competition. Its focus is on those marketplace prac-
tices that deceive or mislead consumers, and those 
that give some competitors an unfair advantage. Its 
mission is to regulate activities in the marketplace. 
Neither the Federal Trade Commission nor any 
other Federal agency except the Food and Drug Ad-
ministration possesses the scientific expertise needed 
to implement effectively all provisions of the Family 
Smoking Prevention and Tobacco Control Act. 
(46) If manufacturers state or imply in commu-
nications directed to consumers through the media 
or through a label, labeling, or advertising, that a to-
bacco product is approved or inspected by the Food 
and Drug Administration or complies with Food and 
Drug Administration standards, consumers are like-
ly to be confused and misled. Depending upon the 
particular language used and its context, such a 
statement could result in consumers being misled 
into believing that the product is endorsed by the 
Food and Drug Administration for use or in con-
sumers being misled about the harmfulness of the 
product because of such regulation, inspection, ap-
proval, or compliance. 
(47) In August 2006 a United States district 
court judge found that the major United States cig-
arette companies continue to target and market to 
youth. USA v. Philip Morris, USA, Inc., et al. (Civil 
Action No. 99–2496 (GK), August 17, 2006). 
(48) In August 2006 a United States district 
court judge found that the major United States cig-
arette companies dramatically increased their adver-
tising and promotional spending in ways that en-
courage youth to start smoking subsequent to the 
signing of the Master Settlement Agreement in 
1998. USA v. Philip Morris, USA, Inc., et al. (Civil 
Action No. 99–2496 (GK), August 17, 2006). 
(49) In August 2006 a United States district 
court judge found that the major United States cig-
arette companies have designed their cigarettes to 
precisely control nicotine delivery levels and provide 
doses of nicotine sufficient to create and sustain ad-
diction while also concealing much of their nicotine- 
related research. USA v. Philip Morris, USA, Inc., 
et al. (Civil Action No. 99–2496 (GK), August 17, 
2006). 
SEC. 3. PURPOSE. 
The purposes of this Act are— 
(1) to provide authority to the Food and Drug 
Administration to regulate tobacco products under 
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.), by recognizing it as the primary 
Federal regulatory authority with respect to the 
manufacture, marketing, and distribution of tobacco 
products as provided for in this Act; 
(2) to ensure that the Food and Drug Adminis-
tration has the authority to address issues of par-
ticular concern to public health officials, especially 
the use of tobacco by young people and dependence 
on tobacco; 
(3) to authorize the Food and Drug Adminis-
tration to set national standards controlling the 
manufacture of tobacco products and the identity, 
public disclosure, and amount of ingredients used in 
such products; 
(4) to provide new and flexible enforcement au-
thority to ensure that there is effective oversight of 
the tobacco industry’s efforts to develop, introduce, 
and promote less harmful tobacco products; 
(5) to vest the Food and Drug Administration 
with the authority to regulate the levels of tar, nico-
tine, and other harmful components of tobacco prod-
ucts; 
(6) in order to ensure that consumers are better 
informed, to require tobacco product manufacturers 
to disclose research which has not previously been
made available, as well as research generated in the 
future, relating to the health and dependency effects 
or safety of tobacco products; 
(7) to continue to permit the sale of tobacco 
products to adults in conjunction with measures to 
ensure that they are not sold or accessible to under-
age purchasers; 
(8) to impose appropriate regulatory controls on 
the tobacco industry; 
(9) to promote cessation to reduce disease risk 
and the social costs associated with tobacco-related 
diseases; and 
(10) to strengthen legislation against illicit 
trade in tobacco products. 
SEC. 4. SCOPE AND EFFECT. 
(a) INTENDED EFFECT.—Nothing in this Act (or an 
amendment made by this Act) shall be construed to— 
(1) establish a precedent with regard to any 
other industry, situation, circumstance, or legal ac-
tion; or 
(2) affect any action pending in Federal, State, 
or Tribal court, or any agreement, consent decree, or 
contract of any kind. 
(b) AGRICULTURAL ACTIVITIES.—The provisions of 
this Act (or an amendment made by this Act) which au-
thorize the Secretary to take certain actions with regard 
to tobacco and tobacco products shall not be construed to 
affect any authority of the Secretary of Agriculture under 
existing law regarding the growing, cultivation, or curing 
of raw tobacco. 
(c) REVENUE ACTIVITIES.—The provisions of this 
Act (or an amendment made by this Act) which authorize 
the Secretary to take certain actions with regard to to-
bacco products shall not be construed to affect any author-
ity of the Secretary of the Treasury under chapter 52 of 
the Internal Revenue Code of 1986. 
SEC. 5. SEVERABILITY. 
If any provision of this Act, the amendments made 
by this Act, or the application of any provision of this Act 
to any person or circumstance is held to be invalid, the 
remainder of this Act, the amendments made by this Act, 
and the application of the provisions of this Act to any 
other person or circumstance shall not be affected and 
shall continue to be enforced to the fullest extent possible.
TITLE I—AUTHORITY OF THE 
FOOD AND DRUG ADMINIS-
TRATION 
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND 
COSMETIC ACT. 
(a) DEFINITION OF TOBACCO PRODUCTS.—Section 
201 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321) is amended by adding at the end the fol-
lowing: 
‘‘(rr)(1) The term ‘tobacco product’ means any prod-
uct made or derived from tobacco that is intended for 
human consumption, including any component, part, or 
accessory of a tobacco product (except for raw materials 
other than tobacco used in manufacturing a component, 
part, or accessory of a tobacco product). 
‘‘(2) The term ‘tobacco product’ does not mean an 
article that is a drug under subsection (g)(1), a device 
under subsection (h), or a combination product described 
in section 503(g). 
‘‘(3) The products described in paragraph (2) shall 
be subject to chapter V of this Act. 
‘‘(4) A tobacco product shall not be marketed in com-
bination with any other article or product regulated under 
this Act (including a drug, biologic, food, cosmetic, med-
ical device, or a dietary supplement).’’.
‘‘(6) COUNTERFEIT TOBACCO PRODUCT.—The 
term ‘counterfeit tobacco product’ means a tobacco 
product (or the container or labeling of such a prod-
uct) that, without authorization, bears the trade-
mark, trade name, or other identifying mark, im-
print, or device, or any likeness thereof, of a tobacco 
product listed in a registration under section 
905(i)(1). 
‘‘(7) DISTRIBUTOR.—The term ‘distributor’ as 
regards a tobacco product means any person who 
furthers the distribution of a tobacco product, 
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 considered 
distributors for purposes of this chapter. 
‘‘(8) ILLICIT TRADE.—The term ‘illicit trade’ 
means any practice or conduct prohibited by law 
which relates to production, shipment, receipt, pos-
session, distribution, sale, or purchase of tobacco 
products including any practice or conduct intended 
to facilitate such activity. 
‘‘(9) INDIAN
COUNTRY.—The term ‘Indian 
country’ has the meaning given such term in section 
1151 of title 18, United States Code.
‘‘(10) INDIAN TRIBE.—The term ‘Indian tribe’ 
has the meaning given such term in section 4(e) of 
the Indian Self-Determination and Education Assist-
ance Act. 
