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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 pre-
viously filed by that person with the Secretary
under this subparagraph or paragraph (1). A
list under this subparagraph shall list a tobacco
product by its established name and shall be ac-
companied 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 reported
under subparagraph (B) a notice of discontinu-
ance that person has resumed the manufacture,
preparation, compounding, or processing for
commercial distribution of the tobacco product
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with respect to which such notice of discontinu-
ance was reported, notice of such resumption, the
date of such resumption, the identity of such to-
bacco product by established name, and other in-
formation required by paragraph (1), unless the
registrant has previously reported such resump-
tion 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 CERTAIN
SUBSTANTIALLY-EQUIVALENT
PRODUCTS
INTO
INTER-
STATE COMMERCE.—
‘‘(1) IN GENERAL.—Each person who is required
to register under this section and who proposes to
begin the introduction or delivery for introduction
into interstate commerce for commercial distribution
of a tobacco product intended for human use that was
not commercially marketed (other than for test mar-
keting) 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 such form and
manner as the Secretary shall prescribe)—
‘‘(A) the basis for such person’s determina-
tion that the tobacco product is substantially
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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 comply
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 to-
bacco product that was first introduced or delivered
for introduction into interstate commerce for commer-
cial 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 Preven-
tion 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 this
subsection tobacco products that are modified by
adding or deleting a tobacco additive, or increas-
ing or decreasing the quantity of an existing to-
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bacco additive, if the Secretary determines
that—
‘‘(i) such modification would be a
minor modification of a tobacco product au-
thorized 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 ap-
propriate 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 Family
Smoking Prevention and Tobacco Control Act,
the Secretary shall issue regulations to imple-
ment 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 the appli-
cability of the requirement to the tobacco product has been
changed by action taken under section 907, section 910, sec-
tion 911, or subsection (d) of this section, and any require-
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ment established by or under section 902, 903, 905, or 909
which is inconsistent with a requirement imposed on such
tobacco product under section 907, section 910, section 911,
or subsection (d) of this section shall not apply to such to-
bacco 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 re-
spect to any other action taken under any such section and
which states the reasons for such action, and each publica-
tion 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 no-
tice or findings is based; and
‘‘(2) the period within which interested persons
may present their comments on the notice or findings
(including the need therefore) orally or in writing,
which period shall be at least 60 days but may not
exceed 90 days unless the time is extended by the Sec-
retary by a notice published in the Federal Register
stating good cause therefore.
‘‘(c) LIMITED CONFIDENTIALITY OF INFORMATION.—
Any information reported to or otherwise obtained by the
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Secretary or the Secretary’s representative under section
903, 904, 907, 908, 909, 910, 911, or 704, or under sub-
section (e) or (f) of this section, which is exempt from disclo-
sure 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 offi-
cers 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 regu-
lation require restrictions on the sale and distribution
of a tobacco product, including restrictions on the ac-
cess to, and the advertising and promotion of, the to-
bacco product, if the Secretary determines that such
regulation would be appropriate for the protection of
the public health. The Secretary may by regulation
impose restrictions on the advertising and promotion
of a tobacco product consistent with and to full extent
permitted by the first amendment to 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 bene-
fits to the population as a whole, including users and
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non-users of the tobacco product, and taking into
account—
‘‘(A) the increased or decreased likelihood
that existing users of tobacco products will stop
using such products; and
‘‘(B) the increased or decreased likelihood
that those who do not use tobacco products will
start using such products.
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 statements
of the restrictions required by a regulation under sub-
section (a) as the Secretary may in such regulation
prescribe.
‘‘(3) LIMITATIONS.—
‘‘(A) IN GENERAL.—No restrictions under
paragraph (1) may—
‘‘(i) prohibit the sale of any tobacco
product in face-to-face transactions by a
specific category of retail outlets; or
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‘‘(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 tobacco prod-
ucts shall be considered as adult written publica-
tions which shall be permitted to contain adver-
tising. Notwithstanding the preceding sentence, if
the Secretary finds that such treatment of match-
books is not appropriate for the protection of the
public health, the Secretary may determine by
regulation that matchbooks shall not be consid-
ered adult written publications.
‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE-
MENTS.—
‘‘(1) METHODS, FACILITIES, AND CONTROLS TO
CONFORM.—
‘‘(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
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HR 4520 EAS
used for, the manufacture, pre-production design
validation (including a process to assess the per-
formance of a tobacco product), packing and
storage of a tobacco product, conform to current
good manufacturing practice, as prescribed in
such regulations, to assure that the public health
is protected and that the tobacco product is in
compliance with this chapter. Good manufac-
turing 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 To-
bacco Products Scientific Advisory Com-
mittee an opportunity to submit rec-
ommendations with respect to the regulation
proposed to be promulgated;
‘‘(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 recommendation
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with respect to proposed regulations under
subparagraph (A); and
‘‘(iv) in establishing the effective date
of a regulation promulgated under this sub-
section, take into account the differences in
the manner in which the different types of
tobacco products have historically been pro-
duced, the financial resources of the dif-
ferent tobacco product manufacturers, and
the state of their existing manufacturing fa-
cilities, and shall provide 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 re-
quirement. Such a petition shall be submitted 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 re-
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quired 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 fa-
cilities and controls proposed to be used for,
the manufacture, packing, and storage of
the tobacco product in lieu of the methods,
facilities, and controls prescribed by the re-
quirement; 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 Sci-
entific Advisory Committee any petition sub-
mitted under subparagraph (A). The Tobacco
Products Scientific Advisory Committee shall re-
port 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 subparagraph
(A); or
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‘‘(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
approve—
‘‘(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, and
storage of the tobacco product in lieu of the
methods, controls, and facilities prescribed
by the requirement are sufficient to assure
that the tobacco product will be in compli-
ance with this chapter.
‘‘(D) CONDITIONS.—An order of the Sec-
retary approving a petition for a variance shall
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prescribe such conditions respecting the methods
used in, and the facilities and controls used for,
the manufacture, packing, and storage of the to-
bacco product to be granted the variance under
the petition as may be necessary to assure that
the tobacco product will be in compliance with
this chapter.
‘‘(E) HEARING.—After the issuance of an
order under subparagraph (B) respecting a peti-
tion, 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 period ending 3 years after the date of enact-
ment of the Family Smoking Prevention and Tobacco
Control Act.
‘‘(f) RESEARCH AND DEVELOPMENT.—The Secretary
may enter into contracts for research, testing, and dem-
onstrations respecting tobacco products and may obtain to-
bacco products for research, testing, and demonstration pur-
poses without regard to section 3324(a) and (b) of title 31,
United States Code, and section 5 of title 41, United States
Code.
‘‘SEC. 907. TOBACCO PRODUCT STANDARDS.
‘‘(a) IN GENERAL.—
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‘‘(1) SPECIAL RULE FOR CIGARETTES.—A ciga-
rette or any of its component parts (including the to-
bacco, filter, or paper) shall not contain, as a con-
stituent (including a smoke constituent) or additive,
an artificial or natural flavor (other than tobacco or
menthol) or an herb or spice, including strawberry,
grape, orange, clove, cinnamon, pineapple, vanilla,
coconut, licorice, cocoa, chocolate, cherry, or coffee,
that is a characterizing flavor of the tobacco product
or tobacco smoke. Nothing in this subparagraph shall
be construed to limit the Secretary’s authority to take
action under this section or other sections of this Act
applicable to menthol or any artificial or natural fla-
vor, herb, or spice not specified in this paragraph.
‘‘(2) REVISION
OF
TOBACCO
PRODUCT
STAND-
ARDS.—The Secretary may revise the tobacco product
standards in paragraph (1) in accordance with sub-
section (b).
