† HR 1256 EAS 
‘‘(c) PROPOSED STANDARDS.— 
‘‘(1) IN GENERAL.—The Secretary shall publish 
in the Federal Register a notice of proposed rule-
making for the establishment, amendment, or revoca-
tion of any tobacco product standard. 
‘‘(2) REQUIREMENTS OF NOTICE.—A notice of 
proposed rulemaking for the establishment or amend-
ment of a tobacco product standard for a tobacco 
product shall— 
‘‘(A) set forth a finding with supporting 
justification that the tobacco product standard is 
appropriate for the protection of the public 
health; 
‘‘(B) invite interested persons to submit a 
draft or proposed tobacco product standard for 
consideration by the Secretary; 
‘‘(C) invite interested persons to submit 
comments on structuring the standard so that it 
does not advantage foreign-grown tobacco over 
domestically grown tobacco; and 
‘‘(D) invite the Secretary of Agriculture to 
provide any information or analysis which the 
Secretary of Agriculture believes is relevant to 
the proposed tobacco product standard.
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‘‘(3) FINDING.—A notice of proposed rulemaking 
for the revocation of a tobacco product standard shall 
set forth a finding with supporting justification that 
the tobacco product standard is no longer appropriate 
for the protection of the public health. 
‘‘(4) COMMENT.—The Secretary shall provide for 
a comment period of not less than 60 days. 
‘‘(d) PROMULGATION.— 
‘‘(1) IN GENERAL.—After the expiration of the 
period for comment on a notice of proposed rule-
making published under subsection (c) respecting a 
tobacco product standard and after consideration of 
comments submitted under subsections (b) and (c) 
and any report from the Tobacco Products Scientific 
Advisory Committee, the Secretary shall— 
‘‘(A) if the Secretary determines that the 
standard would be appropriate for the protection 
of the public health, promulgate a regulation es-
tablishing a tobacco product standard and pub-
lish in the Federal Register findings on the mat-
ters referred to in subsection (c); or 
‘‘(B) publish a notice terminating the pro-
ceeding for the development of the standard to-
gether with the reasons for such termination.
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‘‘(2) EFFECTIVE
DATE.—A regulation estab-
lishing a tobacco product standard shall set forth the 
date or dates upon which the standard shall take ef-
fect, but no such regulation may take effect before 1 
year after the date of its publication unless the Sec-
retary determines that an earlier effective date is nec-
essary for the protection of the public health. Such 
date or dates shall be established so as to minimize, 
consistent with the public health, economic loss to, 
and disruption or dislocation of, domestic and inter-
national trade. In establishing such effective date or 
dates, the Secretary shall consider information sub-
mitted in connection with a proposed product stand-
ard by interested parties, including manufacturers 
and 
tobacco 
growers, 
regarding 
the 
technical 
achievability of compliance with the standard, and 
including information concerning the existence of pat-
ents that make it impossible to comply in the time-
frame envisioned in the proposed standard. If the Sec-
retary determines, based on the Secretary’s evaluation 
of submitted comments, that a product standard can 
be met only by manufacturers requiring substantial 
changes to the methods of farming the domestically 
grown tobacco used by the manufacturer, the effective 
date of that product standard shall be not less than
† HR 1256 EAS 
2 years after the date of publication of the final regu-
lation establishing the standard. 
‘‘(3) LIMITATION ON POWER GRANTED TO THE 
FOOD AND DRUG ADMINISTRATION.—Because of the 
importance of a decision of the Secretary to issue a 
regulation— 
‘‘(A) banning all cigarettes, all smokeless to-
bacco products, all little cigars, all cigars other 
than little cigars, all pipe tobacco, or all roll- 
your-own tobacco products; or 
‘‘(B) requiring the reduction of nicotine 
yields of a tobacco product to zero, 
the Secretary is prohibited from taking such actions 
under this Act. 
‘‘(4) AMENDMENT; REVOCATION.— 
‘‘(A) AUTHORITY.—The Secretary, upon the 
Secretary’s own initiative or upon petition of an 
interested person, may by a regulation, promul-
gated in accordance with the requirements of 
subsection (c) and paragraph (2), amend or re-
voke a tobacco product standard. 
‘‘(B) EFFECTIVE
DATE.—The Secretary 
may declare a proposed amendment of a tobacco 
product standard to be effective on and after its 
publication in the Federal Register and until the
† HR 1256 EAS 
effective date of any final action taken on such 
amendment if the Secretary determines that 
making it so effective is in the public interest. 
‘‘(5) REFERRAL TO ADVISORY COMMITTEE.— 
‘‘(A) IN
GENERAL.—The Secretary may 
refer a proposed regulation for the establishment, 
amendment, or revocation of a tobacco product 
standard to the Tobacco Products Scientific Ad-
visory Committee for a report and recommenda-
tion with respect to any matter involved in the 
proposed regulation which requires the exercise of 
scientific judgment. 
‘‘(B) INITIATION OF REFERRAL.—The Sec-
retary may make a referral under this para-
graph— 
‘‘(i) on the Secretary’s own initiative; 
or 
‘‘(ii) upon the request of an interested 
person that— 
‘‘(I) demonstrates good cause for 
the referral; and 
‘‘(II) is made before the expira-
tion of the period for submission of 
comments on the proposed regulation.
† HR 1256 EAS 
‘‘(C) PROVISION OF DATA.—If a proposed 
regulation is referred under this paragraph to 
the Tobacco Products Scientific Advisory Com-
mittee, the Secretary shall provide the Advisory 
Committee with the data and information on 
which such proposed regulation is based. 
‘‘(D) REPORT AND RECOMMENDATION.—The 
Tobacco Products Scientific Advisory Committee 
shall, within 60 days after the referral of a pro-
posed regulation under this paragraph and after 
independent study of the data and information 
furnished to it by the Secretary and other data 
and information before it, submit to the Sec-
retary a report and recommendation respecting 
such regulation, together with all underlying 
data and information and a statement of the 
reason or basis for the recommendation. 
‘‘(E) PUBLIC AVAILABILITY.—The Secretary 
shall make a copy of each report and rec-
ommendation under subparagraph (D) publicly 
available. 
‘‘(e) MENTHOL CIGARETTES.— 
‘‘(1) 
REFERRAL; 
CONSIDERATIONS.—Imme-
diately upon the establishment of the Tobacco Prod-
ucts Scientific Advisory Committee under section
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bacco product to report promptly to the Secretary any 
corrective action taken or removal from the market of 
a tobacco product undertaken by such manufacturer 
or importer if the removal or correction was under-
taken— 
‘‘(A) to reduce a risk to health posed by the 
tobacco product; or 
‘‘(B) to remedy a violation of this chapter 
caused by the tobacco product which may present 
a risk to health. 
A tobacco product manufacturer or importer of a to-
bacco product who undertakes a corrective action or 
removal from the market of a tobacco product which 
is not required to be reported under this subsection 
shall keep a record of such correction or removal. 
‘‘(2) EXCEPTION.—No report of the corrective ac-
tion or removal of a tobacco product may be required 
under paragraph (1) if a report of the corrective ac-
tion or removal is required and has been submitted 
under subsection (a). 
‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TO-
BACCO PRODUCTS. 
‘‘(a) IN GENERAL.—
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‘‘(1) NEW
TOBACCO
PRODUCT
DEFINED.—For 
purposes of this section the term ‘new tobacco product’ 
means— 
‘‘(A) any tobacco product (including those 
products in test markets) that was not commer-
cially marketed in the United States as of Feb-
ruary 15, 2007; or 
‘‘(B) any modification (including a change 
in design, any component, any part, or any con-
stituent, including a smoke constituent, or in the 
content, delivery or form of nicotine, or any 
other additive or ingredient) of a tobacco product 
where the modified product was commercially 
marketed in the United States after February 15, 
2007. 
‘‘(2) PREMARKET REVIEW REQUIRED.— 
‘‘(A) NEW PRODUCTS.—An order under sub-
section (c)(1)(A)(i) for a new tobacco product is 
required unless— 
‘‘(i) the manufacturer has submitted a 
report under section 905(j); and the Sec-
retary has issued an order that the tobacco 
product— 
‘‘(I) is substantially equivalent to 
a tobacco product commercially mar-
† HR 1256 EAS 
keted (other than for test marketing) in 
the United States as of February 15, 
2007; and 
‘‘(II) is in compliance with the re-
quirements of this Act; or 
‘‘(ii) the tobacco product is exempt 
from the requirements of section 905(j) pur-
suant to a regulation issued under section 
905(j)(3). 
‘‘(B) APPLICATION TO CERTAIN POST-FEB-
RUARY 15, 2007, PRODUCTS.—Subparagraph (A) 
shall not apply to a tobacco product— 
‘‘(i) that was first introduced or deliv-
ered for introduction into interstate com-
merce for commercial distribution in the 
United States after February 15, 2007, and 
prior to the date that is 21 months after the 
date of enactment of the Family Smoking 
Prevention and Tobacco Control Act; and 
‘‘(ii) for which a report was submitted 
under section 905(j) within such 21-month 
period, 
except that subparagraph (A) shall apply to the 
tobacco product if the Secretary issues an order
† HR 1256 EAS 
that the tobacco product is not substantially 
equivalent. 
‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 
‘‘(A) IN GENERAL.—In this section and sec-
tion 905(j), the term ‘substantially equivalent’ or 
‘substantial equivalence’ means, with respect to 
the tobacco product being compared to the predi-
cate tobacco product, that the Secretary by order 
has found that the tobacco product— 
‘‘(i) has the same characteristics as the 
predicate tobacco product; or 
‘‘(ii) has different characteristics and 
the information submitted contains infor-
mation, including clinical data if deemed 
necessary by the Secretary, that dem-
onstrates that it is not appropriate to regu-
late the product under this section because 
the product does not raise different ques-
tions of public health. 
‘‘(B) CHARACTERISTICS.—In subparagraph 
(A), the term ‘characteristics’ means the mate-
rials, ingredients, design, composition, heating 
source, or other features of a tobacco product. 
