risks to the public of tobacco use actually reduce such risks, those
products can cause substantial harm to the public health (section 2(37)
of the Tobacco Control Act). Furthermore, Congress noted that the
dangers of products sold or distributed as MRTPs that do not in fact
reduce risk are so high that FDA must ensure that statements about
MRTPs are complete, accurate, and relate to the overall disease risk of
the product (section 2(40) of the Tobacco Control Act). Accordingly,
Congress determined that manufacturers must demonstrate that such
products meet a series of rigorous criteria, and will benefit the
health of the population as a whole before they may be marketed to
reduce the harm or the risk of tobacco-related disease or to reduce
exposures to harmful substances associated with tobacco products
(section 911 of the FD&C Act (21 U.S.C. 387k)). If new research on the
relative risks presented by the use of smokeless

tobacco products and ENDS products emerges, FDA may consider proposing
changes to the warning label requirements. If it does, the Agency will
initiate a new rulemaking in accordance with the APA.
3. Warning Requirements for Other Media
    (Comment 243) Several comments stated that FDA should clarify the
application of the proposed warnings to television and radio
advertisements, as well as in catalogs, on Internet sites, and on
social media. One comment recommended that advertisers be required to
include a voiceover stating the warning out loud, in a clear,
conspicuous, and neutral manner. Another comment suggested that FDA
clarify in the final regulation that Sec.  1143.3(b) applies only to
print advertising and not to radio and broadcast advertising.
    (Response) FDA clarifies that Sec.  1143.3(b)(1) applies to
cigarette tobacco, roll-your-own tobacco, and covered tobacco products
except for cigars as they have their own warning requirements as
enumerated in Sec.  1143.5(b)(1). The FCLAA (15 U.S.C. 1331 et seq.),
as modified by the Little Cigar Act of 1973 (Pub. L. 93-109), makes it
unlawful to advertise ``cigarettes'' and ``little cigars'' on any
medium of electronic communication subject to the jurisdiction of the
Federal Communications Commission (15 U.S.C. 1333). In 1986, Congress
enacted CSTHEA (15 U.S.C. 4401 et seq.), extending the broadcast ban to
include advertisements for smokeless tobacco products.
    FDA further clarifies that the requirements to include a warning in
Sec.  1143.3(b)(1) and Sec.  1143.5(b)(1) apply to all forms of
advertising, regardless of the medium in which it appears, for
cigarette tobacco, roll-your-own tobacco, and covered tobacco products,
including cigars. This final rule applies to advertisements appearing
in or on, for example, promotional materials (point-of-sale and non-
point-of-sale), billboards, posters, placards, published journals,
newspapers, magazines, other periodicals, catalogues, leaflets,
brochures, direct mail, shelf-talkers, display racks, Internet Web
pages, television, electronic mail correspondence, or be communicated
via mobile telephone, smartphone, microblog, social media Web site, or
other communication tool; Web sites, applications, or other programs
that allow for the sharing of audio, video, or photography files; video
and audio promotions; and items not subject to the sale or distribution
restriction in Sec.  1140.34. Accordingly, the language of Sec. Sec.
1143.3(b)(2) and 1143.5(b)(2) have been changed to clarify that the
formatting requirements only apply to print advertisements and other
advertisements with a visual component. FDA intends to provide guidance
on how to comply with the health warning requirements on unique types
of media.
4. Appropriateness of Required Warnings To Protect Public Health
    (Comment 244) In response to FDA's request in the NPRM, comments
included data and research regarding the effectiveness of health
warnings. They submitted research indicating a need for accurate health
warnings that are large enough to be readable (Refs. 3, 40) and grab
the consumer's attention (Ref. 40). Comments also submitted research
indicating that warning labels influence and increase awareness of the
health risks associated with tobacco (Ref. 36, 37, 250) and discourage
initiation in nonsmoking youth (Ref. 251). One comment cited other
research which found that novel information presented to smokers was
associated with greater relevance of the message and motivation to quit
(Ref. 252).
    (Response) FDA agrees that health warnings are an effective means
to help consumers understand and appreciate the risks of using tobacco
products.
    (Comment 245) Many comments supported the requirement for all
tobacco products to contain health warnings. For example, one comment
cited WHO's 2011 report on the Global Tobacco Epidemic, which states
that effective warning labels increase smokers' awareness of health
risks and increase the likelihood they will think about reducing
tobacco consumption and quitting (Ref. 253). The comment also cited a
cohort study of textual warnings in the United Kingdom, before and
after they were enhanced in 2003 to meet the minimum FCTC standard
(Ref. 37). This study found that, after the enhanced warnings were
implemented, UK smokers were more likely to think about quitting, to
think about the health risks of smoking, and to be deterred from having
a cigarette compared to smokers in Australia and the United States
where smaller warnings did not conform to FCTC standards. Another
comment stated that required warning statements on packages and
advertisements should provide needed information to consumers in a
conspicuous and clear manner.
    (Response) FDA agrees. Health warnings on packages and
advertisements help consumers to understand and appreciate the health
risks of tobacco use and have a number of advantages. The frequency of
exposure is high. In addition, package warnings are delivered both at
the time of tobacco product use and at the point of purchase. Thus, the
messages are delivered to tobacco users at the two most important
times--when users are considering using or purchasing the tobacco
product. The messages on packages also help the public at large,
including potential tobacco users, better understand and appreciate the
health and addictiveness risks of using the products. (See In re
Lorillard et al., 80 FTC 455 (1972); FCLAA; CSTHEA.)
5. Staleness of Warnings
    (Comment 246) Several comments noted that requiring only a single
health warning for some newly deemed tobacco products does not allow
for rotation and the warning will likely grow stale, resulting in
little to no effect on consumers. They argued that FDA should require
multiple warnings for the newly deemed products to allow for rotation
and to maintain their effectiveness. Additionally, comments urged FDA
to revise this warning and the other required health warnings as new
evidence emerges on the health risks associated with tobacco products.
    (Response) FDA acknowledges that the use of a single health warning
for some newly deemed tobacco products could allow the warning to grow
stale over time. While FDA declines to add additional warnings at this
time, FDA issued an ANPRM prior to this deeming rule, seeking comments,
data, research, or other information that may inform regulatory actions
FDA might take with respect to nicotine exposure warnings. FDA also
intends to conduct research and keep abreast of scientific developments
regarding the efficacy of the final health warnings and the ways in
which their efficacy could be improved. FDA will use the results of
this monitoring and research to help determine whether any of the
warning statements should be revised, or if any additional warning
statements should be added, in a future rulemaking.
6. Other Format Issues
    (Comment 247) There were several comments on the general format of
the health warnings. One comment stated that the warning provisions
should require black text on a bright yellow background. According to
the comment, researchers have found that yellow seizes attention, is
the most noticeable, is the color the eye perceives fastest, and
universally signals warning or danger (Refs. 254, 255). Another comment
suggested that the front of the

