ignated by the Secretary as an additive that is not 
a human or animal carcinogen, or otherwise harmful 
to health under intended conditions of use, the man-
ufacturer shall within 60 days of such action so ad-
vise the Secretary in writing. 
‘‘(d) DATA LIST.— 
‘‘(1) IN
GENERAL.—Not later than 3 years 
after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, and annually 
thereafter, the Secretary shall publish in a format 
that is understandable and not misleading to a lay 
person, and place on public display (in a manner de-
termined by the Secretary) the list established under 
subsection (e). 
‘‘(2) CONSUMER
RESEARCH.—The Secretary 
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 Family Smoking 
Prevention and Tobacco Control Act, the Secretary 
shall submit to the appropriate committees of Con-
gress a report on the results of such research, to-
gether with recommendations on whether such publi-
cation should be continued or modified. 
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‘‘(e) DATA COLLECTION.—Not later than 12 months 
after the date of enactment of the Family Smoking Pre-
vention and Tobacco Control Act, the Secretary shall es-
tablish a list of harmful and potentially harmful constitu-
ents, including smoke constituents, to health in each to-
bacco product by brand and by quantity in each brand 
and subbrand. The Secretary shall publish a public notice 
requesting the submission by interested persons of sci-
entific and other information concerning the harmful and 
potentially harmful constituents in tobacco products and 
tobacco smoke. 
‘‘SEC. 905. ANNUAL REGISTRATION. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) 
MANUFACTURE, 
PREPARATION, 
COMPOUNDING, OR PROCESSING.—The term ‘manu-
facture, preparation, compounding, or processing’ 
shall include repackaging or otherwise changing the 
container, wrapper, or labeling of any tobacco prod-
uct package in furtherance of the distribution of the 
tobacco product from the original place of manufac-
ture to the person who makes final delivery or sale 
to the ultimate consumer or user. 
‘‘(2) NAME.—The term ‘name’ shall include in 
the case of a partnership the name of each partner 
and, in the case of a corporation, the name of each 
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corporate officer and director, and the State of in-
corporation. 
‘‘(b) REGISTRATION BY OWNERS AND OPERATORS.— 
On or before December 31 of each year every person who 
owns or operates any establishment in any State engaged 
in the manufacture, preparation, compounding, or proc-
essing of a tobacco product or tobacco products shall reg-
ister with the Secretary the name, places of business, and 
all such establishments of that person. 
‘‘(c) REGISTRATION OF NEW OWNERS AND OPERA-
TORS.—Every person upon first engaging in the manufac-
ture, preparation, compounding, or processing of a tobacco 
product or tobacco products in any establishment owned 
or operated in any State by that person shall immediately 
register with the Secretary that person’s name, place of 
business, and such establishment. 
‘‘(d) REGISTRATION OF ADDED ESTABLISHMENTS.— 
Every person required to register under subsection (b) or 
(c) shall immediately register with the Secretary any addi-
tional establishment which that person owns or operates 
in any State and in which that person begins the manufac-
ture, preparation, compounding, or processing of a tobacco 
product or tobacco products. 
‘‘(e) UNIFORM
PRODUCT
IDENTIFICATION
SYS-
TEM.—The Secretary may by regulation prescribe a uni-
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form system for the identification of tobacco products and 
may require that persons who are required to list such 
tobacco products under subsection (i) shall list such to-
bacco products in accordance with such system. 
‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA-
TION.—The Secretary shall make available for inspection, 
to any person so requesting, any registration filed under 
this section. 
‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB-
LISHMENTS.—Every establishment in any State registered 
with the Secretary under this section shall be subject to 
inspection under section 704, and every such establish-
ment engaged in the manufacture, compounding, or proc-
essing of a tobacco product or tobacco products shall be 
so inspected by 1 or more officers or employees duly des-
ignated by the Secretary at least once in the 2-year period 
beginning with the date of registration of such establish-
ment under this section and at least once in every succes-
sive 2-year period thereafter. 