‘‘(C) LIMITATION.—A tobacco product may 
not be found to be substantially equivalent to a
† HR 1256 EAS 
predicate tobacco product that has been removed 
from the market at the initiative of the Secretary 
or that has been determined by a judicial order 
to be misbranded or adulterated. 
‘‘(4) HEALTH INFORMATION.— 
‘‘(A) SUMMARY.—As part of a submission 
under section 905(j) respecting a tobacco prod-
uct, the person required to file a premarket noti-
fication under such section shall provide an ade-
quate summary of any health information re-
lated to the tobacco product or state that such in-
formation will be made available upon request 
by any person. 
‘‘(B) REQUIRED INFORMATION.—Any sum-
mary under subparagraph (A) respecting a to-
bacco product shall contain detailed information 
regarding data concerning adverse health effects 
and shall be made available to the public by the 
Secretary within 30 days of the issuance of a de-
termination that such tobacco product is sub-
stantially equivalent to another tobacco product. 
‘‘(b) APPLICATION.— 
‘‘(1) CONTENTS.—An application under this sec-
tion shall contain—
† HR 1256 EAS 
‘‘(A) full reports of all information, pub-
lished or known to, or which should reasonably 
be known to, the applicant, concerning investiga-
tions which have been made to show the health 
risks of such tobacco product and whether such 
tobacco product presents less risk than other to-
bacco products; 
‘‘(B) a full statement of the components, in-
gredients, additives, and properties, and of the 
principle or principles of operation, of such to-
bacco product; 
‘‘(C) a full description of the methods used 
in, and the facilities and controls used for, the 
manufacture, processing, and, when relevant, 
packing and installation of, such tobacco prod-
uct; 
‘‘(D) an identifying reference to any tobacco 
product standard under section 907 which would 
be applicable to any aspect of such tobacco prod-
uct, and either adequate information to show 
that such aspect of such tobacco product fully 
meets such tobacco product standard or adequate 
information to justify any deviation from such 
standard;
† HR 1256 EAS 
‘‘(E) such samples of such tobacco product 
and of components thereof as the Secretary may 
reasonably require; 
‘‘(F) specimens of the labeling proposed to 
be used for such tobacco product; and 
‘‘(G) such other information relevant to the 
subject matter of the application as the Secretary 
may require. 
‘‘(2) REFERRAL
TO
TOBACCO
PRODUCTS
SCI-
ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 
application meeting the requirements set forth in 
paragraph (1), the Secretary— 
‘‘(A) may, on the Secretary’s own initiative; 
or 
‘‘(B) may, upon the request of an applicant, 
refer such application to the Tobacco Products Sci-
entific Advisory Committee for reference and for sub-
mission (within such period as the Secretary may es-
tablish) of a report and recommendation respecting 
the application, together with all underlying data 
and the reasons or basis for the recommendation. 
‘‘(c) ACTION ON APPLICATION.— 
‘‘(1) DEADLINE.— 
‘‘(A) IN
GENERAL.—As promptly as pos-
sible, but in no event later than 180 days after
† HR 1256 EAS 
the receipt of an application under subsection 
(b), the Secretary, after considering the report 
and recommendation submitted under subsection 
(b)(2), shall— 
‘‘(i) issue an order that the new prod-
uct may be introduced or delivered for in-
troduction into interstate commerce if the 
Secretary finds that none of the grounds 
specified in paragraph (2) of this subsection 
applies; or 
‘‘(ii) issue an order that the new prod-
uct may not be introduced or delivered for 
introduction into interstate commerce if the 
Secretary finds (and sets forth the basis for 
such finding as part of or accompanying 
such denial) that 1 or more grounds for de-
nial specified in paragraph (2) of this sub-
section apply. 
‘‘(B) RESTRICTIONS
ON
SALE
AND
DIS-
TRIBUTION.—An 
order 
under 
subparagraph 
(A)(i) may require that the sale and distribution 
of the tobacco product be restricted but only to 
the extent that the sale and distribution of a to-
bacco product may be restricted under a regula-
tion under section 906(d).
† HR 1256 EAS 
‘‘(2) DENIAL OF APPLICATION.—The Secretary 
shall deny an application submitted under subsection 
(b) if, upon the basis of the information submitted to 
the Secretary as part of the application and any 
other information before the Secretary with respect to 
such tobacco product, the Secretary finds that— 
‘‘(A) there is a lack of a showing that per-
mitting such tobacco product to be marketed 
would be appropriate for the protection of the 
public health; 
‘‘(B) the methods used in, or the facilities or 
controls used for, the manufacture, processing, or 
packing of such tobacco product do not conform 
to the requirements of section 906(e); 
‘‘(C) based on a fair evaluation of all mate-
rial facts, the proposed labeling is false or mis-
leading in any particular; or 
‘‘(D) such tobacco product is not shown to 
conform in all respects to a tobacco product 
standard in effect under section 907, and there 
is a lack of adequate information to justify the 
deviation from such standard. 
‘‘(3) DENIAL INFORMATION.—Any denial of an 
application shall, insofar as the Secretary determines 
to be practicable, be accompanied by a statement in-
† HR 1256 EAS 
forming the applicant of the measures required to re-
move such application from deniable form (which 
measures may include further research by the appli-
cant in accordance with 1 or more protocols pre-
scribed by the Secretary). 
‘‘(4) BASIS FOR FINDING.—For purposes of this 
section, the finding as to whether the marketing of a 
tobacco product for which an application has been 
submitted is appropriate for the protection of the pub-
lic health shall be determined with respect to the risks 
and benefits to the population as a whole, including 
users and nonusers of the tobacco product, and taking 
into account— 
‘‘(A) the increased or decreased likelihood 
that existing users of tobacco products will stop 
using such products; and 
‘‘(B) the increased or decreased likelihood 
that those who do not use tobacco products will 
start using such products. 
‘‘(5) BASIS FOR ACTION.— 
‘‘(A) INVESTIGATIONS.—For purposes of 
paragraph (2)(A), whether permitting a tobacco 
product to be marketed would be appropriate for 
the protection of the public health shall, when 
appropriate, be determined on the basis of well-
† HR 1256 EAS 
30th day after the date upon which such holder re-
ceives notice of such withdrawal, obtain review thereof 
in accordance with section 912. 
‘‘(3) TEMPORARY
SUSPENSION.—If, after pro-
viding an opportunity for an informal hearing, the 
Secretary determines there is reasonable probability 
that the continuation of distribution of a tobacco 
product under an order would cause serious, adverse 
health consequences or death, that is greater than or-
dinarily caused by tobacco products on the market, 
the Secretary shall by order temporarily suspend the 
authority of the manufacturer to market the product. 
If the Secretary issues such an order, the Secretary 
shall proceed expeditiously under paragraph (1) to 
withdraw such application. 
‘‘(e) SERVICE OF ORDER.—An order issued by the Sec-
retary under this section shall be served— 
‘‘(1) in person by any officer or employee of the 
department designated by the Secretary; or 
‘‘(2) by mailing the order by registered mail or 
certified mail addressed to the applicant at the appli-
cant’s last known address in the records of the Sec-
retary. 
‘‘(f) RECORDS.—
† HR 1256 EAS 
‘‘SEC. 911. MODIFIED RISK TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—No person may introduce or de-
liver for introduction into interstate commerce any modi-
fied risk tobacco product unless an order issued pursuant 
to subsection (g) is effective with respect to such product. 
‘‘(b) DEFINITIONS.—In this section: 
‘‘(1) MODIFIED RISK TOBACCO PRODUCT.—The 
term ‘modified risk tobacco product’ means any to-
bacco product that is sold or distributed for use to re-
duce harm or the risk of tobacco-related disease asso-
ciated with commercially marketed tobacco products. 
‘‘(2) SOLD OR DISTRIBUTED.— 
‘‘(A) IN GENERAL.—With respect to a to-
bacco product, the term ‘sold or distributed for 
use to reduce harm or the risk of tobacco-related 
disease associated with commercially marketed 
tobacco products’ means a tobacco product— 
‘‘(i) the label, labeling, or advertising 
of which represents explicitly or implicitly 
that— 
‘‘(I) the tobacco product presents 
a lower risk of tobacco-related disease 
or is less harmful than one or more 
other commercially marketed tobacco 
products;
† HR 1256 EAS 
‘‘(II) the tobacco product or its 
smoke contains a reduced level of a 
substance or presents a reduced expo-
sure to a substance; or 
‘‘(III) the tobacco product or its 
smoke does not contain or is free of a 
substance; 
‘‘(ii) the label, labeling, or advertising 
of which uses the descriptors ‘light’, ‘mild’, 
or ‘low’ or similar descriptors; or 
‘‘(iii) the tobacco product manufac-
turer of which has taken any action directed 
to consumers through the media or other-
wise, other than by means of the tobacco 
product’s label, labeling, or advertising, 
after the date of enactment of the Family 
Smoking Prevention and Tobacco Control 
Act, respecting the product that would be 
reasonably expected to result in consumers 
believing that the tobacco product or its 
smoke may present a lower risk of disease 
or is less harmful than one or more com-
mercially marketed tobacco products, or 
presents a reduced exposure to, or does not
† HR 1256 EAS 
contain or is free of, a substance or sub-
stances. 
‘‘(B) 
LIMITATION.—No 
tobacco 
product 
shall be considered to be ‘sold or distributed for 
use to reduce harm or the risk of tobacco-related 
disease associated with commercially marketed 
tobacco products’, except as described in sub-
paragraph (A). 
‘‘(C) SMOKELESS TOBACCO PRODUCT.—No 
smokeless tobacco product shall be considered to 
be ‘sold or distributed for use to reduce harm or 
the risk of tobacco-related disease associated with 
commercially marketed tobacco products’ solely 
because its label, labeling, or advertising uses the 
following phrases to describe such product and 
its use: ‘smokeless tobacco’, ‘smokeless tobacco 
product’, ‘not consumed by smoking’, ‘does not 
produce smoke’, ‘smokefree’, ‘smoke-free’, ‘without 
smoke’, ‘no smoke’, or ‘not smoke’. 
