(2) if there is significant scientific agreement 
that, as a result of the tobacco it contains, the to-
bacco product presents a risk to human health that 
is materially higher than the risk presented by— 
(A) such product on the effective date of 
this Act; or 
(B) if such product was not distributed 
commercially domestically on that date, by com-
parable tobacco products of the same style and 
within the same category that were commer-
cially distributed domestically on that date; 
(3) if it has been prepared, packed, or held 
under unsanitary conditions whereby it may have be-
come contaminated with filth; 
(4) if its package is composed, in whole or in 
part, of any poisonous or deleterious substance that 
may render the contents injurious to health; or 
(5) if its ‘‘tar’’ yield is in violation of section 
111. 
SEC. 107. MISBRANDED TOBACCO PRODUCTS. 
A tobacco product shall be deemed to be mis-
branded— 
(1) if its labeling is false or misleading in any 
particular; 
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(2) if in package form unless it bears a label 
containing— 
(A) an identification of the type of product 
it is, by the common or usual name of such 
type of product; 
(B) an accurate statement of the quantity 
of the contents in the package in terms of 
weight, measure, or numerical count, except 
that reasonable variations shall be permitted, 
and exemptions as to small packages shall be 
established by regulations promulgated by the 
Administrator; 
(C) the name and place of business of the 
tobacco product manufacturer, packer, or dis-
tributor; and 
(D) the information required by section 
201(c) and (e) or section 202(c) and (e), as ap-
plicable; 
(3) if any word, statement, or other information 
required by or under authority of this Act to appear 
on the label, labeling, or advertising is not promi-
nently placed thereon with such conspicuousness (as 
compared with other words, statements, or designs 
on the label, labeling, or advertising, as applicable) 
and in such terms as to render it reasonably likely 
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to be read and understood by the ordinary individual 
under customary conditions of purchase and use; 
(4) if any word, statement, or other information 
is required by or under this Act to appear on the 
label, unless such word, statement, or other informa-
tion also appears on the outside container or wrap-
per, if any, of the retail package of such tobacco 
product, or is easily legible through the outside con-
tainer or wrapper; 
(5) if it was manufactured, prepared, or proc-
essed in an establishment not duly registered under 
section 109, if it was not included in a list required 
by section 109, or if a notice or other information 
respecting it was not provided as required by section 
109; 
(6) if its packaging, labeling, or advertising is 
in violation of this Act or of an applicable regulation 
promulgated in accordance with this Act; 
(7) if it contains tobacco or another ingredient 
as to which a required disclosure under this Act was 
not made; 
(8) if it is labeled or advertised, or the tobacco 
contained in it is advertised, as— 
(A) containing ‘‘no additives,’’ or any sub-
stantially similar term, unless the labeling or 
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advertising, as applicable, also contains, clearly 
and prominently, the following disclosure: ‘‘No 
additives in our tobacco does NOT mean 
safer.’’; or 
(B) being ‘‘natural,’’ or any substantially 
similar term, unless the labeling or advertising, 
as applicable, also contains, clearly and promi-
nently, the following disclosure: ‘‘Natural does 
NOT mean safer.’’; 
(9) if in its labeling or advertising a term de-
scriptive of the tobacco in the tobacco product is 
used otherwise than in accordance with a sanction or 
approval granted by a Federal agency; 
(10) if with respect to such tobacco product a 
disclosure required by section 603 was not made; 
(11) if with respect to such tobacco product a 
certification required by section 803 was not sub-
mitted or is materially false or misleading; or 
(12) if its manufacturer or distributor made 
with respect to it a claim prohibited by section 115. 
SEC. 108. SUBMISSION OF HEALTH INFORMATION TO THE 
ADMINISTRATOR. 
(a) REQUIREMENT.—Each tobacco product manufac-
turer or importer, or agents thereof, shall submit to the 
Administrator the following information: 
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(1) Not later than 18 months after the date of 
enactment of the Act, a listing of all ingredients, in-
cluding tobacco, substances, compounds, and addi-
tives that are, as of such date, added by the manu-
facturer to the tobacco, paper, filter, or other part 
of each tobacco product by brand and by quantity in 
each brand and brand style. 