‘‘(11) LITTLE CIGAR.—The term ‘little cigar’ 
means a product that— 
‘‘(A) is a tobacco product; and 
‘‘(B) meets the definition of the term ‘little 
cigar’ in section 3(7) of the Federal Cigarette 
Labeling and Advertising Act. 
‘‘(12) 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. 
‘‘(13) 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 a tobacco product is offered for 
sale, sold, or otherwise distributed to consumers. 
‘‘(14) RETAILER.—The term ‘retailer’ means 
any person, government, or entity who sells tobacco 
products to individuals for personal consumption, or 
who operates a facility where self-service displays of 
tobacco products are permitted.
‘‘(15) ROLL-YOUR-OWN
TOBACCO.—The term 
‘roll-your-own tobacco’ means any tobacco product 
which, because of its appearance, type, packaging, or 
labeling, is suitable for use and likely to be offered 
to, or purchased by, consumers as tobacco for mak-
ing cigarettes. 
‘‘(16) SMALL
TOBACCO
PRODUCT
MANUFAC-
TURER.—The term ‘small tobacco product manufac-
turer’ means a tobacco product manufacturer that 
employs fewer than 350 employees. For purposes of 
determining the number of employees of a manufac-
turer under the preceding sentence, the employees of 
a manufacturer are deemed to include the employees 
of each entity that controls, is controlled by, or is 
under common control with such manufacturer. 
‘‘(17) SMOKE CONSTITUENT.—The term ‘smoke 
constituent’ means any chemical or chemical com-
pound in mainstream or sidestream tobacco smoke 
that either transfers from any component of the cig-
arette to the smoke or that is formed by the combus-
tion or heating of tobacco, additives, or other compo-
nent of the tobacco product. 
‘‘(18) 
SMOKELESS
TOBACCO.—The 
term 
‘smokeless tobacco’ means any tobacco product that 
consists of cut, ground, powdered, or leaf tobacco
and that is intended to be placed in the oral or nasal 
cavity. 
‘‘(19) STATE; TERRITORY.—The terms ‘State’ 
and ‘Territory’ shall have the meanings given to 
such terms in section 201. 
‘‘(20) TOBACCO
PRODUCT
MANUFACTURER.— 
The term ‘tobacco product manufacturer’ means any 
person, including any repacker or relabeler, who— 
‘‘(A) manufactures, fabricates, assembles, 
processes, or labels a tobacco product; or 
‘‘(B) imports a finished tobacco product 
for sale or distribution in the United States. 
‘‘(21) TOBACCO WAREHOUSE.— 
‘‘(A) Subject to subparagraphs (B) and 
(C), the term ‘tobacco warehouse’ includes any 
person— 
‘‘(i) who— 
‘‘(I) removes foreign material 
from tobacco leaf through nothing 
other than a mechanical process; 
‘‘(II) humidifies tobacco leaf with 
nothing other than potable water in 
the form of steam or mist; or 
‘‘(III) de-stems, dries, and packs 
tobacco leaf for storage and shipment;
‘‘(ii) who performs no other actions 
with respect to tobacco leaf; and 
‘‘(iii) who provides to any manufac-
turer to whom the person sells tobacco all 
information related to the person’s actions 
described in clause (i) that is necessary for 
compliance with this Act. 
‘‘(B) The term ‘tobacco warehouse’ ex-
cludes any person who— 
‘‘(i) reconstitutes tobacco leaf; 
‘‘(ii) is a manufacturer, distributor, or 
retailer of a tobacco product; or 
‘‘(iii) applies any chemical, additive, 
or substance to the tobacco leaf other than 
potable water in the form of steam or mist. 
‘‘(C) The definition of the term ‘tobacco 
warehouse’ in subparagraph (A) shall not apply 
to the extent to which the Secretary determines, 
through rulemaking, that regulation under this 
chapter of the actions described in such sub-
paragraph is appropriate for the protection of 
the public health. 
‘‘(22) UNITED
STATES.—The term ‘United 
States’ means the 50 States of the United States of 
America and the District of Columbia, the Common-
wealth of Puerto Rico, Guam, the Virgin Islands, 
American Samoa, Wake Island, Midway Islands, 
Kingman Reef, Johnston Atoll, the Northern Mar-
iana Islands, and any other trust territory or posses-
sion of the United States. 
‘‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—Tobacco products, including 
modified risk tobacco products for which an order has 
been issued in accordance with section 911, shall be regu-
lated by the Secretary under this chapter and shall not 
be subject to the provisions of chapter V. 
‘‘(b) APPLICABILITY.—This chapter shall apply to all 
cigarettes, cigarette tobacco, roll-your-own tobacco, and 
smokeless tobacco and to any other tobacco products that 
the Secretary by regulation deems to be subject to this 
chapter. 
‘‘(c) SCOPE.— 
‘‘(1) IN GENERAL.—Nothing in this chapter, or 
any policy issued or regulation promulgated there-
under, or in sections 101(a), 102, or 103 of title I, 
title II, or title III of the Family Smoking Preven-
tion and Tobacco Control Act, shall be construed to 
affect, expand, or limit the Secretary’s authority 
over (including the authority to determine whether 
products may be regulated), or the regulation of,
products under this Act that are not tobacco prod-
ucts under chapter V or any other chapter. 
‘‘(2) LIMITATION OF AUTHORITY.— 
‘‘(A) IN GENERAL.—The provisions of this 
chapter shall not apply to tobacco leaf that is 
not in the possession of a manufacturer of to-
bacco products, or to the producers of tobacco 
leaf, including tobacco growers, tobacco ware-
houses, and tobacco grower cooperatives, nor 
shall any employee of the Food and Drug Ad-
ministration have any authority to enter onto a 
farm owned by a producer of tobacco leaf with-
out the written consent of such producer. 
‘‘(B) EXCEPTION.—Notwithstanding sub-
paragraph (A), if a producer of tobacco leaf is 
also a tobacco product manufacturer or con-
trolled by a tobacco product manufacturer, the 
producer shall be subject to this chapter in the 
producer’s capacity as a manufacturer. The ex-
ception in this subparagraph shall not apply to 
a producer of tobacco leaf who grows tobacco 
under a contract with a tobacco product manu-
facturer and who is not otherwise engaged in 
the manufacturing process.
‘‘(C) RULE OF CONSTRUCTION.—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 produc-
tion. 
‘‘(d) RULEMAKING PROCEDURES.—Each rulemaking 
under this chapter shall be in accordance with chapter 5 
of title 5, United States Code. This subsection shall not 
be construed to affect the rulemaking provisions of section 
102(a) of the Family Smoking Prevention and Tobacco 
Control Act. 
‘‘(e) CENTER FOR TOBACCO PRODUCTS.—Not later 
than 90 days after the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act, the Sec-
retary shall establish within the Food and Drug Adminis-
tration the Center for Tobacco Products, which shall re-
port to the Commissioner of Food and Drugs in the same 
manner as the other agency centers within the Food and 
Drug Administration. The Center shall be responsible for 
the implementation of this chapter and related matters as-
signed by the Commissioner. 