‘‘(3) EFFECTIVE DATE.—The provisions of para-
graph (2)(A)(ii) shall take effect 12 months after the 
date of enactment of the Family Smoking Prevention 
and Tobacco Control Act for those products whose 
label, labeling, or advertising contains the terms de-
scribed in such paragraph on such date of enactment.
100 
† HR 1256 EAS 
The effective date shall be with respect to the date of 
manufacture, provided that, in any case, beginning 
30 days after such effective date, a manufacturer shall 
not introduce into the domestic commerce of the 
United States any product, irrespective of the date of 
manufacture, that is not in conformance with para-
graph (2)(A)(ii). 
‘‘(c) TOBACCO DEPENDENCE PRODUCTS.—A product 
that is intended to be used for the treatment of tobacco de-
pendence, including smoking cessation, is not a modified 
risk tobacco product under this section if it has been ap-
proved as a drug or device by the Food and Drug Adminis-
tration and is subject to the requirements of chapter V. 
‘‘(d) FILING.—Any person may file with the Secretary 
an application for a modified risk tobacco product. Such 
application shall include— 
‘‘(1) a description of the proposed product and 
any proposed advertising and labeling; 
‘‘(2) the conditions for using the product; 
‘‘(3) the formulation of the product; 
‘‘(4) sample product labels and labeling; 
‘‘(5) all documents (including underlying sci-
entific information) relating to research findings con-
ducted, supported, or possessed by the tobacco product 
manufacturer relating to the effect of the product on
101 
† HR 1256 EAS 
tobacco-related diseases and health-related conditions, 
including information both favorable and unfavorable 
to the ability of the product to reduce risk or exposure 
and relating to human health; 
‘‘(6) data and information on how consumers ac-
tually use the tobacco product; and 
‘‘(7) such other information as the Secretary 
may require. 
‘‘(e) PUBLIC AVAILABILITY.—The Secretary shall make 
the application described in subsection (d) publicly avail-
able (except matters in the application which are trade se-
crets or otherwise confidential, commercial information) 
and shall request comments by interested persons on the in-
formation contained in the application and on the label, 
labeling, and advertising accompanying such application. 
‘‘(f) ADVISORY COMMITTEE.— 
‘‘(1) IN GENERAL.—The Secretary shall refer to 
the Tobacco Products Scientific Advisory Committee 
any application submitted under this section. 
‘‘(2) RECOMMENDATIONS.—Not later than 60 
days after the date an application is referred to the 
Tobacco Products Scientific Advisory Committee 
under paragraph (1), the Advisory Committee shall 
report its recommendations on the application to the 
Secretary.
102 
† HR 1256 EAS 
‘‘(g) MARKETING.— 
‘‘(1) MODIFIED RISK PRODUCTS.—Except as pro-
vided in paragraph (2), the Secretary shall, with re-
spect to an application submitted under this section, 
issue an order that a modified risk product may be 
commercially marketed only if the Secretary deter-
mines that the applicant has demonstrated that such 
product, as it is actually used by consumers, will— 
‘‘(A) significantly reduce harm and the risk 
of tobacco-related disease to individual tobacco 
users; and 
‘‘(B) benefit the health of the population as 
a whole taking into account both users of tobacco 
products and persons who do not currently use 
tobacco products. 
‘‘(2) SPECIAL RULE FOR CERTAIN PRODUCTS.— 
‘‘(A) IN
GENERAL.—The Secretary may 
issue an order that a tobacco product may be in-
troduced or delivered for introduction into inter-
state commerce, pursuant to an application 
under this section, with respect to a tobacco 
product that may not be commercially marketed 
under paragraph (1) if the Secretary makes the 
findings required under this paragraph and de-
103 
† HR 1256 EAS 
termines that the applicant has demonstrated 
that— 
‘‘(i) such order would be appropriate 
to promote the public health; 
‘‘(ii) any aspect of the label, labeling, 
and advertising for such product that would 
cause the tobacco product to be a modified 
risk tobacco product under subsection (b) is 
limited to an explicit or implicit represen-
tation that such tobacco product or its 
smoke does not contain or is free of a sub-
stance or contains a reduced level of a sub-
stance, or presents a reduced exposure to a 
substance in tobacco smoke; 
‘‘(iii) scientific evidence is not avail-
able and, using the best available scientific 
methods, cannot be made available without 
conducting long-term epidemiological stud-
ies for an application to meet the standards 
set forth in paragraph (1); and 
‘‘(iv) the scientific evidence that is 
available without conducting long-term epi-
demiological studies demonstrates that a 
measurable and substantial reduction in 
morbidity or mortality among individual
117 
† HR 1256 EAS 
cluding interim relief, as provided for in such chapter. A 
regulation or denial described in subsection (a) shall be re-
viewed in accordance with section 706(2)(A) of title 5, 
United States Code. 
‘‘(c) FINALITY OF JUDGMENT.—The judgment of the 
court affirming or setting aside, in whole or in part, any 
regulation or order shall be final, subject to review by the 
Supreme Court of the United States upon certiorari or cer-
tification, as provided in section 1254 of title 28, United 
States Code. 
‘‘(d) OTHER REMEDIES.—The remedies provided for 
in this section shall be in addition to, and not in lieu of, 
any other remedies provided by law. 
‘‘(e) REGULATIONS AND ORDERS MUST RECITE BASIS 
IN RECORD.—To facilitate judicial review, a regulation or 
order issued under section 906, 907, 908, 909, 910, or 916 
shall contain a statement of the reasons for the issuance 
of such regulation or order in the record of the proceedings 
held in connection with its issuance. 
‘‘SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS. 
‘‘The Secretary shall issue regulations to require that 
retail establishments for which the predominant business is 
the sale of tobacco products comply with any advertising 
restrictions applicable to retail establishments accessible to 
individuals under the age of 18.
118 
† HR 1256 EAS 
‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH 
THE FEDERAL TRADE COMMISSION. 
‘‘(a) JURISDICTION.— 
‘‘(1) IN GENERAL.—Except where expressly pro-
vided in this chapter, nothing in this chapter shall be 
construed as limiting or diminishing the authority of 
the Federal Trade Commission to enforce the laws 
under its jurisdiction with respect to the advertising, 
sale, or distribution of tobacco products. 
‘‘(2) ENFORCEMENT.—Any advertising that vio-
lates this chapter or a provision of the regulations re-
ferred to in section 102 of the Family Smoking Pre-
vention and Tobacco Control Act, is an unfair or de-
ceptive act or practice under section 5(a) of the Fed-
eral Trade Commission Act and shall be considered a 
violation of a rule promulgated under section 18 of 
that Act. 
‘‘(b) COORDINATION.—With respect to the requirements 
of section 4 of the Federal Cigarette Labeling and Adver-
tising Act and section 3 of the Comprehensive Smokeless 
Tobacco Health Education Act of 1986— 
‘‘(1) the Chairman of the Federal Trade Com-
mission shall coordinate with the Secretary con-
cerning the enforcement of such Act as such enforce-
ment relates to unfair or deceptive acts or practices
119 
† HR 1256 EAS 
in the advertising of cigarettes or smokeless tobacco; 
and 
‘‘(2) the Secretary shall consult with the Chair-
man of such Commission in revising the label state-
ments and requirements under such sections. 
‘‘SEC. 915. REGULATION REQUIREMENT. 
‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not 
later than 36 months after the date of enactment of the 
Family Smoking Prevention and Tobacco Control Act, the 
Secretary shall promulgate regulations under this Act that 
meet the requirements of subsection (b). 
‘‘(b) CONTENTS OF RULES.—The regulations promul-
gated under subsection (a)— 
‘‘(1) shall require testing and reporting of to-
bacco product constituents, ingredients, and additives, 
including smoke constituents, by brand and subbrand 
that the Secretary determines should be tested to pro-
tect the public health, provided that, for purposes of 
the testing requirements of this paragraph, tobacco 
products manufactured and sold by a single tobacco 
product manufacturer that are identical in all re-
spects except the labels, packaging design, logo, trade 
dress, trademark, brand name, or any combination 
thereof, shall be considered as a single brand; and
120 
† HR 1256 EAS 
‘‘(2) may require that tobacco product manufac-
turers, packagers, or importers make disclosures relat-
ing to the results of the testing of tar and nicotine 
through labels or advertising or other appropriate 
means, and make disclosures regarding the results of 
the testing of other constituents, including smoke con-
stituents, ingredients, or additives, that the Secretary 
determines should be disclosed to the public to protect 
the public health and will not mislead consumers 
about the risk of tobacco-related disease. 
‘‘(c) AUTHORITY.—The Secretary shall have the au-
thority under this chapter to conduct or to require the test-
ing, reporting, or disclosure of tobacco product constituents, 
including smoke constituents. 
‘‘(d) SMALL TOBACCO PRODUCT MANUFACTURERS.— 
‘‘(1) FIRST COMPLIANCE DATE.—The initial reg-
ulations promulgated under subsection (a) shall not 
impose requirements on small tobacco product manu-
facturers before the later of— 
‘‘(A) the end of the 2-year period following 
the final promulgation of such regulations; and 
‘‘(B) the initial date set by the Secretary for 
compliance with such regulations by manufac-
turers that are not small tobacco product manu-
facturers.