(2) A description of the content, delivery, and 
form of nicotine in each tobacco product measured 
in milligrams of nicotine in accordance with regula-
tions promulgated by the Administrator in accord-
ance with section 4(e) of the Federal Cigarette La-
beling and Advertising Act. 
(3) Beginning 4 years after the date of enact-
ment of this Act, a listing of all constituents, includ-
ing smoke constituents as applicable, identified by 
the Administrator as harmful to health in each to-
bacco product, and as applicable in the smoke of 
each tobacco product, by brand and by quantity in 
each brand and subbrand. 
(b) DATA SUBMISSION.—At the request of the Ad-
ministrator, each tobacco product manufacturer or im-
porter of tobacco products, or agents thereof, shall submit 
the following: 
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(1) Any or all documents (including underlying 
scientific information) relating to research activities, 
and research findings, conducted, supported, or pos-
sessed by the manufacturer (or agents thereof) on 
the health, toxicological, or physiologic effects of to-
bacco products and their constituents (including 
smoke constituents), ingredients, components, and 
additives. 
(2) Any or all documents (including underlying 
scientific information) relating to research activities, 
and research findings, conducted, supported, or pos-
sessed by the manufacturer (or agents thereof) that 
relate to the issue of whether a significant reduction 
in risk to health from tobacco products can occur 
upon the employment of technology available to the 
manufacturer. 
An importer of a tobacco product not manufactured in the 
United States shall supply the information required of a 
tobacco product manufacturer under this subsection. 
(c) DATA LIST.— 
(1) IN GENERAL.—Not later than 4 years after 
the date of enactment of the Act, and annually 
thereafter, the Administrator shall publish in a for-
mat that is understandable and not misleading to a 
lay person, and place on public display (in a manner 
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determined by the Administrator) the list established 
under subsection (d). 
(2) CONSUMER RESEARCH.—The Administrator 
shall conduct periodic consumer research to ensure 
that the list published under paragraph (1) is not 
misleading to lay persons. Not later than 5 years 
after the date of enactment of the Act, the Adminis-
trator shall submit to the appropriate committees of 
Congress a report on the results of such research, 
together with recommendations on whether such 
publication should be continued or modified. 
(d) DATA COLLECTION.—Not later than 36 months 
after the date of enactment of this Act, the Administrator 
shall establish, and periodically revise as appropriate, a 
list of harmful constituents, including smoke constituents, 
to health in each tobacco product by brand and by quan-
tity in each brand and subbrand. 
SEC. 109. REGISTRATION AND LISTING. 
(a) DEFINITIONS.—As used in this section: 
(1) The term ‘‘manufacture, preparation, or 
processing’’ shall include repackaging or otherwise 
changing the container, wrapper, or label of any to-
bacco product package other than the carton in fur-
therance of the distribution of the tobacco product 
from the original place of manufacture to the person 
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that makes final delivery or sale to the ultimate con-
sumer or user, but shall not include the addition of 
a tax marking or other marking required by law to 
an already packaged tobacco product. 
(2) The term ‘‘name’’ shall include in the case 
of a partnership the name of the general partner 
and, in the case of a privately held corporation, the 
name of the chief executive officer of the corporation 
and the State of incorporation. 
(b) ANNUAL REGISTRATION.—Commencing one year 
after enactment, on or before December 31 of each year, 
every person that owns or operates any establishment in 
any State engaged in the manufacture, preparation, or 
processing of a tobacco product or products for commer-
cial distribution domestically shall register with the Ad-
ministrator its name, places of business, and all such es-
tablishments. 
(c) NEW PRODUCERS.—Every person upon first en-
gaging, for commercial distribution domestically, in the 
manufacture, preparation, or processing of a tobacco prod-
uct or products in any establishment that it owns or oper-
ates in any State shall immediately register with the Ad-
ministrator its name, places of business, and such estab-
lishment. 