‘‘(f) OFFICE TO ASSIST SMALL TOBACCO PRODUCT 
MANUFACTURERS.—The Secretary shall establish within
the Food and Drug Administration an identifiable office 
to provide technical and other nonfinancial assistance to 
small tobacco product manufacturers to assist them in 
complying with the requirements of this Act. 
‘‘(g) CONSULTATION PRIOR TO RULEMAKING.—Prior 
to promulgating rules under this chapter, the Secretary 
shall endeavor to consult with other Federal agencies as 
appropriate. 
‘‘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 added poisonous or added dele-
terious substance that may render the product inju-
rious 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 injurious to health; 
‘‘(3) its package is composed, in whole or in 
part, of any poisonous or deleterious substance 
which may render the contents injurious to health; 
‘‘(4) the manufacturer or importer of the to-
bacco product fails to pay a user fee assessed to
such manufacturer or importer pursuant to section 
919 by the date specified in section 919 or by the 
30th day after final agency action on a resolution of 
any dispute as to the amount of such fee; 
‘‘(5) it is, or purports to be or is represented 
as, a tobacco product which is subject to a tobacco 
product standard established under section 907 un-
less such tobacco product is in all respects in con-
formity with such standard; 
‘‘(6)(A) it is required by section 910(a) to have 
premarket review and does not have an order in ef-
fect under section 910(c)(1)(A)(i); or 
‘‘(B) it is in violation of an order under section 
910(c)(1)(A); 
‘‘(7) 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 
‘‘(8) it is in violation of section 911. 
‘‘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; 
‘‘(B) an accurate statement of the quantity 
of the contents in terms of weight, measure, or 
numerical count; 
‘‘(C) an accurate statement of the percent-
age of the tobacco used in the product that is 
domestically grown tobacco and the percentage 
that is foreign grown tobacco; and 
‘‘(D) the statement required under section 
920(a), 
except that under subparagraph (B) reasonable vari-
ations 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 an establishment 
not duly registered under section 905(b), 905(c), 
905(d), or 905(h), if it was not included in a list re-
quired by section 905(i), if a notice or other infor-
mation respecting it was not provided as required by 
such section or section 905(j), or if it does not bear 
such symbols from the uniform system for identifica-
tion of tobacco products prescribed under section 
905(e) as the Secretary by regulation requires;
Secretary shall publish a public notice requesting the sub-
mission by interested persons of scientific and other infor-
mation concerning the harmful and potentially harmful 
constituents in tobacco products and tobacco smoke. 
‘‘SEC. 905. ANNUAL REGISTRATION. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) 
MANUFACTURE, 
PREPARATION, 
COMPOUNDING, OR PROCESSING.—The term ‘manu-
facture, preparation, compounding, or processing’ 
shall include repackaging or otherwise changing the 
container, wrapper, or labeling of any tobacco prod-
uct package in furtherance of the distribution of the 
tobacco product from the original place of manufac-
ture to the person who makes final delivery or sale 
to the ultimate consumer or user. 
‘‘(2) NAME.—The term ‘name’ shall include in 
the case of a partnership the name of each partner 
and, in the case of a corporation, the name of each 
corporate officer and director, and the State of in-
corporation. 
‘‘(b) REGISTRATION BY OWNERS AND OPERATORS.— 
On or before December 31 of each year, every person who 
owns or operates any establishment in any State engaged 
in the manufacture, preparation, compounding, or proc-
essing of a tobacco product or tobacco products shall reg-
ister with the Secretary the name, places of business, and 
all such establishments of that person. If enactment of the 
Family Smoking Prevention and Tobacco Control Act oc-
curs in the second half of the calendar year, the Secretary 
shall designate a date no later than 6 months into the 
subsequent calendar year by which registration pursuant 
to this subsection shall occur. 
‘‘(c) REGISTRATION BY 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) shall list such to-
bacco products in accordance with such system. 
‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA-
TION.—The Secretary shall make available for inspection, 
to any person so requesting, any registration filed under 
this section. 
‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB-
LISHMENTS.—Every establishment registered with the 
Secretary under this section shall be subject to inspection 
under section 704 or subsection (h), and every such estab-
lishment engaged in the manufacture, compounding, or 
processing of a tobacco product or tobacco products shall 
be so inspected by 1 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) REGISTRATION
BY
FOREIGN
ESTABLISH-
MENTS.—Any establishment within any foreign country 
engaged in the manufacture, preparation, compounding, 
or processing of a tobacco product or tobacco products, 
shall register under this section under regulations promul-
gated by the Secretary. Such regulations shall require 
such establishment to provide the information required by 
subsection (i) 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), 
(d), or (h) shall, at the time of registration under 
any such subsection, file with the Secretary a list of 
all tobacco products which are being manufactured, 
prepared, compounded, or processed by that person 
for commercial distribution and which have not been 
included in any list of tobacco products filed by that 
person with the Secretary under this paragraph or 
paragraph (2) before such time of registration. Such 
list shall be prepared in such form and manner as 
the Secretary may prescribe and shall be accom-
panied by— 
‘‘(A) in the case of a tobacco product con-
tained in the applicable list with respect to 
which a tobacco product standard has been es-
tablished under section 907 or which is subject 
to section 910, a reference to the authority for 
the marketing of such tobacco product and a 
copy of all labeling for such tobacco product; 
‘‘(B) in the case of any other tobacco prod-
uct contained in an applicable list, a copy of all 
consumer information and other labeling for 
such tobacco product, a representative sampling 
of advertisements for such tobacco product, 
and, upon request made by the Secretary for 
good cause, a copy of all advertisements for a 
particular tobacco product; and 
‘‘(C) if the registrant filing a list has de-
termined that a tobacco product contained in 
such list is not subject to a tobacco product 
standard established under section 907, a brief 
statement of the basis upon which the reg-
istrant made such determination if the Sec-
retary requests such a statement with respect 
to that particular tobacco product. 
‘‘(2) 
CONSULTATION
WITH
RESPECT
TO 
FORMS.—The Secretary shall consult with the Sec-
retary of the Treasury in developing the forms to be 
used for registration under this section to minimize 
the burden on those persons required to register
with both the Secretary and the Tax and Trade Bu-
reau of the Department of the Treasury. 
‘‘(3) 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). A list under this subparagraph shall list a 
tobacco product by its established name and 
shall be accompanied by the other information 
required by paragraph (1). 
‘‘(B) If since the date the registrant last 
made a report under this paragraph that person 
has discontinued the manufacture, preparation, 
compounding, or processing for commercial dis-
tribution of a tobacco product included in a list 
filed under subparagraph (A) or paragraph (1), 
notice of such discontinuance, the date of such
regulation under subparagraph (A) for at 
least 4 years following the effective date 
established by the Secretary for such regu-
lation. 
