SEC. 2. FINDINGS.
The Congress finds the following:
(1) The use of tobacco products by the Nation’s
children is a pediatric disease of epic proportions
that results in new generations of tobacco-dependent
children and adults.
(2) A consensus exists within the scientific and
medical communities that tobacco products are in-
herently dangerous and cause cancer, heart disease,
and other serious adverse health effects.
(3) Nicotine is addictive.
(4) Virtually all new users of tobacco products
are under the minimum legal age to purchase such
products.
(5) Tobacco advertising and marketing con-
tribute significantly to the use of nicotine-containing
tobacco products by adolescents.
(6) Because past efforts to restrict advertising
and marketing of tobacco products have failed ade-
quately to curb tobacco use by adolescents, com-
prehensive restrictions on the sale, promotion, and
distribution of such products are needed.
(7) Federal and State governments have lacked
the legal and regulatory authority and resources
they need to address comprehensively the public
health and societal problems caused by the use of to-
bacco products.
(8) Federal and State public health officials,
the public health community, and the public at large
recognize that the tobacco industry should be subject
to ongoing oversight.
(9) Under article I, section 8 of the Constitu-
tion, the Congress is vested with the responsibility
for regulating interstate commerce and commerce
with Indian tribes.
(10) The sale, distribution, marketing, adver-
tising, and use of tobacco products are activities in
and substantially affecting interstate commerce be-
cause they are sold, marketed, advertised, and dis-
tributed in interstate commerce on a nationwide
basis, and have a substantial effect on the Nation’s
economy.
(11) The sale, distribution, marketing, adver-
tising, and use of such products substantially affect
interstate commerce through the health care and
other costs attributable to the use of tobacco prod-
ucts.
(12) It is in the public interest for Congress to
adopt comprehensive public health legislation be-
cause of tobacco’s unique position in the Nation’s
history and economy and the need to prevent the
sale, distribution, marketing and advertising of to-
bacco products to persons under the minimum legal
age to purchase such products.
(13) The public interest requires a timely, fair,
equitable, and consistent result that will serve the
public interest by restricting throughout the Nation
the sale, distribution, marketing, and advertising of
tobacco products only to persons of legal age to pur-
chase such products.
(14) Public health authorities estimate that the
benefits to the Nation of enacting Federal legislation
to accomplish these goals would be significant in
human and economic terms.
(15) Reducing the use of tobacco by minors by
50 percent would prevent well over 60,000 early
deaths each year and save up to $43 billion each
year in reduced medical costs, improved productivity,
and the avoidance of premature deaths.
(16) Advertising, marketing, and promotion of
tobacco products have been especially directed to at-
tract young persons to use tobacco products and
these efforts have resulted in increased use of such
products by youth. Past efforts to oversee these ac-
tivities have not been successful in adequately pre-
venting such increased use.
(17) Tobacco advertising increases the size of
the tobacco market by increasing consumption of to-
bacco products including increasing tobacco use by
young people.
(18) Children are more influenced by tobacco
advertising than adults and they smoke the most ad-
vertised brands.
(19) Tobacco company documents indicate that
young people are an important and often crucial seg-
ment of the tobacco market.
(20) Advertising restrictions will have a positive
effect on the smoking rates of young people.
(21) Restrictions on advertising are necessary
to prevent unrestricted tobacco advertising from un-
dermining legislation prohibiting access to young
people.
(22) It is in the public interest for Congress to
adopt legislation to address the public health crisis
created by actions of the tobacco industry.
SEC. 3. DEFINITIONS.
(a) FEDERAL CIGARETTE LABELING AND ADVER-
TISING ACT.—Section 3(1) of the Federal Cigarette La-
beling and Advertising Act is amended—
(1) in subparagraph (A) by striking ‘‘and’’;
(2) in subparagraph (B) by striking the period
and inserting ‘‘; and’’; and
(3) by inserting the following new subparagraph
at the end thereof:
‘‘(C) any tobacco product, in any form, in-
cluding bidis and kreteks, if the tobacco in the
product is heated or burned and is functional in
the product, and the product, because of its ap-
pearance, the type of tobacco used in the filler,
or its packaging and labeling, is likely to be of-
fered to, or purchased by, consumers as a ciga-
rette or as roll-your-own tobacco.’’.
(b) THIS ACT.—In this Act:
(1) BRAND.—The term ‘‘brand’’ means a vari-
ety of tobacco product distinguished by the tobacco
used, tar content, nicotine content, flavoring used,
size, filtration, or packaging, logo, registered trade-
mark or brand name, identifiable pattern of colors,
or any combination of such attributes.
(2) CIGARETTE.—The term ‘‘cigarette’’ has the
meaning given that term by section 3(1) of the Fed-
eral Cigarette Labeling and Advertising Act (15
U.S.C. 1332(1)).
(3) CIGARETTE TOBACCO.—The term ‘‘cigarette
tobacco’’ means any product that consists of loose
tobacco that is intended for use by consumers in a
cigarette. Unless otherwise stated, the requirements
for cigarettes shall also apply to cigarette tobacco.
(4) COMMERCE.—The term ‘‘commerce’’ has
the meaning given that term by section 3(2) of the
Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1332(2)).
(5) CONSTITUENT.—The term ‘‘constituent’’ in
relation to cigarettes means any element of main-
stream or sidestream smoke.
(6) DISTRIBUTOR.—The term ‘‘distributor’’ as
regards a tobacco product means any person who
furthers the distribution of cigarette or smokeless to-
bacco, whether domestic or imported, at any point
from the original place of manufacture to the person
who sells or distributes the product to individuals for
personal consumption. Common carriers are not con-
sidered distributors for purposes of this Act.
