(iii) relating to any other requirement 
under subparagraph (B); and 
(B) may, where appropriate for the protec-
tion of the public health, include— 
(i) provisions respecting the construc-
tion, components, ingredients, additives, 
constituents, including smoke constituents, 
and properties of the smoking article; 
(ii) provisions for the testing (on a 
sample basis or, if necessary, on an indi-
vidual basis) of the smoking article; 
(iii) provisions for the measurement of 
the smoking article characteristics of the 
smoking article; and 
(iv) provisions requiring that the re-
sults of each or of certain of the tests of 
the smoking article required to be made 
under clause (ii) show that the smoking ar-
ticle is in conformity with the portions of 
the standard for which the test or tests 
were required. 
(4) PERIODIC REEVALUATION OF SMOKING AR-
TICLE STANDARDS.—The Administrator may provide 
for periodic evaluation of smoking article standards 
established under this section to determine whether 
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such standards should be changed to reflect new 
medical, scientific, or other technological data. 
(5) CIGARETTE ‘‘TAR’’ LIMITS.— 
(A) NO INCREASE IN ‘‘TAR’’ YIELDS.—No 
cigarette manufacturer shall distribute for sale 
domestically a brand style of cigarettes that 
generates a ‘‘tar’’ yield greater than the ‘‘tar’’ 
yield of that brand style of cigarettes on the 
date of introduction of this Act, as determined 
by the ISO smoking regimen and its associated 
tolerances. The ‘‘tar’’ tolerances for cigarettes 
with ISO ‘‘tar’’ yields in the range of 1 to 20 
milligrams per cigarette, based on variations 
arising from sampling procedure, test method, 
and sampled product, itself, are the greater of 
plus or minus— 
(i) 15 percent; or 
(ii) 1 milligram per cigarette. 
(B) LIMIT
ON
NEW
CIGARETTES.—After 
the effective date of this Act, no cigarette man-
ufacturer shall manufacture for commercial dis-
tribution domestically a brand style of ciga-
rettes that both— 
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(i) was not in commercial distribution 
domestically on the effective date of this 
Act, and 
(ii) generates a ‘‘tar’’ yield of greater 
than 20 milligrams per cigarette as deter-
mined by the ISO smoking regimen and its 
associated tolerances. 
(C) LIMIT
ON
ALL
CIGARETTES.—After 
December 31, 2010, no cigarette manufacturer 
shall manufacture for commercial distribution 
domestically a brand style of cigarettes that 
generates a ‘‘tar’’ yield greater than 20 milli-
grams per cigarette as determined by the ISO 
smoking regimen and its associated tolerances. 
(D) REVIEW
BY
ADMINISTRATOR.—After 
the effective date of this Act, the Administrator 
shall evaluate the available scientific evidence 
addressing the potential relationship between 
historical ‘‘tar’’ yield values and risk of harm to 
smokers. If upon a review of that evidence, and 
after consultation with technical experts of the 
Tobacco Harm Reduction Center and the Cen-
ters for Disease Control and Prevention and no-
tice and an opportunity for public comment, the 
Administrator determines, that a reduction in 
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‘‘tar’’ yield may reasonably be expected to pro-
vide a meaningful reduction of the risk or risks 
of harm to smokers, the Administrator shall 
issue an order that— 
(i) provides that no cigarette manu-
facturer shall manufacture for commercial 
distribution domestically a cigarette that 
generates a ‘‘tar’’ yield that exceeds 14 
milligrams as determined by the ISO 
smoking regimen and its associated toler-
ances; and 
(ii) provides a reasonable time for 
manufacturers to come into compliance 
with such prohibition. 
(6) INVOLVEMENT
OF
OTHER
AGENCIES; IN-
FORMED
PERSONS.—In carrying out duties under 
this section, the Administrator shall endeavor to— 
(A) use personnel, facilities, and other 
technical support available in other Federal 
agencies; 
(B) consult with other Federal agencies 
concerned with standard setting and other na-
tionally or internationally recognized standard- 
setting entities; and 
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(C) 
invite 
appropriate 
participation, 
through joint or other conferences, workshops, 
or other means, by informed persons represent-
ative of scientific, professional, industry, agri-
cultural, or consumer organizations who in the 
Administrator’s judgment can make a signifi-
cant contribution. 
(b) CONSIDERATIONS BY ADMINISTRATOR.— 
(1) TECHNICAL ACHIEVABILITY.—The Adminis-
trator shall consider information submitted in con-
nection with a proposed standard regarding the tech-
nical achievability of compliance with such standard. 
(2) OTHER
CONSIDERATIONS.—The Adminis-
trator shall consider all other information submitted 
in connection with a proposed standard, such as the 
creation of a significant demand for contraband or 
other tobacco products that do not meet the require-
ments of this Act and the significance of such de-
mand. 
(c) PROPOSED STANDARDS.— 
(1) IN
GENERAL.—The Administrator shall 
publish in the Federal Register a notice of proposed 
rulemaking for the establishment, amendment, or 
revocation of any smoking article standard. 
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(2) REQUIREMENTS OF NOTICE.—A notice of 
proposed rulemaking for the establishment or 
amendment of a smoking article standard shall— 
(A) set forth a finding with supporting jus-
tification that the smoking article standard is 
appropriate for the protection of the public 
health; 
(B) invite interested persons to submit a 
draft or proposed smoking article standard for 
consideration by the Administrator; 
(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 smoking article standard. 
(3) FINDING.—A notice of proposed rulemaking 
for the revocation of a smoking article standard 
shall set forth a finding with supporting justification 
that the smoking article standard is no longer ap-
propriate for the protection of the public health. 
(4) COMMENT.—The Administrator shall pro-
vide for a comment period of not less than 90 days. 