‘‘(2) EXEMPTIONS; VARIANCES.— 
‘‘(A) PETITION.—Any person subject to 
any requirement prescribed under paragraph 
(1) may petition the Secretary for a permanent 
or temporary exemption or variance from such 
requirement. Such a petition shall be submitted 
to the Secretary in such form and manner as 
the Secretary shall prescribe and shall— 
‘‘(i) in the case of a petition for an ex-
emption from a requirement, set forth the 
basis for the petitioner’s determination 
that compliance with the requirement is 
not required to assure that the tobacco 
product will be in compliance with this 
chapter; 
‘‘(ii) in the case of a petition for a 
variance from a requirement, set forth the 
methods proposed to be used in, and the 
facilities and controls proposed to be used 
for, the manufacture, packing, and storage 
of the tobacco product in lieu of the meth-
ods, facilities, and controls prescribed by 
the requirement; and 
‘‘(iii) contain such other information 
as the Secretary shall prescribe. 
‘‘(B) REFERRAL TO THE TOBACCO PROD-
UCTS SCIENTIFIC ADVISORY COMMITTEE.—The 
Secretary may refer to the Tobacco Products 
Scientific Advisory Committee any petition sub-
mitted under subparagraph (A). The Tobacco 
Products Scientific Advisory Committee shall 
report its recommendations to the Secretary 
with respect to a petition referred to it within 
60 days after the date of the petition’s referral. 
Within 60 days after— 
‘‘(i) the date the petition was sub-
mitted to the Secretary under subpara-
graph (A); or 
‘‘(ii) the day after the petition was re-
ferred to the Tobacco Products Scientific 
Advisory Committee, 
whichever occurs later, the Secretary shall by 
order either deny the petition or approve it. 
‘‘(C) APPROVAL.—The Secretary may ap-
prove—
‘‘(i) a petition for an exemption for a 
tobacco product from a requirement if the 
Secretary determines that compliance with 
such requirement is not required to assure 
that the tobacco product will be in compli-
ance with this chapter; and 
‘‘(ii) a petition for a variance for a to-
bacco product from a requirement if the 
Secretary determines that the methods to 
be used in, and the facilities and controls 
to be used for, the manufacture, packing, 
and storage of the tobacco product in lieu 
of the methods, facilities, and controls pre-
scribed by the requirement are sufficient to 
assure that the tobacco product will be in 
compliance with this chapter. 
‘‘(D) CONDITIONS.—An order of the Sec-
retary approving a petition for a variance shall 
prescribe such conditions respecting the meth-
ods used in, and the facilities and controls used 
for, the manufacture, packing, and storage of 
the tobacco product to be granted the variance 
under the petition as may be necessary to as-
sure that the tobacco product will be in compli-
ance with this chapter.
‘‘(E) HEARING.—After the issuance of an 
order under subparagraph (B) respecting a pe-
tition, the petitioner shall have an opportunity 
for an informal hearing on such order. 
‘‘(3) COMPLIANCE.—Compliance with require-
ments under this subsection shall not be required be-
fore the end of the 3-year period following the date 
of enactment of 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 
tobacco products for research, testing, and demonstration 
purposes. 
‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 
‘‘(a) IN GENERAL.— 
‘‘(1) SPECIAL RULES.— 
‘‘(A) SPECIAL RULE FOR CIGARETTES.— 
Beginning 3 months after the date of enact-
ment of the Family Smoking Prevention and 
Tobacco Control Act, a cigarette or any of its 
component parts (including the tobacco, filter, 
or paper) shall not contain, as a constituent (in-
cluding a smoke constituent) or additive, an ar-
tificial or natural flavor (other than tobacco or
menthol) or an herb or spice, including straw-
berry, grape, orange, clove, cinnamon, pine-
apple, vanilla, coconut, licorice, cocoa, chocolate, 
cherry, or coffee, that is a characterizing flavor 
of the tobacco product or tobacco smoke. Noth-
ing 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 nat-
ural flavor, herb, or spice not specified in this 
subparagraph. 
‘‘(B) ADDITIONAL SPECIAL RULE.—Begin-
ning 2 years after the date of enactment of the 
Family Smoking Prevention and Tobacco Con-
trol Act, a tobacco product manufacturer shall 
not use tobacco, including foreign grown to-
bacco, that contains a pesticide chemical res-
idue that is at a level greater than is specified 
by any tolerance applicable under Federal law 
to domestically grown tobacco. 
‘‘(2) REVISION OF TOBACCO PRODUCT STAND-
ARDS.—The Secretary may revise the tobacco prod-
uct standards in paragraph (1) in accordance with 
subsection (c). 
‘‘(3) TOBACCO PRODUCT STANDARDS.—
‘‘(A) IN
GENERAL.—The Secretary may 
adopt tobacco product standards in addition to 
those in paragraph (1) if the Secretary finds 
that a tobacco product standard is appropriate 
for the protection of the public health. 
‘‘(B) DETERMINATIONS.— 
‘‘(i) CONSIDERATIONS.—In making a 
finding described in subparagraph (A), the 
Secretary shall consider scientific evidence 
concerning— 
‘‘(I) the risks and benefits to the 
population as a whole, including users 
and nonusers of tobacco products, of 
the proposed standard; 
‘‘(II) the increased or decreased 
likelihood that existing users of to-
bacco products will stop using such 
products; and 
‘‘(III) the increased or decreased 
likelihood that those who do not use 
tobacco products will start using such 
products. 
‘‘(ii) 
ADDITIONAL
CONSIDER-
ATIONS.—In the event that the Secretary 
makes a determination, set forth in a pro-
posed tobacco product standard in a pro-
posed rule, that it is appropriate for the 
protection of public health to require the 
reduction or elimination of an additive, 
constituent (including a smoke constitu-
ent), or other component of a tobacco 
product because the Secretary has found 
that the additive, constituent, or other 
component is or may be harmful, any 
party objecting to the proposed standard 
on the ground that the proposed standard 
will not reduce or eliminate the risk of ill-
ness or injury may provide for the Sec-
retary’s consideration scientific evidence 
that demonstrates that the proposed stand-
ard will not reduce or eliminate the risk of 
illness or injury. 
‘‘(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 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 subparagraph (B); 
‘‘(B) shall, where appropriate for the pro-
tection of the public health, include— 
‘‘(i) provisions respecting the con-
struction, components, ingredients, addi-
tives, constituents, including smoke con-
stituents, 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 required; and 
‘‘(v) a provision requiring that the 
sale and distribution of the tobacco prod-
uct be restricted but only to the extent 
that the sale and distribution of a tobacco 
product may be restricted under a regula-
tion under section 906(d); 
‘‘(C) shall, where appropriate, require the 
use and prescribe the form and content of label-
ing for the proper use of the tobacco product; 
and 
‘‘(D) shall require tobacco products con-
taining foreign-grown tobacco to meet the same 
standards applicable to tobacco products con-
taining domestically grown tobacco. 
‘‘(5) PERIODIC
REEVALUATION
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 
medical, scientific, or other technological data. The 
Secretary may provide for testing under paragraph 
(4)(B) by any person.
‘‘(ii) upon the request of an interested 
person that— 
‘‘(I) demonstrates good cause for 
the referral; and 
‘‘(II) is made before the expira-
tion of the period for submission of 
comments on the proposed regulation. 
‘‘(C) PROVISION OF DATA.—If a proposed 
regulation is referred under this paragraph to 
the Tobacco Products Scientific Advisory Com-
mittee, the Secretary shall provide the Advisory 
Committee with the data and information on 
which such proposed regulation is based. 