(7) INGREDIENT.—The term ‘‘ingredient’’ in
relation to cigarettes or smokeless tobacco products
means any substance, chemical, or compound (other
than tobacco, water, or reconstituted tobacco sheet
made wholly from tobacco) added, or specified for
addition, by the manufacturer to the tobacco, paper,
or filter of a cigarette, or to the tobacco of a smoke-
less tobacco product, including flavorants, processing
aids, casing sauces, preservatives, and combustion
modifiers.
(8) MANUFACTURER.—The term ‘‘manufac-
turer’’ means any person who manufactures tobacco
products intended to be sold in the United States.
The term ‘‘manufacturer’’ shall include an importer
or other first purchaser for resale in the United
States of tobacco products manufactured outside of
the United States or tobacco products manufactured
in the United States but not intended for sale in the
United States.
(9) NICOTINE.—The term ‘‘nicotine’’ means the
chemical 
substance 
named 
3-(1-Methyl-2-
pyrrolidinyl) pyridine or C[10]H[14]N[2], including
any salt or complex of nicotine.
(10) PACKAGE.—The term ‘‘package’’ means a
pack, box, carton, or container of any kind or, if no
other container, any wrapping (including cello-
phane), in which cigarettes or smokeless tobacco are
offered for sale, sold, or otherwise distributed to con-
sumers.
(11) RETAILER.—The term ‘‘retailer’’ means
any person who sells cigarettes or smokeless tobacco
to individuals for personal consumption, or who op-
erates a facility where self-service displays of tobacco
products are permitted.
(12) SECRETARY.—Except where the context
otherwise requires, the term ‘‘Secretary’’ means the
Secretary of Health and Human Services.
(13) SMOKELESS TOBACCO.—The term ‘‘smoke-
less tobacco’’ means any product that consists of
cut, ground, powdered, or leaf tobacco and that is
intended to be placed in the oral or nasal cavity.
SEC. 4. AMENDMENT OF FEDERAL FOOD, DRUG, AND COS-
METIC ACT OF 1938.
(a) DEFINITION.—Section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321) is amended by
adding at the end the following:
‘‘(kk) The term ‘tobacco product’ means any
product made or derived from tobacco that is in-
tended for human consumption, including any com-
ponent, part, or accessory of a tobacco product (ex-
cept for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a
tobacco product).
‘‘(ll) The definitions contained in section 3 of
the National Youth Smoking Reduction Act shall
apply with respect to chapter IX.’’.
(b) FDA AUTHORITY OVER TOBACCO PRODUCTS.—
The Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.) is amended—
(1) by redesignating chapter IX as chapter X;
(2) by redesignating sections 901 through 907
as sections 1001 through 1007; and
(3) by inserting after section 803 the following:
‘‘CHAPTER IX—TOBACCO
PRODUCTS
‘‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.
‘‘(a) IN GENERAL.—Tobacco products shall be regu-
lated by the Secretary under this chapter and shall not
be subject to the provisions of chapter V, unless—
‘‘(1) such products are intended for use in the
diagnosis, cure, mitigation, treatment, or prevention
of 
disease 
(within 
the 
meaning 
of 
section
201(g)(1)(B) or section 201(h)(2)); or
‘‘(2) a health claim is made for such products
under section 201(g)(1)(C) or 201(h)(3), unless the
product is a reduced risk product pursuant to sec-
tion 912.
‘‘(b) APPLICABILITY.—This chapter shall apply to all
tobacco products subject to the provisions of part 897 of
title 21, Code of Federal Regulations, and to any other
tobacco products that the Secretary by regulation deems
to be subject to this chapter.
‘‘(c) SCOPE.—
‘‘(1) Nothing in this chapter shall be construed
to affect the Secretary’s authority over, or the regu-
lation of, products under this Act that are not to-
bacco products under chapter V of the Federal
Food, Drug and Cosmetic Act or any other chapter
of that Act.
‘‘(2) The provisions of this chapter shall not
apply to tobacco leaf that is not in the possession of
the manufacturer, or to the producers of tobacco
leaf, including tobacco growers, tobacco warehouses,
and tobacco grower cooperatives, nor shall any em-
ployee of the Food and Drug Administration have
any authority whatsoever to enter onto a farm
owned by a producer of tobacco leaf without the
written consent of such producer. Notwithstanding
any other provision of this subparagraph, if a pro-
ducer of tobacco leaf is also a tobacco product man-
ufacturer or controlled by a tobacco product manu-
facturer, the producer shall be subject to this chap-
ter in the producer’s capacity as a manufacturer.
Nothing in this chapter shall be construed to grant
the Secretary authority to promulgate regulations on
any matter that involves the production of tobacco
leaf or a producer thereof, other than activities by
a manufacturer affecting production. For purposes
of the preceding sentence, the term ‘controlled by’
means a member of the same controlled group of
corporations as that term is used in section 52(a)
of the Internal Revenue Code of 1986, or under
common control within the meaning of the regula-
tions promulgated under section 52(b) of such Code.
‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS.