‘‘(h) FOREIGN
ESTABLISHMENTS
SHALL
REG-
ISTER.—Any establishment within any foreign country en-
gaged in the manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco products, shall 
register under this section under regulations promulgated 
by the Secretary. Such regulations shall require such es-
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tablishment to provide the information required by sub-
section (i) of this section and shall include provisions for 
registration of any such establishment upon condition that 
adequate and effective means are available, by arrange-
ment with the government of such foreign country or oth-
erwise, to enable the Secretary to determine from time to 
time whether tobacco products manufactured, prepared, 
compounded, or processed in such establishment, if im-
ported or offered for import into the United States, shall 
be refused admission on any of the grounds set forth in 
section 801(a). 
‘‘(i) REGISTRATION INFORMATION.— 
‘‘(1) PRODUCT LIST.—Every person who reg-
isters with the Secretary under subsection (b), (c), 
(d), or (h) shall, at the time of registration under 
any such subsection, file with the Secretary a list of 
all tobacco products which are being manufactured, 
prepared, compounded, or processed by that person 
for commercial distribution and which has not been 
included in any list of tobacco products filed by that 
person with the Secretary under this paragraph or 
paragraph (2) before such time of registration. Such 
list shall be prepared in such form and manner as 
the Secretary may prescribe and shall be accom-
panied by— 
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‘‘(A) in the case of a tobacco product con-
tained in the applicable list with respect to 
which a tobacco product standard has been es-
tablished under section 907 or which is subject 
to section 910, a reference to the authority for 
the marketing of such tobacco product and a 
copy of all labeling for such tobacco product; 
‘‘(B) in the case of any other tobacco prod-
uct contained in an applicable list, a copy of all 
consumer information and other labeling for 
such tobacco product, a representative sampling 
of advertisements for such tobacco product, 
and, upon request made by the Secretary for 
good cause, a copy of all advertisements for a 
particular tobacco product; and 
‘‘(C) if the registrant filing a list has de-
termined that a tobacco product contained in 
such list is not subject to a tobacco product 
standard established under section 907, a brief 
statement of the basis upon which the reg-
istrant made such determination if the Sec-
retary requests such a statement with respect 
to that particular tobacco product. 
‘‘(2) BIANNUAL REPORT OF ANY CHANGE IN 
PRODUCT LIST.—Each person who registers with the 
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Secretary under this section shall report to the Sec-
retary once during the month of June of each year 
and once during the month of December of each 
year the following: 
‘‘(A) A list of each tobacco product intro-
duced by the registrant for commercial distribu-
tion which has not been included in any list 
previously filed by that person with the Sec-
retary under this subparagraph or paragraph 
(1). A list under this subparagraph shall list a 
tobacco product by its established name and 
shall be accompanied by the other information 
required by paragraph (1). 
‘‘(B) If since the date the registrant last 
made a report under this paragraph that person 
has discontinued the manufacture, preparation, 
compounding, or processing for commercial dis-
tribution of a tobacco product included in a list 
filed under subparagraph (A) or paragraph (1), 
notice of such discontinuance, the date of such 
discontinuance, and the identity of its estab-
lished name. 
‘‘(C) If since the date the registrant re-
ported under subparagraph (B) a notice of dis-
continuance that person has resumed the manu-
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facture, preparation, compounding, or proc-
essing for commercial distribution of the to-
bacco product with respect to which such notice 
of discontinuance was reported, notice of such 
resumption, the date of such resumption, the 
identity of such tobacco product by established 
name, and other information required by para-
graph (1), unless the registrant has previously 
reported such resumption to the Secretary 
under this subparagraph. 
‘‘(D) Any material change in any informa-
tion previously submitted under this paragraph 
or paragraph (1). 