‘‘(3) TOBACCO PRODUCT STANDARDS.—The Sec-
retary may adopt tobacco product standards in addi-
tion to those in paragraph (1) if the Secretary finds
that a tobacco product standard is appropriate for the
protection of the public health. This finding shall be
determined with respect to the risks and benefits to
the population as a whole, including users and non-
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users of the tobacco product, and taking into
account—
‘‘(A) the increased or decreased likelihood
that existing users of tobacco products will stop
using such products; and
‘‘(B) the increased or decreased likelihood
that those who do not use tobacco products will
start using such products.
‘‘(4) CONTENT
OF
TOBACCO
PRODUCT
STAND-
ARDS.—A tobacco product standard established under
this section for a tobacco product—
‘‘(A) shall include provisions that are ap-
propriate for the protection of the public health,
including provisions, where appropriate—
‘‘(i) for the reduction of nicotine yields
of the product;
‘‘(ii) for the reduction or elimination
of other constituents, including smoke con-
stituents, or harmful components of the
product; or
‘‘(iii) relating to any other require-
ment under (B);
‘‘(B) shall, where appropriate for the protec-
tion of the public health, include—
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‘‘(i) provisions respecting the construc-
tion, components, ingredients, additives,
constituents, including smoke constituents,
and properties of the tobacco product;
‘‘(ii) provisions for the testing (on a
sample basis or, if necessary, on an indi-
vidual basis) of the tobacco product;
‘‘(iii) provisions for the measurement
of the tobacco product characteristics of the
tobacco product;
‘‘(iv) provisions requiring that the re-
sults of each or of certain of the tests of the
tobacco product required to be made under
clause (ii) show that the tobacco product is
in conformity with the portions of the
standard for which the test or tests were re-
quired; and
‘‘(v) a provision requiring that the sale
and distribution of the tobacco product be
restricted but only to the extent that the sale
and distribution of a tobacco product may
be restricted under a regulation under sec-
tion 906(d); and
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‘‘(C) shall, where appropriate, require the
use and prescribe the form and content of label-
ing for the proper use of the tobacco product.
‘‘(5) PERIODIC
RE-EVALUATION
OF
TOBACCO
PRODUCT STANDARDS.—The Secretary shall provide
for periodic evaluation of tobacco product standards
established under this section to determine whether
such standards should be changed to reflect new med-
ical, scientific, or other technological data. The Sec-
retary may provide for testing under paragraph
(4)(B) by any person.
‘‘(6) INVOLVEMENT
OF
OTHER
AGENCIES; IN-
FORMED PERSONS.—In carrying out duties under this
section, the Secretary 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
‘‘(C) 
invite 
appropriate 
participation,
through joint or other conferences, workshops, or
other means, by informed persons representative
of scientific, professional, industry, agricultural,
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or consumer organizations who in the Secretary’s
judgment can make a significant contribution.
‘‘(b) ESTABLISHMENT OF STANDARDS.—
‘‘(1) NOTICE.—
‘‘(A) IN
GENERAL.—The Secretary shall
publish in the Federal Register a notice of pro-
posed rulemaking for the establishment, amend-
ment, or revocation of any tobacco product
standard.
‘‘(B) REQUIREMENTS OF NOTICE.—A notice
of proposed rulemaking for the establishment or
amendment of a tobacco product standard for a
tobacco product shall—
‘‘(i) set forth a finding with supporting
justification that the tobacco product stand-
ard is appropriate for the protection of the
public health;
‘‘(ii) set forth proposed findings with
respect to the risk of illness or injury that
the tobacco product standard is intended to
reduce or eliminate; and
‘‘(iii) invite interested persons to sub-
mit an existing tobacco product standard
for the tobacco product, including a draft or
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proposed tobacco product standard, for con-
sideration by the Secretary.