‘‘A tobacco product shall be deemed to be adulterated
if—
‘‘(1) it consists in whole or in part of any filthy,
putrid, or decomposed substance, or is otherwise
contaminated by any poisonous or deleterious sub-
stance that may render the product more injurious
to health;
‘‘(2) it has been prepared, packed, or held
under insanitary conditions whereby it may have
been contaminated with filth, or whereby it may
have been rendered more injurious to health;
‘‘(3) its container is composed, in whole or in
part, of any poisonous or deleterious substance
which may render the contents more injurious to
health;
‘‘(4) it is, or purports to be or is represented
as, a tobacco product which is subject to a perform-
ance standard established under section 907 unless
such tobacco product is in all respects in conformity
with such standard;
‘‘(5) it is required by section 910(a) to have
premarket approval, is not exempt under section
906(f), and does not have an approved application in
effect;
‘‘(6) the methods used in, or the facilities or
controls used for, its manufacture, packing or stor-
age are not in conformity with applicable require-
ments under section 906(e)(1) or an applicable con-
dition prescribed by an order under section
906(e)(2); or
‘‘(7) it is a tobacco product for which an ex-
emption has been granted under section 906(f) for
investigational use and the person who was granted
such exemption or any investigator who uses such
tobacco product under such exemption fails to com-
ply with a requirement prescribed by or under such
section.
‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS.
‘‘(a) IN GENERAL.—A tobacco product shall be
deemed to be misbranded—
‘‘(1) if its labeling is false or misleading in any
particular;
‘‘(2) if in package form unless it bears a label
containing—
‘‘(A) the name and place of business of the
tobacco product manufacturer, packer, or dis-
tributor; and
‘‘(B) an accurate statement of the quantity
of the contents in terms of weight, measure, or
numerical count,
except that under subparagraph (B) of this para-
graph reasonable variations shall be permitted, and
exemptions as to small packages shall be established,
by regulations prescribed by the Secretary;
‘‘(3) if any word, statement, or other informa-
tion required by or under authority of this chapter
to appear on the label or labeling is not prominently
placed thereon with such conspicuousness (as com-
pared with other words, statements or designs in the
labeling) and in such terms as to render it likely to
be read and understood by the ordinary individual
under customary conditions of purchase and use;
‘‘(4) if it has an established name, unless its
label bears, to the exclusion of any other nonpropri-
etary name, its established name prominently print-
ed in type as required by the Secretary by regula-
tion;
‘‘(5) if the Secretary has issued regulations re-
quiring that its labeling bear adequate directions for
use, or adequate warnings against use by children,
that are necessary for the protection of users unless
its labeling conforms in all respects to such regula-
tions;
‘‘(6) if it was manufactured, prepared, propa-
gated, compounded, or processed in any State in an
establishment not duly registered under section
905(b), if it was not included in a list required by
section 905(i), if a notice or other information re-
specting it was not provided as required by such sec-
tion or section 905(j), or if it does not bear such
symbols from the uniform system for identification
of tobacco products prescribed under section 905(e)
as the Secretary by regulation requires;
‘‘(7) if, in the case of any tobacco product dis-
tributed or offered for sale in any State—
or the formula showing quantitatively each
ingredient of such tobacco product to the
extent required in regulations which shall
be issued by the Secretary after an oppor-
tunity for a hearing;
‘‘(9) unless, in the case of any tobacco product
distributed or offered for sale in any State, the man-
ufacturer, packer, or distributor thereof includes in
all advertisements the information required by sec-
tion 916(c);
‘‘(10) if it is a tobacco product subject to a per-
formance standard established under section 907,
unless it bears such labeling as may be prescribed in
such performance standard; or
‘‘(11) if there was a failure or refusal—
‘‘(A) to comply with any requirement pre-
scribed under section 904 or 908; or
‘‘(B) to furnish any material or informa-
tion required by or under section 909.
‘‘(b) 
PRIOR
APPROVAL
OF
STATEMENTS
ON
LABEL.—The Secretary may, by regulation, require prior
approval of statements made on the label of a tobacco
product. No regulation issued under this subsection may
require prior approval by the Secretary of the content of
any advertisement and no advertisement of a tobacco
product, published after the date of enactment of this Act
shall, with respect to the matters specified in this section
or covered by regulations issued hereunder, be subject to
the provisions of sections 12 through 15 of the Federal
Trade Commission Act (15 U.S.C. 52 through 55). This
subsection does not apply to any printed matter which the
Secretary determines to be labeling as defined in section
201(m).
‘‘SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE
SECRETARY.
‘‘(a) REQUIREMENT.—Not later than 6 months after
the date of enactment of this Act, each tobacco product
manufacturer or importer of tobacco products, or agents
thereof, shall submit to the Secretary the following infor-
mation:
‘‘(1) A listing of all tobacco ingredients, sub-
stances and compounds that are, on such date,
added by the manufacturer to the tobacco, paper, fil-
ter, or other component of each tobacco product by
brand and by quantity in each brand and subbrand.
‘‘(2) A description of the content, delivery, and
form of nicotine in each tobacco product measured
in milligrams of nicotine.
‘‘(3) All documents (including underlying sci-
entific information) relating to research activities,
and research findings, conducted, supported, or pos-
sessed by the manufacturer (or agents thereof) on
the health, behavioral, or physiologic effects of to-
bacco products, their constituents, ingredients, and
components, and tobacco additives, described in
paragraph (1).
‘‘(4) All documents (including underlying sci-
entific 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 reduction in risk to
health from tobacco products can occur upon the
employment of technology available or known to the
manufacturer.
‘‘(5) All documents (including underlying sci-
entific information) relating to marketing research
involving the use of tobacco products.
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.
‘‘(b) ANNUAL SUBMISSION.—A tobacco product man-
ufacturer or importer that is required to submit informa-
tion under subsection (a) shall update such information
on an annual basis under a schedule determined by the
Secretary.
‘‘(c) TIME FOR SUBMISSION.—
‘‘(1) NEW PRODUCTS.—At least 90 days prior
to the delivery for introduction into interstate com-
merce of a tobacco product not on the market on the
date of enactment of this chapter, the manufacturer
of such product shall provide the information re-
quired under subsection (a) and such product shall
be subject to the annual submission under sub-
section (b).