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to minimize, consistent with the public health, eco-
nomic loss to, and disruption or dislocation of, do-
mestic and international trade. In establishing such 
effective date or dates, the Administrator shall con-
sider information submitted in connection with a 
proposed product standard by interested parties, in-
cluding manufacturers and tobacco growers, regard-
ing the technical achievability of compliance with the 
standard, and including information concerning the 
existence of patents that make it impossible to com-
ply in the timeframe envisioned in the proposed 
standard. 
(3) LIMITATION
ON
POWER
GRANTED.—Be-
cause of the importance of a decision of the Admin-
istrator to issue a regulation— 
(A) banning cigarettes, smokeless smoking 
articles, little cigars, cigars other than little ci-
gars, pipe tobacco, or roll-your-own smoking ar-
ticles; 
(B) requiring the reduction of ‘‘tar’’ or nic-
otine yields of a smoking article to zero; 
(C) prohibiting the sale of any smoking ar-
ticle in face-to-face transactions by a specific 
category of retail outlets; 
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(D) establishing a minimum age of sale of 
smoking articles to any person older than 18 
years of age; or 
(E) requiring that the sale or distribution 
of a smoking article be limited to the written or 
oral authorization of a practitioner licensed by 
law to prescribe medical products, 
the Administrator is prohibited from taking such ac-
tions under this Act. 
(4) MATCHBOOKS.—For purposes of any regu-
lations issued by the Administrator under this Act, 
matchbooks of conventional size containing not more 
than 20 paper matches, and which are customarily 
given away for free with the purchase of smoking ar-
ticles, shall be considered as adult-written publica-
tions which shall be permitted to contain advertising. 
(5) AMENDMENT; REVOCATION.— 
(A) 
AUTHORITY.—The 
Administrator, 
upon the Administrator’s own initiative or upon 
petition of an interested person, may by a regu-
lation, promulgated in accordance with the re-
quirements of subsection (c) and paragraph (2), 
amend or revoke a smoking article standard. 
(B) EFFECTIVE
DATE.—The Adminis-
trator may declare a proposed amendment of a 
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smoking article standard to be effective on and 
after its publication in the Federal Register and 
until the effective date of any final action taken 
on such amendment if the Administrator deter-
mines that making it so effective is in the pub-
lic interest. 
(6) REFERRAL TO ADVISORY COMMITTEE.— 
(A) IN
GENERAL.—The Administrator 
shall refer a proposed regulation for the estab-
lishment, amendment, or revocation of a smok-
ing article standard to the Tobacco Products 
Scientific Advisory Committee for a report and 
recommendation with respect to any matter in-
volved in the proposed regulation which requires 
the exercise of scientific judgment. 
(B) INITIATION OF REFERRAL.—The Ad-
ministrator shall make a referral under this 
paragraph— 
(i) on the Administrator’s own initia-
tive; or 
(ii) upon the request of an interested 
person that— 
(I) demonstrates good cause for 
the referral; and 
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(II) is made before the expiration 
of the period for submission of com-
ments on the proposed regulation. 
(C) PROVISION OF DATA.—If a proposed 
regulation is referred under this paragraph to 
the Tobacco Products Scientific Advisory Com-
mittee, the Administrator shall provide the Ad-
visory Committee with the data and information 
on which such proposed regulation is based. 
(D) REPORT
AND
RECOMMENDATION.— 
The Tobacco Products Scientific Advisory Com-
mittee shall, within 90 days after the referral of 
a proposed regulation under this paragraph and 
after independent study of the data and infor-
mation furnished to it by the Administrator and 
other data and information before it, submit to 
the Administrator a report and recommendation 
respecting such regulation, together with all un-
derlying data and information and a statement 
of the reason or basis for the recommendation. 
(E) PUBLIC AVAILABILITY.—The Adminis-
trator shall make a copy of each report and rec-
ommendation under subparagraph (D) publicly 
available. 
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SEC. 112. NOTIFICATION AND OTHER REMEDIES. 
(a) NOTIFICATION.—If the Administrator determines 
that— 
(1) a tobacco product which is introduced or de-
livered for introduction into interstate commerce for 
commercial distribution presents an unreasonable 
risk of substantial harm materially above the risk 
for death and disease of tobacco products currently 
in interstate commerce, to the public health; and 
(2) notification under this subsection is nec-
essary to eliminate the unreasonable risk of such 
harm and no more practicable means is available 
under the provisions of this Act (other than this sec-
tion) to eliminate such risk, 
the Administrator may issue such order as may be nec-
essary to assure that adequate notification is provided in 
an appropriate form, by the persons and means best suited 
under the circumstances involved, to all persons who 
should properly receive such notification in order to elimi-
nate such risk. The Administrator may order notification 
by any appropriate means, including public service an-
nouncements. Before issuing an order under this sub-
section, the Administrator shall consult with the persons 
who are to give notice under the order. 
(b) NO EXEMPTION FROM OTHER LIABILITY.—Com-
pliance with an order issued under this section shall not 
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relieve any person from liability under Federal or State 
law. In awarding damages for economic loss in an action 
brought for the enforcement of any such liability, the value 
to the plaintiff in such action of any remedy provided 
under such order shall be taken into account. 
(c) RECALL AUTHORITY.— 
(1) IN GENERAL.—If the Administrator finds 
that there is a reasonable probability that a tobacco 
product contains a manufacturing or other defect 
not ordinarily contained in tobacco products on the 
market that would cause serious, acute adverse 
health consequences or death, the Administrator 
shall issue an order requiring the appropriate person 
(including the manufacturers, importers, distribu-
tors, or retailers of the tobacco product) to imme-
diately cease distribution of such tobacco product. 
The order shall provide the person subject to the 
order with an opportunity for an informal hearing, 
to be held not later than 10 days after the date of 
the issuance of the order, on the actions required by 
the order and on whether the order should be 
amended to require a recall of such tobacco product. 
If, after providing an opportunity for such a hear-
ing, the Administrator determines that inadequate 
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tailers and other persons who distributed such 
tobacco product. If a significant number of such 
persons cannot be identified, the Administrator 
shall notify such persons under section 705(b). 