package should include a short and explicit warning statement that is
large enough to be readily visible and readable, and the back of the
package should contain a warning large enough to more fully develop the
basis for the front warning statement. The comment noted that the
combination of short and salient health claims on the front of the
package with more fully developed health information on the back would
produce better consumer awareness and understanding, and greater
believability of the health claim in the mind of the consumer. Finally,
several comments stated that newly deemed products should be required
to display large graphic warnings.
    (Response) FDA declines to make these suggested changes at this
time. The format requirements included with this final rule are similar
to those included in a 2001 EU directive, which have been shown to
increase the effectiveness of health warnings. EU Directive 2001/37/EC
requires that tobacco warnings in all member countries meet certain
minimum standards that are similar to those that FDA is finalizing here
(i.e., the EU required health warnings comprise 30 percent of the area
on the front of package and 40 percent on the back of the package; are
in black Helvetica bold type on a white background; occupy the greatest
possible proportion of the warning area set aside for the text
required; and messages are centered in the warning area and surrounded
by a black border of 3 to 4 millimeters (mm) in width). Before the 2001
Directive, warnings in most EU countries were very small and general.
In one study conducted for the European Commission, a majority of
respondents stated that the Directive's new warning format was more
effective and more credible than the previous format (Ref. 256). A
study of Spanish university students also concluded that text warnings
based on the Directive significantly increased perceptions of the risk
of tobacco products (Ref. 257). Additionally, studies showed that the
requirement that the warnings appear in black text on a white
background or white text on a black background improved the legibility
and noticeability of the warnings (Refs. 7, 38).
    FDA believes that the prescribed format of the health warnings will
be effective in helping consumers better understand and appreciate the
risks of these products. However, FDA intends to conduct research and
keep abreast of scientific developments regarding the efficacy of the
final health warnings and the ways in which their efficacy could be
improved. If FDA determines that modification of the format
requirements is appropriate, we will consider changing these
requirements in a future rulemaking.
    (Comment 248) FDA received a large number of comments regarding the
size of the required health warnings. Several comments agreed with the
format requirements proposed in the rule. One comment cited a study
concluding that youth and adults are more likely to recall larger
warnings, rate larger warnings as having greater impact, and often
equate the size of the warning with the magnitude of the risk (Ref.
36). The comment also stated that requiring health warnings that cover
at least 30 percent of the front and back of cigarette packages is
consistent with the FCTC.
    Several comments argued that the required health warnings are too
large. One comment stated that if the warnings are too large, they
could have the unintended effect of making consumers numb to the
warning message or otherwise lead to consumers ignoring the warning.
Another comment stated that the size of FDA's proposed addictiveness
warning should be evaluated in the context of the other information
that already appears on the packaging of noncombusted tobacco products.
This comment asserted that packaging for certain newly deemed products
includes detailed warnings and other information important to reduce
risks from inappropriate use or handling of the product and that such
information may not fit on the package if the proposed health warning
occupies 30 percent of the principal display.
    Several comments stated that the proposed warning statement should
not be required on cigars sold individually and not in product
packages. One cigar retailer stated that requiring warnings on 30
percent of the principal display panels would be excessive. The comment
believed that a health warning covering 30 percent of each cigar box
would be excessive when there are multiple boxes, particularly when
combined with the requirement for a warning sign at the point of sale.
Another comment asserted that the size of the proposed health warnings
would be inconsistent with the First Amendment.
    Other comments argued that FDA should require larger health
warnings. One comment stated that numerous studies show that youth and
adults are more likely to recall larger warning messages and rate
larger messages as having a greater impact (Ref. 37). Another comment
stated that the FCTC suggests that warnings should cover 50 percent or
more of a pack's principal surface, a standard adopted by a number of
countries.
    (Response) FDA finds that the required size of the health warnings
is appropriate for the protection of public health. The IOM, Congress,
and Article 11 of the FCTC recognize the importance of having the
warnings cover at least 30 percent of the area of the principal display
panels, and users are more likely to recall warnings that are a larger
size and that appear on the front/major surfaces of the tobacco package
(Ref. 7). The 30-percent warning label area requirement for product
packages is also consistent with the size requirements for similar
text-only warnings for smokeless tobacco mandated by Congress in CSTHEA
(15 U.S.C. 4402(a)(2)(A)). FDA does not believe that the 30-percent
warning label area requirement will make consumers numb to the warning
message. Rather, FDA believes that the size of the warnings will be
effective in helping consumers better understand and appreciate the
critical information presented by the health warning.
    FDA also believes that the 30-percent warning label area
requirement is consistent with the First Amendment (as discussed in
section II.B). Although the warning will occupy at least 30 percent of
the packaging, there will remain sufficient space for additional
warnings, manufacturer instructions, and branding. However, FDA intends
to conduct research and keep abreast of scientific developments
regarding the efficacy of the health warnings in the final rule and the
ways in which their efficacy could be improved. If FDA determines that
larger warnings would be more effective for these newly deemed
products, the Agency will issue a new NPRM in accordance with the APA.
    (Comment 249) Comments stated that FDA should not require
manufacturers to use a font size that occupies the greatest possible
proportion of the warning area because that would leave limited, if
any, white space and may prove to be illegible. These comments
suggested that FDA reduce the font size requirement to be consistent
with smokeless tobacco warnings, which are required to take up 60 to 70
percent of the warning area.
    (Response) FDA disagrees. Newly deemed tobacco products are sold in
a variety of packaging sizes. By requiring the font size to be at least
12-point font, FDA is ensuring that the required warning statement will
be noticed by consumers regardless of the package size. Further, FDA
believes that this requirement will leave adequate background space so
that the warning is

legible. The format requirements are similar to those included in a
2001 EU directive (requiring warnings to occupy the greatest possible
portion of the warning area set aside for the required text), which
have been shown to increase the effectiveness of health warnings, as
further discussed in this section of the document. FDA is not aware of
any legibility issues with the EU health warnings and does not expect
any legibility issues with the health warnings included in this final
rule.
    The size of the warning clearly matters, as recall increases
significantly with font size (Ref. 258). In a study on recall of health
warnings in smokeless tobacco ads, conducted with 895 young males, 63
percent of participants recalled a high contrast warning in 10-point
font; doubling the font size for the warning to a 20-point font
increased recall from 63 percent to 76 percent representing a 20
percent improvement in recall (id.). Research on cigarette package
warnings confirms that larger warnings are better noticed and more
likely to be recalled (Ref. 7 at App. C-3; Refs. 38, 49). These studies
support FDA's conclusion that requiring the proposed warnings to appear
in at least 12-point font size will improve their noticeability.
    (Comment 250) At least one comment believed that requiring warnings
to occupy at least 20 percent of the area of an advertisement would
result in warning statements that, while visible, are more likely to be
ignored. This comment suggested that appropriate warning statements be
presented in a minimum font size (e.g., no smaller than 11-point type).
    (Response) FDA is unaware of any evidence stating that a health
warning occupying at least 20 percent of the area of an advertisement
is likely to be ignored. Nevertheless, to ensure that the statements
are visible and effectively conveying information, FDA is finalizing
Sec. Sec.  1143.3(b)(2)(ii) and 1143.5(b)(2)(ii) to require a minimum
12-point font size for the health warnings on advertisements. Moreover,
the requirement that the warning statement occupy at least 20 percent
of the area of the advertisement is the same as the statutory
requirement for press and poster advertisements for smokeless tobacco
products (section 3(b)(2)(B) of CSTHEA (15 U.S.C. 4402(b)(2)(B))).
    (Comment 251) At least one comment expressed concern with the font
requirements of the labeling provisions because they require businesses
to purchase a software package that provides either or both of the
prescribed fonts (Helvetica and Arial), and these are proprietary
fonts.
    (Response) FDA disagrees. Both Helvetica and Arial fonts are
included in common printing software. Thus, the requirement that
manufacturers use Helvetica or Arial font should not cause them to
incur any additional costs. However, we also have included language
throughout part 1143, which allows manufacturers to use other similar
sans serif fonts in order to provide additional flexibility while still
ensuring that the warnings are conspicuous and legible to consumers.
    (Comment 252) Many comments argued for different formatting
requirements for the health warnings. Some suggested that they should
be consistent with the current FTC Consent Decree, which requires that
health warnings be clear and conspicuous in relation to the other
communications on the packaging and be presented in a black box format
to attract consumer attention. One comment stated that FDA should
accept alternative warning sizes, placements, and font sizes for
different packaging sizes and configurations, as long as the warning is
clear and conspicuous. This comment urged FDA to be flexible about the
size and placement of the warnings on deemed products, some of which
are offered in packaging sizes and configurations very different from
cigarette and smokeless tobacco packaging. This comment also noted that
it can be difficult to identify the two principal display panels.
    (Response) FDA disagrees. FDA has concluded that the formatting
requirements for the health warnings, which are similar to the
requirements for smokeless products and similar to those suggested by
FCTC, are appropriate for the protection of the public health. In
addition, we have added language to this final rule which recognizes
that if a product package is too small to bear the required warning
statement, the manufacturer of the product can include the warning
statement on the outer carton or on a hang tag attached to the product
package.
    To clarify how to determine the principal display panels, FDA is
defining ``principal display panels'' of a product package as the
panels of a package that are most likely to be displayed, presented,
shown or examined by the consumer. In addition, the principal display
panels should be large enough to accommodate all mandatory label
information in a clear and conspicuous manner. The principal display
panels may be on an outer carton for small vials holding e-liquids.
7. Waterpipe Tobacco
    (Comment 253) One comment argued that the required warning should
not be applied to hookah (or waterpipe tobacco) because there is a lack
of substantial scientific evidence of the addictiveness of this
product. The comment expressed the belief that the majority of
waterpipe tobacco smokers in the United States use the product once a
week or less. Another comment asserted that studies of noncigarette
products, including waterpipe tobacco, show that these products are
perceived to present less risk of harm and addictiveness, thereby
encouraging use among young adults. The comment added that strong
warnings regarding the addictiveness of all tobacco products may reduce
trial and use in vulnerable populations (Ref. 259).
    (Response) FDA disagrees that the addictiveness warning should not
be applied to waterpipe tobacco. Waterpipe tobacco contains nicotine,
which is the primary addictive chemical in tobacco products.
Researchers have observed nicotine dependence characteristics in some
users (Refs. 238, 239, 240), with one study showing that waterpipe
tobacco use suppressed withdrawal symptoms just as cigarette smoking
suppresses withdrawal symptoms (Ref. 240). Because waterpipe smoking
sessions last longer than smoking a cigarette and there is increased
smoke volume, a single session of waterpipe smoking (which typically
lasts 20 to 80 minutes) likely exposes users to more nicotine than
smoking a cigarette (which typically takes 5 to 7 minutes). Indeed, a
meta-analysis of studies regarding waterpipe use showed that a single
episode of waterpipe use is associated with exposure to 1.7 times the
nicotine in a single cigarette.
    FDA agrees that there is consumer confusion about the addictiveness
of waterpipe tobacco. Whereas studies have shown that cigarette and
waterpipe tobacco smoking deliver similar nicotine levels, one study
showed that 46.3 percent of high school students wrongly believed that
waterpipe tobacco is less addictive or less harmful than cigarettes,
and one-third of these students wrongly believed that the product had
less nicotine, no nicotine, or was generally less addictive than
cigarettes (Ref. 260). Mistaken beliefs that waterpipe tobacco smoking
is ``safer or less addictive than cigarettes'' were more prevalent
among those who had ever used waterpipe tobacco (78.2 percent) compared
to nonusers (31.6 percent) (Ref. 260). A study of nearly 2,000
university students found that waterpipe tobacco was considered by