‘‘(2) MODIFICATION OF EXISTING PRODUCTS.—
If at any time a tobacco product manufacturer adds
to its tobacco products a new tobacco additive, in-
creases or decreases the quantity of an existing to-
bacco additive or the nicotine content, delivery, or
form, or eliminates a tobacco additive from any to-
bacco product, the manufacturer shall within 60
days of such action so advise the Secretary in writ-
ing and reference such modification in submissions
made under subsection (b).
‘‘SEC. 905. ANNUAL REGISTRATION.
‘‘(a) DEFINITIONS.—As used in this section—
‘‘(1) consistent with the provisions of section
901(c)(2), the term ‘manufacture, preparation,
compounding, or processing’ shall include repack-
aging or otherwise changing the container, wrapper,
or labeling of any tobacco product package in fur-
therance of the distribution of the tobacco product
from the original place of manufacture to the person
who makes final delivery or sale to the ultimate con-
sumer or user; and
‘‘(2) 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 cor-
porate officer and director, and the State of incorpo-
ration.
‘‘(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-
form system for the identification of tobacco products and
may require that persons who are required to list such
tobacco products under subsection (i) of this section shall
list such tobacco 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 one or more officers or employees duly
designated by the Secretary at least once in the 2-year
period beginning with the date of registration of such es-
tablishment under this section and at least once in every
successive 2-year period thereafter.
‘‘(h) FOREIGN ESTABLISHMENTS MAY REGISTER.—
Any establishment within any foreign country engaged in
the manufacture, preparation, compounding, or processing
of a tobacco product or tobacco products, may register
under this section under regulations promulgated by the
Secretary. Such regulations shall require such establish-
ment to provide the information required by subsection (i)
of this section and shall include provisions for registration
of any such establishment upon condition that adequate
and effective means are available, by arrangement with the
government of such foreign country or otherwise, to enable
the Secretary to determine from time to time whether to-
bacco products manufactured, prepared, compounded, or
processed in such establishment, if imported 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),
or (d) of this section shall, at the time of registra-
tion under any such subsection, file with the Sec-
retary 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 pre-
scribe and shall be accompanied by—
‘‘(A) in the case of a tobacco product con-
tained in the applicable list with respect to
which a performance standard has been estab-
lished 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 performance stand-
ard established under section 907, a brief state-
ment of the basis upon which the registrant
made such determination if the Secretary re-
quests 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
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) of this subsection. A list under this sub-
paragraph shall list a tobacco product by its es-
tablished 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-
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.—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 mar-
keted (other than for test marketing) in the United States
as of the date of enactment of this Act, as defined by the
Secretary by regulation shall, at least 90 days before mak-
ing such introduction or delivery, report to the Secretary
(in such form and manner as the Secretary shall by regu-
lation prescribe)—
‘‘(1) the basis for such person’s determination
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 the date of
this Act’s enactment, that is in compliance with the
requirements of this Act; and
‘‘(2) action taken by such person to comply
with the requirements under section 907 that are
applicable to the tobacco product.
‘‘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 applicability of the requirement to the tobacco product
has been changed by action taken under section 907, sec-
tion 910, or subsection (d) of this section, and any re-
quirement 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,
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, or 910, 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
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 thereof) 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
Secretary by a notice published in the Federal Reg-
ister stating good cause therefor.
‘‘(c) LIMITED
CONFIDENTIALITY
OF
INFORMA-
TION.—Any information reported to or otherwise obtained
by the Secretary or the Secretary’s representative under
section 904, 905, 907, 908, 909, 910, 912, 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) The Secretary may by regulation require
that a tobacco product be restricted to sale or dis-
tribution upon such conditions, including restrictions
on the access to, and the advertising and promotion
of, the tobacco product, as the Secretary may pre-
scribe in such regulation if the Secretary determines
that such regulation would be appropriate for the
prevention of, or decrease in, the use of tobacco
products by children under the age at which tobacco
products may be legally purchased. No such condi-
tion may require that the sale or distribution of a
tobacco product be limited to the written or oral au-
thorization of a practitioner licensed by law to pre-
scribe medical products.
‘‘(2) The label of a tobacco product shall bear
such appropriate statements of the restrictions re-
quired by a regulation under subsection (a) as the
Secretary may in such regulation prescribe.
‘‘(3) No restriction under paragraph (1) may
prohibit the sale of any tobacco product in face-to-
face transactions by a specific category of retail out-
lets.
‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE-
MENTS.—
‘‘(1) METHODS, FACILITIES, AND CONTROLS TO
CONFORM.—
‘‘(A) The Secretary may, in accordance
with subparagraph (B), prescribe regulations
requiring that the methods used in, and the fa-
cilities and controls used for, the manufacture,
pre-production design validation (including a
process to assess the performance of a tobacco
product), packing and storage of a tobacco
product, conform to current good manufac-
turing practice for an agricultural product, as
prescribed in such regulations, to assure that
the public health is protected and that the to-
bacco product is in compliance with this chap-
ter.
‘‘(B) The Secretary shall—
‘‘(i) before promulgating any regula-
tion under subparagraph (A), afford an ad-
visory committee an opportunity to submit
recommendations with respect to the regu-
lation 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 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) Any person subject to any require-
ment prescribed under paragraph (1) may peti-
tion the Secretary for a permanent or tem-
porary 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 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) The Secretary may refer to an advi-
sory committee any petition submitted under
subparagraph (A). The advisory committee
shall report its recommendations to the Sec-
retary 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 an advisory committee,
whichever occurs later, the Secretary shall by
order either deny the petition or approve it.
‘‘(C) 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 pre-
scribed by the requirement are sufficient to
assure that the tobacco product will be in
compliance with this chapter.