‘‘(C) STANDARD.—Upon a determination by
the Secretary that an additive, constituent (in-
cluding smoke constituent), or other component
of the product that is the subject of the proposed
tobacco product standard is harmful, it shall be
the burden of any party challenging the proposed
standard to prove that the proposed standard
will not reduce or eliminate the risk of illness or
injury.
‘‘(D) FINDING.—A notice of proposed rule-
making for the revocation of a tobacco product
standard shall set forth a finding with sup-
porting justification that the tobacco product
standard is no longer appropriate for the protec-
tion of the public health.
‘‘(E) CONSIDERATION BY SECRETARY.—The
Secretary shall consider all information sub-
mitted in connection with a proposed standard,
including information concerning the counter-
vailing effects of the tobacco product standard on
the health of adolescent tobacco users, adult to-
bacco users, or non-tobacco users, such as the cre-
ation of a significant demand for contraband or
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other tobacco products that do not meet the re-
quirements of this chapter and the significance of
such demand, and shall issue the standard if the
Secretary determines that the standard would be
appropriate for the protection of the public
health.
‘‘(F) COMMENT.—The Secretary shall pro-
vide for a comment period of not less than 60
days.
‘‘(2) PROMULGATION.—
‘‘(A) IN GENERAL.—After the expiration of
the period for comment on a notice of proposed
rulemaking published under paragraph (1) re-
specting a tobacco product standard and after
consideration of such comments and any report
from the Tobacco Products Scientific Advisory
Committee, the Secretary shall—
‘‘(i) promulgate a regulation estab-
lishing a tobacco product standard and
publish in the Federal Register findings on
the matters referred to in paragraph (1); or
‘‘(ii) publish a notice terminating the
proceeding for the development of the stand-
ard together with the reasons for such ter-
mination.
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‘‘(B) EFFECTIVE
DATE.—A regulation es-
tablishing a tobacco product standard shall set
forth the date or dates upon which the standard
shall take effect, but no such regulation may take
effect before 1 year after the date of its publica-
tion unless the Secretary determines that an ear-
lier effective date is necessary for the protection
of the public health. Such date or dates shall be
established so as to minimize, consistent with the
public health, economic loss to, and disruption or
dislocation of, domestic and international trade.
‘‘(3) POWER RESERVED TO CONGRESS.—Because
of the importance of a decision of the Secretary to
issue a regulation establishing a tobacco product
standard—
‘‘(A) banning all cigarettes, all smokeless to-
bacco products, all little cigars, all cigars other
than little cigars, all pipe tobacco, or all roll
your own tobacco products; or
‘‘(B) requiring the reduction of nicotine
yields of a tobacco product to zero,
Congress expressly reserves to itself such power.
‘‘(4) AMENDMENT; REVOCATION.—
‘‘(A) AUTHORITY.—The Secretary, upon the
Secretary’s own initiative or upon petition of an
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interested person may by a regulation, promul-
gated in accordance with the requirements of
paragraphs (1) and (2)(B), amend or revoke a
tobacco product standard.
‘‘(B) EFFECTIVE
DATE.—The Secretary
may declare a proposed amendment of a tobacco
product standard to be effective on and after its
publication in the Federal Register and until the
effective date of any final action taken on such
amendment if the Secretary determines that
making it so effective is in the public interest.
‘‘(5) REFERENCE
TO
ADVISORY
COMMITTEE.—
The Secretary may—
‘‘(A) on the Secretary’s own initiative, refer
a proposed regulation for the establishment,
amendment, or revocation of a tobacco product
standard; or
‘‘(B) upon the request of an interested per-
son which demonstrates good cause for referral
and which is made before the expiration of the
period for submission of comments on such pro-
posed regulation,
refer such proposed regulation to the Tobacco Products Sci-
entific Advisory Committee, for a report and recommenda-
tion with respect to any matter involved in the proposed
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regulation which requires the exercise of scientific judgment.