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‘‘(2) TESTING AND REPORTING INITIAL COMPLI-
ANCE PERIOD.— 
‘‘(A) 4-YEAR PERIOD.—The initial regula-
tions promulgated under subsection (a) shall give 
each small tobacco product manufacturer a 4- 
year period over which to conduct testing and re-
porting for all of its tobacco products. Subject to 
paragraph (1), the end of the first year of such 
4-year period shall coincide with the initial date 
of compliance under this section set by the Sec-
retary with respect to manufacturers that are 
not small tobacco product manufacturers or the 
end of the 2-year period following the final pro-
mulgation of such regulations, as described in 
paragraph (1)(A). A small tobacco product man-
ufacturer shall be required— 
‘‘(i) to conduct such testing and report-
ing for 25 percent of its tobacco products 
during each year of such 4-year period; and 
‘‘(ii) to conduct such testing and re-
porting for its largest-selling tobacco prod-
ucts (as determined by the Secretary) before 
its other tobacco products, or in such other 
order of priority as determined by the Sec-
retary.
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‘‘(B) 
CASE-BY-CASE
DELAY.—Notwith-
standing subparagraph (A), the Secretary may, 
on a case-by-case basis, delay the date by which 
an individual small tobacco product manufac-
turer must conduct testing and reporting for its 
tobacco products under this section based upon a 
showing of undue hardship to such manufac-
turer. Notwithstanding the preceding sentence, 
the Secretary shall not extend the deadline for a 
small tobacco product manufacturer to conduct 
testing and reporting for all of its tobacco prod-
ucts beyond a total of 5 years after the initial 
date of compliance under this section set by the 
Secretary with respect to manufacturers that are 
not small tobacco product manufacturers. 
‘‘(3) SUBSEQUENT
AND
ADDITIONAL
TESTING 
AND REPORTING.—The regulations promulgated under 
subsection (a) shall provide that, with respect to any 
subsequent or additional testing and reporting of to-
bacco products required under this section, such test-
ing and reporting by a small tobacco product manu-
facturer shall be conducted in accordance with the 
timeframes described in paragraph (2)(A), except 
that, in the case of a new product, or if there has been 
a modification described in section 910(a)(1)(B) of
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from completing the required testing during the pe-
riod described in paragraph (3). 
‘‘(f) RULE OF CONSTRUCTION.—Nothing in subsection 
(d) or (e) shall be construed to authorize the extension of 
any deadline, or to otherwise affect any timeframe, under 
any provision of this Act or the Family Smoking Preven-
tion and Tobacco Control Act other than this section. 
‘‘SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHOR-
ITY. 
‘‘(a) IN GENERAL.— 
‘‘(1) PRESERVATION.—Except as provided in 
paragraph (2)(A), nothing in this chapter, or rules 
promulgated under this chapter, shall be construed to 
limit the authority of a Federal agency (including the 
Armed Forces), a State or political subdivision of a 
State, or the government of an Indian tribe to enact, 
adopt, promulgate, and enforce any law, rule, regula-
tion, or other measure with respect to tobacco prod-
ucts that is in addition to, or more stringent than, 
requirements established under this chapter, including 
a law, rule, regulation, or other measure relating to 
or prohibiting the sale, distribution, possession, expo-
sure to, access to, advertising and promotion of, or 
use of tobacco products by individuals of any age, in-
formation reporting to the State, or measures relating
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to fire safety standards for tobacco products. No pro-
vision of this chapter shall limit or otherwise affect 
any State, tribal, or local taxation of tobacco prod-
ucts. 
‘‘(2) PREEMPTION OF CERTAIN STATE AND LOCAL 
REQUIREMENTS.— 
‘‘(A) IN GENERAL.—No State or political 
subdivision of a State may establish or continue 
in effect with respect to a tobacco product any 
requirement which is different from, or in addi-
tion to, any requirement under the provisions of 
this chapter relating to tobacco product stand-
ards, 
premarket 
review, 
adulteration, 
mis-
branding, labeling, registration, good manufac-
turing standards, or modified risk tobacco prod-
ucts. 
‘‘(B) EXCEPTION.—Subparagraph (A) does 
not apply to requirements relating to the sale, 
distribution, possession, information reporting to 
the State, exposure to, access to, the advertising 
and promotion of, or use of, tobacco products by 
individuals of any age, or relating to fire safety 
standards for tobacco products. Information dis-
closed to a State under subparagraph (A) that is 
exempt from disclosure under section 552(b)(4)
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of title 5, United States Code, shall be treated as 
a trade secret and confidential information by 
the State. 
‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT 
LIABILITY.—No provision of this chapter relating to a to-
bacco product shall be construed to modify or otherwise af-
fect any action or the liability of any person under the 
product liability law of any State. 
‘‘SEC. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY 
COMMITTEE. 
‘‘(a) ESTABLISHMENT.—Not later than 6 months after 
the date of enactment of the Family Smoking Prevention 
and Tobacco Control Act, the Secretary shall establish a 12- 
member advisory committee, to be known as the Tobacco 
Products Scientific Advisory Committee (in this section re-
ferred to as the ‘Advisory Committee’). 
‘‘(b) MEMBERSHIP.— 
‘‘(1) IN GENERAL.— 
‘‘(A) MEMBERS.—The Secretary shall ap-
point as members of the Tobacco Products Sci-
entific Advisory Committee individuals who are 
technically qualified by training and experience 
in medicine, medical ethics, science, or tech-
nology involving the manufacture, evaluation, or 
use of tobacco products, who are of appropriately
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diversified professional backgrounds. The com-
mittee shall be composed of— 
‘‘(i) 7 individuals who are physicians, 
dentists, scientists, or health care profes-
sionals practicing in the area of oncology, 
pulmonology, cardiology, toxicology, phar-
macology, addiction, or any other relevant 
specialty; 
‘‘(ii) 1 individual who is an officer or 
employee of a State or local government or 
of the Federal Government; 
‘‘(iii) 1 individual as a representative 
of the general public; 
‘‘(iv) 1 individual as a representative 
of the interests of the tobacco manufacturing 
industry; 
‘‘(v) 1 individual as a representative of 
the interests of the small business tobacco 
manufacturing industry, which position 
may be filled on a rotating, sequential basis 
by representatives of different small business 
tobacco manufacturers based on areas of ex-
pertise relevant to the topics being consid-
ered by the Advisory Committee; and
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‘‘(vi) 1 individual as a representative 
of the interests of the tobacco growers. 
‘‘(B) NONVOTING MEMBERS.—The members 
of the committee appointed under clauses (iv), 
(v), and (vi) of subparagraph (A) shall serve as 
consultants to those described in clauses (i) 
through (iii) of subparagraph (A) and shall be 
nonvoting representatives. 
‘‘(C) CONFLICTS OF INTEREST.—No mem-
bers of the committee, other than members ap-
pointed pursuant to clauses (iv), (v), and (vi) of 
subparagraph (A) shall, during the member’s 
tenure on the committee or for the 18-month pe-
riod prior to becoming such a member, receive 
any salary, grants, or other payments or support 
from any business that manufactures, distrib-
utes, markets, or sells cigarettes or other tobacco 
products. 
‘‘(2) LIMITATION.—The Secretary may not ap-
point to the Advisory Committee any individual who 
is in the regular full-time employ of the Food and 
Drug Administration or any agency responsible for 
the enforcement of this Act. The Secretary may ap-
point Federal officials as ex officio members.
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† HR 1256 EAS 
‘‘(3) CHAIRPERSON.—The Secretary shall des-
ignate 1 of the members appointed under clauses (i), 
(ii), and (iii) of paragraph (1)(A) to serve as chair-
person. 
‘‘(c) DUTIES.—The Tobacco Products Scientific Advi-
sory Committee shall provide advice, information, and rec-
ommendations to the Secretary— 
‘‘(1) as provided in this chapter; 
‘‘(2) on the effects of the alteration of the nicotine 
yields from tobacco products; 
‘‘(3) on whether there is a threshold level below 
which nicotine yields do not produce dependence on 
the tobacco product involved; and 
‘‘(4) on its review of other safety, dependence, or 
health issues relating to tobacco products as requested 
by the Secretary. 
‘‘(d) COMPENSATION; SUPPORT; FACA.— 
‘‘(1) COMPENSATION AND TRAVEL.—Members of 
the Advisory Committee who are not officers or em-
ployees of the United States, while attending con-
ferences or meetings of the committee or otherwise en-
gaged in its business, shall be entitled to receive com-
pensation at rates to be fixed by the Secretary, which 
may not exceed the daily equivalent of the rate in ef-
fect under the Senior Executive Schedule under sec-
135 
† HR 1256 EAS 
shall be the amount specified in subsection (b)(1) for such 
year, subject to subsection (c). 
‘‘(b) ASSESSMENT OF USER FEE.— 
‘‘(1) 
AMOUNT
OF
ASSESSMENT.—The 
total 
amount of user fees authorized to be assessed and col-
lected under subsection (a) for a fiscal year is the fol-
lowing, as applicable to the fiscal year involved: 
‘‘(A) For fiscal year 2009, $85,000,000 
(subject to subsection (e)). 
‘‘(B) For fiscal year 2010, $235,000,000. 
‘‘(C) For fiscal year 2011, $450,000,000. 
‘‘(D) For fiscal year 2012, $477,000,000. 
‘‘(E) For fiscal year 2013, $505,000,000. 
‘‘(F) For fiscal year 2014, $534,000,000. 
‘‘(G) For fiscal year 2015, $566,000,000. 
‘‘(H) For fiscal year 2016, $599,000,000. 
‘‘(I) For fiscal year 2017, $635,000,000. 
‘‘(J) For fiscal year 2018, $672,000,000. 
‘‘(K) For fiscal year 2019 and each subse-
quent fiscal year, $712,000,000. 
‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS OF 
TOBACCO PRODUCTS.— 
‘‘(A) IN GENERAL.—The total user fees as-
sessed and collected under subsection (a) each fis-
cal year with respect to each class of tobacco
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† HR 1256 EAS 
products shall be an amount that is equal to the 
applicable percentage of each class for the fiscal 
year multiplied by the amount specified in para-
graph (1) for the fiscal year. 
‘‘(B) APPLICABLE PERCENTAGE.— 
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (A), the applicable percentage 
for a fiscal year for each of the following 
classes of tobacco products shall be deter-
mined in accordance with clause (ii): 
‘‘(I) Cigarettes. 