those students to be less addictive than e-cigarettes, marijuana, cigar
products, smokeless tobacco, and cigarettes (Ref. 261). Research found
that college students who had used waterpipes within the past 30 days
considered them less addictive and less harmful than never-users did
(Ref. 26). Similarly, another study found that ``[freshmen college]
students who used waterpipes and cigars perceived them as less harmful
than regular cigarettes'' (Ref. 262). Moreover, research has shown that
such false beliefs about product risks can be a significant predictor
of subsequent use behavior (Refs. 263, 264). For instance, adolescents
with the lowest perceptions of short-term risks related to smoking were
2.68 times more likely to initiate smoking (Ref. 264). We note that the
Surgeon General's 2014 Report provides an objective discussion of
nicotine and addiction, where ``nicotine addiction develops as a
neurobiologic adaptation to chronic nicotine exposure. However, all
forms of nicotine delivery do not pose an equal risk in establishing or
maintaining nicotine addiction'' (Ref. 9 at 112). Thus, pattern of use
is a factor in the facilitation of addiction.
    (Comment 254) One comment stated that FDA should require the
addictiveness warning on all components of waterpipe tobacco use,
including those products without nicotine or tobacco.
    (Response) FDA disagrees. FDA finds that requiring health warnings
on covered tobacco products only (and not on the components and parts
that are not made or derived from tobacco) is appropriate to protect
the public health, because youth and young adults will not be able to
use such components and parts, and potentially suffer the consequences
of tobacco use, without also using the covered tobacco product. In the
event that FDA later determines it is appropriate for the protection of
the public health to extend the warning requirements to components and
parts that are not made or derived from tobacco, the Agency will
initiate a new rulemaking in accordance with APA requirements.
8. Dissolvable Products
    (Comment 255) One comment suggested that FDA recognize all
dissolvable tobacco products as smokeless tobacco products for the
purpose of warning label regulation and, as a result, subject all
dissolvables to the smokeless warning requirements in section 204 of
the Tobacco Control Act.
    (Response) ``Smokeless tobacco product'' is defined in section
900(18) of the FD&C Act and for purposes of the warning requirements in
CSTHEA (as amended by the Tobacco Control 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.'' Some dissolvable
tobacco products do not meet the definition of ``smokeless tobacco
product'' because they do not contain cut, ground, powdered, or leaf
tobacco; instead, these products contain nicotine extracted from
tobacco. These products are the dissolvable products covered by this
final rule. Because they do not meet the statutory definition of a
smokeless tobacco product, FDA cannot recognize them as such, as
suggested by the comments. If FDA determines that the warning
statements for any type of dissolvable product should be revised, or if
any additional warning statements should be added to them, the Agency
will initiate a new rulemaking in accordance with APA requirements.
    (Comment 256) One comment stated that the use of an addictiveness
warning would serve to protect the public health by more clearly
identifying dissolvable products as addictive tobacco products and
differentiating them from candy.
    (Response) FDA agrees. Certain tobacco products have a candy-like
appearance, frequently are sold next to candy, and are packaged in a
way that makes them more attractive to children, which can mislead
consumers to think that they are, in fact, candy (Refs. 54, 215). The
addictiveness warning will clearly identify these products as tobacco
products and help differentiate them from candy.
9. Premium Cigars and Unpackaged Cigars
    (Comment 257) Several comments stated that not requiring warnings
on premium cigars and those sold individually and without product
packages would greatly diminish the effectiveness of the cigar
warnings. One comment stated there are many instances where cigars are
purchased as gifts and, in those instances, the recipients would not
see these warnings. One comment also stated that if a purchaser
receives with the premium cigar any wrapper, container, pack or bag,
then FDA should require that it include a health warning. This would
ensure that if the premium cigar is given for a celebratory occasion,
or if a minor obtained a premium cigar from an adult and did not see
the point-of-sale warning, the user would be warned of the health
risks. Another comment stated that the warning labels should be
permanently affixed to or inside the cellophane wrappers in which the
cigars are sold and in a way that is clearly visible to potential
purchasers.
    (Response) FDA understands these concerns. However, for those
cigars sold individually and not in a product package, the placement of
warnings at the point of sale will be adequate to disseminate the
required health information and is appropriate for the protection of
the public health. For cigars that are sold in cellophane wrappers,
these wrappers are considered packaging and, under this final rule,
must include the required cigar warnings. In addition, FDA notes that
youth attempting to purchase these cigars would be prohibited from
doing so under the minimum age requirements included in this final
rule.
    (Comment 258) One comment expressed concern that the NPRM did not
provide for warnings where premium cigars and cigars sold individually
and without product packaging are sold online. The comment suggested
that these cigars should either not be allowed to be sold individually
or that individual cigars should be required to be packaged and include
a warning label.
    (Response) Under the Internal Revenue Code and TTB regulations,
cigars that are taxpaid upon removal from the factory or release from
customs custody must be in the packages in which they will be delivered
to the ultimate consumer (bearing any marks or notices required by the
Internal Revenue Code and TTB regulations) at the time of removal, and
must remain in those consumer packages until taken from the package by
the consumer or in the presence of the consumer. Removing taxpaid
cigars from the package, other than in the presence of the waiting
consumer, is a violation of the Internal Revenue Code. Cigars may
nonetheless be sold individually, provided that the individual product
packaging meets the requirements of the IRC and TTB regulations. An
online retailer sending such individual cigars purchased online can
comply with FDA's requirements by placing the warning statement on the
box or container that is used to ship the product. In addition, FDA
clarifies that the warning requirements apply to all forms of
advertising, regardless of the medium in which they appear. As stated
previously, advertisements subject to this final rule may appear in or
on, for example, promotional materials (point-of-sale and non-point-of-
sale), billboards, posters, placards, published journals, newspapers,
magazines, other periodicals, catalogues, leaflets, brochures, direct
mail, shelf-talkers, display racks, Internet Web pages, television,
electronic mail