(3) REMEDY
NOT
EXCLUSIVE.—The remedy 
provided by this subsection shall be in addition to 
remedies provided by subsection (a). 
SEC. 113. RECORDS AND REPORTS ON TOBACCO PROD-
UCTS. 
Every person who is a tobacco product manufacturer 
or importer of a tobacco product shall establish and main-
tain such records, make such reports, and provide such 
information, as the Administrator may by regulation rea-
sonably require to assure that such tobacco product is not 
adulterated or misbranded. 
SEC. 114. APPLICATION FOR REVIEW OF CERTAIN SMOKING 
ARTICLES. 
(a) IN GENERAL.— 
(1) NEW
SMOKING
ARTICLE
DEFINED.—For 
purposes of this section the term ‘‘new smoking arti-
cle’’ means— 
(A) any smoking article that was not com-
mercially marketed in the United States as of 
the date of enactment of this Act; and 
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(B) any smoking article that incorporates 
a significant modification (including changes in 
design, component, part, or constituent, includ-
ing a smoke constituent, or in the content, de-
livery or form of nicotine, or other additive or 
ingredient) of a smoking article where the 
modified product was commercially marketed in 
the United States after the date of enactment 
of this Act. 
(2) PREMARKET REVIEW REQUIRED.— 
(A) NEW
PRODUCTS.—An order under 
subsection (c)(1)(A) for a new smoking article 
is required unless the product— 
(i) is substantially equivalent to a 
smoking article commercially marketed in 
the United States as of date of enactment 
of this Act; and 
(ii) is in compliance with the require-
ments of this Act. 
(B) CONSUMER
TESTING.—This section 
shall not apply to smoking articles that are pro-
vided to adult tobacco consumers for purposes 
of consumer testing. For purposes of this sec-
tion, the term ‘‘consumer testing’’ means an as-
sessment of smoking articles that is conducted 
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by or under the control and direction of a man-
ufacturer for the purpose of evaluating con-
sumer acceptance of such smoking articles, uti-
lizing only the quantity of cigarettes that is rea-
sonably necessary for such assessment 
(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 
(A) IN
GENERAL.—In this section, the 
term ‘‘substantially equivalent’’ or ‘‘substantial 
equivalence’’ means, with respect to the smok-
ing article being compared to the predicate 
smoking article, that the Administrator by 
order has found that the smoking article— 
(i) has the same general characteris-
tics as the predicate smoking article; or 
(ii) has different characteristics and 
the information submitted contains infor-
mation, including clinical data if deemed 
necessary by the Administrator, that dem-
onstrates that it is not appropriate to reg-
ulate the product under this section be-
cause the product does not raise different 
questions of public health for the consumer 
of the product. 
(B) CHARACTERISTICS.—In subparagraph 
(A), the term ‘‘characteristics’’ means the mate-
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rials, ingredients, design, composition, heating 
source, or other features of a smoking article. 
(C) LIMITATION.—A smoking article may 
not be found to be substantially equivalent to a 
predicate smoking article that has been re-
moved from the market at the initiative of the 
Administrator or that has been determined by 
a judicial order to be misbranded or adulter-
ated. 
(4) HEALTH INFORMATION.—As part of a sub-
mission respecting a smoking article, the person re-
quired to file a premarket notification shall provide 
an adequate summary of any health information re-
lated to the smoking article or state that such infor-
mation will be made available upon request by any 
person. 
(b) APPLICATION.— 
(1) CONTENTS.—An application under this sec-
tion shall contain— 
(A) full reports of all information, pub-
lished or known to, or which should reasonably 
be known to, the applicant, concerning inves-
tigations which have been made to show the 
health risks of such smoking article and wheth-
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er such smoking article presents less risk than 
other smoking articles; 
(B) a full statement of the components, in-
gredients, additives, and properties, and of the 
principle or principles of operation, of such 
smoking article; 
(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 smoking arti-
cle; 
(D) an identifying reference to any smok-
ing article standard under section 111 which 
would be applicable to any aspect of such smok-
ing article, and either adequate information to 
show that such aspect of such smoking article 
fully meets such smoking article standard or 
adequate information to justify any deviation 
from such standard; 
(E) such samples of such smoking article 
and of components thereof as the Administrator 
may reasonably require; 
(F) specimens of the labeling proposed to 
be used for such smoking article; and 
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(G) such other information relevant to the 
subject matter of the application as the Admin-
istrator 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 Administrator— 
(A) may, on the Administrator’s own ini-
tiative; or 
(B) may, upon the request of an applicant, 
refer such application to the Tobacco Products Sci-
entific Advisory Committee for reference and for 
submission (within such period as the Administrator 
may establish) of a report and recommendation re-
specting the application, together with all underlying 
data and the reasons or basis for the recommenda-
tion. 
(c) ACTION ON APPLICATION.— 
(1) DEADLINE.—As promptly as possible, but 
in no event later than 90 days after the receipt of 
an application under subsection (b), the Adminis-
trator, after considering the report and rec-
ommendation submitted under subsection (b)(2), 
shall— 
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essing, or packing of such smoking article do 
not conform to the requirements of section 
110(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 smoking article is not shown to 
conform to a smoking article standard in effect 
under section 111, and there is a lack of ade-
quate information to justify the deviation from 
such standard. 
(3) DENIAL INFORMATION.—Any denial of an 
application shall, insofar as the Administrator deter-
mines to be practicable, be accompanied by a state-
ment informing the applicant of the measures re-
quired to remove such application from deniable 
form (which measures may include further research 
by the applicant in accordance with 1 or more proto-
cols prescribed by the Administrator). 
(4) BASIS FOR FINDING.—For purposes of this 
section, the finding as to whether the commercial in-
troduction of a smoking article for which an applica-
tion has been submitted is appropriate for the pro-
tection of the public health shall be determined with 
respect to the risks and benefits to the users of the 
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smoking article, and taking into account whether 
such commercial introduction is reasonably likely to 
increase the morbidly and mortality among indi-
vidual tobacco users. 