‘‘(II) Cigars, including small ci-
gars and cigars other than small ci-
gars. 
‘‘(III) Snuff. 
‘‘(IV) Chewing tobacco. 
‘‘(V) Pipe tobacco. 
‘‘(VI) Roll-your-own tobacco. 
‘‘(ii) ALLOCATIONS.—The applicable 
percentage of each class of tobacco product 
described in clause (i) for a fiscal year shall 
be the percentage determined under section 
625(c) of Public Law 108–357 for each such 
class of product for such fiscal year.
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† HR 1256 EAS 
‘‘(iii) 
REQUIREMENT
OF
REGULA-
TIONS.—Notwithstanding clause (ii), no 
user fees shall be assessed on a class of to-
bacco products unless such class of tobacco 
products is listed in section 901(b) or is 
deemed by the Secretary in a regulation 
under section 901(b) to be subject to this 
chapter. 
‘‘(iv) REALLOCATIONS.—In the case of 
a class of tobacco products that is not listed 
in section 901(b) or deemed by the Sec-
retary in a regulation under section 901(b) 
to be subject to this chapter, the amount of 
user fees that would otherwise be assessed to 
such class of tobacco products shall be re-
allocated to the classes of tobacco products 
that are subject to this chapter in the same 
manner and based on the same relative per-
centages otherwise determined under clause 
(ii). 
‘‘(3) DETERMINATION
OF
USER
FEE
BY
COM-
PANY.— 
‘‘(A) IN GENERAL.—The total user fee to be 
paid by each manufacturer or importer of a par-
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† HR 1256 EAS 
ticular class of tobacco products shall be deter-
mined for each quarter by multiplying— 
‘‘(i) such manufacturer’s or importer’s 
percentage share as determined under para-
graph (4); by 
‘‘(ii) the portion of the user fee amount 
for the current quarter to be assessed on all 
manufacturers and importers of such class 
of tobacco products as determined under 
paragraph (2). 
‘‘(B) NO FEE IN EXCESS OF PERCENTAGE 
SHARE.—No manufacturer or importer of to-
bacco products shall be required to pay a user fee 
in excess of the percentage share of such manu-
facturer or importer. 
‘‘(4) ALLOCATION OF ASSESSMENT WITHIN EACH 
CLASS OF TOBACCO PRODUCT.—The percentage share 
of each manufacturer or importer of a particular 
class of tobacco products of the total user fee to be 
paid by all manufacturers or importers of that class 
of tobacco products shall be the percentage determined 
for purposes of allocations under subsections (e) 
through (h) of section 625 of Public Law 108–357. 
‘‘(5) 
ALLOCATION
FOR
CIGARS.—Notwith-
standing paragraph (4), if a user fee assessment is
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† HR 1256 EAS 
‘‘(C) For purposes of this paragraph, the term ‘quali-
fied adult-only facility’ means a facility or restricted area 
that— 
‘‘(i) requires each person present to provide to a 
law enforcement officer (whether on or off duty) or to 
a security guard licensed by a governmental entity 
government-issued identification showing a photo-
graph and at least the minimum age established by 
applicable law for the purchase of smokeless tobacco; 
‘‘(ii) does not sell, serve, or distribute alcohol; 
‘‘(iii) is not located adjacent to or immediately 
across from (in any direction) a space that is used 
primarily for youth-oriented marketing, promotional, 
or other activities; 
‘‘(iv) is a temporary structure constructed, des-
ignated, and operated as a distinct enclosed area for 
the purpose of distributing free samples of smokeless 
tobacco in accordance with this subparagraph; 
‘‘(v) is enclosed by a barrier that— 
‘‘(I) is constructed of, or covered with, an 
opaque material (except for entrances and exits); 
‘‘(II) extends from no more than 12 inches 
above the ground or floor (which area at the bot-
tom of the barrier must be covered with material 
that restricts visibility but may allow airflow) to
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† HR 1256 EAS 
at least 8 feet above the ground or floor (or to 
the ceiling); and 
‘‘(III) prevents persons outside the qualified 
adult-only facility from seeing into the qualified 
adult-only facility, unless they make unreason-
able efforts to do so; and 
‘‘(vi) does not display on its exterior— 
‘‘(I) any tobacco product advertising; 
‘‘(II) a brand name other than in conjunc-
tion with words for an area or enclosure to iden-
tify an adult-only facility; or 
‘‘(III) any combination of words that would 
imply to a reasonable observer that the manufac-
turer, distributor, or retailer has a sponsorship 
that would violate section 897.34(c). 
‘‘(D) Distribution of samples of smokeless tobacco 
under this subparagraph permitted to be taken out of the 
qualified adult-only facility shall be limited to 1 package 
per adult consumer containing no more than 0.53 ounces 
(15 grams) of smokeless tobacco. If such package of smoke-
less tobacco contains individual portions of smokeless to-
bacco, the individual portions of smokeless tobacco shall not 
exceed 8 individual portions and the collective weight of 
such individual portions shall not exceed 0.53 ounces (15 
grams). Any manufacturer, distributor, or retailer who dis-
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† HR 1256 EAS 
tributes or causes to be distributed free samples also shall 
take reasonable steps to ensure that the above amounts are 
limited to one such package per adult consumer per day. 
‘‘(3) Notwithstanding subparagraph (2), no manufac-
turer, distributor, or retailer may distribute or cause to be 
distributed any free samples of smokeless tobacco— 
‘‘(A) to a sports team or entertainment group; or 
‘‘(B) at any football, basketball, baseball, soccer, 
or hockey event or any other sporting or entertain-
ment event determined by the Secretary to be covered 
by this subparagraph. 
‘‘(4) The Secretary shall implement a program to en-
sure compliance with this paragraph and submit a report 
to the Congress on such compliance not later than 18 
months after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act. 
‘‘(5) Nothing in this paragraph shall be construed to 
authorize any person to distribute or cause to be distributed 
any sample of a tobacco product to any individual who has 
not attained the minimum age established by applicable 
law for the purchase of such product.’’. 
(3) AMENDMENTS TO RULE.—Prior to making 
amendments to the rule published under paragraph 
(1), the Secretary shall promulgate a proposed rule in
151 
† HR 1256 EAS 
accordance with chapter 5 of title 5, United States 
Code. 
(4) RULE OF CONSTRUCTION.—Except as pro-
vided in paragraph (3), nothing in this section shall 
be construed to limit the authority of the Secretary to 
amend, in accordance with chapter 5 of title 5, 
United States Code, the regulation promulgated pur-
suant to this section, including the provisions of such 
regulation relating to distribution of free samples. 
(5) ENFORCEMENT
OF
RETAIL
SALE
PROVI-
SIONS.—The Secretary of Health and Human Serv-
ices shall ensure that the provisions of this division, 
the amendments made by this division, and the im-
plementing regulations (including such provisions, 
amendments, and regulations relating to the retail 
sale of tobacco products) are enforced with respect to 
the United States and Indian tribes. 
(6) QUALIFIED ADULT-ONLY FACILITY.—A quali-
fied adult-only facility (as such term is defined in 
section 897.16(d) of the final rule published under 
paragraph (1)) that is also a retailer and that com-
mits a violation as a retailer shall not be subject to 
the limitations in section 103(q) and shall be subject 
to penalties applicable to a qualified adult-only facil-
ity.
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† HR 1256 EAS 
(7) CONGRESSIONAL REVIEW PROVISIONS.—Sec-
tion 801 of title 5, United States Code, shall not 
apply to the final rule published under paragraph 
(1). 
(b) LIMITATION ON ADVISORY OPINIONS.—As of the 
date of enactment of this Act, the following documents 
issued by the Food and Drug Administration shall not con-
stitute advisory opinions under section 10.85(d)(1) of title 
21, Code of Federal Regulations, except as they apply to 
tobacco products, and shall not be cited by the Secretary 
of Health and Human Services or the Food and Drug Ad-
ministration as binding precedent: 
(1) The preamble to the proposed rule in the doc-
ument titled ‘‘Regulations Restricting the Sale and 
Distribution of Cigarettes and Smokeless Tobacco 
Products to Protect Children and Adolescents’’ (60 
Fed. Reg. 41314–41372 (August 11, 1995)). 
(2) The document titled ‘‘Nicotine in Cigarettes 
and Smokeless Tobacco Products is a Drug and These 
Products Are Nicotine Delivery Devices Under the 
Federal Food, Drug, and Cosmetic Act’’ (60 Fed. Reg. 
41453–41787 (August 11, 1995)). 
(3) The preamble to the final rule in the docu-
ment titled ‘‘Regulations Restricting the Sale and 
Distribution of Cigarettes and Smokeless Tobacco to
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† HR 1256 EAS 
Protect Children and Adolescents’’ (61 Fed. Reg. 
44396–44615 (August 28, 1996)). 
(4) The document titled ‘‘Nicotine in Cigarettes 
and Smokeless Tobacco is a Drug and These Products 
are Nicotine Delivery Devices Under the Federal 
Food, Drug, and Cosmetic Act; Jurisdictional Deter-
mination’’ (61 Fed. Reg. 44619–45318 (August 28, 
1996)). 
SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN-
ERAL PROVISIONS. 
(a) AMENDMENT OF FEDERAL FOOD, DRUG, AND COS-
METIC ACT.—Except as otherwise expressly provided, when-
ever in this section an amendment is expressed in terms 
of an amendment to, or repeal of, a section or other provi-
sion, the reference is to a section or other provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.). 