‘‘(D) REPORT
AND
RECOMMENDATION.— 
The Tobacco Products Scientific Advisory Com-
mittee shall, within 60 days after the referral of 
a proposed regulation under this paragraph and 
after independent study of the data and infor-
mation furnished to it by the Secretary and 
other data and information before it, submit to 
the Secretary a report and recommendation re-
specting such regulation, together with all un-
derlying data and information and a statement 
of the reason or basis for the recommendation.
‘‘(E) PUBLIC
AVAILABILITY.—The Sec-
retary shall make a copy of each report and rec-
ommendation under subparagraph (D) publicly 
available. 
‘‘(e) MENTHOL CIGARETTES.— 
‘‘(1) 
REFERRAL; 
CONSIDERATIONS.—Imme-
diately upon the establishment of the Tobacco Prod-
ucts Scientific Advisory Committee under section 
917(a), the Secretary shall refer to the Committee 
for report and recommendation, under section 
917(c)(4), the issue of the impact of the use of men-
thol in cigarettes on the public health, including 
such use among children, African Americans, His-
panics, and other racial and ethnic minorities. In its 
review, the Tobacco Products Scientific Advisory 
Committee shall address the considerations listed in 
subsections (a)(3)(B)(i) and (b). 
‘‘(2) REPORT
AND
RECOMMENDATION.—Not 
later than 1 year after its establishment, the To-
bacco Product Scientific Advisory Committee shall 
submit to the Secretary the report and recommenda-
tions required pursuant to paragraph (1). 
‘‘(3) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed to limit the Sec-
retary’s authority to take action under this section 
or other sections of this Act applicable to menthol. 
‘‘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 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 
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. 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 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) 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 occur and shall require periodic reports to 
the Secretary describing the progress of the re-
call. 
‘‘(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 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). 
‘‘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) 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 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 correc-
tion 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 
action or removal of a tobacco product may be re-
quired under paragraph (1) if a report of the correc-
tive action or removal is required and has been sub-
mitted under subsection (a). 
‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TO-
BACCO PRODUCTS. 
‘‘(a) IN GENERAL.— 
‘‘(1) NEW TOBACCO PRODUCT DEFINED.—For 
purposes of this section the term ‘new tobacco prod-
uct’ means— 
‘‘(A) any tobacco product (including those 
products in test markets) that was not commer-
cially marketed in the United States as of Feb-
ruary 15, 2007; 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 prod-
uct where the modified product was commer-
cially marketed in the United States after Feb-
ruary 15, 2007. 
‘‘(2) PREMARKET REVIEW REQUIRED.— 
‘‘(A) NEW
PRODUCTS.—An order under 
subsection (c)(1)(A)(i) for a new tobacco prod-
uct is required unless— 
‘‘(i) the manufacturer has submitted a 
report under section 905(j); and the Sec-
retary has issued an order that the tobacco 
product— 
‘‘(I) is substantially equivalent to 
a tobacco product commercially mar-
keted (other than for test marketing) 
in the United States as of February 
15, 2007; and 
‘‘(II) is in compliance with the 
requirements of this Act; or 
‘‘(ii) the tobacco product is exempt 
from the requirements of section 905(j) 
pursuant to a regulation issued under sec-
tion 905(j)(3).
‘‘(B) APPLICATION TO CERTAIN POST-FEB-
RUARY 15, 2007, 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 February 15, 2007, 
and prior to the date that is 21 months 
after the date of enactment of the Family 
Smoking Prevention and Tobacco Control 
Act; and 
‘‘(ii) for which a report was submitted 
under section 905(j) within such 21-month 
period, 
except that subparagraph (A) shall apply to the 
tobacco product if the Secretary issues an order 
that the tobacco product is not substantially 
equivalent. 
‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 
‘‘(A) IN
GENERAL.—In this section and 
section 905(j), the term ‘substantially equiva-
lent’ or ‘substantial equivalence’ means, with 
respect to the tobacco product being compared 
to the predicate tobacco product, that the Sec-
retary 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 does not raise different 
questions of public health. 
‘‘(B) 
CHARACTERISTICS.—In 
subpara-
graph (A), the term ‘characteristics’ means the 
materials, 
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 re-
moved from the market at the initiative of the 
Secretary or that has been determined by a ju-
dicial order to be misbranded or adulterated. 
‘‘(4) HEALTH INFORMATION.—
er such tobacco product presents less risk than 
other tobacco products; 
‘‘(B) a full statement of the components, 
ingredients, additives, and properties, and of 
the principle or principles of operation, of such 
tobacco 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 to-
bacco product standard under section 907 
which would be applicable to any aspect of such 
tobacco product, and either adequate informa-
tion to show that such aspect of such tobacco 
product fully meets such tobacco product stand-
ard or adequate information to justify any devi-
ation 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) REFERRAL 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 initia-
tive; or 
‘‘(B) may, upon the request of an appli-
cant, 
refer such application to the Tobacco Products Sci-
entific Advisory Committee for reference and for 
submission (within such period as the Secretary may 
establish) of a report and recommendation respect-
ing the application, together with all underlying data 
and the reasons or basis for the recommendation. 
‘‘(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 
and recommendation submitted under sub-
section (b)(2), shall—
‘‘(i) issue an order that the new prod-
uct may be introduced or delivered for in-
troduction into interstate commerce if the 
Secretary finds that none of the grounds 
specified in paragraph (2) of this sub-
section applies; or 
‘‘(ii) issue an order that the new prod-
uct may not be introduced or delivered for 
introduction into interstate commerce 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 under subparagraph 
(A)(i) may require that the sale and distribu-
tion 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 section 906(d). 
‘‘(2) DENIAL OF APPLICATION.—The Secretary 
shall deny an application submitted under subsection 
(b) if, upon the basis of the information submitted 
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 be appropriate for the protection of the 
public health; 
‘‘(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 tobacco product 
standard in effect under section 907, and there 
is a lack of adequate information 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 
remove such application from deniable form (which 
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 the marketing 
of a tobacco product for which an application has 
been submitted 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, 
including 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 in-
clude 1 or more clinical investigations by ex-
perts qualified by training and experience to 
evaluate the tobacco 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 the Tobacco Products Scientific Advi-
sory Committee, and after due notice and oppor-
tunity for informal hearing for a tobacco product for 
which an order was issued under subsection 
(c)(1)(A)(i), issue an order withdrawing the order 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— 
‘‘(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 
reviewed, 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 reviewed, 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 such order 
was issued, that such tobacco product is not 
shown to conform in all respects to a tobacco 
product standard which is in effect under sec-
tion 907, compliance with which was a condi-
tion to the issuance of an order relating to the 
application, and that there is a lack of adequate 
information to justify the deviation from such 
standard. 
‘‘(2) APPEAL.—The holder of an application 
subject to an order issued under paragraph (1) with-
drawing an order issued pursuant to subsection 
(c)(1)(A)(i) may, by petition filed on or before the 
30th day after the date upon which such holder re-
ceives notice of such withdrawal, obtain review there-
of in accordance with section 912.