‘‘(j) REPORT PRECEDING INTRODUCTION OF CER-
TAIN
SUBSTANTIALLY-EQUIVALENT
PRODUCTS
INTO 
INTERSTATE COMMERCE.— 
‘‘(1) IN
GENERAL.—Each person who is re-
quired to register under this section and who pro-
poses to begin the introduction or delivery for intro-
duction into interstate commerce for commercial dis-
tribution of a tobacco product intended for human 
use that was not commercially marketed (other than 
for test marketing) in the United States as of June 
1, 2003, shall, at least 90 days prior to making such 
introduction or delivery, report to the Secretary (in 
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such form and manner as the Secretary shall pre-
scribe)— 
‘‘(A) the basis for such person’s determina-
tion that the tobacco product is substantially 
equivalent, within the meaning of section 910, 
to a tobacco product commercially marketed 
(other than for test marketing) in the United 
States as of June 1, 2003, that is in compliance 
with the requirements of this Act; and 
‘‘(B) action taken by such person to com-
ply with the requirements under section 907 
that are applicable to the tobacco product. 
‘‘(2) APPLICATION TO CERTAIN POST JUNE 1, 
2003 PRODUCTS.—A report under this subsection for 
a tobacco product that was first introduced or deliv-
ered for introduction into interstate commerce for 
commercial distribution in the United States after 
June 1, 2003, and prior to the date that is 15 
months after the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act shall 
be submitted to the Secretary not later than 15 
months after such date of enactment. 
‘‘(3) EXEMPTIONS.— 
‘‘(A) IN GENERAL.—The Secretary may by 
regulation, exempt from the requirements of 
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this subsection tobacco products that are modi-
fied by adding or deleting a tobacco additive, or 
increasing or decreasing the quantity of an ex-
isting tobacco additive, if the Secretary deter-
mines that— 
‘‘(i) such modification would be a 
minor modification of a tobacco product 
authorized for sale under this Act; 
‘‘(ii) a report under this subsection is 
not necessary to ensure that permitting the 
tobacco product to be marketed would be 
appropriate for protection of the public 
health; and 
‘‘(iii) an exemption is otherwise appro-
priate. 
‘‘(B) REGULATIONS.—Not later than 9 
months after the date of enactment of the Fam-
ily Smoking Prevention and Tobacco Control 
Act, the Secretary shall issue regulations to im-
plement this paragraph. 
‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 
OF TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—Any requirement established by 
or under section 902, 903, 905, or 909 applicable to a 
tobacco product shall apply to such tobacco product until 
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the applicability of the requirement to the tobacco product 
has been changed by action taken under section 907, sec-
tion 910, section 911, or subsection (d) of this section, 
and any requirement established by or under section 902, 
903, 905, or 909 which is inconsistent with a requirement 
imposed on such tobacco product under section 907, sec-
tion 910, section 911, 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 under section 
907, 908, 909, 910, or 911 or under this section, any 
other notice which is published in the Federal Register 
with respect to any other action taken under any such sec-
tion and which states the reasons for such action, and 
each publication of findings required to be made in con-
nection 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 
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the Secretary by a notice published in the Federal 
Register stating good cause therefore. 
‘‘(c) LIMITED
CONFIDENTIALITY
OF
INFORMA-
TION.—Any information reported to or otherwise obtained 
by the Secretary or the Secretary’s representative under 
section 903, 904, 907, 908, 909, 910, 911, or 704, 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 chapter, or when relevant in any proceeding under 
this chapter. 
‘‘(d) RESTRICTIONS.— 
‘‘(1) IN GENERAL.—The Secretary may by reg-
ulation require restrictions on the sale and distribu-
tion of a tobacco product, including restrictions on 
the access to, and the advertising and promotion of, 
the tobacco product, if the Secretary determines that 
such regulation would be appropriate for the protec-
tion of the public health. The Secretary may by reg-
ulation impose restrictions on the advertising and 
promotion of a tobacco product consistent with and 
to full extent permitted by the first amendment to 
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the Constitution. The finding as to whether such 
regulation would be appropriate for the protection of 
the public health shall be determined with respect to 
the risks and benefits to the population as a whole, 
including users and non-users of the tobacco prod-
uct, 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. 