(b) SECTION 301.—Section 301 (21 U.S.C. 331) is 
amended— 
(1) in subsection (a), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’; 
(2) in subsection (b), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’; 
(3) in subsection (c), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’;
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† HR 1256 EAS 
(4) in subsection (e)— 
(A) by striking the period after ‘‘572(i)’’; 
and 
(B) by striking ‘‘or 761 or the refusal to 
permit access to’’ and inserting ‘‘761, 909, or 
920 or the refusal to permit access to’’; 
(5) in subsection (g), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’; 
(6) in subsection (h), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’; 
(7) in subsection (j)— 
(A) by striking the period after ‘‘573’’; and 
(B) by striking ‘‘708, or 721’’ and inserting 
‘‘708, 721, 904, 905, 906, 907, 908, 909, or 
920(b)’’; 
(8) in subsection (k), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’; 
(9) by striking subsection (p) and inserting the 
following: 
‘‘(p) The failure to register in accordance with section 
510 or 905, the failure to provide any information required 
by section 510(j), 510(k), 905(i), or 905(j), or the failure 
to provide a notice required by section 510(j)(2) or 
905(i)(3).’’;
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(10) by striking subsection (q)(1) and inserting 
the following: 
‘‘(q)(1) The failure or refusal— 
‘‘(A) to comply with any requirement prescribed 
under section 518, 520(g), 903(b), 907, 908, or 915; 
‘‘(B) to furnish any notification or other mate-
rial or information required by or under section 519, 
520(g), 904, 909, or 920; or 
‘‘(C) to comply with a requirement under section 
522 or 913.’’; 
(11) in subsection (q)(2), by striking ‘‘device,’’ 
and inserting ‘‘device or tobacco product,’’; 
(12) in subsection (r), by inserting ‘‘or tobacco 
product’’ after the term ‘‘device’’ each time that such 
term appears; and 
(13) by adding at the end the following: 
‘‘(oo) The sale of tobacco products in violation of a 
no-tobacco-sale order issued under section 303(f). 
‘‘(pp) The introduction or delivery for introduction 
into interstate commerce of a tobacco product in violation 
of section 911. 
‘‘(qq)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, 
stamp (including tax stamp), tag, label, or other identifica-
tion device upon any tobacco product or container or label-
156 
† HR 1256 EAS 
ing thereof so as to render such tobacco product a counterfeit 
tobacco product. 
‘‘(2) Making, selling, disposing of, or keeping in posses-
sion, control, or custody, or concealing any punch, die, 
plate, stone, or other item that is designed to print, imprint, 
or reproduce the trademark, trade name, or other identi-
fying mark, imprint, or device of another or any likeness 
of any of the foregoing upon any tobacco product or con-
tainer or labeling thereof so as to render such tobacco prod-
uct a counterfeit tobacco product. 
‘‘(3) The doing of any act that causes a tobacco prod-
uct to be a counterfeit tobacco product, or the sale or dis-
pensing, or the holding for sale or dispensing, of a counter-
feit tobacco product. 
‘‘(rr) The charitable distribution of tobacco products. 
‘‘(ss) The failure of a manufacturer or distributor to 
notify the Attorney General and the Secretary of the Treas-
ury of their knowledge of tobacco products used in illicit 
trade. 
‘‘(tt) Making any express or implied statement or rep-
resentation directed to consumers with respect to a tobacco 
product, in a label or labeling or through the media or ad-
vertising, that either conveys, or misleads or would mislead 
consumers into believing, that—
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‘‘(1) the product is approved by the Food and 
Drug Administration; 
‘‘(2) the Food and Drug Administration deems 
the product to be safe for use by consumers; 
‘‘(3) the product is endorsed by the Food and 
Drug Administration for use by consumers; or 
‘‘(4) the product is safe or less harmful by virtue 
of— 
‘‘(A) its regulation or inspection by the 
Food and Drug Administration; or 
‘‘(B) its compliance with regulatory re-
quirements set by the Food and Drug Adminis-
tration; 
including any such statement or representation ren-
dering the product misbranded under section 903.’’. 
(c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f)) 
is amended— 
(1) in paragraph (5)— 
(A) by striking ‘‘paragraph (1), (2), (3), or 
(4)’’ each place such appears and inserting 
‘‘paragraph (1), (2), (3), (4), or (9)’’; 
(B) in subparagraph (A)— 
(i) by striking ‘‘assessed’’ the first time 
it appears and inserting ‘‘assessed, or a no- 
tobacco-sale order may be imposed,’’; and
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(ii) by striking ‘‘penalty’’ the second 
time it appears and inserting ‘‘penalty, or 
upon whom a no-tobacco-sale order is to be 
imposed,’’; 
(C) in subparagraph (B)— 
(i) by inserting after ‘‘penalty,’’ the 
following: ‘‘or the period to be covered by a 
no-tobacco-sale order,’’; and 
(ii) by adding at the end the following: 
‘‘A no-tobacco-sale order permanently pro-
hibiting an individual retail outlet from 
selling tobacco products shall include provi-
sions that allow the outlet, after a specified 
period of time, to request that the Secretary 
compromise, modify, or terminate the 
order.’’; and 
(D) by adding at the end the following: 
‘‘(D) The Secretary may compromise, modify, or ter-
minate, with or without conditions, any no-tobacco-sale 
order.’’; 
(2) in paragraph (6)— 
(A) by inserting ‘‘or the imposition of a no- 
tobacco-sale order’’ after the term ‘‘penalty’’ each 
place such term appears; and
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(B) by striking ‘‘issued.’’ and inserting 
‘‘issued, or on which the no-tobacco-sale order 
was imposed, as the case may be.’’; and 
(3) by adding at the end the following: 
‘‘(8) If the Secretary finds that a person has committed 
repeated violations of restrictions promulgated under sec-
tion 906(d) at a particular retail outlet then the Secretary 
may impose a no-tobacco-sale order on that person prohib-
iting the sale of tobacco products in that outlet. A no-to-
bacco-sale order may be imposed with a civil penalty under 
paragraph (1). Prior to the entry of a no-sale order under 
this paragraph, a person shall be entitled to a hearing pur-
suant to the procedures established through regulations of 
the Food and Drug Administration for assessing civil 
money penalties, including at a retailer’s request a hearing 
by telephone, or at the nearest regional or field office of the 
Food and Drug Administration, or at a Federal, State, or 
county facility within 100 miles from the location of the 
retail outlet, if such a facility is available. 
‘‘(9) CIVIL MONETARY PENALTIES FOR VIOLATION OF 
TOBACCO PRODUCT REQUIREMENTS.— 
‘‘(A) IN
GENERAL.—Subject to subparagraph 
(B), any person who violates a requirement of this 
Act which relates to tobacco products shall be liable 
to the United States for a civil penalty in an amount
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not to exceed $15,000 for each such violation, and not 
to exceed $1,000,000 for all such violations adju-
dicated in a single proceeding. 
‘‘(B) ENHANCED PENALTIES.— 
‘‘(i) Any person who intentionally violates 
a requirement of section 902(5), 902(6), 904, 
908(c), or 911(a), shall be subject to a civil mon-
etary penalty of— 
‘‘(I) not to exceed $250,000 per viola-
tion, and not to exceed $1,000,000 for all 
such violations adjudicated in a single pro-
ceeding; or 
‘‘(II) in the case of a violation that 
continues after the Secretary provides writ-
ten notice to such person, $250,000 for the 
first 30-day period (or any portion thereof) 
that the person continues to be in violation, 
and such amount shall double for every 30- 
day period thereafter that the violation con-
tinues, not to exceed $1,000,000 for any 30- 
day period, and not to exceed $10,000,000 
for all such violations adjudicated in a sin-
gle proceeding.
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‘‘(ii) Any person who violates a requirement 
of section 911(g)(2)(C)(ii) or 911(i)(1), shall be 
subject to a civil monetary penalty of— 
‘‘(I) not to exceed $250,000 per viola-
tion, and not to exceed $1,000,000 for all 
such violations adjudicated in a single pro-
ceeding; or 
‘‘(II) in the case of a violation that 
continues after the Secretary provides writ-
ten notice to such person, $250,000 for the 
first 30-day period (or any portion thereof) 
that the person continues to be in violation, 
and such amount shall double for every 30- 
day period thereafter that the violation con-
tinues, not to exceed $1,000,000 for any 30- 
day period, and not to exceed $10,000,000 
for all such violations adjudicated in a sin-
gle proceeding. 
‘‘(iii) In determining the amount of a civil 
penalty under clause (i)(II) or (ii)(II), the Sec-
retary shall take into consideration whether the 
person is making efforts toward correcting the 
violation of the requirements of the section for 
which such person is subject to such civil pen-
alty.’’.
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(d) SECTION 304.—Section 304 (21 U.S.C. 334) is 
amended— 
(1) in subsection (a)(2)— 
(A) by striking ‘‘and’’ before ‘‘(D)’’; and 
(B) by striking ‘‘device.’’ and inserting the 
following: ‘‘device, and (E) Any adulterated or 
misbranded tobacco product.’’; 
(2) in subsection (d)(1), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(3) in subsection (g)(1), by inserting ‘‘or tobacco 
product’’ after the term ‘‘device’’ each place such term 
appears; and 
(4) in subsection (g)(2)(A), by inserting ‘‘or to-
bacco product’’ after ‘‘device’’. 
(e) SECTION
505.—Section 505(n)(2) (21 U.S.C. 
355(n)(2)) is amended by striking ‘‘section 904’’ and insert-
ing ‘‘section 1004’’. 
(f) SECTION 523.—Section 523(b)(2)(D) (21 U.S.C. 
360m(b)(2)(D)) is amended by striking ‘‘section 903(g)’’ 
and inserting ‘‘section 1003(g)’’. 
(g) 
SECTION
702.—Section 
702(a)(1) 
(U.S.C. 
372(a)(1)) is amended— 
(1) 
by 
striking 
‘‘(a)(1)’’ 
and 
inserting 
‘‘(a)(1)(A)’’; and 
(2) by adding at the end the following:
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‘‘(B)(i) For a tobacco product, to the extent feasible, 
the Secretary shall contract with the States in accordance 
with this paragraph to carry out inspections of retailers 
within that State in connection with the enforcement of this 
Act. 
‘‘(ii) The Secretary shall not enter into any contract 
under clause (i) with the government of any of the several 
States to exercise enforcement authority under this Act on 
Indian country without the express written consent of the 
Indian tribe involved.’’. 