(d) WITHDRAWAL AND TEMPORARY SUSPENSION.— 
(1) IN
GENERAL.—The Administrator shall, 
upon obtaining, where appropriate, advice on sci-
entific matters from the Tobacco Products Scientific 
Advisory Committee, and after due notice and op-
portunity for informal hearing for a smoking article 
for which an order was issued under subsection 
(c)(1)(A), issue an order withdrawing the order if 
the Administrator finds— 
(A) that the continued marketing of such 
smoking article no longer is appropriate for the 
protection of the public health; 
(B) that the application contained or was 
accompanied by an untrue statement of a mate-
rial fact; 
(C) that the applicant— 
(i) has failed to establish a system for 
maintaining records, or has repeatedly or 
deliberately failed to maintain records or to 
make reports, required by an applicable 
regulation under section 113; or 
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(ii) has refused to permit access to, or 
copying or verification of, such records as 
required by section 110; or 
(D) on the basis of new information before 
the Administrator with respect to such smoking 
article, evaluated together with the evidence be-
fore the Administrator when the application 
was reviewed, that the methods used in, or the 
facilities and controls used for, the manufac-
ture, processing, packing, or installation of such 
smoking article do not conform with the re-
quirements of section 110(e) and were not 
brought into conformity with such requirements 
within a reasonable time after receipt of written 
notice from the Administrator of noncon-
formity; 
(E) on the basis of new information before 
the Administrator, evaluated together with the 
evidence before the Administrator when the ap-
plication was reviewed, that the labeling of such 
smoking article, based on a fair evaluation of 
all material facts, is false or misleading in any 
particular and was not corrected within a rea-
sonable time after receipt of written notice from 
the Administrator of such fact; or 
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(F) on the basis of new information before 
the Administrator, evaluated together with the 
evidence before the Administrator when such 
order was issued, that such smoking article is 
not shown to conform in all respects to a smok-
ing article standard which is in effect under 
section 111, compliance with which was a con-
dition to the issuance of an order relating to 
the application, and that there is a lack of ade-
quate information to justify the deviation from 
such standard. 
(2) APPEAL.—The holder of an application sub-
ject to an order issued under paragraph (1) with-
drawing an order issued pursuant to subsection 
(c)(1)(A) may, by petition filed on or before the 
30th day after the date upon which such holder re-
ceives notice of such withdrawal, obtain review there-
of in accordance with section 116. 
(3) TEMPORARY
SUSPENSION.—If, after pro-
viding an opportunity for an informal hearing, the 
Administrator determines there is reasonable prob-
ability that the continuation of distribution of a 
smoking article under an order would cause serious, 
adverse health consequences or death, that is greater 
than ordinarily caused by smoking articles on the 
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market, the Administrator shall by order temporarily 
suspend the authority of the manufacturer to mar-
ket the product. If the Administrator issues such an 
order, the Administrator shall proceed expeditiously 
under paragraph (1) to withdraw such application. 
(e) SERVICE OF ORDER.—An order issued by the Ad-
ministrator under this section shall be served— 
(1) in person by any officer or employee of the 
department designated by the Administrator; or 
(2) by mailing the order by registered mail or 
certified mail addressed to the applicant at the ap-
plicant’s last known address in the records of the 
Administrator. 
(f) RECORDS.— 
(1) ADDITIONAL INFORMATION.—In the case of 
any smoking article for which an order issued pursu-
ant to subsection (c)(1)(A) for an application filed 
under subsection (b) is in effect, the applicant shall 
establish and maintain such records, and make such 
reports to the Administrator, as the Administrator 
may by regulation, or by order with respect to such 
application, prescribe on the basis of a finding that 
such records and reports are necessary in order to 
enable the Administrator to determine, or facilitate 
a determination of, whether there is or may be 
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grounds for withdrawing or temporarily suspending 
such order. 
(2) ACCESS
TO
RECORDS.—Each person re-
quired under this section to maintain records, and 
each person in charge of custody thereof, shall, upon 
request of an officer or employee designated by the 
Administrator, permit such officer or employee at all 
reasonable times to have access to and copy and 
verify such records. 
(g) INVESTIGATIONAL SMOKING ARTICLE EXEMP-
TION FOR INVESTIGATIONAL USE.—The Administrator 
may exempt smoking articles intended for investigational 
use from the provisions of this Act under such conditions 
as the Administrator may by regulation prescribe. 
SEC. 115. 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 
reduce harm or the risk of tobacco-related disease 
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(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 as-
sociated with commercially marketed tobacco 
products’’. 
(3) EFFECTIVE DATE.—The provisions of para-
graph (2)(A)(ii) shall take effect 12 months after 
the date of enactment of the Act. 
(c) TOBACCO DEPENDENCE PRODUCTS.—A product 
that is intended to be used for the treatment of tobacco 
dependence, 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 Center and is subject 
to the requirements of chapter V. 
(d) FILING.—Any person may file with the Adminis-
trator 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 
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conducted, supported, or possessed by the tobacco 
product manufacturer relating to the effect of the 
product on tobacco-related diseases and health-re-
lated conditions, including information both favor-
able 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 Administrator 
may require. 
(e) PUBLIC AVAILABILITY.—The Administrator shall 
make the application described in subsection (d) publicly 
available (except matters in the application which are 
trade secrets or otherwise confidential, commercial infor-
mation) and shall request comments by interested persons 
on the information contained in the application and on the 
label, labeling, and advertising accompanying such appli-
cation. 
(f) ADVISORY COMMITTEE.— 
(1) IN
GENERAL.—The Administrator shall 
refer to the Tobacco Products Scientific Advisory 
Committee any application submitted under this sec-
tion. 
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(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 
Administrator. 