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(d) 
REGISTRATION
OF
FOREIGN
ESTABLISH-
MENTS.— 
(1) Commencing one year after enactment of 
this Act, on or before December 31 of each year, the 
person that, within any foreign country, owns or op-
erates any establishment engaged in the manufac-
ture, preparation, or processing of a tobacco product 
that is imported or offered for import into the 
United States shall, through electronic means or 
other means permitted by the Administrator, reg-
ister with the Administrator the name and place of 
business of each such establishment, the name of the 
United States agent for the establishment, and the 
name of each importer of such tobacco product in 
the United States that is known to such person. 
(2) Such person also shall provide the informa-
tion required by subsection (j), including sales made 
by mail, or through the Internet, or other electronic 
means. 
(3) The Administrator is authorized to enter 
into cooperative arrangements with officials of for-
eign countries to ensure that adequate and effective 
means are available for purposes of determining, 
from time to time, whether tobacco products manu-
factured, prepared, or processed by an establishment 
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described in paragraph (1), if imported or offered 
for import into the United States, shall be refused 
admission on any of the grounds set forth in section 
708. 
(e) ADDITIONAL ESTABLISHMENTS.—Every person 
duly registered in accordance with the foregoing sub-
sections of this section shall immediately register with the 
Administrator any additional establishment that it owns 
or operates and in which it begins the manufacture, prepa-
ration, or processing of a tobacco product or products for 
commercial distribution domestically or for import into the 
United States. 
(f) EXCLUSIONS FROM APPLICATION OF THIS SEC-
TION.—The foregoing subsections of this section shall not 
apply to— 
(1) persons that manufacture, prepare, or proc-
ess tobacco products solely for use in research, 
teaching, chemical or biological analysis, or export; 
or 
(2) such other classes of persons as the Admin-
istrator may by regulation exempt from the applica-
tion of this section upon a finding that registration 
by such classes of persons in accordance with this 
section is not necessary for the protection of the 
public health. 
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(g) INSPECTION OF PREMISES.—Every establishment 
registered with the Administrator pursuant to this section 
shall be subject to inspection pursuant to section 706; and 
every such establishment engaged in the manufacture, 
preparation, or processing of a tobacco product or prod-
ucts shall be so inspected by one or more officers or em-
ployees duly designated by the Administrator at least once 
in the two-year period beginning with the date of registra-
tion of such establishment pursuant to this section and 
at least once in every successive two-year period there-
after, except that inspection of establishments outside the 
United States may be conducted by other personnel pursu-
ant to a cooperative arrangement under subsection (d)(3). 
(h) FILING OF LISTS OF TOBACCO PRODUCTS MANU-
FACTURED, PREPARED, OR PROCESSED BY REGISTRANTS; 
STATEMENTS; ACCOMPANYING DISCLOSURES.— 
(1) Every person that registers with the Admin-
istrator under subsection (b), (c), (d), or (e) shall, 
at the time of registration under any such sub-
section, file with the Administrator a list of all 
brand styles (with each brand style in each list listed 
by the common or usual name of the tobacco prod-
uct category to which it belongs and by any propri-
etary name) that are being manufactured, prepared, 
or processed by such person for commercial distribu-
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tion domestically or for import into the United 
States, and that such person has not included in any 
list of tobacco products filed by such person with the 
Administrator under this paragraph or paragraph 
(2) before such time of registration. Such list shall 
be prepared in such form and manner as the Admin-
istrator may prescribe, and shall be accompanied by 
the label for each such brand style and a representa-
tive sampling of any other labeling and advertising 
for each; 
(2) Each person that registers with the Admin-
istrator under this section shall report to the Admin-
istrator each August for the preceding six-month pe-
riod from January through June, and each February 
for the preceding six-month period form July 
through December, following information: 
(A) A list of each brand style introduced 
by the registrant for commercial distribution 
domestically or for import into the United 
States that has not been included in any list 
previously filed by such registrant with the Ad-
ministrator under this subparagraph or para-
graph (1). A list under this subparagraph shall 
list a brand style by the common or usual name 
of the tobacco product category to which it be-
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sumption, the date of such resumption, the 
identity of such brand style (by the common or 
usual name of the tobacco product category to 
which it belongs and by any proprietary name), 
and the other information required by para-
graph (1), unless the registrant has previously 
reported such resumption to the Administrator 
pursuant to this subparagraph. 