(h) SECTION 703.—Section 703 (21 U.S.C. 373) is 
amended— 
(1) by inserting ‘‘tobacco product,’’ after the 
term ‘‘device,’’ each place such term appears; and 
(2) by inserting ‘‘tobacco products,’’ after the 
term ‘‘devices,’’ each place such term appears. 
(i) SECTION 704.—Section 704 (21 U.S.C. 374) is 
amended— 
(1) in subsection (a)(1)— 
(A) by striking ‘‘devices, or cosmetics’’ each 
place it appears and inserting ‘‘devices, tobacco 
products, or cosmetics’’; 
(B) by striking ‘‘or restricted devices’’ each 
place it appears and inserting ‘‘restricted de-
vices, or tobacco products’’; and
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(C) by striking ‘‘and devices and subject to’’ 
and all that follows through ‘‘other drugs or de-
vices’’ and inserting ‘‘devices, and tobacco prod-
ucts and subject to reporting and inspection 
under regulations lawfully issued pursuant to 
section 505 (i) or (k), section 519, section 520(g), 
or chapter IX and data relating to other drugs, 
devices, or tobacco products’’; 
(2) in subsection (b), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’; and 
(3) in subsection (g)(13), by striking ‘‘section 
903(g)’’ and inserting ‘‘section 1003(g)’’. 
(j) SECTION 705.—Section 705(b) (21 U.S.C. 375(b)) 
is amended by inserting ‘‘tobacco products,’’ after ‘‘de-
vices,’’. 
(k) SECTION 709.—Section 709 (21 U.S.C. 379a) is 
amended by inserting ‘‘tobacco product,’’ after ‘‘device,’’. 
(l) SECTION 801.—Section 801 (21 U.S.C. 381) is 
amended— 
(1) in subsection (a)— 
(A) by inserting ‘‘tobacco products,’’ after 
the term ‘‘devices,’’; 
(B) by inserting ‘‘or section 905(h)’’ after 
‘‘section 510’’; and
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(C) by striking the term ‘‘drugs or devices’’ 
each time such term appears and inserting 
‘‘drugs, devices, or tobacco products’’; 
(2) in subsection (e)(1)— 
(A) by inserting ‘‘tobacco product’’ after 
‘‘drug, device,’’; and 
(B) by inserting ‘‘, and a tobacco product 
intended for export shall not be deemed to be in 
violation of section 906(e), 907, 911, or 920(a),’’ 
before ‘‘if it—’’; and 
(3) by adding at the end the following: 
‘‘(p)(1) Not later than 36 months after the date of en-
actment of the Family Smoking Prevention and Tobacco 
Control Act, and annually thereafter, the Secretary shall 
submit to the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives, a report regard-
ing— 
‘‘(A) the nature, extent, and destination of 
United States tobacco product exports that do not 
conform to tobacco product standards established pur-
suant to this Act; 
‘‘(B) the public health implications of such ex-
ports, including any evidence of a negative public 
health impact; and
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‘‘(C) recommendations or assessments of policy 
alternatives available to Congress and the executive 
branch to reduce any negative public health impact 
caused by such exports. 
‘‘(2) The Secretary is authorized to establish appro-
priate information disclosure requirements to carry out this 
subsection.’’. 
(m) SECTION 1003.—Section 1003(d)(2)(C) (as redes-
ignated by section 101(b)) is amended— 
(1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 
(2) inserting ‘‘, and tobacco products’’ after ‘‘de-
vices’’. 
(n) SECTION 1009.—Section 1009(b) (as redesignated 
by section 101(b)) is amended by striking ‘‘section 908’’ and 
inserting ‘‘section 1008’’. 
(o) SECTION 409 OF THE FEDERAL MEAT INSPECTION 
ACT.—Section 409(a) of the Federal Meat Inspection Act 
(21 U.S.C. 679(a)) is amended by striking ‘‘section 902(b)’’ 
and inserting ‘‘section 1002(b)’’. 
(p) RULE OF CONSTRUCTION.—Nothing in this section 
is intended or shall be construed to expand, contract, or 
otherwise modify or amend the existing limitations on State 
government authority over tribal restricted fee or trust 
lands. 
(q) GUIDANCE AND EFFECTIVE DATES.—
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(1) IN GENERAL.—The Secretary of Health and 
Human Services shall issue guidance— 
(A) defining the term ‘‘repeated violation’’, 
as used in section 303(f)(8) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) as 
amended by subsection (c), as including at least 
5 violations of particular requirements over a 
36-month period at a particular retail outlet 
that constitute a repeated violation and pro-
viding for civil penalties in accordance with 
paragraph (2); 
(B) providing for timely and effective notice 
by certified or registered mail or personal deliv-
ery to the retailer of each alleged violation at a 
particular retail outlet prior to conducting a fol-
lowup compliance check, such notice to be sent to 
the location specified on the retailer’s registra-
tion or to the retailer’s registered agent if the re-
tailer has provider such agent information to the 
Food and Drug Administration prior to the vio-
lation; 
(C) providing for a hearing pursuant to the 
procedures established through regulations of the 
Food and Drug Administration for assessing 
civil money penalties, including at a retailer’s
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request a hearing by telephone or at the nearest 
regional or field office of the Food and Drug Ad-
ministration, and providing for an expedited 
procedure for the administrative appeal of an al-
leged violation; 
(D) providing that a person may not be 
charged with a violation at a particular retail 
outlet unless the Secretary has provided notice to 
the retailer of all previous violations at that out-
let; 
(E) establishing that civil money penalties 
for multiple violations shall increase from one 
violation to the next violation pursuant to para-
graph (2) within the time periods provided for 
in such paragraph; 
(F) providing that good faith reliance on 
the presentation of a false government-issued 
photographic identification that contains a date 
of birth does not constitute a violation of any 
minimum age requirement for the sale of tobacco 
products if the retailer has taken effective steps 
to prevent such violations, including— 
(i) adopting and enforcing a written 
policy against sales to minors;
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(ii) informing its employees of all ap-
plicable laws; 
(iii) establishing disciplinary sanctions 
for employee noncompliance; and 
(iv) requiring its employees to verify 
age by way of photographic identification 
or electronic scanning device; and 
(G) providing for the Secretary, in deter-
mining whether to impose a no-tobacco-sale order 
and in determining whether to compromise, 
modify, or terminate such an order, to consider 
whether the retailer has taken effective steps to 
prevent violations of the minimum age require-
ments for the sale of tobacco products, including 
the steps listed in subparagraph (F). 
(2) PENALTIES FOR VIOLATIONS.— 
(A) IN GENERAL.—The amount of the civil 
penalty to be applied for violations of restric-
tions promulgated under section 906(d), as de-
scribed in paragraph (1), shall be as follows: 
(i) With respect to a retailer with an 
approved training program, the amount of 
the civil penalty shall not exceed—
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(I) in the case of the first viola-
tion, $0.00 together with the issuance 
of a warning letter to the retailer; 
(II) in the case of a second viola-
tion within a 12-month period, $250; 
(III) in the case of a third viola-
tion within a 24-month period, $500; 
(IV) in the case of a fourth viola-
tion within a 24-month period, $2,000; 
(V) in the case of a fifth violation 
within a 36-month period, $5,000; and 
(VI) in the case of a sixth or sub-
sequent violation within a 48-month 
period, $10,000 as determined by the 
Secretary on a case-by-case basis. 
(ii) With respect to a retailer that does 
not have an approved training program, the 
amount of the civil penalty shall not ex-
ceed— 
(I) in the case of the first viola-
tion, $250; 
(II) in the case of a second viola-
tion within a 12-month period, $500; 
(III) in the case of a third viola-
tion within a 24-month period, $1,000;
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(IV) in the case of a fourth viola-
tion within a 24-month period, $2,000; 
(V) in the case of a fifth violation 
within a 36-month period, $5,000; and 
(VI) in the case of a sixth or sub-
sequent violation within a 48-month 
period, $10,000 as determined by the 
Secretary on a case-by-case basis. 
(B) TRAINING PROGRAM.—For purposes of 
subparagraph (A), the term ‘‘approved training 
program’’ means a training program that com-
plies with standards developed by the Food and 
Drug Administration for such programs. 
(C) 
CONSIDERATION
OF
STATE
PEN-
ALTIES.—The Secretary shall coordinate with the 
States in enforcing the provisions of this Act 
and, for purposes of mitigating a civil penalty 
to be applied for a violation by a retailer of any 
restriction promulgated under section 906(d), 
shall consider the amount of any penalties paid 
by the retailer to a State for the same violation. 
(3) GENERAL
EFFECTIVE
DATE.—The amend-
ments made by paragraphs (2), (3), and (4) of sub-
section (c) shall take effect upon the issuance of guid-
ance described in paragraph (1) of this subsection.
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(4) SPECIAL EFFECTIVE DATE.—The amendment 
made by subsection (c)(1) shall take effect on the date 
of enactment of this Act. 
(5) PACKAGE LABEL REQUIREMENTS.—The pack-
age label requirements of paragraphs (3) and (4) of 
section 903(a) of the Federal Food, Drug, and Cos-
metic Act (as amended by this division) shall take ef-
fect on the date that is 12 months after the date of 
enactment of this Act. The package label requirements 
of paragraph (2) of such section 903(a) for cigarettes 
shall take effect on the date that is 15 months after 
the issuance of the regulations required by section 
4(d) of the Federal Cigarette Labeling and Adver-
tising Act (15 U.S.C. 1333), as amended by section 
201 of this division. The package label requirements 
of paragraph (2) of such section 903(a) for tobacco 
products other than cigarettes shall take effect on the 
date that is 12 months after the date of enactment of 
this Act. The effective date shall be with respect to the 
date of manufacture, provided that, in any case, be-
ginning 30 days after such effective date, a manufac-
turer shall not introduce into the domestic commerce 
of the United States any product, irrespective of the 
date of manufacture, that is not in conformance with
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section 903(a) (2), (3), and (4) and section 920(a) of 
the Federal Food, Drug, and Cosmetic Act. 