(g) MARKETING.— 
(1) MODIFIED
RISK
PRODUCTS.—Except as 
provided in paragraph (2), the Administrator shall, 
with respect to an application submitted under this 
section, issue an order that a modified risk product 
may be commercially marketed only if the Adminis-
trator determines that the applicant has dem-
onstrated 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) is reasonably likely to result in meas-
urable and substantial reductions in morbidity 
and mortality among individual tobacco users. 
(2) SPECIAL RULE FOR CERTAIN PRODUCTS.— 
(A) IN GENERAL.—The Administrator may 
issue an order that a tobacco product may be 
introduced or delivered for introduction into 
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interstate 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-
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 sub-
section (b) is limited to an explicit or im-
plicit representation that such tobacco 
product or its smoke does not contain or is 
free of a substance or contains a reduced 
level of a substance, or presents a reduced 
exposure to a substance in tobacco smoke; 
(iii) scientific evidence is not available 
and, using the best available scientific 
methods, cannot be made available without 
conducting long-term epidemiological stud-
ies for an application to meet the stand-
ards set forth in paragraph (1); and 
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(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 
tobacco users is reasonably likely in subse-
quent studies. 
(B) ADDITIONAL
FINDINGS
REQUIRED.— 
To issue an order under subparagraph (A) the 
Administrator must also find that the applicant 
has demonstrated that— 
(i) the magnitude of the overall reduc-
tions in exposure to the substance or sub-
stances which are the subject of the appli-
cation is substantial, such substance or 
substances are harmful, and the product as 
actually used exposes consumers to the 
specified reduced level of the substance or 
substances; 
(ii) the product as actually used by 
consumers will not expose them to higher 
levels of other harmful substances com-
pared to the similar types of tobacco prod-
ucts then on the market unless such in-
creases are minimal and the reasonably 
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likely overall impact of use of the product 
remains a substantial and measurable re-
duction in overall morbidity and mortality 
among individual tobacco users; 
(iii) testing of actual consumer per-
ception shows that, as the applicant pro-
poses to label and market the product, con-
sumers will not be misled into believing 
that the product— 
(I) is or has been demonstrated 
to be significantly less harmful; or 
(II) presents or has been dem-
onstrated to present significant less of 
a risk of disease than other commer-
cially marketed tobacco products; and 
(iv) issuance of an order with respect 
to the application is expected to benefit the 
health of users of tobacco products. 
(3) BASIS.—The determinations under para-
graphs (1) and (2) shall be based on— 
(A) the scientific evidence submitted by the 
applicant; and 
(B) scientific evidence and other informa-
tion that is made available to the Adminis-
trator. 
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of change and identity of the reference tobacco 
product and a quantitative comparison of the 
amount of the substance claimed to be reduced 
shall be stated in immediate proximity to the 
most prominent claim. 
(i) POSTMARKET SURVEILLANCE AND STUDIES.— 
(1) IN GENERAL.—The Administrator shall re-
quire, with respect to a product for which an appli-
cant obtained an order under subsection (g)(1), that 
the applicant conduct postmarket surveillance and 
studies for such a tobacco product to determine the 
impact of the order issuance on consumer percep-
tion, behavior, and health, to enable the Adminis-
trator to review the accuracy of the determinations 
upon which the order was based, and to provide in-
formation that the Administrator determines is oth-
erwise necessary regarding the use or health risks 
involving the tobacco product. The results of 
postmarket surveillance and studies shall be sub-
mitted to the Administrator on an annual basis. 
(2) SURVEILLANCE
PROTOCOL.—Each appli-
cant required to conduct a surveillance of a tobacco 
product under paragraph (1) shall, within 30 days 
after receiving notice that the applicant is required 
to conduct such surveillance, submit, for the ap-
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100 
proval of the Administrator, a protocol for the re-
quired surveillance. The Administrator, within 30 
days of the receipt of such protocol, shall determine 
if the principal investigator proposed to be used in 
the surveillance has sufficient qualifications and ex-
perience to conduct such surveillance and if such 
protocol will result in collection of the data or other 
information designated by the Administrator as nec-
essary to protect the public health. 
(j) WITHDRAWAL OF AUTHORIZATION.—The Admin-
istrator, after an opportunity for an informal hearing, 
shall withdraw an order under subsection (g) if the Ad-
ministrator determines that— 
(1) the applicant, based on new information, 
can no longer make the demonstrations required 
under subsection (g), or the Administrator can no 
longer make the determinations required under sub-
section (g); 
(2) the application failed to include material in-
formation or included any untrue statement of mate-
rial fact; 
(3) any explicit or implicit representation that 
the product reduces risk or exposure is no longer 
valid, including if— 
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101 
(A) a tobacco product standard is estab-
lished pursuant to section 111; 
(B) an action is taken that affects the 
risks presented by other commercially marketed 
tobacco products that were compared to the 
product that is the subject of the application; or 
(C) any postmarket surveillance or studies 
reveal that the order is no longer consistent 
with the protection of the public health; 
(4) the applicant failed to conduct or submit 
the postmarket surveillance and studies required 
under subsection (g)(2)(C)(ii) or subsection (i); or 
(5) the applicant failed to meet a condition im-
posed under subsection (h). 
(k) CHAPTER IV OR V.—A product for which the Ad-
ministrator has issued an order pursuant to subsection (g) 
shall not be subject to chapter IV or V of the Federal 
Food, Drug, and Cosmetic Act. 