‘‘(D) An order of the Secretary approving
a petition for a variance shall prescribe such
conditions respecting the methods used in, and
the facilities and controls used for, the manu-
facture, packing, and storage of the tobacco
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) After the issuance of an order under
subparagraph (B) respecting a petition, the pe-
titioner shall have an opportunity for an infor-
mal hearing on such order.
‘‘(f) EXEMPTION FOR INVESTIGATIONAL USE.—The
Secretary may exempt tobacco products intended for in-
vestigational use from this chapter under such conditions
as the Secretary may prescribe by regulation.
‘‘(g) RESEARCH
AND DEVELOPMENT.—The Sec-
retary may enter into contracts for research, testing, and
demonstrations respecting tobacco products and may ob-
tain tobacco products for research, testing, and dem-
onstration purposes 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. PERFORMANCE STANDARDS.
‘‘(a) IN GENERAL.—
‘‘(1) FINDING REQUIRED.—The Secretary may
adopt performance standards for a tobacco product
if the Secretary finds that a performance 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, in-
cluding users and 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.
‘‘(2) CONTENT
OF
PERFORMANCE
STAND-
ARDS.—A performance standard established under
this section for a tobacco product—
‘‘(A) shall include provisions to provide
performance that is appropriate for the protec-
tion 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 harmful constituents or harmful
components of the product; or
‘‘(iii) relating to any other require-
ment under (B);
‘‘(B) shall, where necessary to be appro-
priate for the protection of the public health,
include—
‘‘(i) provisions respecting the con-
struction, components, ingredients, 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 performance characteristics of the
tobacco product; and
‘‘(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 required; and
‘‘(C) shall not render the tobacco product
unacceptable for adult consumption.
‘‘(3) PERIODIC
REEVALUATION
OF
PERFORM-
ANCE STANDARDS.—The Secretary shall provide for
periodic evaluation of performance standards estab-
lished under this section to determine whether such
standards should be changed to reflect new medical,
scientific, or other technological data. The Secretary
may provide for testing under paragraph (2) by any
person.
‘‘(4) INVOLVEMENT OF OTHER AGENCIES; IN-
FORMED
PERSONS.—In carrying out duties under
this section, the Secretary shall, to the maximum ex-
tent practicable—
‘‘(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 represent-
ative of scientific, professional, industry, or con-
sumer organizations who in the Secretary’s
judgment can make a significant contribution.
‘‘(b) ESTABLISHMENT OF STANDARDS.—
‘‘(1) NOTICE.—
‘‘(A) The Secretary shall publish in the
Federal Register a notice of proposed rule-
making for the establishment, amendment, or
revocation of any performance standard for a
tobacco product.
‘‘(B) A notice of proposed rulemaking for
the establishment or amendment of a perform-
ance standard for a tobacco product shall—
‘‘(i) set forth a finding with sup-
porting justification that the performance
standard 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 performance standard is intended to
reduce or eliminate; and
‘‘(iii) invite interested persons to sub-
mit an existing performance standard for
the tobacco product, including a draft or
proposed performance standard, for consid-
eration by the Secretary.
‘‘(C) A notice of proposed rulemaking for
the revocation of a performance standard shall
set forth a finding with supporting justification
that the performance standard is no longer nec-
essary to be appropriate for the protection of
the public health.
‘‘(D) The Secretary shall consider all infor-
mation submitted in connection with a proposed
standard, including information concerning the
countervailing effects of the performance stand-
ard on the health of adolescent tobacco users,
adult tobacco users, or non-tobacco users, such
as the creation of a significant demand for con-
traband or other tobacco products that do not
meet the requirements 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 protec-
tion of the public health.
‘‘(E) The Secretary shall provide for a
comment period of not less than 60 days.
‘‘(2) PROMULGATION.—
‘‘(A) After the expiration of the period for
comment on a notice of proposed rulemaking
published under paragraph (1) respecting a per-
formance standard and after consideration of
such comments and any report from an advi-
sory committee, the Secretary shall—
‘‘(i) promulgate a regulation estab-
lishing a performance standard and pub-
lish 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
standard together with the reasons for
such termination.
‘‘(B) A regulation establishing a perform-
ance standard shall set forth the date or dates
upon which the standard shall take effect, but
no such regulation may take effect before one
year after the date of its publication unless the
Secretary determines that an earlier effective
date is necessary for the protection of the pub-
lic health. Such date or dates shall be estab-
lished 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.—Be-
cause of the importance of any decision to issue a
regulation establishing a performance standard—
‘‘(A) eliminating all cigarettes, all smoke-
less tobacco products, or any similar class of to-
bacco products, or
‘‘(B) requiring the reduction of nicotine
yields of a tobacco product to zero,
Congress expressly reserves to itself the power to
make such a decision.
‘‘(4) AMENDMENT; REVOCATION.—
‘‘(A) The Secretary, upon the Secretary’s
own initiative or upon petition of an interested
person may by a regulation, promulgated in ac-
cordance with the requirements of paragraphs
(1) and (2)(B) of this subsection, amend or re-
voke a performance standard.
‘‘(B) The Secretary may declare a pro-
posed amendment of a performance 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 ef-
fective is in the public interest.