correspondence, or be communicated via mobile telephone, smartphone,
microblog, social media Web site, or other communication tool; Web
sites, applications, or other programs that allow for the sharing of
audio, video, or photography files; video and audio promotions; and
items subject to the sale or distribution restriction in Sec.  1140.34.
As stated in Sec.  1143.5(b)(2), the formatting requirements only apply
to advertisements with a visual component. FDA intends to provide
guidance on how to comply with the health warning requirements on
unique types of media.
    (Comment 259) One comment stated that premium cigars sold
individually should include a health warning on the cigar tube, if
applicable, or FDA should require retailers to provide a paper warning
to the purchaser or put cigars in bags that are pre-printed with the
warning labels.
    (Response) It is unclear exactly how this comment intends to affix
the warning to the premium cigar. If this comment is referring to
affixing a warning to the cigar tube, this may damage the cigar and,
therefore, is impractical. If this comment is seeking to add the
warning to the tube that packages some individual cigars, FDA does not
believe this is appropriate. Cigars sold individually in product
packages, including cigars sold in tubes, must comply with the warning
statement requirements for packaging. For cigars sold individually and
not in product packages, the required warning statements must instead
be posted at the retailer's point of sale. FDA believes that the point
of sale signage requirement will ensure that premium cigar purchasers,
as well as purchasers of other individual cigars, receive the required
health warnings while allowing persons selling or distributing the
cigars to maintain existing business practices.
    (Comment 260) One comment expressed concern about retailers having
to forfeit counter space for the placement of health warnings for
cigars sold individually and not in product packages. The comment
stated that this space is reserved for some of the most profitable
items for sale in convenience stores. The comment also stated that the
U.S. Circuit Court of Appeals for the District of Columbia struck down
a similar, judicially imposed warning requirement that required
retailers to set aside valuable retail space to display a point-of-sale
sign. (United States v. Philip Morris USA Inc., 566 F.3d 1095 (D.C.
Cir. 2009).)
    (Response) FDA believes that the point-of-sale warnings are
necessary and appropriate for the protection of public health. FDA
notes that the requirement only applies where cigars are sold
individually and unpackaged, and will ensure that consumers of these
products are exposed to the same health warnings as consumers of other
cigar products. FDA also believes the point-of-sale warnings are
necessary to prevent manufacturers and retailers of cigars from
circumventing the warning requirement by selling their products without
packaging.
    Moreover, the United States v. Philip Morris holding cited in the
comment was not on the merits and in any event is not applicable here.
That case involved corrective statements mandated in a civil Racketeer
Influenced and Corrupt Organizations Act (RICO) case brought against
the United States' major cigarette companies. After finding the
defendants liable for racketeering and fraud, the lower court issued an
injunction that required the defendants to disseminate public
statements in order to prevent and restrain future fraud. The
statements were required to appear in various types of media--including
large-point-of-sale signs present at the checkout counter of retailers
that participated in defendants' ``participating retailer'' programs.
On appeal, noting that the retailers were not involved in the RICO
litigation but were negatively affected by the injunctive remedy, and
had not had the opportunity to present arguments against the point-of-
sale location before the lower court ruled, the appellate court vacated
the point-of-sale requirement on due process grounds, and remanded for
further consideration by the lower court. Philip Morris USA Inc., 566
F.3d at 1141-42. The appellate court did not rule on whether mandatory
point-of-sale corrective statements in valuable retail space are
permissible under the RICO statute, but simply ruled that before the
district court could impose such a requirement, the RICO statute
required ``considering the rights of third parties and existing
contracts'' (id. at 1145). By contrast, these warning requirements are
being issued under the Tobacco Control Act, not the RICO statute; and
are the product of notice-and-comment rulemaking.
10. Cigarettes and Roll-Your-Own
    (Comment 261) Some comments stated that FDA should conform the
proposed health warnings for cigarette tobacco and roll-your-own
tobacco to the federally mandated health warnings for cigarettes
required by section 4(s) of FCLAA and to health warnings that FDA
mandates for cigarettes in the future.
    (Response) FDA disagrees. Cigarette tobacco and roll-your-own
tobacco do not meet the definition of the term ``cigarette'' in section
3(1) of FCLAA. Because cigarette tobacco and roll-your-own tobacco are
not cigarettes as defined by FCLAA, they do not need to comply with
section 4 of FCLAA requiring cigarette warnings and, therefore, do not
contain any warning to alert consumers of the health effects of these
products. Instead, the Tobacco Control Act defines cigarette tobacco
and roll-your-own tobacco in sections 900(4) and 900(15) of the FD&C
Act, respectively. The lack of a warning on these tobacco products may
lead consumers to believe that they are safe products. Therefore, with
this final rule, FDA is requiring that manufacturers of such products
comply with the addiction warning in Sec.  1143.3 and any other future
health warnings that FDA mandates for these products, where
appropriate.
    (Comment 262) Some comments expressed concern about the following
warning as applied to pipe tobacco products: ``WARNING: This product
contains nicotine derived from tobacco. Nicotine is an addictive
chemical.'' They stated that this warning is not appropriate for these
products because the first sentence of the warning suggests that it is
targeted at e-cigarettes whose nicotine is derived from tobacco, not
tobacco itself. Other comments expressed concern that the word
``derived'' would not be well understood by the majority of consumers
and introduced unnecessary complexity. They also noted that the
statement that the nicotine is derived from tobacco does not provide
information that is relevant to the user's health. One comment
suggested a number of changes to the proposed addiction warning,
including a simpler alternative: ``WARNING: This product contains
nicotine. Nicotine is an addictive chemical.''
    (Response) FDA agrees with concerns using the word ``derived.'' FDA
has concluded that the suggested warning statement ``WARNING: This
product contains nicotine. Nicotine is an addictive chemical'' is a
more appropriate warning label because it provides an accurate warning
for both products that contain leaf tobacco and products that contain
nicotine derived from tobacco. It is also clearer and does not
introduce unnecessarily complex terms that may make it more difficult
for consumers to understand and appreciate the risks of addiction.
Similarly, FDA is revising the alternative statement to