(l) IMPLEMENTING REGULATIONS OR GUIDANCE.— 
(1) SCIENTIFIC EVIDENCE.—Not later than 2 
years after the date of enactment of the Act, the Ad-
ministrator shall issue regulations or guidance (or 
any combination thereof) on the scientific evidence 
required for assessment and ongoing review of modi-
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102 
fied risk tobacco products. Such regulations or guid-
ance shall— 
(A) to the extent that adequate scientific 
evidence exists, establish minimum standards 
for scientific studies needed prior to issuing an 
order under subsection (g) to show a reasonable 
likelihood that a substantial reduction in mor-
bidity or mortality among individual tobacco 
users occurs for products described in sub-
section (g)(1) or is reasonably likely for prod-
ucts described in subsection (g)(2); 
(B) include validated biomarkers, inter-
mediate clinical endpoints, and other feasible 
outcome measures, as appropriate; 
(C) establish minimum standards for 
postmarket studies, that shall include regular 
and long-term assessments of health outcomes 
and mortality, intermediate clinical endpoints, 
consumer perception of harm reduction, and the 
impact on quitting behavior and new use of to-
bacco products, as appropriate; 
(D) establish minimum standards for re-
quired postmarket surveillance, including ongo-
ing assessments of consumer perception; and 
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103 
(E) establish a reasonable timetable for the 
Administrator to review an application under 
this section. 
(2) CONSULTATION.—The regulations or guid-
ance issued under paragraph (1) may be developed 
in consultation with the Institute of Medicine, and 
with the input of other appropriate scientific and 
medical experts, on the design and conduct of such 
studies and surveillance. 
(3) REVISION.—The regulations or guidance 
under paragraph (1) shall be revised on a regular 
basis as new scientific information becomes avail-
able. 
(4) NEW TOBACCO PRODUCTS.—Not later than 
2 years after the date of enactment of the Act, the 
Administrator shall issue a regulation or guidance 
that permits the filing of a single application for any 
tobacco product that is a new tobacco product under 
section 114 and which the applicant seeks to com-
mercially market under this section. 
SEC. 116. JUDICIAL REVIEW. 
(a) RIGHT TO REVIEW.— 
(1) IN
GENERAL.—Not later than 60 days 
after— 
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104 
(A) the promulgation of a regulation under 
section 111 establishing, amending, or revoking 
a tobacco product standard; or 
(B) a denial of an application under sec-
tion 114(c), 
any person adversely affected by such regulation or 
denial may file a petition for judicial review of such 
regulation or denial with the United States Court of 
Appeals for the District of Columbia or for the cir-
cuit in which such person resides or has their prin-
cipal place of business. 
(2) REQUIREMENTS.— 
(A) COPY OF PETITION.—A copy of the pe-
tition filed under paragraph (1) shall be trans-
mitted by the clerk of the court involved to the 
Administrator. 
(B) RECORD
OF
PROCEEDINGS.—On re-
ceipt of a petition under subparagraph (A), the 
Administrator shall file in the court in which 
such petition was filed— 
(i) the record of the proceedings on 
which the regulation or order was based; 
and 
(ii) a statement of the reasons for the 
issuance of such a regulation or order. 
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105 
(C) DEFINITION OF RECORD.—In this sec-
tion, the term ‘‘record’’ means— 
(i) all notices and other matter pub-
lished in the Federal Register with respect 
to the regulation or order reviewed; 
(ii) all information submitted to the 
Administrator with respect to such regula-
tion or order; 
(iii) proceedings of any panel or advi-
sory committee with respect to such regu-
lation or order; 
(iv) any hearing held with respect to 
such regulation or order; and 
(v) any other information identified by 
the Administrator, in the administrative 
proceeding held with respect to such regu-
lation or order, as being relevant to such 
regulation or order. 
(b) STANDARD OF REVIEW.—Upon the filing of the 
petition under subsection (a) for judicial review of a regu-
lation or order, the court shall have jurisdiction to review 
the regulation or order in accordance with chapter 7 of 
title 5, United States Code, and to grant appropriate re-
lief, including interim relief, as provided for in such chap-
ter. A regulation or denial described in subsection (a) shall 
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106 
be reviewed 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 
certification, 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 110, 111, 112, 113, 114, or 
119 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. 117. JURISDICTION OF AND COORDINATION WITH THE 
FEDERAL TRADE COMMISSION. 
Except where expressly provided in this Act, nothing 
in this Act 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 adver-
tising, sale, or distribution of tobacco products. 
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107 
SEC. 118. REGULATION REQUIREMENT. 
(a) TESTING, REPORTING, AND DISCLOSURE.—Not 
later than 36 months after the date of enactment of the 
Act, the Administrator 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 annual testing and reporting of 
tobacco product constituents, ingredients, and addi-
tives, including smoke constituents, by brand style 
that the Administrator determines should be tested 
to protect the public health, provided that, for pur-
poses of the testing requirements of this paragraph, 
tobacco products manufactured and sold by a single 
tobacco product manufacturer that are identical in 
all respects except the labels, packaging design, logo, 
trade dress, trademark, brand name, or any com-
bination thereof, shall be considered as a single 
brand style; and 
(2) may require that tobacco product manufac-
turers, packagers, or importers make disclosures re-
lating to the results of the testing of tar and nico-
tine through labels or advertising. 
(c) AUTHORITY.—The Administrator shall have the 
authority under this Act to conduct or to require the test-
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108 
ing, reporting, or disclosure of tobacco product constitu-
ents, including smoke constituents. 
(d) JOINT LABORATORY TESTING SERVICES.—The 
Administrator shall allow any 2 or more tobacco product 
manufacturers to join together to purchase laboratory 
testing services required by this section on a group basis 
in order to ensure that such manufacturers receive access 
to, and fair pricing of, such testing services. 
(e) EXTENSIONS FOR LIMITED LABORATORY CAPAC-
ITY.— 
(1) IN GENERAL.—The regulations promulgated 
under subsection (a) shall provide that a tobacco 
product manufacturer shall not be considered to be 
in violation of this section before the applicable 
deadline, if— 
(A) the tobacco products of such manufac-
turer are in compliance with all other require-
ments of this Act; and 
(B) the conditions described in paragraph 
(2) are met. 