If a proposed regulation is referred under this paragraph
to the Tobacco Products Scientific Advisory Committee, the
Secretary shall provide the advisory committee with the
data and information on which such proposed regulation
is based. The Tobacco Products Scientific Advisory Com-
mittee shall, within 60 days after the referral of a proposed
regulation and after independent study of the data and in-
formation furnished to it by the Secretary and other data
and information before it, submit to the Secretary a report
and recommendation respecting such regulation, together
with all underlying data and information and a statement
of the reason or basis for the recommendation. A copy of
such report and recommendation shall be made public by
the Secretary.
‘‘SEC. 908. NOTIFICATION AND OTHER REMEDIES.
‘‘(a) NOTIFICATION.—If the Secretary 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 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
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under the provisions of this chapter (other than this
section) to eliminate such risk,
the Secretary may issue such order as may be necessary
to assure that adequate notification is provided in an ap-
propriate form, by the persons and means best suited under
the circumstances involved, to all persons who should prop-
erly receive such notification in order to eliminate such
risk. The Secretary may order notification by any appro-
priate means, including public service announcements. Be-
fore issuing an order under this subsection, the Secretary
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
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 Secretary finds that
there is a reasonable probability that a tobacco prod-
uct contains a manufacturing or other defect not ordi-
narily contained in tobacco products on the market
that would cause serious, adverse health consequences
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or death, the Secretary shall issue an order requiring
the appropriate person (including the manufacturers,
importers, distributors, or retailers of the tobacco
product) to immediately cease distribution of such to-
bacco product. The order shall provide the person sub-
ject 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 re-
quired by the order and on whether the order should
be amended to require a recall of such tobacco prod-
uct. If, after providing an opportunity for such a
hearing, the Secretary determines that inadequate
grounds exist to support the actions required by the
order, the Secretary 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 Secretary determines that the
order should be amended to include a recall of
the tobacco product with respect to which the
order was issued, the Secretary shall, except as
provided in subparagraph (B), amend the order
to require a recall. The Secretary shall specify a
timetable in which the tobacco product recall will
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occur and shall require periodic reports to the
Secretary describing the progress of the recall.
‘‘(B) NOTICE.—An amended order under
subparagraph (A)—
‘‘(i) shall not include recall of a to-
bacco 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 Secretary may use the assistance of retailers
and other persons who distributed such tobacco
product. If a significant number of such persons
cannot be identified, the Secretary shall notify
such persons under section 705(b).
‘‘(3) REMEDY NOT EXCLUSIVE.—The remedy pro-
vided by this subsection shall be in addition to rem-
edies provided by subsection (a) of this section.
‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD-
UCTS.
‘‘(a) IN GENERAL.—Every person who is a tobacco
product manufacturer or importer of a tobacco product
shall establish and maintain such records, make such re-
ports, and provide such information, as the Secretary may
by regulation reasonably require to assure that such tobacco
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product is not adulterated or misbranded and to otherwise
protect public health. Regulations prescribed under the pre-
ceding sentence—
‘‘(1) may require a tobacco product manufac-
turer or importer to report to the Secretary whenever
the manufacturer or importer receives or otherwise be-
comes aware of information that reasonably suggests
that one of its marketed tobacco products may have
caused or contributed to a serious unexpected adverse
experience associated with the use of the product or
any significant increase in the frequency of a serious,
expected adverse product experience;
‘‘(2) shall require reporting of other significant
adverse tobacco product experiences as determined by
the Secretary to be necessary to be reported;
‘‘(3) shall not impose requirements unduly bur-
densome to a tobacco product manufacturer or im-
porter, taking into account the cost of complying with
such requirements and the need for the protection of
the public health and the implementation of this
chapter;
‘‘(4) when prescribing the procedure for making
requests for reports or information, shall require that
each request made under such regulations for submis-
sion of a report or information to the Secretary state
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the reason or purpose for such request and identify to
the fullest extent practicable such report or informa-
tion;
‘‘(5) when requiring submission of a report or
information to the Secretary, shall state the reason or
purpose for the submission of such report or informa-
tion and identify to the fullest extent practicable such
report or information; and
‘‘(6) may not require that the identity of any
patient or user be disclosed in records, reports, or in-
formation required under this subsection unless re-
quired for the medical welfare of an individual, to de-
termine risks to public health of a tobacco product, or
to verify a record, report, or information submitted
under this chapter.