(D) Any material change in any informa-
tion previously submitted pursuant to this para-
graph (2) or paragraph (1). 
(i) 
ELECTRONIC
REGISTRATION.—Registrations 
under subsections (b), (c), (d), and (e) (including the sub-
mission of updated information) shall be submitted to the 
Administrator by electronic means, unless the Adminis-
trator grants a request for waiver of such requirement be-
cause use of electronic means is not reasonable for the 
person requesting such waiver. 
SEC. 110. GENERAL PROVISIONS RESPECTING CONTROL OF 
TOBACCO PRODUCTS. 
(a) IN GENERAL.—Any requirement established by or 
under section 106, 107, or 113 applicable to a tobacco 
product shall apply to such tobacco product until the ap-
plicability of the requirement to the tobacco product has 
been changed by action taken under section 111, section 
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114, section 115, or subsection (d) of this section, and 
any requirement established by or under section 106, 107, 
or 113 which is inconsistent with a requirement imposed 
on such tobacco product under section 111, section 114, 
section 115, or subsection (d) of this section shall not 
apply to such tobacco product. 
(b) INFORMATION ON PUBLIC ACCESS AND COM-
MENT.—Each notice of proposed rulemaking or other noti-
fication under section 111, 112, 113, 114, or 115 or under 
this section, any other notice which is published in the 
Federal Register with respect to any other action taken 
under any such section and which states the reasons for 
such action, and each publication of findings required to 
be made in connection with rulemaking under any such 
section shall set forth— 
(1) the manner in which interested persons may 
examine data and other information on which the 
notice or findings is based; and 
(2) the period within which interested persons 
may present their comments on the notice or find-
ings (including the need therefore) orally or in writ-
ing, which period shall be at least 60 days but may 
not exceed 90 days unless the time is extended by 
the Administrator by a notice published in the Fed-
eral Register stating good cause therefore. 
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(c) LIMITED CONFIDENTIALITY OF INFORMATION.— 
Any information reported to or otherwise obtained by the 
Administrator or the Administrator’s representative under 
section 107, 108, 111, 112, 113, 114, 115, or 504, or 
under subsection (e) or (f) of this section, which is exempt 
from disclosure under subsection (a) of section 552 of title 
5, United States Code, by reason of subsection (b)(4) of 
that section shall be considered confidential and shall not 
be disclosed, except that the information may be disclosed 
to other officers or employees concerned with carrying out 
this Act, or when relevant in any proceeding under this 
Act. 
(d) RESTRICTIONS.— 
(1) IN
GENERAL.—The Administrator may 
issue regulations, consistent with this Act, regarding 
tobacco products if the Administrator determines 
that such regulation would be appropriate for the 
protection of the public health. The finding as to 
whether such regulation would be appropriate for 
the protection of the public health shall be deter-
mined with respect to the risks and benefits to the 
users of the tobacco product, and taking into ac-
count that the standard is reasonably likely to result 
in measurable and substantial reductions in mor-
bidly and mortality among individual tobacco users. 
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(2) LABEL STATEMENTS.—The label of a to-
bacco product shall bear such appropriate state-
ments of the restrictions required by a regulation 
under subsection (a) as the Administrator may in 
such regulation prescribe. 
(e) GOOD MANUFACTURING PRACTICE REQUIRE-
MENTS.— 
(1) METHODS, FACILITIES, AND CONTROLS TO 
CONFORM.— 
(A) IN GENERAL.—In applying manufac-
turing restrictions to tobacco, the Administrator 
shall, in accordance with subparagraph (B), 
prescribe regulations (which may differ based 
on the type of tobacco product involved) requir-
ing that the methods used in, and the facilities 
and controls used for, the manufacture, 
preproduction design validation (including a 
process to assess the performance of a tobacco 
product), packing, and storage of a tobacco 
product conform to current good manufacturing 
practice, or hazard analysis and critical control 
point methodology, as prescribed in such regu-
lations to assure that the public health is pro-
tected and that the tobacco product is in com-
pliance with this Act. Such regulations may 
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provide for the testing of raw tobacco for pes-
ticide chemical residues after a tolerance for 
such chemical residues has been established. 