‘‘(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 order would cause serious, adverse 
health consequences or death, that is greater than 
ordinarily caused by tobacco products on the market, 
the Secretary shall by order temporarily suspend the 
authority of the manufacturer to market the prod-
uct. If the Secretary issues such an order, the Sec-
retary shall proceed expeditiously under paragraph 
(1) to withdraw such application. 
‘‘(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. 
‘‘(f) RECORDS.— 
‘‘(1) ADDITIONAL INFORMATION.—In the case 
of any tobacco product for which an order issued 
pursuant to subsection (c)(1)(A)(i) for an applica-
tion filed under subsection (b) is in effect, the appli-
cant shall establish and maintain such records, and 
make such reports to the Secretary, as the Secretary 
may by regulation, or by order with respect to such 
application, prescribe on the basis of a finding that 
such records and reports are necessary in order to 
enable the Secretary to determine, or facilitate a de-
termination of, whether there is or may be grounds 
for withdrawing or temporarily suspending such 
order. 
‘‘(2) ACCESS TO RECORDS.—Each person re-
quired under this section to maintain records, and 
each person in charge of custody thereof, shall, upon 
request of an officer or employee designated by the 
Secretary, permit such officer or employee at all rea-
sonable times to have access to and copy and verify 
such records. 
‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMP-
TION FOR INVESTIGATIONAL USE.—The Secretary may 
exempt tobacco products intended for investigational use 
from the provisions of this chapter under such conditions 
as the Secretary may by regulation prescribe. 
‘‘SEC. 911. MODIFIED RISK TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—No person may introduce or de-
liver for introduction into interstate commerce any modi-
fied risk tobacco product unless an order issued pursuant 
to subsection (g) is effective with respect to such product. 
‘‘(b) DEFINITIONS.—In this section: 
‘‘(1) MODIFIED RISK TOBACCO PRODUCT.—The 
term ‘modified risk tobacco product’ means any to-
bacco product that is sold or distributed for use to 
reduce harm or the risk of tobacco-related disease 
associated with commercially marketed tobacco prod-
ucts. 
‘‘(2) SOLD OR DISTRIBUTED.— 
‘‘(A) IN GENERAL.—With respect to a to-
bacco product, the term ‘sold or distributed for 
use to reduce harm or the risk of tobacco-re-
lated disease associated with commercially mar-
keted tobacco products’ means a tobacco prod-
uct— 
‘‘(i) the label, labeling, or advertising 
of which represents explicitly or implicitly 
that— 
‘‘(I) the tobacco product presents 
a lower risk of tobacco-related disease 
or is less harmful than one or more 
other commercially marketed tobacco 
products;
‘‘(II) the tobacco product or its 
smoke contains a reduced level of a 
substance or presents a reduced expo-
sure to a substance; or 
‘‘(III) the tobacco product or its 
smoke does not contain or is free of a 
substance; 
‘‘(ii) the label, labeling, or advertising 
of which uses the descriptors ‘light’, ‘mild’, 
or ‘low’ or similar descriptors; or 
‘‘(iii) the tobacco product manufac-
turer of which has taken any action di-
rected to consumers through the media or 
otherwise, other than by means of the to-
bacco product’s label, labeling, or adver-
tising, after the date of enactment of the 
Family Smoking Prevention and Tobacco 
Control Act, respecting the product that 
would be reasonably expected to result in 
consumers believing that the tobacco prod-
uct or its smoke may present a lower risk 
of disease or is less harmful than one or 
more commercially marketed tobacco prod-
ucts, or presents a reduced exposure to, or
does not contain or is free of, a substance 
or substances. 
‘‘(B) LIMITATION.—No tobacco product 
shall be considered to be ‘sold or distributed for 
use to reduce harm or the risk of tobacco-re-
lated disease associated with commercially mar-
keted tobacco products’, except as described in 
subparagraph (A). 
‘‘(C) SMOKELESS TOBACCO PRODUCT.—No 
smokeless tobacco product shall be considered 
to be ‘sold or distributed for use to reduce harm 
or the risk of tobacco-related disease associated 
with commercially marketed tobacco products’ 
solely because its label, labeling, or advertising 
uses the following phrases to describe such 
product and its use: ‘smokeless tobacco’, 
‘smokeless tobacco product’, ‘not consumed by 
smoking’, 
‘does 
not 
produce 
smoke’, 
‘smokefree’, ‘smoke-free’, ‘without smoke’, ‘no 
smoke’, or ‘not smoke’. 
‘‘(3) EFFECTIVE
DATE.—The provisions of 
paragraph (2)(A)(ii) shall take effect 12 months 
after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act for those prod-
ucts whose label, labeling, or advertising contains
100 
the terms described in such paragraph on such date 
of enactment. The effective date shall be with re-
spect to the date of manufacture, provided that, in 
any case, beginning 30 days after such effective 
date, a manufacturer shall not introduce into the do-
mestic commerce of the United States any product, 
irrespective of the date of manufacture, that is not 
in conformance with paragraph (2)(A)(ii). 
‘‘(c) TOBACCO DEPENDENCE PRODUCTS.—A product 
that is intended to be used for the treatment of tobacco 
dependence, including smoking cessation, is not a modified 
risk tobacco product under this section if it has been ap-
proved as a drug or device by the Food and Drug Adminis-
tration and is subject to the requirements of chapter V. 
‘‘(d) FILING.—Any person may file with the Sec-
retary an application for a modified risk tobacco product. 
Such application shall include— 
‘‘(1) a description of the proposed product and 
any proposed advertising and labeling; 
‘‘(2) the conditions for using the product; 
‘‘(3) the formulation of the product; 
‘‘(4) sample product labels and labeling; 
‘‘(5) all documents (including underlying sci-
entific information) relating to research findings 
conducted, supported, or possessed by the tobacco
101 
product manufacturer relating to the effect of the 
product on tobacco-related diseases and health-re-
lated conditions, including information both favor-
able and unfavorable to the ability of the product to 
reduce risk or exposure and relating to human 
health; 
‘‘(6) data and information on how consumers 
actually use the tobacco product; and 
‘‘(7) such other information as the Secretary 
may require. 
‘‘(e) PUBLIC AVAILABILITY.—The Secretary shall 
make the application described in subsection (d) publicly 
available (except matters in the application which are 
trade secrets or otherwise confidential, commercial infor-
mation) and shall request comments by interested persons 
on the information contained in the application and on the 
label, labeling, and advertising accompanying such appli-
cation. 
‘‘(f) ADVISORY COMMITTEE.— 
‘‘(1) IN GENERAL.—The Secretary shall refer to 
the Tobacco Products Scientific Advisory Committee 
any application submitted under this section. 
‘‘(2) RECOMMENDATIONS.—Not later than 60 
days after the date an application is referred to the 
Tobacco Products Scientific Advisory Committee
102 
under paragraph (1), the Advisory Committee shall 
report its recommendations on the application to the 
Secretary. 
‘‘(g) MARKETING.— 
‘‘(1) MODIFIED
RISK
PRODUCTS.—Except as 
provided in paragraph (2), the Secretary shall, with 
respect to an application submitted under this sec-
tion, issue an order that a modified risk product 
may be commercially marketed only if the Secretary 
determines that the applicant has demonstrated that 
such product, as it is actually used by consumers, 
will— 
‘‘(A) significantly reduce harm and the 
risk of tobacco-related disease to individual to-
bacco users; and 
‘‘(B) benefit the health of the population 
as a whole taking into account both users of to-
bacco products and persons who do not cur-
rently use tobacco products. 