(2) CONDITIONS.—Notwithstanding the require-
ments of this section, the Administrator may delay 
the date by which a tobacco product manufacturer 
must be in compliance with the testing and reporting 
required by this section until such time as the test-
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109 
ing is reported if, not later than 90 days before the 
deadline for reporting in accordance with this sec-
tion, a tobacco product manufacturer provides evi-
dence to the Administrator demonstrating that— 
(A) the manufacturer has submitted the 
required products for testing to a laboratory 
and has done so sufficiently in advance of the 
deadline to create a reasonable expectation of 
completion by the deadline; 
(B) the products currently are awaiting 
testing by the laboratory; and 
(C) neither that laboratory nor any other 
laboratory is able to complete testing by the 
deadline at customary, nonexpedited testing 
fees. 
(3) EXTENSION.—The Administrator, taking 
into account the laboratory testing capacity that is 
available to tobacco product manufacturers, shall re-
view and verify the evidence submitted by a tobacco 
product manufacturer in accordance with paragraph 
(2). If the Administrator finds that the conditions 
described in such paragraph are met, the Adminis-
trator shall notify the tobacco product manufacturer 
that the manufacturer shall not be considered to be 
in violation of the testing and reporting require-
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111 
SEC. 119. PRESERVATION OF STATE AND LOCAL AUTHOR-
ITY. 
(a) IN GENERAL.— 
(1) PRESERVATION.—Except as provided in 
paragraph (2)(A), nothing in this Act, or rules pro-
mulgated under this Act, 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, regu-
lation, or other measure with respect to tobacco 
products that is in addition to requirements estab-
lished under this Act, including a law, rule, regula-
tion, or other measure relating to or prohibiting the 
sale, distribution, possession, or use of tobacco prod-
ucts by individuals of any age, information reporting 
to the State. No provision of this Act shall limit or 
otherwise affect any State, Tribal, or local taxation 
of tobacco products. 
(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 
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112 
this Act relating to tobacco product standards, 
premarket review, adulteration, misbranding, 
labeling, 
registration, 
good 
manufacturing 
standards, or modified risk tobacco products. 
(B) EXCEPTION.—Subparagraph (A) does 
not apply to requirements relating to the sale, 
distribution, possession, information reporting 
to the State, use of, tobacco product by individ-
uals of any age. Information disclosed to a 
State under subparagraph (A) that is exempt 
from disclosure under section 552(b)(4) 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 Act relating to a tobacco 
product shall be construed to modify or otherwise affect 
any action or the liability of any person under the product 
liability law of any State. 
SEC. 120. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COM-
MITTEE. 
(a) ESTABLISHMENT.—Not later than 6 months after 
the date of enactment of this Act, the Administrator shall 
establish a 16-member advisory committee, to be known 
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113 
as the Tobacco Products Scientific Advisory Committee 
(in this section referred to as the ‘‘Advisory Committee’’). 
(b) MEMBERSHIP.— 
(1) IN GENERAL.— 
(A) MEMBERS.—The Administrator shall 
appoint as members of the Tobacco Harm Re-
duction 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 appro-
priately diversified professional backgrounds. 
The committee shall be composed of— 
(i) 6 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) 2 individuals who are an officer or 
employee of a State or local government or 
of the Federal Government; 
(iii) 2 representatives of the general 
public; 
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114 
(iv) 2 representatives of the interests 
of the tobacco manufacturing industry; 
(v) 1 representative of the interests of 
the small business tobacco manufacturing 
industry, which position may be filled on a 
rotating, sequential basis by representa-
tives of different small business tobacco 
manufacturers based on areas of expertise 
relevant to the topics being considered by 
the Advisory Committee; 
(vi) 1 individual as a representative of 
the interests of the tobacco growers; and 
(vii) 1 individual who is an expert in 
illicit trade of tobacco products. 
(B) 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 
period prior to becoming such a member, re-
ceive any salary, grants, or other payments or 
support from any business that manufactures, 
distributes, markets, or sells cigarettes or other 
tobacco products or government agency with 
any form of jurisdiction over tobacco products. 
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115 
(2) LIMITATION.—The Administrator may not 
appoint to the Advisory Committee any individual 
who is in the regular full-time employ of the To-
bacco Harm Reduction Center or any agency respon-
sible for the enforcement of this Act. The Adminis-
trator may appoint Federal officials as ex officio 
members. 
(3) CHAIRPERSON.—The Administrator shall 
designate 1 of the members appointed under clauses 
(i), (ii), and (iii) of paragraph (1)(A) to serve as 
chairperson. 
(c) DUTIES.—The Tobacco Products Scientific Advi-
sory Committee shall provide advice, information, and rec-
ommendations to the Administrator— 
(1) as provided in this Act; 
(2) on the implementation of prevention, ces-
sation, and harm reduction policies; 
(3) on implementation of policies and programs 
to fully inform consumers of the respective risks of 
tobacco products; and 
(4) on its review of other safety, dependence, or 
health issues relating to tobacco products as re-
quested by the Administrator. 
(d) COMPENSATION; SUPPORT; FACA.— 
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(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 
engaged in its business, shall be entitled to receive 
compensation at rates to be fixed by the Adminis-
trator, which may not exceed the daily equivalent of 
the rate in effect under the Senior Executive Sched-
ule under section 5382 of title 5, United States 
Code, for each day (including travel time) they are 
so engaged; and while so serving away from their 
homes or regular places of business each member 
may be allowed travel expenses, including per diem 
in lieu of subsistence, as authorized by section 5703 
of title 5, United States Code, for persons in the 
Government service employed intermittently. 
(2) ADMINISTRATIVE SUPPORT.—The Adminis-
trator shall furnish the Advisory Committee clerical 
and other assistance. 
(3) NONAPPLICATION OF FACA.—Section 14 of 
the Federal Advisory Committee Act does not apply 
to the Advisory Committee. 
(e) PROCEEDINGS OF ADVISORY PANELS AND COM-
MITTEES.—The Advisory Committee shall make and 
maintain a transcript of any proceeding of the panel or 
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committee. Each such panel and committee shall delete 
from any transcript made under this subsection informa-
tion which is exempt from disclosure under section 552(b) 
of title 5, United States Code. 