(B) REQUIREMENTS.—The Administrator 
shall— 
(i) before promulgating any regulation 
under subparagraph (A), afford the To-
bacco Products Scientific Advisory Com-
mittee an opportunity to submit rec-
ommendations with respect to the regula-
tion proposed to be promulgated; 
(ii) before promulgating any regula-
tion under subparagraph (A), afford oppor-
tunity for an oral hearing; 
(iii) provide the Tobacco Products 
Scientific Advisory Committee a reasonable 
time to make its recommendation with re-
spect to proposed regulations under sub-
paragraph (A); and 
(iv) in establishing the effective date 
of a regulation promulgated under this 
subsection, take into account the dif-
ferences in the manner in which the dif-
ferent types of tobacco products have his-
torically been produced, the financial re-
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sources of the different tobacco product 
manufacturers, and the state of their exist-
ing manufacturing facilities, and shall pro-
vide for a reasonable period of time for 
such manufacturers to conform to good 
manufacturing practices but no earlier 
than four years from date of enactment. 
(C) ADDITIONAL
SPECIAL
RULE.—A to-
bacco product manufactured in or imported into 
the United States shall not contain foreign- 
grown flue-cured or burley tobacco that— 
(i) was knowingly grown or processed 
using a pesticide chemical that is not ap-
proved under applicable Federal law for 
use in domestic tobacco farming and proc-
essing; or 
(ii) in the case of a pesticide chemical 
that is so approved, was grown or proc-
essed using the pesticide chemical in a 
manner inconsistent with the approved la-
beling for use of the pesticide chemical in 
domestic tobacco farming and processing. 
(D) EXCLUSION.—Subparagraph (C)(ii) 
shall not apply to tobacco products manufac-
tured with foreign-grown flue-cured or burley 
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tobacco so long as that foreign grown tobacco 
was either— 
(i) in the inventory of a manufacturer 
prior to the effective date, or 
(ii) planted by the farmer prior to the 
effective date of this Act and utilized by 
the manufacturer no later than 3 years 
after the effective date. 
(E) SETTING OF MAXIMUM RESIDUE LIM-
ITS.—The Administrator shall adopt the fol-
lowing pesticide residue standards: 
Pesticide residue standards 
The maximum concentration of residues of the fol-
lowing pesticides allowed in flue-cured or burley tobacco, 
expressed as parts by weight of the residue per one million 
parts by weight of the tobacco (PPM) are: 
CHLORDANE.....3.0 
DIBROMOCHLOROPROPANE (DBCP).....1.0 
DICAMBA (Temporary).... 5.0 
ENDRIN....0.1 
ETHYLENE DIBROMIDE (EDB)....0.1 
FORMOTHION.....0.5 
HEXACHLOROBENZENE (HCB)....0.1 
METHOXYCHLOR.....0.1 
TOXAPHENE.....0.3 
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2,4-D (Temporary).....5.0 
2,4,5-T.....0.1 
Sum of ALDRIN and DIELDRIN.....0.1 
Sum of CYPERMETHRIN and PERMETHRIN 
(Temporary).....3.0 
Sum of DDT, TDE (DDD), and DDE .....0.4 
Sum of HEPTACHLOR and HEPTACHLOR EP-
OXIDE.....0.1 
(F) MAXIMUM RESIDUE LIMITS.—The Ad-
ministrator shall adopt regulations within one 
year of the effective date of this Act to establish 
maximum residue limits for pesticides identified 
under subparagraph (E) but not included in the 
table of such subparagraph to account for the 
fact that weather and agronomic conditions will 
cause pesticides identified in subparagraph (E) 
to be detected in foreign-grown tobacco even 
where the farmer has not knowingly added such 
pesticide. 