(6) ADVERTISING
REQUIREMENTS.—The adver-
tising requirements of section 903(a)(8) of the Federal 
Food, Drug, and Cosmetic Act (as amended by this 
division) shall take effect on the date that is 12 
months after the date of enactment of this Act. 
SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PUR-
CHASE TOBACCO PRODUCTS. 
The Secretary of Health and Human Services shall— 
(1) convene an expert panel to conduct a study 
on the public health implications of raising the min-
imum age to purchase tobacco products; and 
(2) not later than 5 years after the date of enact-
ment of this Act, submit a report to the Congress on 
the results of such study. 
SEC. 105. ENFORCEMENT ACTION PLAN FOR ADVERTISING 
AND PROMOTION RESTRICTIONS. 
(a) ACTION PLAN.— 
(1) DEVELOPMENT.—Not later than 6 months 
after the date of enactment of this Act, the Secretary 
of Health and Human Services (in this section re-
ferred to as the ‘‘Secretary’’) shall develop and pub-
lish an action plan to enforce restrictions adopted 
pursuant to section 906 of the Federal Food, Drug,
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† HR 1256 EAS 
and Cosmetic Act, as added by section 101(b) of this 
division, or pursuant to section 102(a) of this divi-
sion, on promotion and advertising of menthol and 
other cigarettes to youth. 
(2) CONSULTATION.—The action plan required 
by paragraph (1) shall be developed in consultation 
with public health organizations and other stake-
holders with demonstrated expertise and experience in 
serving minority communities. 
(3) PRIORITY.—The action plan required by 
paragraph (1) shall include provisions designed to en-
sure enforcement of the restrictions described in para-
graph (1) in minority communities. 
(b) STATE AND LOCAL ACTIVITIES.— 
(1) INFORMATION
ON
AUTHORITY.—Not later 
than 3 months after the date of enactment of this Act, 
the Secretary shall inform State, local, and tribal 
governments of the authority provided to such entities 
under section 5(c) of the Federal Cigarette Labeling 
and Advertising Act, as added by section 203 of this 
division, or preserved by such entities under section 
916 of the Federal Food, Drug, and Cosmetic Act, as 
added by section 101(b) of this division. 
(2) COMMUNITY ASSISTANCE.—At the request of 
communities seeking assistance to prevent underage
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tobacco use, the Secretary shall provide such assist-
ance, including assistance with strategies to address 
the prevention of underage tobacco use in commu-
nities with a disproportionate use of menthol ciga-
rettes by minors. 
SEC. 106. STUDIES OF PROGRESS AND EFFECTIVENESS. 
(a) FDA REPORT.—Not later than 3 years after the 
date of enactment of this Act, and not less than every 2 
years thereafter, the Secretary of Health and Human Serv-
ices shall submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives, a 
report concerning— 
(1) the progress of the Food and Drug Adminis-
tration in implementing this division, including 
major accomplishments, objective measurements of 
progress, and the identification of any areas that 
have not been fully implemented; 
(2) impediments identified by the Food and 
Drug Administration to progress in implementing 
this division and to meeting statutory timeframes; 
(3) data on the number of new product applica-
tions received under section 910 of the Federal Food, 
Drug, and Cosmetic Act and modified risk product 
applications received under section 911 of such Act,
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in an alternating fashion under the plan submitted 
under subsection (c). 
‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU-
TION.—The provisions of this subsection do not apply 
to a tobacco product manufacturer or distributor of 
cigarettes which does not manufacture, package, or 
import cigarettes for sale or distribution within the 
United States. 
‘‘(4) APPLICABILITY TO RETAILERS.—A retailer 
of cigarettes shall not be in violation of this subsection 
for packaging that— 
‘‘(A) contains a warning label; 
‘‘(B) is supplied to the retailer by a license- 
or permit-holding tobacco product manufacturer, 
importer, or distributor; and 
‘‘(C) is not altered by the retailer in a way 
that is material to the requirements of this sub-
section. 
‘‘(b) ADVERTISING REQUIREMENTS.— 
‘‘(1) IN GENERAL.—It shall be unlawful for any 
tobacco product manufacturer, importer, distributor, 
or retailer of cigarettes to advertise or cause to be ad-
vertised within the United States any cigarette unless 
its advertising bears, in accordance with the require-
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ments of this section, one of the labels specified in 
subsection (a). 
‘‘(2) TYPOGRAPHY, ETC.—Each label statement 
required by subsection (a) in cigarette advertising 
shall comply with the standards set forth in this 
paragraph. For press and poster advertisements, each 
such statement and (where applicable) any required 
statement relating to tar, nicotine, or other con-
stituent (including a smoke constituent) yield shall 
comprise at least 20 percent of the area of the adver-
tisement and shall appear in a conspicuous and 
prominent format and location at the top of each ad-
vertisement within the trim area. The Secretary may 
revise the required type sizes in such area in such 
manner as the Secretary determines appropriate. The 
word ‘WARNING’ shall appear in capital letters, and 
each label statement shall appear in conspicuous and 
legible type. The text of the label statement shall be 
black if the background is white and white if the 
background is black, under the plan submitted under 
subsection (c). The label statements shall be enclosed 
by a rectangular border that is the same color as the 
letters of the statements and that is the width of the 
first downstroke of the capital ‘W’ of the word 
‘WARNING’ in the label statements. The text of such
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label statements shall be in a typeface pro rata to the 
following requirements: 45-point type for a whole- 
page broadsheet newspaper advertisement; 39-point 
type for a half-page broadsheet newspaper advertise-
ment; 39-point type for a whole-page tabloid news-
paper advertisement; 27-point type for a half-page 
tabloid newspaper advertisement; 31.5-point type for 
a double page spread magazine or whole-page maga-
zine advertisement; 22.5-point type for a 28 centi-
meter by 3 column advertisement; and 15-point type 
for a 20 centimeter by 2 column advertisement. The 
label statements shall be in English, except that— 
‘‘(A) in the case of an advertisement that 
appears in a newspaper, magazine, periodical, 
or other publication that is not in English, the 
statements shall appear in the predominant lan-
guage of the publication; and 
‘‘(B) in the case of any other advertisement 
that is not in English, the statements shall ap-
pear in the same language as that principally 
used in the advertisement. 
‘‘(3) 
MATCHBOOKS.—Notwithstanding 
para-
graph (2), for matchbooks (defined as containing not 
more than 20 matches) customarily given away with 
the purchase of tobacco products, each label statement
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required by subsection (a) may be printed on the in-
side cover of the matchbook. 
‘‘(4) ADJUSTMENT
BY
SECRETARY.—The Sec-
retary may, through a rulemaking under section 553 
of title 5, United States Code, adjust the format and 
type sizes for the label statements required by this sec-
tion; the text, format, and type sizes of any required 
tar, nicotine yield, or other constituent (including 
smoke constituent) disclosures; or the text, format, 
and type sizes for any other disclosures required 
under the Federal Food, Drug, and Cosmetic Act. The 
text of any such label statements or disclosures shall 
be required to appear only within the 20 percent area 
of cigarette advertisements provided by paragraph 
(2). The Secretary shall promulgate regulations which 
provide for adjustments in the format and type sizes 
of any text required to appear in such area to ensure 
that the total text required to appear by law will fit 
within such area. 
‘‘(c) MARKETING REQUIREMENTS.— 
‘‘(1) RANDOM
DISPLAY.—The label statements 
specified in subsection (a)(1) shall be randomly dis-
played in each 12-month period, in as equal a num-
ber of times as is possible on each brand of the prod-
uct and be randomly distributed in all areas of the
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† HR 1256 EAS 
United States in which the product is marketed in ac-
cordance with a plan submitted by the tobacco prod-
uct manufacturer, importer, distributor, or retailer 
and approved by the Secretary. 
‘‘(2) ROTATION.—The label statements specified 
in subsection (a)(1) shall be rotated quarterly in al-
ternating sequence in advertisements for each brand 
of cigarettes in accordance with a plan submitted by 
the tobacco product manufacturer, importer, dis-
tributor, or retailer to, and approved by, the Sec-
retary. 
‘‘(3) REVIEW.—The Secretary shall review each 
plan submitted under paragraph (2) and approve it 
if the plan— 
‘‘(A) will provide for the equal distribution 
and display on packaging and the rotation re-
quired in advertising under this subsection; and 
‘‘(B) assures that all of the labels required 
under this section will be displayed by the to-
bacco product manufacturer, importer, dis-
tributor, or retailer at the same time. 
‘‘(4) APPLICABILITY TO RETAILERS.—This sub-
section and subsection (b) apply to a retailer only if 
that retailer is responsible for or directs the label 
statements required under this section except that this
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paragraph shall not relieve a retailer of liability if 
the retailer displays, in a location open to the public, 
an advertisement that does not contain a warning 
label or has been altered by the retailer in a way that 
is material to the requirements of this subsection and 
subsection (b). 
‘‘(d) GRAPHIC LABEL STATEMENTS.—Not later than 
24 months after the date of enactment of the Family Smok-
ing Prevention and Tobacco Control Act, the Secretary shall 
issue regulations that require color graphics depicting the 
negative health consequences of smoking to accompany the 
label statements specified in subsection (a)(1). The Sec-
retary may adjust the type size, text and format of the label 
statements specified in subsections (a)(2) and (b)(2) as the 
Secretary determines appropriate so that both the graphics 
and the accompanying label statements are clear, con-
spicuous, legible and appear within the specified area.’’. 
(b) EFFECTIVE DATE.—The amendment made by sub-
section (a) shall take effect 15 months after the issuance 
of the regulations required by subsection (a). Such effective 
date shall be with respect to the date of manufacture, pro-
vided that, in any case, beginning 30 days after such effec-
tive date, a manufacturer shall not introduce into the do-
mestic commerce of the United States any product, irrespec-
tive of the date of manufacture, that is not in conformance