SEC. 121. DRUG PRODUCTS USED TO TREAT TOBACCO DE-
PENDENCE. 
(a) REPORT ON INNOVATIVE PRODUCTS.— 
(1) IN GENERAL.—Not later than 3 years after 
the date of enactment of this Act, the Administrator, 
after consultation with recognized scientific, medical, 
and public health experts (including both Federal 
agencies and nongovernmental entities, the Institute 
of Medicine of the National Academy of Sciences, 
and the Society for Research on Nicotine and To-
bacco), shall submit to the Congress a report that 
examines how best to promote, and encourage the 
development and use by current tobacco users of in-
novative tobacco and nicotine products and treat-
ments (including nicotine-based and non-nicotine- 
based products and treatments) to better achieve, in 
a manner that best protects and promotes the public 
health— 
(A) total abstinence from tobacco use; 
(B) reductions in consumption of tobacco; 
and 
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(C) reductions in the harm associated with 
continued tobacco use by moving current users 
to noncombustible tobacco products. 
(2) RECOMMENDATIONS.—The report under 
paragraph (1) shall include the recommendations of 
the Administrator on how the Tobacco Harm and 
Reduction Center should coordinate and facilitate 
the exchange of information on such innovative 
products and treatments among relevant offices and 
centers within the Center and within the National 
Institutes of Health, the Centers for Disease Control 
and Prevention, and other relevant Federal and 
State agencies. 
SEC. 122. ADVERTISING AND MARKETING OF TOBACCO 
PRODUCTS. 
(a) Within 18 months of enactment of the Act, the 
Administrator shall report to Congress on the benefits to 
public health of imposing restrictions or prohibitions on 
the advertising and marketing, consistent with or in addi-
tion to such restrictions or prohibitions contained in the 
Master Settlement Agreement, on tobacco products. 
(b) The Administrator shall specify in the report con-
stitutional free speech implications for each recommended 
restriction or prohibition. 
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(c) The Administrator shall also specify the class of 
tobacco products to which the prohibition or restriction 
would be applicable and the impact of such actions on 
harm reduction policies, practices, and accurate informa-
tion available to tobacco users. 
(d) The Administrator shall establish and consult 
with an advisory committee consisting of experts in con-
stitutional law, harm reduction policies, marketing prac-
tices, and consumer behavior in preparing this report. 
TITLE II—TOBACCO PRODUCTS 
WARNINGS; 
CONSTITUENT 
AND 
SMOKE 
CONSTITUENT 
DISCLOSURE 
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 
(a) AMENDMENT.—Section 4 of the Federal Ciga-
rette Labeling and Advertising Act (15 U.S.C. 1333) is 
amended to read as follows: 
‘‘SEC. 4. LABELING. 
‘‘(a) LABEL REQUIREMENTS.— 
‘‘(1) IN GENERAL.—It shall be unlawful for any 
person to manufacture, package, sell, offer to sell, 
distribute, or import for sale or distribution within 
the United States any cigarettes the package of 
which fails to bear, in accordance with the require-
ments of this section, one of the following labels: 
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‘‘WARNING: Cigarettes are addictive. 
‘‘WARNING: Tobacco smoke can harm 
your children. 
‘‘WARNING: Cigarettes cause fatal lung 
disease. 
‘‘WARNING: Cigarettes cause cancer. 
‘‘WARNING: Cigarettes cause strokes and 
heart disease. 
‘‘WARNING: Smoking during pregnancy 
can harm your baby. 
‘‘WARNING: Smoking can kill you. 
‘‘WARNING: Tobacco smoke causes fatal 
lung disease in nonsmokers. 
‘‘WARNING: Quitting smoking now great-
ly reduces serious risks to your health. 
‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—Each 
label statement required by paragraph (1) shall be 
located in the lower portion of the front panel of the 
package, directly on the package underneath the cel-
lophane or other clear wrapping. Each label state-
ment shall comprise at least the bottom 25 percent 
of the front panel of the package. The word 
‘WARNING’ shall appear in capital letters and all 
text shall be in conspicuous and legible 17-point 
type, unless the text of the label statement would oc-
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‘‘WARNING: Smokeless tobacco is addict-
ive. 
‘‘(2) The label statements required by para-
graph (1) shall be introduced by each smokeless to-
bacco product manufacturer, packager, importer, 
distributor, or retailer of smokeless tobacco products 
concurrently into the distribution chain of such 
products. 
‘‘(3) The provisions of this subsection do not 
apply to a smokeless tobacco product manufacturer 
or distributor of any smokeless tobacco product that 
does not manufacture, package, or import smokeless 
tobacco products for sale or distribution within the 
United States. 
‘‘(4) A retailer of smokeless tobacco products 
shall not be in violation of this subsection for pack-
aging that— 
‘‘(A) contains a warning label; 
‘‘(B) is supplied to the retailer by a 
license- or permit-holding smokeless 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. 
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the package of a tobacco product shall bear a list of the 
common or usual names of the ingredients present in the 
tobacco product in an amount greater than 0.1 percent 
of the total dry weight of the tobacco (including all ingre-
dients), that shall comply with the following: 
(1) Such listing of ingredients shall appear 
under, or be conspicuously accompanied by, the 
heading ‘‘Tobacco and principal tobacco ingredi-
ents’’. 
(2) Tobacco may be listed as ‘‘tobacco,’’ and 
shall be the first listed ingredient. 
(3) After tobacco, the ingredients shall be listed 
in descending order of predominance, by weight. 
(4) Spices and natural and artificial flavors 
may be listed, respectively, as ‘‘spices’’ and ‘‘natural 
and artificial flavors’’ without naming each. 
(5) Preservatives may be listed as ‘‘preserva-
tives’’ without naming each. 
(6) The disclosure of any ingredient in accord-
ance with this section may, at the option of the to-
bacco 
product 
manufacturer, 
designate 
the 
functionality or purpose of that ingredient. 
(7) The package say state ‘‘Not for sale to mi-
nors’’. 
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