read ``This product is made from tobacco.'' to remove use of the word
``derived,'' which may not be easily understood. However, FDA disagrees
with comments stating that this warning should not be required on pipe
tobacco packages because pipe tobacco contains nicotine, which is the
primary addictive constituent in tobacco products.
    Thus, FDA has changed Sec.  1143.3(a)(1) to require that for
cigarette tobacco, roll-your-own tobacco, and covered tobacco products
other than cigars, it is unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale or
distribution within the United States such product unless the tobacco
product bears the following required warning statement on each product
package label: ``WARNING: This product contains nicotine. Nicotine is
an addictive chemical.''
11. Addictiveness Warning
    (Comment 263) One comment stated that the need to inform consumers
about the addictiveness of nicotine has been implicitly recognized by a
number of manufacturers of e-cigarette products. The comment stated
that a recent investigation by the staff of 11 U.S. Senators and
Representatives of the practices of 9 of the largest e-cigarette
manufacturers revealed that, although their product warning labels
``lack uniformity and may confuse consumers,'' 6 of the 9 companies
included some form of nicotine warning as part of their packaging or
instructions for use, in addition to the nicotine warning these
companies included to satisfy California's Proposition 65 (see Ref.
31). Although the warnings are not as comprehensive as FDA's required
health warnings in terms of size and prominence, they reflect the
companies' own recognition that their products are addictive and that
consumers should be informed of their addictive properties.
    (Response) Requiring health warnings on all newly deemed tobacco
products will help consumers better understand and appreciate the
addictive properties of these products.
    (Comment 264) Some comments questioned whether large cigars,
particularly premium cigars, should be required to carry an addiction
warning because users do not inhale the cigar smoke.
    (Response) Regardless of whether cigar smokers inhale, they are
still subject to the addictive effects through nicotine absorption
(Refs. 32, 34). 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). Therefore, consumers using premium or other
cigars can become addicted to cigars given the absorption of nicotine.
Accordingly, FDA finds that it is appropriate for the protection of the
public health to require this warning on all cigars.
12. Alternative Statement/Certification for Products Without Nicotine:
``This Product Is Derived From Tobacco.''
    (Comment 265) Several comments expressed concern about requiring a
tobacco product that does not contain nicotine to have an alternate
health warning stating that, ``this product is derived from tobacco.''
These comments stated that future products that are not derived from
tobacco would fall outside of FDA's jurisdiction and, therefore, would
not be required to include this statement on product packages.
    (Response) FDA agrees. If a product is not made or derived from
tobacco, it would not be required to bear the alternative statement.
However, if a product is made or derived from tobacco but does not
contain nicotine, the product is required to bear the alternative
statement. As discussed in section XVI.B, FDA is revising this
alternative statement to read ``This product is made from tobacco.''
    (Comment 266) Several comments stated that FDA should not permit
use of the alternate statement ``This product is derived from tobacco''
because there are studies showing instances of e-cigarette products
being labeled as zero nicotine and actually containing nicotine (Refs.
20, 170).
    (Response) FDA disagrees. If a tobacco product manufacturer has
mislabeled its product to indicate that it does not contain nicotine
when in fact it actually does, the manufacturer will be subject to
enforcement action for misbranding and the product will be required to
bear the addictiveness warning (instead of the alternative statement).
    (Comment 267) A few comments suggested that the alternative warning
statement will cause consumer confusion because most people believe
nicotine causes cancer and the alternative statement suggests there is
a difference in the health risks based on solely the presence of
nicotine. Other comments stated that the alternative statement should
not use the term ``tobacco product'' because e-cigarettes do not
contain tobacco leaf. These comments also stated that the words
``tobacco product'' could also potentially cause confusion because
consumers do not consider e-cigarettes to be tobacco products.
    (Response) FDA disagrees that the language in the alternative
statement will cause confusion. The alternative statement does not use
the term ``tobacco product'' and does not state that any ENDS product
contains tobacco. Instead, the alternative statement included with this
final rule states: ``This product is made from tobacco.''
    FDA is not aware of any currently marketed tobacco product that
does not contain nicotine. If such a product is introduced in the
future, FDA believes it is important that both consumers and retailers
be alerted that, although it may not contain nicotine, it is
nevertheless a tobacco product. From a public health perspective, FDA
believes that it is important to convey this factual information to
consumers because tobacco products (i.e., products made or derived from
tobacco) could contain other addictive chemicals (like anabasine or
nornicotine) and/or dangerous toxicants and can be psychologically
addictive as well. For example, users of de-nicotinized cigarettes
consistently report a significant degree of subjective satisfaction
(Refs. 265, 266, 267). The alternative warning statement is especially
important in light of the recent proliferation of novel tobacco
products (e.g., dissolvables that may appear like candy) that do not
resemble traditional tobacco products, and therefore, which consumers
may not know are made from tobacco. As the comments noted, some
consumers are not even aware that e-cigarettes are tobacco products.
    FDA believes that the fact that a product without nicotine is made
from tobacco is important factual information that should be conveyed
to both consumers and retailers. In addition to providing consumers
with significant information that could affect their health, the
statement will help ensure that retailers are aware that the product is
and must be treated as a tobacco product. This will result in increased
retailer compliance with the minimum age and photo identification
requirements, as well as other applicable requirements. FDA believes
that this factual alternative statement is the simplest, least
burdensome, and yet effective way to inform both consumers and
retailers that, despite the absence of nicotine, the product is still a
tobacco product that, like other tobacco products, may not be purchased
by or sold to persons under the age of 18 and requires the presentation
and examination of a photo identification card.

13. Warning: Cigars Are Not a Safe Alternative to Cigarettes
    (Comment 268) A few comments noted that evidence indicates there is
a widespread perception, particularly among young people, that cigars
are less hazardous than cigarettes and this perception may be
contributing to the increased incidence of cigar smoking. According to
the comments, one study found that adult cigar smokers in general are
three times more likely to believe cigars are a safe alternative to
cigarettes compared to those who do not smoke cigars (Ref. 268). They
also cited an online survey of college students at six colleges in the
southeastern United States, which found that smokers of little cigars
and cigarillos ``were more likely to report perceiving the harm of
little cigars, cigarillos, and cigars to be less than that of
cigarettes'' when compared to nonusers (Ref. 269). In addition, a study
of middle school and high school students in Massachusetts found that
34.9 percent of current youth cigar users agreed that ``cigars are not
as bad for you as cigarettes,'' while only 12.2 percent of the total
study population of students agreed with the statement (Ref. 270). The
comments also cited a similar study that included a focus group study
of 230 middle school, high school, and college students, which found
that 30 percent of teen cigar users made the statement that, compared
to cigarettes, cigars are less risky, and only 10 percent of teens with
no cigar experience made that statement (Ref. 271).
    (Response) FDA agrees that there is an unsubstantiated perception,
especially among young people, that cigars are less hazardous than
cigarettes (see 79 FR at 23158). This warning requirement will help to
consumers understand and appreciate the risks of cigars.
14. Warning: Tobacco Smoke Increases the Risk of Lung Cancer and Heart
Disease, Even in Nonsmokers
    (Comment 269) The comments differed as to whether the warning
``Tobacco Smoke Increases the Risk of Lung Cancer and Heart Disease,
Even in Nonsmokers'' was appropriate. Some comments thought that the
health warning was appropriate. At least one noted that a causal
relationship exists between secondhand smoke exposure and lung cancer
among lifetime nonsmokers, and individuals living with smokers had a 20
to 30 percent increase in the risk of developing lung cancer from
secondhand exposure (Ref. 272 at 445). They stated that, since all
cigars produce higher levels of toxicants than cigarette smoke, the
science clearly supports the proposed warning.
    However, several other comments stated that the scientific evidence
does not support the claim that ``secondhand smoke causes premature
death and disease in youth and in adults who do not smoke.'' One of
these comments stated that the epidemiological links between ``being
married to a smoker'' and increased disease are tenuous at best. While
these comments agreed that on a per-stick basis, cigars can produce
larger amounts of environmental tobacco smoke than do cigarettes, they
stated that it is not accurate to conclude that this exposes household
members to a considerable involuntary health risk.
    (Response) FDA agrees with the comments stating that this warning
is appropriate for the protection of the public health. It is well
established that secondhand smoke causes premature death and disease in
youth and in adults who do not smoke (Ref. 272 at 445, 532). Adult
exposure to secondhand smoke has immediate adverse effects on the
cardiovascular system and causes lung cancer and coronary heart disease
(id.). Tobacco smoke contains over 7,000 compounds, and there are more
than 70 carcinogens in sidestream and mainstream smoke generated from
cigars (Refs. 9, 70, 273). Mainstream cigar smoke is the smoke that one
draws into his or her mouth from the butt end or mouthpiece of a cigar;
whereas sidestream cigar smoke is the smoke emitted from the burning
cone of a cigar during the interval between puffs (Ref. 69 at 65).
Cigar smoke ``tar'' appears to be at least as carcinogenic as cigarette
smoke ``tar'' (Ref. 272). The Surgeon General recently reiterated that
cigar smoke contains the same toxic substances as cigarette smoke, with
varying concentrations of these constituents found in different types
and sizes of cigars (Ref. 69 at 17-18; Ref. 272 at 362).
    There is a causal relationship between lung cancer and secondhand
smoke. Exposure of nonsmokers to secondhand smoke also has been shown
to cause a significant increase in urinary levels of metabolites of
tobacco-specific nitrosamines, a carcinogen that specifically links
exposure to secondhand smoke with an increased risk for lung cancer
(Ref. 69 at 65). All cigars produce higher levels of carcinogenic
tobacco-specific nitrosamines per gram in mainstream cigar smoke than
cigarettes produce in mainstream cigarette smoke (id. at 75-76). Cigar
smoke also produces measurable amounts of lead and cadmium (id. at 75-
76). Little cigars with filter tips and regular cigars contain higher
levels of certain nitrosamines in sidestream smoke than do filtered tip
cigarettes (Ref. 69 at 81).
    The Surgeon General has reiterated that there is considerable
evidence that certain nitrosamines are major factors in the development
of lung cancer (Ref. 272 at 30). According to the Surgeon General, the
evidence is sufficient to infer a causal relationship between
secondhand smoke exposure and lung cancer among lifetime nonsmokers
(Ref. 272 at 434). Individuals living with smokers have a 20 to 30
percent increase in risk of developing lung cancer from secondhand
exposure (id. at 445). Although data particular to cigars are not
available, FDA believes it is reasonable to expect that cigar smoke
would produce similar effects as cigarette smoke, given that data from
the National Cancer Institute (NCI) cigar monograph shows that some
carcinogens determined to cause lung cancer are present at higher
levels in cigar smoke than in cigarette smoke and are present at levels
comparable to other carcinogens linked to lung cancer (Ref. 69 at 76-
93).
    There is also a causal relationship between secondhand smoke and
heart disease. The health warning statement indicating that tobacco
smoke can cause heart disease is thoroughly supported by the evidence
reiterated in reports from the Surgeon General. FDA believes it is
reasonable to conclude that this finding would produce similar effects
with respect to secondhand cigar smoke exposure based on the similar
smoke profiles for cigars and cigarettes, the risk of coronary heart
disease associated with active cigar smoking, and the low levels of
toxicant exposure that can cause coronary heart disease (Ref. 272).
    In a 2006 Surgeon General's report regarding the health effects of
exposure to secondhand smoke, the evidence demonstrated that exposure
of adults to secondhand smoke had immediate adverse effects on the
cardiovascular system and caused coronary heart disease (id. at 11).
Secondhand smoke increased the risk of coronary heart disease nearly as
much as active heavy smoking. In fact, the estimated increase in risk
of coronary heart disease from exposure to secondhand smoke was 25 to
30 percent above that of unexposed persons (id. at 519; Ref. 273 at
532). Based on these data, the Surgeon General concluded that ``the
evidence is sufficient to infer a causal relationship between exposure
to secondhand smoke and increased risks of coronary heart disease
morbidity and mortality among both men and women'' (Ref. 272 at 15).
The IOM agreed, concluding that there is a causal relationship between