In prescribing regulations under this subsection, the Sec-
retary shall have due regard for the professional ethics of
the medical profession and the interests of patients. The
prohibitions of paragraph (6) continue to apply to records,
reports, and information concerning any individual who
has been a patient, irrespective of whether or when he ceases
to be a patient.
‘‘(b) REPORTS OF REMOVALS AND CORRECTIONS.—
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), the Secretary shall by regulation require a
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tobacco product manufacturer or importer of a to-
bacco product to report promptly to the Secretary any
corrective action taken or removal from the market of
a tobacco product undertaken by such manufacturer
or importer if the removal or correction was
undertaken—
‘‘(A) to reduce a risk to health posed by the
tobacco product; or
‘‘(B) to remedy a violation of this chapter
caused by the tobacco product which may present
a risk to health.
A tobacco product manufacturer or importer of a to-
bacco product who undertakes a corrective action or
removal from the market of a tobacco product which
is not required to be reported under this subsection
shall keep a record of such correction or removal.
‘‘(2) EXCEPTION.—No report of the corrective ac-
tion or removal of a tobacco product may be required
under paragraph (1) if a report of the corrective ac-
tion or removal is required and has been submitted
under subsection (a).
‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TO-
BACCO PRODUCTS.
‘‘(a) IN GENERAL.—
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‘‘(1) NEW
TOBACCO
PRODUCT
DEFINED.—For
purposes of this section the term ‘new tobacco product’
means—
‘‘(A) any tobacco product (including those
products in test markets) that was not commer-
cially marketed in the United States as of June
1, 2003; or
‘‘(B) any modification (including a change
in design, any component, any part, or any con-
stituent, including a smoke constituent, or in the
content, delivery or form of nicotine, or any
other additive or ingredient) of a tobacco product
where the modified product was commercially
marketed in the United States after June 1,
2003.
‘‘(2) PREMARKET APPROVAL REQUIRED.—
‘‘(A) NEW PRODUCTS.—Approval under this
section of an application for premarket approval
for any new tobacco product is required unless—
‘‘(i) the manufacturer has submitted a
report under section 905(j); and
‘‘(ii) the Secretary has issued an order
that the tobacco product—
‘‘(I) is substantially equivalent to
a tobacco product commercially mar-
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keted (other than for test marketing) in
the United States as of June 1, 2003;
and
‘‘(II)(aa) is in compliance with
the requirements of this Act; or
‘‘(bb) is exempt from the require-
ments of section 905(j) pursuant to a
regulation 
issued 
under 
section
905(j)(3).
‘‘(B) APPLICATION TO CERTAIN POST JUNE
1, 2003 PRODUCTS.—Subparagraph (A) shall not
apply to a tobacco product—
‘‘(i) that was first introduced or deliv-
ered for introduction into interstate com-
merce for commercial distribution in the
United States after June 1, 2003, and prior
to the date that is 15 months after the date
of enactment of the Family Smoking Pre-
vention and Tobacco Control Act; and
‘‘(ii) for which a report was submitted
under section 905(j) within such 15-month
period, until the Secretary issues an order
that the tobacco product is not substantially
equivalent.
‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.—
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‘‘(A) IN GENERAL.—In this section and sec-
tion 905(j), the terms ‘substantially equivalent’
or ‘substantial equivalence’ mean, with respect to
the tobacco product being compared to the predi-
cate tobacco product, that the Secretary by order
has found that the tobacco product—
‘‘(i) has the same characteristics as the
predicate tobacco product; or
‘‘(ii) has different characteristics and
the information submitted contains infor-
mation, including clinical data if deemed
necessary by the Secretary, that dem-
onstrates that it is not appropriate to regu-
late the product under this section because
the product does not raise different ques-
tions of public health.