‘‘(5) REFERENCE TO ADVISORY COMMITTEE.—
The Secretary—
‘‘(A) may, on the Secretary’s own initia-
tive, refer a proposed regulation for the estab-
lishment, amendment, or revocation of a per-
formance standard; or
‘‘(B) shall, upon the request of an inter-
ested person which demonstrates good cause for
referral and which is made before the expiration
of the period for submission of comments on
such proposed regulation,
refer such proposed regulation to an advisory com-
mittee, for a report and recommendation with re-
spect to any matter involved in the proposed regula-
tion which requires the exercise of scientific judg-
ment. If a proposed regulation is referred under this
subparagraph to the advisory committee, the Sec-
retary shall provide the advisory committee with the
data and information on which such proposed regu-
lation is based. The advisory committee shall, within
60 days after the referral of a proposed regulation
and after independent study of the data and infor-
mation furnished to it by the Secretary and other
data and information before it, submit to the Sec-
retary a report and recommendation respecting such
regulation, together with all underlying data and in-
formation and a statement of the reason or basis for
the recommendation. A copy of such report and rec-
ommendation 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
delivered for introduction into interstate commerce
for commercial distribution presents a risk of sub-
stantial harm to the public health exceeding the
risks posed by tobacco products marketed before the
date of enactment of this Act; and
‘‘(2) notification under this subsection is nec-
essary to eliminate the unreasonable risk of such
harm and no more practicable means is available
under the provisions of this 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 properly receive such notification in order to elimi-
nate such risk. The Secretary may order notification by
any appropriate means, including public service announce-
ments. Before 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.—
Compliance with an order issued under this section shall
not relieve any person from liability under Federal or
State law.
‘‘(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 or-
dinarily contained in tobacco products on the market
that would cause serious, adverse health con-
sequences or death, the Secretary shall issue an
order requiring the appropriate person (including
the manufacturers, importers, distributors, or retail-
ers of the tobacco product) to immediately cease dis-
tribution of such tobacco product. The order shall
provide the person subject to the order with an op-
portunity for an informal hearing, to be held not
later than 10 days after the date of the issuance of
the order, on the actions required by the order and
on whether the order should be amended to require
a recall of such tobacco product. If, after providing
an opportunity for such a hearing, the Secretary de-
termines 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) 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 prod-
uct with respect to which the order was issued,
the Secretary shall, except as provided in sub-
paragraph (B), amend the order to require a
recall. The Secretary shall specify a timetable in
which the tobacco product recall will occur and
shall require periodic reports to the Secretary
describing the progress of the recall.
‘‘(B) An amended order under subpara-
graph (A)—
‘‘(i) shall not include recall of a to-
bacco product from individuals; and
‘‘(ii) shall provide for notice to per-
sons 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 retail-
ers and other persons who distributed such to-
bacco 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
provided by this subsection shall be in addition to
remedies 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 to-
bacco product is not adulterated or misbranded and to
otherwise protect public health. Regulations prescribed
under the preceding sentence—
‘‘(1) may require a tobacco product manufac-
turer or importer to report to the Secretary when-
ever the manufacturer or importer receives or other-
wise becomes aware of information that reasonably
suggests that one of its marketed tobacco products
may have caused or contributed to a serious unex-
pected adverse experience associated with the use of
the product or any significant increase in the fre-
quency of a serious, expected adverse product experi-
ence;
‘‘(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 protec-
tion 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
submission of a report or information to the Sec-
retary state the reason or purpose for such request
and identify to the fullest extent practicable such re-
port or information;
‘‘(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 in-
formation and identify to the fullest extent prac-
ticable such report or information; and
‘‘(6) may not require that the identity of any
patient or user be disclosed in records, reports, or
information required under this subsection unless re-
quired for the medical welfare of an individual, to
determine risks to public health of a tobacco prod-
uct, or to verify a record, report, or information sub-
mitted 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) of this subsection 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) Except as provided in paragraph (3), the
Secretary shall by regulation require a tobacco prod-
uct manufacturer or importer of a tobacco product
to report promptly to the Secretary any corrective
action taken or removal from the market of a to-
bacco 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 tobacco
product who undertakes a corrective action or removal
from the market of a tobacco product which is not re-
quired to be reported under this subsection shall keep a
record of such correction or removal.
‘‘(2) No report of the corrective action or re-
moval of a tobacco product may be required under
paragraph (1) if a report of the corrective action or
removal is required and has been submitted under
subsection (a) of this section.
‘‘SEC. 910. PREMARKET REVIEW OF CERTAIN TOBACCO
PRODUCTS.
‘‘(a) IN GENERAL.—
‘‘(1) PREMARKET APPROVAL REQUIRED.—Ap-
proval under this section of an application for pre-
market approval for any tobacco product, other than
a reduced risk product under section 912, that is not
commercially marketed (other than for test mar-
keting) in the United States as of the date of this
Act’s enactment, is required unless the manufacturer
has submitted a report under section 905(j), and the
Secretary has not suspended the distribution of such
product under this paragraph. Within 90 days of the
submission of a report under section 905(j), the Sec-
retary may by order suspend the distribution of the
tobacco product that is the subject of that report if
the Secretary determines that there is a reasonable
likelihood that the tobacco product is not substan-
tially equivalent to a tobacco product commercially
marketed (other than for test marketing) in the
United States as of the date of this Act’s enactment,
that is in compliance with the requirements of this
Act. If the Secretary fails to issue an order within
this 90-day period, then the tobacco product that is
the subject of that report shall be deemed to be sub-
stantially equivalent to a predicate tobacco product.
The issuance of an order under this paragraph shall
constitute final agency action for purposes of section
702 of title 5, the United States Code; provided,
that the Secretary may rescind or modify an order
issued under this paragraph at any time.
‘‘(2) SUBSTANTIALLY EQUIVALENT DEFINED.—
‘‘(A) For purposes of this section and sec-
tion 905(j), the term ‘substantially equivalent’
or ‘substantial equivalence’ mean, with respect
to the tobacco product being compared to the
predicate 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 reg-
ulate the product under this section be-
cause the product could not reasonably be
expected to increase the health risks to
consumers compared to a conventional to-
bacco product that is commercially mar-
keted in the United States and that is in
compliance with the requirements of this
Act.