(2) EXEMPTIONS; VARIANCES.— 
(A) PETITION.—Any person subject to any 
requirement prescribed under paragraph (1) 
may petition the Administrator for a permanent 
or temporary exemption or variance from such 
requirement. Such a petition shall be submitted 
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to the Administrator in such form and manner 
as the Administrator shall prescribe and shall— 
(i) in the case of a petition for an ex-
emption from a requirement, set forth the 
basis for the petitioner’s determination 
that compliance with the requirement is 
not required to assure that the tobacco 
product will be in compliance with this Act; 
(ii) in the case of a petition for a vari-
ance from a requirement, set forth the 
methods proposed to be used in, and the 
facilities and controls proposed to be used 
for, the manufacture, packing, and storage 
of the tobacco product in lieu of the meth-
ods, facilities, and controls prescribed by 
the requirement; and 
(iii) contain such other information as 
the Administrator shall prescribe. 
(B) REFERRAL TO THE TOBACCO PROD-
UCTS SCIENTIFIC ADVISORY COMMITTEE.—The 
Administrator may refer to the Tobacco Prod-
ucts Scientific Advisory Committee any petition 
submitted under subparagraph (A). The To-
bacco Products Scientific Advisory Committee 
shall report its recommendations to the Admin-
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istrator with respect to a petition referred to it 
within 60 days after the date of the petition’s 
referral. Within 60 days after— 
(i) the date the petition was submitted 
to the Administrator under subparagraph 
(A); or 
(ii) the day after the petition was re-
ferred to the Tobacco Products Scientific 
Advisory Committee, 
whichever occurs later, the Administrator shall 
by order either deny the petition or approve it. 
(C) APPROVAL.—The Administrator may 
approve— 
(i) a petition for an exemption for a 
tobacco product from a requirement if the 
Administrator determines that compliance 
with such requirement is not required to 
assure that the tobacco product will be in 
compliance with this Act; and 
(ii) a petition for a variance for a to-
bacco product from a requirement if the 
Administrator determines that the methods 
to be used in, and the facilities and con-
trols to be used for, the manufacture, 
packing, and storage of the tobacco prod-
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uct in lieu of the methods, facilities, and 
controls prescribed by the requirement are 
sufficient to assure that the tobacco prod-
uct will be in compliance with this Act. 
(D) CONDITIONS.—An order of the Admin-
istrator approving a petition for a variance shall 
prescribe such conditions respecting the meth-
ods used in, and the facilities and controls used 
for, the manufacture, packing, and storage of 
the tobacco product to be granted the variance 
under the petition as may be necessary to as-
sure that the tobacco product will be in compli-
ance with this Act. 
(E) HEARING.—After the issuance of an 
order under subparagraph (B) respecting a pe-
tition, the petitioner shall have an opportunity 
for an informal hearing on such order. 
(3) COMPLIANCE.—Compliance with require-
ments under this subsection shall not be required be-
fore the end of the 3-year period following the date 
of enactment of this Act. 
(f) RESEARCH AND DEVELOPMENT.—The Adminis-
trator may enter into contracts for research, testing, and 
demonstrations respecting tobacco products and may ob-
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grounds exist to support the actions required by the 
order, the Administrator shall vacate the order. 
(2) AMENDMENT OF ORDER TO REQUIRE RE-
CALL.— 
(A) IN GENERAL.—If, after providing an 
opportunity for an informal hearing under 
paragraph (1), the Administrator determines 
that the order should be amended to include a 
recall of the tobacco product with respect to 
which the order was issued, the Administrator 
shall, except as provided in subparagraph (B), 
amend the order to require a recall. The Ad-
ministrator shall specify a timetable in which 
the tobacco product recall will occur and shall 
require periodic reports to the Administrator 
describing the progress of the recall. 
(B) NOTICE.—An amended order under 
subparagraph (A)— 
(i) shall not include recall of a tobacco 
product from individuals; and 
(ii) shall provide for notice to persons 
subject to the risks associated with the use 
of such tobacco product. 
In providing the notice required by clause (ii), 
the Administrator may use the assistance of re-
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