‘‘(B) CHARACTERISTICS.—In subparagraph
(A), the term ‘characteristics’ means the mate-
rials, ingredients, design, composition, heating
source, or other features of a tobacco product.
‘‘(C) LIMITATION.—A tobacco product may
not be found to be substantially equivalent to a
predicate tobacco product that has been removed
from the market at the initiative of the Secretary
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or that has been determined by a judicial order
to be misbranded or adulterated.
‘‘(4) HEALTH INFORMATION.—
‘‘(A) SUMMARY.—As part of a submission
under section 905(j) respecting a tobacco prod-
uct, the person required to file a premarket noti-
fication under such section shall provide an ade-
quate summary of any health information re-
lated to the tobacco product or state that such in-
formation will be made available upon request
by any person.
‘‘(B) REQUIRED INFORMATION.—Any sum-
mary under subparagraph (A) respecting a to-
bacco product shall contain detailed information
regarding data concerning adverse health effects
and shall be made available to the public by the
Secretary within 30 days of the issuance of a de-
termination that such tobacco product is sub-
stantially equivalent to another tobacco product.
‘‘(b) APPLICATION.—
‘‘(1) CONTENTS.—An application for premarket
approval shall contain—
‘‘(A) full reports of all information, pub-
lished or known to, or which should reasonably
be known to, the applicant, concerning investiga-
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tions which have been made to show the health
risks of such tobacco product and whether such
tobacco product presents less risk than other to-
bacco products;
‘‘(B) a full statement of the components, in-
gredients, additives, and properties, and of the
principle or principles of operation, of such to-
bacco product;
‘‘(C) a full description of the methods used
in, and the facilities and controls used for, the
manufacture, processing, and, when relevant,
packing and installation of, such tobacco prod-
uct;
‘‘(D) an identifying reference to any tobacco
product standard under section 907 which would
be applicable to any aspect of such tobacco prod-
uct, and either adequate information to show
that such aspect of such tobacco product fully
meets such tobacco product standard or adequate
information to justify any deviation from such
standard;
‘‘(E) such samples of such tobacco product
and of components thereof as the Secretary may
reasonably require;
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‘‘(F) specimens of the labeling proposed to
be used for such tobacco product; and
‘‘(G) such other information relevant to the
subject matter of the application as the Secretary
may require.
‘‘(2) REFERENCE TO TOBACCO PRODUCTS SCI-
ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an
application meeting the requirements set forth in
paragraph (1), the Secretary—
‘‘(A) may, on the Secretary’s own initiative;
or
‘‘(B) may, upon the request of an applicant,
refer such application to the Tobacco Products Sci-
entific Advisory Committee for reference and for sub-
mission (within such period as the Secretary may es-
tablish) of a report and recommendation respecting
approval of the application, together with all under-
lying data and the reasons or basis for the rec-
ommendation.
‘‘(c) ACTION ON APPLICATION.—
‘‘(1) DEADLINE.—
‘‘(A) IN
GENERAL.—As promptly as pos-
sible, but in no event later than 180 days after
the receipt of an application under subsection
(b), the Secretary, after considering the report
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and recommendation submitted under paragraph
(2) of such subsection, shall—
‘‘(i) issue an order approving the ap-
plication if the Secretary finds that none of
the grounds for denying approval specified
in paragraph (2) of this subsection applies;
or
‘‘(ii) deny approval of the application
if the Secretary finds (and sets forth the
basis for such finding as part of or accom-
panying such denial) that 1 or more
grounds for denial specified in paragraph
(2) of this subsection apply.