‘‘(B) For purposes of subparagraph (A),
the term ‘characteristics’ means the materials,
ingredients, design, composition, heating source,
or other features of a tobacco product.
‘‘(C) A tobacco product may not be found
to be substantially equivalent to a predicate to-
bacco product that has been removed from the
market at the initiative of the Secretary or that
has been determined by a judicial order to be
misbranded or adulterated.
‘‘(3) HEALTH INFORMATION.—
‘‘(A) As part of a submission under section
905(j) respecting a tobacco product, the person
required to file a premarket notification under
such section shall provide an adequate summary
of any health information related to the tobacco
product or state that such information will be
made available upon request by any person.
‘‘(B) Any summary under subparagraph
(A) respecting a tobacco product shall contain
detailed information regarding data concerning
adverse health effects and shall be made avail-
able to the public by the Secretary within 30
days of the issuance of a determination that
such tobacco product is substantially equivalent
to another tobacco product. The communication
that such product is a reduced risk product
may comply with requirements prescribed by
the Secretary relating to such communication,
and the Secretary may require prior approval
of the communication, in each case in accord-
ance with section 912.
‘‘(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-
tions which have been made to show the health
risks of such tobacco product and whether such
tobacco product presents greater risk than
other tobacco products;
‘‘(B) a full statement of the components,
ingredients, and properties, and of the principle
or principles of operation, of such tobacco prod-
uct;
‘‘(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 per-
formance standard under section 907 which
would be applicable to any aspect of such to-
bacco product, and either adequate information
to show that such aspect of such tobacco prod-
uct fully meets such performance 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;
‘‘(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 Sec-
retary may require.
‘‘(2) REFERENCE TO ADVISORY COMMITTEE.—
Upon receipt of an application meeting the require-
ments set forth in paragraph (1), the Secretary—
‘‘(A) may, on the Secretary’s own initia-
tive; or
‘‘(B) shall, upon the request of an appli-
cant,
refer such application to an advisory committee and
for submission (within such period as the Secretary
may establish) of a report and recommendation re-
specting approval of the application, together with
all underlying data and the reasons or basis for the
recommendation.
‘‘(c) ACTION ON APPLICATION.—
‘‘(1) DEADLINE.—
‘‘(A) As promptly as possible, but in no
event later than 180 days after the receipt of
an application under subsection (b) of this sec-
tion, the Secretary, after considering the report
and recommendation submitted under para-
graph (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 one or more
grounds for denial specified in paragraph
(2) of this subsection apply.
‘‘(B) 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
tobacco product may be restricted under a regu-
lation 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 sub-
mitted to the Secretary as part of the application
and any other information before the Secretary with
respect to such tobacco product, the Secretary finds
that—
‘‘(A) there is a lack of a showing that per-
mitting such tobacco product to be marketed
would pose no greater risk to the public health
than currently marketed tobacco products;
‘‘(B) the methods used in, or the facilities
or controls used for, the manufacture, proc-
essing, 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 performance stand-
ard in effect under section 907, compliance with
which is a condition to approval of the applica-
tion, and there is a lack of adequate informa-
tion to justify the deviation from such standard.
‘‘(3) DENIAL INFORMATION.—Any denial of an
application shall, insofar as the Secretary determines
to be practicable, be accompanied by a statement in-
forming the applicant of the measures required to
place such application in approvable form (which
measures may include further research by the appli-
cant in accordance with one or more protocols pre-
scribed by the Secretary).
‘‘(4) BASIS FOR ACTION.—
‘‘(A) For purposes of paragraph (2)(A),
whether permitting a tobacco product to be
marketed would be appropriate for the protec-
tion of the public health shall, when appro-
priate, be determined on the basis of well-con-
trolled investigations, which may include one or
more clinical investigations by experts qualified
by training and experience to evaluate the to-
bacco product.
‘‘(B) If the Secretary determines that
there exists valid scientific evidence (other than
evidence derived from investigations 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
product, issue an order withdrawing approval of the
application if the Secretary finds—
‘‘(A) that the continued marketing of such
tobacco product poses greater risks to the pub-
lic health than other available products;
‘‘(B) that the application contained or was
accompanied by an untrue statement of a mate-
rial fact;
‘‘(C) that the applicant—
‘‘(i) has failed to establish a system
for maintaining records, or has repeatedly
or deliberately failed to maintain records
or to make reports, required by an applica-
ble regulation 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 be-
fore the Secretary with respect to such tobacco
product, evaluated together with the evidence
before the Secretary when the application was
approved, that the methods used in, or the fa-
cilities and controls used for, the manufacture,
processing, packing, or installation of such to-
bacco product do not conform with the require-
ments of section 906(e) and were not brought
into conformity with such requirements within a
reasonable time after receipt of written notice
from the Secretary of nonconformity;
‘‘(E) on the basis of new information be-
fore the Secretary, evaluated together with the
evidence before the Secretary when the applica-
tion was approved, that the labeling of such to-
bacco product, based on a fair evaluation of all
material facts, is false or misleading in any par-
ticular and was not corrected within a reason-
able time after receipt of written notice from
the Secretary of such fact; or
‘‘(F) on the basis of new information be-
fore the Secretary, evaluated together with the
evidence before the Secretary when the applica-
tion was approved, that such tobacco product is
not shown to conform in all respects to a per-
formance standard which is in effect under sec-
tion 907, compliance with which was a condi-
tion to approval of the application, and that
there is a lack of adequate information to jus-
tify the deviation from such standard.