No such regulation may require that the sale or dis-
tribution of a tobacco product be limited to the writ-
ten or oral authorization of a practitioner licensed 
by law to prescribe medical products. 
‘‘(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 Secretary may in such 
regulation prescribe. 
‘‘(3) LIMITATIONS.— 
‘‘(A) IN GENERAL.—No restrictions under 
paragraph (1) may— 
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‘‘(i) prohibit the sale of any tobacco 
product in face-to-face transactions by a 
specific category of retail outlets; or 
‘‘(ii) establish a minimum age of sale 
of tobacco products to any person older 
than 18 years of age. 
‘‘(B) MATCHBOOKS.—For purposes of any 
regulations issued by the Secretary, matchbooks 
of conventional size containing not more than 
20 paper matches, and which are customarily 
given away for free with the purchase of to-
bacco products shall be considered as adult 
written publications which shall be permitted to 
contain advertising. Notwithstanding the pre-
ceding sentence, if the Secretary finds that such 
treatment of matchbooks is not appropriate for 
the protection of the public health, the Sec-
retary may determine by regulation that match-
books shall not be considered adult written pub-
lications. 
‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE-
MENTS.— 
‘‘(1) METHODS, FACILITIES, AND CONTROLS TO 
CONFORM.— 
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‘‘(A) IN GENERAL.—The Secretary may, in 
accordance with subparagraph (B), prescribe 
regulations (which may differ based on the type 
of tobacco product involved) requiring that the 
methods used in, and the facilities and controls 
used for, the manufacture, pre-production de-
sign 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, as pre-
scribed in such regulations, to assure that the 
public health is protected and that the tobacco 
product is in compliance with this chapter. 
Good manufacturing practices may include the 
testing of raw tobacco for pesticide chemical 
residues regardless of whether a tolerance for 
such chemical residues has been established. 
‘‘(B) 
REQUIREMENTS.—The 
Secretary 
shall— 
‘‘(i) before promulgating any regula-
tion under subparagraph (A), afford the 
Tobacco Products Scientific Advisory Com-
mittee an opportunity to submit rec-
ommendations with respect to the regula-
tion proposed to be promulgated; 
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‘‘(ii) before promulgating any regula-
tion under subparagraph (A), afford oppor-
tunity for an oral hearing; 
‘‘(iii) provide the advisory committee a 
reasonable time to make its recommenda-
tion with respect to proposed regulations 
under subparagraph (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-
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. 
‘‘(2) EXEMPTIONS; VARIANCES.— 
‘‘(A) PETITION.—Any person subject to 
any requirement prescribed under paragraph 
(1) may petition the Secretary for a permanent 
or temporary exemption or variance from such 
requirement. Such a petition shall be submitted 
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to the Secretary in such form and manner as 
the Secretary 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 
chapter; 
‘‘(ii) in the case of a petition for a 
variance 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 Secretary shall prescribe. 
‘‘(B) REFERRAL TO THE TOBACCO PROD-
UCTS SCIENTIFIC ADVISORY COMMITTEE.—The 
Secretary may refer to the Tobacco Products 
Scientific Advisory Committee any petition sub-
mitted under subparagraph (A). The Tobacco 
Products Scientific Advisory Committee shall 
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report its recommendations to the Secretary 
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 sub-
mitted to the Secretary under subpara-
graph (A); or 
‘‘(ii) the day after the petition was re-
ferred to the Tobacco Products Scientific 
Advisory Committee, whichever occurs 
later, the Secretary shall by order either 
deny the petition or approve it. 
‘‘(C) APPROVAL.—The Secretary may ap-
prove— 
‘‘(i) a petition for an exemption for a 
tobacco product from a requirement if the 
Secretary determines that compliance with 
such requirement is not required to assure 
that the tobacco product will be in compli-
ance with this chapter; and 
‘‘(ii) a petition for a variance for a to-
bacco product from a requirement if the 
Secretary determines that the methods to 
be used in, and the facilities and controls 
to be used for, the manufacture, packing, 
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