‘‘(2) SPECIAL RULE FOR CERTAIN PRODUCTS.— 
‘‘(A) IN
GENERAL.—The Secretary may 
issue an order that a tobacco product may be 
introduced or delivered for introduction into 
interstate commerce, pursuant to an application 
under this section, with respect to a tobacco
105 
duction in overall morbidity and mortality 
among individual tobacco users; 
‘‘(iii) testing of actual consumer per-
ception shows that, as the applicant pro-
poses to label and market the product, con-
sumers will not be misled into believing 
that the product— 
‘‘(I) is or has been demonstrated 
to be less harmful; or 
‘‘(II) presents or has been dem-
onstrated to present less of a risk of 
disease than 1 or more other commer-
cially marketed tobacco products; and 
‘‘(iv) issuance of an order with respect 
to the application is expected to benefit the 
health of the population as a whole taking 
into account both users of tobacco prod-
ucts and persons who do not currently use 
tobacco products. 
‘‘(C) CONDITIONS OF MARKETING.— 
‘‘(i) IN GENERAL.—Applications sub-
ject to an order under this paragraph shall 
be limited to a term of not more than 5 
years, but may be renewed upon a finding 
by the Secretary that the requirements of
106 
this paragraph continue to be satisfied 
based on the filing of a new application. 
‘‘(ii) AGREEMENTS BY APPLICANT.— 
An order under this paragraph shall be 
conditioned on the applicant’s agreement 
to conduct postmarket surveillance and 
studies and to submit to the Secretary the 
results of such surveillance and studies to 
determine the impact of the order on con-
sumer perception, behavior, and health and 
to enable the Secretary to review the accu-
racy of the determinations upon which the 
order was based in accordance with a pro-
tocol approved by the Secretary. 
‘‘(iii) ANNUAL SUBMISSION.—The re-
sults of such postmarket surveillance and 
studies described in clause (ii) shall be 
submitted annually. 
‘‘(3) BASIS.—The determinations under para-
graphs (1) and (2) shall be based on— 
‘‘(A) the scientific evidence submitted by 
the applicant; and 
‘‘(B) scientific evidence and other informa-
tion that is made available to the Secretary.
107 
‘‘(4) BENEFIT
TO
HEALTH
OF
INDIVIDUALS 
AND OF POPULATION AS A WHOLE.—In making the 
determinations under paragraphs (1) and (2), the 
Secretary shall take into account— 
‘‘(A) the relative health risks to individuals 
of the tobacco product that is the subject of the 
application; 
‘‘(B) the increased or decreased likelihood 
that existing users of tobacco products who 
would otherwise stop using such products will 
switch to the tobacco product that is the subject 
of the application; 
‘‘(C) the increased or decreased likelihood 
that persons who do not use tobacco products 
will start using the tobacco product that is the 
subject of the application; 
‘‘(D) the risks and benefits to persons 
from the use of the tobacco product that is the 
subject of the application as compared to the 
use of products for smoking cessation approved 
under chapter V to treat nicotine dependence; 
and 
‘‘(E) comments, data, and information 
submitted by interested persons. 
‘‘(h) ADDITIONAL CONDITIONS FOR MARKETING.—
108 
‘‘(1) MODIFIED
RISK
PRODUCTS.—The Sec-
retary shall require for the marketing of a product 
under this section that any advertising or labeling 
concerning modified risk products enable the public 
to comprehend the information concerning modified 
risk and to understand the relative significance of 
such information in the context of total health and 
in relation to all of the diseases and health-related 
conditions associated with the use of tobacco prod-
ucts. 
‘‘(2) COMPARATIVE CLAIMS.— 
‘‘(A) IN GENERAL.—The Secretary may re-
quire for the marketing of a product under this 
subsection that a claim comparing a tobacco 
product to 1 or more other commercially mar-
keted tobacco products shall compare the to-
bacco product to a commercially marketed to-
bacco product that is representative of that type 
of tobacco product on the market (for example 
the average value of the top 3 brands of an es-
tablished regular tobacco product). 
‘‘(B) QUANTITATIVE
COMPARISONS.—The 
Secretary may also require, for purposes of sub-
paragraph (A), that the percent (or fraction) of 
change and identity of the reference tobacco
109 
product and a quantitative comparison of the 
amount of the substance claimed to be reduced 
shall be stated in immediate proximity to the 
most prominent claim. 
‘‘(3) LABEL DISCLOSURE.— 
‘‘(A) IN GENERAL.—The Secretary may re-
quire the disclosure on the label of other sub-
stances in the tobacco product, or substances 
that may be produced by the consumption of 
that tobacco product, that may affect a disease 
or health-related condition or may increase the 
risk of other diseases or health-related condi-
tions associated with the use of tobacco prod-
ucts. 
‘‘(B) CONDITIONS OF USE.—If the condi-
tions of use of the tobacco product may affect 
the risk of the product to human health, the 
Secretary may require the labeling of conditions 
of use. 
‘‘(4) TIME.—An order issued under subsection 
(g)(1) shall be effective for a specified period of 
time. 
‘‘(5) ADVERTISING.—The Secretary may re-
quire, with respect to a product for which an appli-
cant obtained an order under subsection (g)(1), that
110 
the product comply with requirements relating to ad-
vertising and promotion of the tobacco product. 
‘‘(i) POSTMARKET SURVEILLANCE AND STUDIES.— 
‘‘(1) IN
GENERAL.—The Secretary shall re-
quire, with respect to a product for which an appli-
cant obtained an order under subsection (g)(1), that 
the applicant conduct postmarket surveillance and 
studies for such a tobacco product to determine the 
impact of the order issuance on consumer percep-
tion, behavior, and health, to enable the Secretary to 
review the accuracy of the determinations upon 
which the order was based, and to provide informa-
tion that the Secretary determines is otherwise nec-
essary regarding the use or health risks involving 
the tobacco product. The results of postmarket sur-
veillance and studies shall be submitted to the Sec-
retary on an annual basis. 
‘‘(2) SURVEILLANCE
PROTOCOL.—Each appli-
cant required to conduct a surveillance of a tobacco 
product under paragraph (1) shall, within 30 days 
after receiving notice that the applicant is required 
to conduct such surveillance, submit, for the ap-
proval of the Secretary, a protocol for the required 
surveillance. The Secretary, within 60 days of the 
receipt of such protocol, shall determine if the prin-
116 
transmitted by the clerk of the court involved to 
the Secretary. 
‘‘(B) RECORD OF PROCEEDINGS.—On re-
ceipt of a petition under subparagraph (A), the 
Secretary shall file in the court in which such 
petition was filed— 
‘‘(i) the record of the proceedings on 
which the regulation or order was based; 
and 
‘‘(ii) a statement of the reasons for 
the issuance of such a regulation or order. 