‘‘(2) APPEAL.—The holder of an application
subject to an order issued under paragraph (1) with-
drawing approval of the application may, by petition
filed on or before the thirtieth day after the date
upon which he receives notice of such withdrawal,
obtain review thereof in accordance with subsection
(e) of this section.
‘‘(3) TEMPORARY SUSPENSION.—If, after pro-
viding an opportunity for an informal hearing, the
Secretary determines there is reasonable probability
that the continuation of distribution of a tobacco
product under an approved application would cause
serious, adverse health consequences or death, that
is greater than ordinarily caused by tobacco prod-
ucts on the market, the Secretary shall by order
temporarily suspend the approval of the application
approved under this section. If the Secretary issues
such an order, the Secretary shall proceed expedi-
tiously under paragraph (1) to withdraw such appli-
cation.
‘‘(e) SERVICE OF ORDER.—An order issued by the
Secretary under this section shall be served—
‘‘(1) in person by any officer or employee of the
department designated by the Secretary; or
‘‘(2) by mailing the order by registered mail or
certified mail addressed to the applicant at the ap-
plicant’s last known address in the records of the
Secretary.
‘‘SEC. 911. JUDICIAL REVIEW.
‘‘(a) IN GENERAL.—Not later than 30 days after—
‘‘(1) the promulgation of a regulation under
section 907 establishing, amending, or revoking a
performance standard for a tobacco product; or
‘‘(2) a denial of an application for approval
under section 910(c),
any person adversely affected by such regulation or order
may file a petition with the United States Court of Ap-
peals for the District of Columbia or for the circuit where-
in such person resides or has his principal place of busi-
ness for judicial review of such regulation or order. A copy
of the petition shall be transmitted by the clerk of the
court to the Secretary or other officer designated by the
Secretary for that purpose. The Secretary shall file in the
court the record of the proceedings on which the Secretary
based the Secretary’s regulation or order and each record
or order shall contain a statement of the reasons for its
issuance and the basis, on the record, for its issuance. For
purposes of this section, the term ‘record’ means all no-
tices and other matter published in the Federal Register
with respect to the regulation or order reviewed, all infor-
mation submitted to the Secretary with respect to such
regulation or order, proceedings of any panel or advisory
committee with respect to such regulation or order, any
hearing held with respect to such regulation or order, and
any other information identified by the Secretary, in the
administrative proceeding held with respect to such regu-
lation or order, as being relevant to such regulation or
order.
‘‘(b) COURT MAY ORDER SECRETARY TO MAKE AD-
DITIONAL FINDINGS.—If the petitioner applies to the
court for leave to adduce additional data, views, or argu-
ments respecting the regulation or order being reviewed
and shows to the satisfaction of the court that such addi-
tional data, views, or arguments are material and that
there were reasonable grounds for the petitioner’s failure
to adduce such data, views, or arguments in the pro-
ceedings before the Secretary, the court may order the
Secretary to provide additional opportunity for the oral
presentation of data, views, or arguments and for written
submissions. The Secretary may modify the Secretary’s
findings, or make new findings by reason of the additional
data, views, or arguments so taken and shall file with the
court such modified or new findings, and the Secretary’s
recommendation, if any, for the modification or setting
aside of the regulation or order being reviewed, with the
return of such additional data, views, or arguments.
‘‘(c) STANDARD OF REVIEW.—Upon the filing of the
petition under subsection (a) of this section for judicial
review of a regulation or order, the court shall have juris-
diction to review the regulation or order in accordance
with chapter 7 of title 5, United States Code, and to grant
appropriate relief, including interim relief, as provided in
such chapter. A regulation or order described in paragraph
(1) or (2) of subsection (a) of this section shall not be
affirmed if it is found to be unsupported by substantial
evidence on the record taken as a whole.
‘‘(d) FINALITY OF JUDGMENT.—The judgment of the
court affirming or setting aside, in whole or in part, any
regulation or order shall be final, subject to review by the
Supreme Court of the United States upon certiorari or
certification, as provided in section 1254 of title 28,
United States Code.
‘‘(e) OTHER REMEDIES.—The remedies provided for
in this section shall be in addition to and not in lieu of
any other remedies provided by law.
‘‘(f) REGULATIONS
AND ORDERS MUST RECITE
BASIS IN RECORD.—To facilitate judicial review under
this section or under any other provision of law of a regu-
lation or order issued under section 906, 907, 908, 909,
910, or 913, each such regulation or order shall contain
a statement of the reasons for its issuance and the basis,
in the record of the proceedings held in connection with
its issuance, for its issuance.
‘‘SEC. 912. REDUCED RISK TOBACCO PRODUCTS.
‘‘(a) REQUIREMENTS.—
‘‘(1) IN GENERAL.—For purposes of this sec-
tion, the term ‘reduced risk tobacco product’ means
a tobacco product designated by the Secretary under
paragraph (2).
‘‘(2) DESIGNATION.—
‘‘(A) IN
GENERAL.—A product may be
designated by the Secretary as a reduced risk
tobacco product if the Secretary finds that the
product is demonstrated to significantly reduce
harm to individuals caused by a tobacco prod-
uct and is otherwise appropriate to protect pub-
lic health, based on an application submitted by
the manufacturer of the product (or other re-
sponsible person) that—
‘‘(i)(I) demonstrates through testing
on animals and short-term human testing
that use of such product results in inges-
tion or inhalation of a substantially lower
yield of toxic substances than use of an-
other tobacco product in the same or dif-
ferent category as the proposed reduced
risk product; or
‘‘(II) 
contains 
scientific 
evidence
showing that use of such product results in
a substantially lower potential risk to
health in one or more specific respects
than use of another tobacco product in the