secondhand smoke exposure and cardiovascular disease, as well as a
causal relationship between secondhand smoke exposure and acute
myocardial infarction (Ref. 275 at 219).
    Even a relatively brief exposure to secondhand tobacco smoke can
lead to heart disease, as some studies have demonstrated. The IOM found
there is compelling circumstantial evidence that a relatively brief
exposure to secondhand smoke can bring about an acute coronary event
(id. at 220).
    Given that the effects of secondhand smoke on coronary heart
disease are linked to the combustion of tobacco itself, FDA concludes
that exposure to secondhand cigar smoke can cause the same or similarly
dangerous effects as exposure to secondhand cigarette smoke. Thus, FDA
believes the warning statement that ``Tobacco smoke increases the risk
of lung cancer and heart disease, even in nonsmokers'' is appropriate
for the protection of the public health.
15. Warning: Cigar Smoking Can Cause Cancers of the Mouth and Throat,
Even if You Do Not Inhale
    (Comment 270) Several comments disagreed with FDA's rationale for
the warning ``Cigar smoking can cause cancers of the mouth and throat,
even if you do not inhale.'' These comments noted that the rationale
depends almost exclusively on Monograph 9 from the National Cancer
Institute, which did not distinguish among cigar types and, therefore,
should not be required for premium cigars. They also stated that cigars
are safe products if users do not inhale the smoke, as illustrated by
experimental data showing minimal toxicity because cigar smokers do not
inhale (Refs. 32, 74).
    (Response) FDA disagrees. The fact that Monograph 9 did not
distinguish among types of cigars does not mean that it only applies to
certain cigar types. In fact, the statement in the Monograph applied to
all types of cigars. Any cigar use exposes the mouth and throat to
tobacco smoke and can cause several different types of cancer even
without inhalation (Refs. 69, 104). For example, one study found an
increased risk of head and neck cancers for those who do not smoke
cigarettes but had previously smoked cigars (Ref. 104).
    While inhaling cigar smoke poses higher risk rates than not
inhaling, significant risk still exists for those who do not inhale. In
addition, most cigar smokers do inhale some amount of smoke and are not
aware that they are doing it, including those who do not intend to
inhale (Ref. 33).
16. 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 FTC and
the seven largest U.S. cigar manufacturers. (See, e.g., In re Swisher
International, Inc., Docket No. C-3964.) FDA proposed not to require
the fifth warning (SURGEON GENERAL WARNING: Tobacco Use Increases the
Risk of Infertility, Stillbirth and Low Birth Weight) because although
cigarette smoke causes these health effects (and cigar smoke is similar
to cigarette smoke), the Agency stated it was not aware of studies
specifically linking cigars to all three reproductive effects. FDA
requested comment on its proposal to require the use of only four of
the five current FTC warnings for cigars.
    During the comment period, FDA received several comments
encouraging FDA to reconsider its proposal and finalize the rule to
include all five warnings. In response to these comments, FDA
reconsidered whether to require use of the FTC reproductive health
warning. While FDA agrees that FTC's general warning statement
``Tobacco Use Increases the Risk of Infertility, Stillbirth and Low
Birth Weight'' is a factually correct statement and recognizes that
cigar smoke is similar to cigarette smoke in both chemical content and
effects, on balance, FDA prefers a warning that is specific to cigars.
Therefore, FDA has reconsidered the issue and is including a fifth
warning statement to read ``WARNING: Cigar Use While Pregnant Can Harm
You and Your Baby.'' which is well supported by direct evidence and is
appropriate for the protection of the public health. However, FDA is
also allowing manufacturers to use the FTC warning, which is
appropriate for the protection of the public health, as an optional
alternative to the new reproductive health warning.
    The FTC warning is about tobacco smoke generally, and the statement
itself is well supported by scientific evidence. Researchers have
confirmed that smoking causes negative effects on fertility,
pregnancies, and infants and children born to women who smoke. For
example, cigarette smoking increases rates of preterm delivery,
shortened gestation, and orofacial clefts, and studies have indicated
that women who smoke are twice as likely to have low birth weight
infants as women who do not smoke (Ref. 9 at p. 499; Ref. 275 at pp.
569, 576). In addition, scientific evidence supports that women who
smoke have an increased risk of infertility and stillbirth (Ref. 276).
It also causes an increased risk of sudden infant death syndrome (SIDS)
for infants whose mothers smoke during and after pregnancy (Ref. 275 at
pp. 587 and 601). In addition, scientific evidence supports the
conclusion that cigar smoke has similarly toxic effects. NCI's
Monograph 9 states:

there is no reason to expect that cigar smoke would be any less
toxic for the mother or fetus. Regular cigar smoking, particularly
with inhalation, should be presumed to have risks similar to that of
cigarette smoking for the pregnant smoker.