‘‘(B) RESTRICTIONS
ON
SALE
AND
DIS-
TRIBUTION.—An order approving an application
for a tobacco product may require as a condition
to such approval that the sale and distribution
of the tobacco product be restricted but only to
the extent that the sale and distribution of a to-
bacco product may be restricted under a regula-
tion under section 906(d).
‘‘(2) DENIAL OF APPROVAL.—The Secretary shall
deny approval of an application for a tobacco product
if, upon the basis of the information submitted to the
Secretary as part of the application and any other
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information before the Secretary with respect to such
tobacco product, the Secretary finds that—
‘‘(A) there is a lack of a showing that per-
mitting such tobacco product to be marketed
would be appropriate for the protection of the
public health;
‘‘(B) the methods used in, or the facilities or
controls used for, the manufacture, processing, or
packing of such tobacco product do not conform
to the requirements of section 906(e);
‘‘(C) based on a fair evaluation of all mate-
rial facts, the proposed labeling is false or mis-
leading in any particular; or
‘‘(D) such tobacco product is not shown to
conform in all respects to a tobacco product
standard in effect under section 907, compliance
with which is a condition to approval of the ap-
plication, and there is a lack of adequate infor-
mation to justify the deviation from such stand-
ard.
‘‘(3) DENIAL INFORMATION.—Any denial of an
application shall, insofar as the Secretary determines
to be practicable, be accompanied by a statement in-
forming the applicant of the measures required to
place such application in approvable form (which
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measures may include further research by the appli-
cant in accordance with 1 or more protocols pre-
scribed by the Secretary).
‘‘(4) BASIS FOR FINDING.—For purposes of this
section, the finding as to whether approval of a to-
bacco product is appropriate for the protection of the
public health shall be determined with respect to the
risks and benefits to the population as a whole, in-
cluding users and nonusers of the tobacco product,
and taking into account—
‘‘(A) the increased or decreased likelihood
that existing users of tobacco products will stop
using such products; and
‘‘(B) the increased or decreased likelihood
that those who do not use tobacco products will
start using such products.
‘‘(5) BASIS FOR ACTION.—
‘‘(A) INVESTIGATIONS.—For purposes of
paragraph (2)(A), whether permitting a tobacco
product to be marketed would be appropriate for
the protection of the public health shall, when
appropriate, be determined on the basis of well-
controlled investigations, which may include 1 or
more clinical investigations by experts qualified
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by training and experience to evaluate the to-
bacco product.
‘‘(B) OTHER EVIDENCE.—If the Secretary
determines that there exists valid scientific evi-
dence (other than evidence derived from inves-
tigations described in subparagraph (A)) which
is sufficient to evaluate the tobacco product the
Secretary may authorize that the determination
for purposes of paragraph (2)(A) be made on the
basis of such evidence.
‘‘(d) WITHDRAWAL AND TEMPORARY SUSPENSION.—
‘‘(1) IN GENERAL.—The Secretary shall, upon
obtaining, where appropriate, advice on scientific
matters from an advisory committee, and after due
notice and opportunity for informal hearing to the
holder of an approved application for a tobacco prod-
uct, issue an order withdrawing approval of the ap-
plication if the Secretary finds—
‘‘(A) that the continued marketing of such
tobacco product 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—
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‘‘(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 reg-
ulation under section 909;
‘‘(ii) has refused to permit access to, or
copying or verification of, such records as
required by section 704; or
‘‘(iii) has not complied with the re-
quirements of section 905;
‘‘(D) on the basis of new information before
the Secretary with respect to such tobacco prod-
uct, evaluated together with the evidence before
the Secretary when the application was ap-
proved, that the methods used in, or the facilities
and controls used for, the manufacture, proc-
essing, packing, or installation of such tobacco
product do not conform with the requirements of
section 906(e) and were not brought into con-
formity with such requirements within a reason-
able time after receipt of written notice from the
Secretary of nonconformity;
‘‘(E) on the basis of new information before
the Secretary, evaluated together with the evi-
dence before the Secretary when the application