(Ref. 69 at 10). On balance, FDA prefers a warning that is specific to
cigars, so FDA is finalizing this rule with different warning language
specifically relating to cigars that the Agency concludes is
appropriate for the protection of the public health. However, given the
accuracy of the original FTC warning on its face, given that cigar
smoke contains and delivers the same harmful constituents as cigarette
smoke, and given extensive evidence that cigar smoke has similar
physiological effects on the body, it is also appropriate for the
protection of the public health for FDA to allow the use of the
optional alternative (SURGEON GENERAL WARNING: Tobacco Use Increases
the Risk of Infertility, Stillbirth and Low Birth Weight) to the
reproductive health warning.
    FDA selected the new warning language for several reasons. First,
FDA finds that this warning is supported by direct scientific evidence
that nicotine adversely affects maternal and fetal health (Ref. 9).
Second, this warning uses the term ``cigar use'' rather than ``tobacco
use,'' because the warning would appear on cigars only. Third, FDA
finds that this is powerful and comprehensible phrasing, which will be
understandable to a wide audience. Nevertheless, FDA recognizes that
many cigar manufacturers currently use FTC's truthful warning on the
reproductive risks of tobacco smoke. Therefore, FDA is also allowing an
optional alternative (SURGEON GENERAL WARNING: Tobacco Use Increases
the Risk of Infertility, Stillbirth and Low Birth Weight) to the
reproductive health warning to comply with the warning requirements for
cigars. FDA expects that allowing the optional alternative will benefit
entities bound by the FTC consent decrees.
    (Comment 271) Comments from cigar makers contended that because the
NPRM and the FTC consent orders both required five warnings, but not
the same

five warnings, manufacturers would not be able to use one set of
warnings to comply with both regimes. As one comment put it, ``For
example, manufacturers could not ensure a random display of FDA's five
warnings `in as equal a number of times as is possible,' as required by
the NPRM, while including the reproductive effects warning required by
FTC in that random distribution.'' This comment went on to state that a
reproductive warning for cigars is also required by California's
Proposition 65, and added that in response to an inquiry from FTC at
the time of the FTC consent orders, the California Attorney General
agreed that ``compliance with the FTC Consent Order will result in
compliance with Proposition 65.'' (Comments of Altria Client Services
Inc. on behalf of John Middleton Co., FDA-2014-N-0189-79814.)
    Other comments urged that there is scientific support to require a
reproductive warning for cigars. For example, one comment asserted that
this warning is based on data related to cigarette smoke, and given
that cigarette smoke is very similar to cigar smoke, and in many cases,
cigar smoke is more dangerous than cigarette smoke, it is a logical
conclusion that this warning is appropriate for cigars. Another comment
noted that the 2014 U.S. Surgeon General Report on tobacco use devotes
an entire chapter to the health effects of nicotine and documents that
nicotine crosses the placenta and concentrates in the fetus (Ref. 9).
The comment also noted that nicotine constricts vessels and thus limits
the amount of nutrients and oxygen delivered to the fetus.
    (Response) While FDA is unaware of data directly and explicitly
linking cigar smoke to such reproductive issues, FDA recognizes the
similarities between cigarette smoke and cigar smoke. On balance, FDA
prefers a warning specific to cigars. However, as noted previously, FDA
is allowing an optional alternative (SURGEON GENERAL WARNING: Tobacco
Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight)
to the reproductive health warning to comply with the warning
requirements for cigars. FDA expects that allowing the optional
alternative will benefit entities bound by the FTC consent decrees.
    (Comment 272) One comment expressed concern that the exclusion of
the reproductive effects warning in a final rule (i.e., the FTC warning
that states ``Tobacco Use Increases The Risk Of Infertility, Stillbirth
And Low Birth Weight''), and the subsequent advertising and sale of
cigar packages without the warning, could result in claims that the FTC
consent orders have been violated. The comment requested that FDA
ensure that the absence of such warning in any final rule will not
result in a claim that the FTC consent orders have been violated.
    (Response) In the NPRM, FDA indicated that it planned to consult
with FTC ``to harmonize national requirements for health warnings on
cigar product packages and in advertisements'' (79 FR 23142 at 23163).
As noted previously, FDA has given careful consideration to the
comments and the scientific evidence on this issue and has decided to
require a reproductive health warning for cigars, and the Agency has
discussed this evidence and decision with FTC. At this time, FDA is not
aware of any concerns from FTC regarding the cigar warnings included
with this final rule.
17. Rotation of Warnings on Advertisements
    (Comment 273) Several comments stated that rotational warning
requirements should be simple, streamlined, and easily administrated,
especially for small businesses. One comment suggested that it should
be sufficient to print equal numbers of labels containing all six
warnings and rely on the randomness of market distribution patterns
without the administrative burden of demonstrating to FDA in a written
rotational plan, and in subsequent facility inspections, that FDA can
determine that each different warning was equally displayed to each
consumer for each brand during a 12-month period.
    (Response) While FDA recognizes that the random display and
distribution of warning statements on cigar product packages and the
rotation of statements on advertisements can result in administrative
and financial costs for cigar manufacturers, FDA does not believe it
would be sufficient to rely on the randomness of market distribution
patterns. Relying on random distribution would not ensure that the
different health warning messages are reaching as many individuals as
possible, and the health warnings may grow stale from overuse if
repeated too many times for the same individual. Thus, FDA is requiring
warning statements for cigar packages to be randomly displayed in each
12-month period in as equal a number of times as possible on each brand
of cigar. The required warning statements also are required to be
randomly distributed in all areas of the United States in which the
product is marketed. The random display and distribution of required
warning statements for cigar packages must be carried out in accordance
with a warning plan submitted by the cigar manufacturer, importer,
distributor, or retailer to, and approved by FDA.
    FDA is also requiring that the required warning statements be
rotated quarterly in alternating sequence in each advertisement for
each brand of cigar, regardless of whether the cigar is sold in product
packaging. This rotation of warning statements in cigar advertisements
also must be done in accordance with a warning plan submitted to FDA by
the cigar manufacturer, importer, distributor, or retailer to, and
approved by FDA. As stated in Sec.  1143.5(c)(3) of this final rule,
each person required to randomly display and distribute or rotate
warnings in accordance with an FDA-approved plan under this part must
submit a proposed warning plan to FDA no later than either 12 months
after [date of publication of final rule], or 12 months before
advertising or commercially marketing a product that is subject to such
requirement, whichever is later. This 12-month submission timeframe
provides cigar entities time to develop and submit warning plans to
FDA. FDA encourages firms to submit warning plans any time within this
12-month period, and FDA plans to begin reviewing warning plans as soon
as they are received. FDA is establishing this effective date at 12
months before the effective date of the required warnings for cigars
described under part 1143 (24 months after the publication of the final
rule) because the Agency anticipates that there will be a need for
communication with submitters during its review of the warning plan
submissions. This submission effective date also helps FDA to ensure
that its surveillance program for compliance with the warning label
requirements under Sec.  1143 is implemented as of the effective date
of 24 months after the publication of the final rule.
    FDA intends to work with manufacturers, importers, distributors, or
retailers to get an approved warning plan in place. Cigar entities may
wish to contact FDA to discuss the submission of their warning plans in
order to make the approval process more orderly and efficient. FDA's
review and approval of a warning plan enables the Agency to more
effectively conduct surveillance and inspection activities to ensure
compliance with the warning label requirements under Sec.  1143, once
effective, by providing a guide regarding the expected rotation of the
various warnings as required by the regulation. In addition, the review
and approval

process will help manufacturers, importers, distributors, and retailers
understand the requirements under this part; and help cigar entities
minimize potential economic loss from the commercial distribution of
nonconforming products in the market.
    Additionally, FDA believes that it will be able to complete its
review of the submitted warning plans by the effective date of the
required cigar warnings. In FDA's experience with the review of warning
plans for smokeless tobacco products, no smokeless tobacco product
manufacturer, importer, distributor, or retailer was delayed or
prevented from advertising or distributing smokeless tobacco products
due to FDA's review of its warning plan, and FDA does not anticipate a
different outcome here. FDA intends to issue a guidance document within
12 months after publication of the final rule to assist the cigar
industry with the requirements for the submission of warning plans. In
addition, if FDA receives a higher volume of warning plans than
anticipated, and determines that it will not be able to review and
approve submitted warning plans by the 24-month effective date, FDA may
also consider implementing a compliance policy to ensure that cigar
entities are not delayed or prevented from advertising or distributing
cigars due to FDA's review of their warning plans.
    These requirements are consistent with those established by
Congress in the Tobacco Control Act for currently regulated tobacco
products. Section 3 of CSTHEA (as amended by section 204 of the Tobacco
Control Act) requires the random distribution and rotation of warnings
for smokeless tobacco products. Further, rotation of cigar warning
statements already occurs under the FTC consent decrees. The WHO also
has recognized the need to rotate health warnings for tobacco products.
The WHO's FCTC, evidence of a strong worldwide consensus regarding a
regulatory strategy for addressing the serious negative impacts of
tobacco products, calls for warnings that are ``rotating'' and ``large,
clear, visible and legible'' (WHO FCTC article 11.1(b)).
    (Comment 274) One comment stated that the proposed requirement that
the warning statements be permanent or irremovable is ambiguous and
does not specifically address whether labels applied by manufacturers
(which manufacturers intend not to be removed but technically are
removable) are compliant with the rule.
    (Response) Section 1143.9 requires that the health warnings be
indelibly printed on or permanently affixed to packages and
advertisements. If a warning statement can be removed, then it is not
permanent and does not meet the requirements of Sec.  1143.9. Removable
or impermanent warnings on packages and in advertisements could become
separated from the package or advertisement and thus would not meet the
requirement that they be conspicuous on the package or advertisement.
Removable warnings would run counter to FDA's purpose of effectively
conveying risk information to consumers.
18. Warnings for E-Liquids
    (Comment 275) Several comments recommended that FDA require
multiple and rotating warnings on all e-liquids that contain nicotine.
They stated the potential consequences of nicotine use need to be
listed explicitly, as explicit warnings are associated with greater
perception of potential danger than vague or general warnings (Ref.
277). Suggestions for e-cigarette warning label content included: (1)
Toxicity and potential lethality of nicotine; (2) danger to skin and
eyes; (3) danger from ingestion of nicotine liquids; (4) other
potential health hazards, including burns and explosions, from ENDS
use; (5) keep out of reach of children; (6) information about the
heating mechanism (coil) and energy source (battery); (7) information
about overheating or overuse, including risk of fire (if applicable);
(8) warnings or precautions about use in or near water as well as any
electrical shocks; and (9) warnings and instructions about replacing
components and parts.
    Another comment believed the Agency should consider requiring
manufacturers of e-cigarettes to provide additional information for
consumers in e-cigarette packaging, and as appropriate, for other newly
deemed tobacco products. The comment suggested that this information
could be presented using communication principles similar to those used
in ``Drug Facts'' for over-the-counter drugs and should include
information such as the nicotine addiction warning, age limits,
warnings about danger to children and pets, and information about use
during pregnancy and breast feeding.
    (Response) At this time, FDA finds it is appropriate for the
protection of the public health to require the warning regarding the
addictiveness of nicotine on ENDS. However, as we have stated
previously, this deeming regulation is a foundational rule, affording
the Agency the ability to publish additional regulations as necessary
and appropriate for the protection of the public health. FDA remains
concerned about all of the health risks and hazards listed in this
comment and will be focusing efforts and resources on future efforts to
prevent nicotine poisoning in both users and nonusers. Therefore, FDA
issued an ANPRM prior to this deeming rule, seeking comments, data,
research, or other information that may inform regulatory actions FDA
might take with respect to nicotine exposure warnings and the use of
child-resistant packaging. In addition, elsewhere in this issue of the
Federal Register, FDA has made available draft guidance for public
comment, which when final will represent 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.
    (Comment 276) Several comments noted that FDA should establish
alternative methods for providing health warnings on tobacco products
with small packages, such as e-cigarettes. One comment noted that FDA
has created special rules for small food packages and small over-the-
counter drug packages where the size of the package prevents the
manufacturer from satisfying certain mandatory labeling requirements.
This comment suggested that FDA implement similar alternatives for
displaying warnings on small e-cigarette packages, and that the warning
on advertising materials should not exceed 10 percent of the area of
the advertisement. Another comment asserted that many e-liquids are
packaged in relatively small 10 milliliter vials and that FDA should
consider package size and design when mandating health warnings.
    (Response) To address the issue of tobacco products with small
packages, we have added Sec.  1143.3(d) to this final rule, which
states that a tobacco product that would otherwise be required to bear
the warning in Sec.  1143.3(a)(1) but is too small or otherwise unable
to accommodate a label with sufficient space to bear the information is
exempt from compliance with the requirement provided the information
and specifications required under Sec.  1143.3(a)(1) and (a)(2) appear
on the carton or other outer container or wrapper if the carton, outer
container, or wrapper has sufficient space to bear such information, or
appears on a tag otherwise permanently affixed to the tobacco product
package. In these cases, the carton, outer container, wrapper, or tag
will serve as the location of the

principal display panels. For example, FDA is aware that e-liquids are
frequently sold in small vials that may be unable to accommodate a
label with sufficient space to bear a health warning. In addition,
small boxes of replacement cartridges will be required to carry a
warning if they contain nicotine or tobacco, or are otherwise made or
derived from tobacco, and, therefore, are covered tobacco products.
Such products also may not have sufficient space to bear a health
warning. In these cases, a manufacturer could include such information
on the carton or other outer container or wrapper if the carton, outer
container, or wrapper has sufficient space to bear the information, or
appear on a tag that is permanently affixed to the tobacco product
package. With respect to the part of this comment stating that health
warnings on advertising materials should not exceed 10 percent of the
area of the advertisement, see the NPRM (79 FR 23142 at 23164) for
additional discussion regarding the need for prominent health warnings.

XVII. National Environmental Policy Act

    The Agency has carefully considered the potential environmental
effects of deeming products to be subject to the FD&C Act and the age
and identification restrictions. FDA has concluded that the actions
will not have a significant impact on the human environment, and that
an environmental impact statement is not required. The Agency's finding
of no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Division
of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
    FDA's responses to comments regarding the proposed Environmental
Assessment are included in the following paragraphs.
    (Comment 277) One comment stated that FDA erroneously relied upon
the environmental impact analyses required by the National
Environmental Policy Act (NEPA), suggesting that the Agency should
review and analyze the total environmental impact of the rule.
    (Response) FDA disagrees. The analysis of a regulation's
environmental impact is governed by NEPA, which requires FDA to assess,
as an integral part of its decisionmaking process, the environmental
impacts of any proposed Federal action to ascertain the environmental
consequences of that action on the quality of the human environment and
to ensure that the interested and affected public is appropriately
informed. FDA satisfied these requirements with the preparation of a
proposed environmental assessment and a final environmental assessment
(Ref. 278).
    (Comment 278) One comment requested that FDA issue a new
Environmental Assessment due to ``the loss of irreplaceable cultural
historical resources that directly relate to the heritage of the [Ybor
City National Historic Landmark] District, the City of Tampa, the State
of Florida[, and] the United States of America.''
    (Response) FDA denies this request. FDA prepared its Environmental
Assessment in accordance with the requirements of 21 CFR part 25. FDA
properly accounted for all potential environmental consequences of that
action on the quality of the human environment. Therefore, a new
Environmental Assessment is unnecessary and contrary to the
requirements of NEPA (Ref. 279).

XVIII. Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public
Law 104-4). Executive Orders 12866 and 13563 direct us to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). We have developed a comprehensive Economic Analysis of Impacts
that assesses the impacts of the final rule. We believe that this final
rule is a significant regulatory action as defined by Executive Order
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. We find that the final rule will have a significant economic
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $144
million, using the most current (2014) Implicit Price Deflator for the
Gross Domestic Product. This final rule would result in a 1-year
expenditure that meets or exceeds this amount.
    This final rule finalizes Option 1 of the NPRM, which 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,
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.
    While FDA currently has authority to regulate cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco under chapter IX
of the FD&C Act, under the final rule, all additional tobacco products
that meet the statutory definition, except accessories of those newly
deemed tobacco products, will be subject to chapter IX of the FD&C Act