‘‘(C) DEFINITION
OF
RECORD.—In this 
section, the term ‘record’ means— 
‘‘(i) all notices and other matter pub-
lished in the Federal Register with respect 
to the regulation or order reviewed; 
‘‘(ii) all information submitted to the 
Secretary with respect to such regulation 
or order; 
‘‘(iii) proceedings of any panel or ad-
visory committee with respect to such reg-
ulation or order; 
‘‘(iv) any hearing held with respect to 
such regulation or order; and
117 
‘‘(v) any other information identified 
by the Secretary, in the administrative pro-
ceeding held with respect to such regula-
tion or order, as being relevant to such 
regulation or order. 
‘‘(b) STANDARD OF REVIEW.—Upon the filing of the 
petition under subsection (a) for judicial review of a regu-
lation or order, the court shall have jurisdiction to review 
the regulation or order in accordance with chapter 7 of 
title 5, United States Code, and to grant appropriate re-
lief, including interim relief, as provided for in such chap-
ter. A regulation or denial described in subsection (a) shall 
be reviewed in accordance with section 706(2)(A) of title 
5, United States Code. 
‘‘(c) FINALITY OF JUDGMENT.—The judgment of the 
court affirming or setting aside, in whole or in part, any 
regulation or order shall be final, subject to review by the 
Supreme Court of the United States upon certiorari or 
certification, as provided in section 1254 of title 28, 
United States Code. 
‘‘(d) OTHER REMEDIES.—The remedies provided for 
in this section shall be in addition to, and not in lieu of, 
any other remedies provided by law. 
‘‘(e) REGULATIONS
AND ORDERS MUST RECITE 
BASIS IN RECORD.—To facilitate judicial review, a regula-
118 
tion or order issued under section 906, 907, 908, 909, 
910, or 916 shall contain a statement of the reasons for 
the issuance of such regulation or order in the record of 
the proceedings held in connection with its issuance. 
‘‘SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS. 
‘‘The Secretary shall issue regulations to require that 
retail establishments for which the predominant business 
is the sale of tobacco products comply with any advertising 
restrictions applicable to retail establishments accessible 
to individuals under the age of 18. 
‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH 
THE FEDERAL TRADE COMMISSION. 
‘‘(a) JURISDICTION.— 
‘‘(1) IN
GENERAL.—Except where expressly 
provided in this chapter, nothing in this chapter 
shall be construed as limiting or diminishing the au-
thority of the Federal Trade Commission to enforce 
the laws under its jurisdiction with respect to the 
advertising, sale, or distribution of tobacco products. 
‘‘(2) ENFORCEMENT.—Any advertising that vio-
lates this chapter or a provision of the regulations 
referred to in section 102 of the Family Smoking 
Prevention and Tobacco Control Act, is an unfair or 
deceptive act or practice under section 5(a) of the 
Federal Trade Commission Act and shall be consid-
119 
ered a violation of a rule promulgated under section 
18 of that Act. 
‘‘(b) COORDINATION.—With respect to the require-
ments of section 4 of the Federal Cigarette Labeling and 
Advertising Act and section 3 of the Comprehensive 
Smokeless Tobacco Health Education Act of 1986— 
‘‘(1) the Chairman of the Federal Trade Com-
mission shall coordinate with the Secretary con-
cerning the enforcement of such Act as such enforce-
ment relates to unfair or deceptive acts or practices 
in the advertising of cigarettes or smokeless tobacco; 
and 
‘‘(2) the Secretary shall consult with the Chair-
man of such Commission in revising the label state-
ments and requirements under such sections. 
‘‘SEC. 915. REGULATION REQUIREMENT. 
‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not 
later than 36 months after the date of enactment of the 
Family Smoking Prevention and Tobacco Control Act, the 
Secretary shall promulgate regulations under this Act that 
meet the requirements of subsection (b). 
‘‘(b) CONTENTS OF RULES.—The regulations pro-
mulgated under subsection (a)— 
‘‘(1) shall require testing and reporting of to-
bacco product constituents, ingredients, and addi-
120 
tives, including smoke constituents, by brand and 
subbrand that the Secretary determines should be 
tested to protect the public health, provided that, for 
purposes of the testing requirements of this para-
graph, tobacco products manufactured and sold by a 
single tobacco product manufacturer that are iden-
tical in all respects except the labels, packaging de-
sign, logo, trade dress, trademark, brand name, or 
any combination thereof, shall be considered as a 
single brand; and 
‘‘(2) may require that tobacco product manu-
facturers, packagers, or importers make disclosures 
relating to the results of the testing of tar and nico-
tine through labels or advertising or other appro-
priate means, and make disclosures regarding the 
results of the testing of other constituents, including 
smoke constituents, ingredients, or additives, that 
the Secretary determines should be disclosed to the 
public to protect the public health and will not mis-
lead consumers about the risk of tobacco-related dis-
ease. 
‘‘(c) AUTHORITY.—The Secretary shall have the au-
thority under this chapter to conduct or to require the 
testing, reporting, or disclosure of tobacco product con-
stituents, including smoke constituents.
121 
‘‘(d) SMALL
TOBACCO
PRODUCT
MANUFACTUR-
ERS.— 
‘‘(1) FIRST
COMPLIANCE
DATE.—The initial 
regulations promulgated under subsection (a) shall 
not impose requirements on small tobacco product 
manufacturers before the later of— 
‘‘(A) the end of the 2-year period following 
the final promulgation of such regulations; and 
‘‘(B) the initial date set by the Secretary 
for compliance with such regulations by manu-
facturers that are not small tobacco product 
manufacturers. 
‘‘(2) TESTING AND REPORTING INITIAL COM-
PLIANCE PERIOD.— 
‘‘(A) 4-YEAR PERIOD.—The initial regula-
tions promulgated under subsection (a) shall 
give each small tobacco product manufacturer a 
4-year period over which to conduct testing and 
reporting for all of its tobacco products. Subject 
to paragraph (1), the end of the first year of 
such 4-year period shall coincide with the initial 
date of compliance under this section set by the 
Secretary with respect to manufacturers that 
are not small tobacco product manufacturers or 
the end of the 2-year period following the final
123 
tial date of compliance under this section set by 
the Secretary with respect to manufacturers 
that are not small tobacco product manufactur-
ers. 
‘‘(3) SUBSEQUENT AND ADDITIONAL TESTING 
AND
REPORTING.—The regulations promulgated 
under subsection (a) shall provide that, with respect 
to any subsequent or additional testing and report-
ing of tobacco products required under this section, 
such testing and reporting by a small tobacco prod-
uct manufacturer shall be conducted in accordance 
with the timeframes described in paragraph (2)(A), 
except that, in the case of a new product, or if there 
has been a modification described in section 
910(a)(1)(B) of any product of a small tobacco 
product manufacturer since the last testing and re-
porting required under this section, the Secretary 
shall require that any subsequent or additional test-
ing and reporting be conducted in accordance with 
the same timeframe applicable to manufacturers 
that are not small tobacco product manufacturers. 
‘‘(4) JOINT LABORATORY TESTING SERVICES.— 
The Secretary shall allow any 2 or more small to-
bacco product manufacturers to join together to pur-
chase laboratory testing services required by this
124 
section on a group basis in order to ensure that such 
manufacturers receive access to, and fair pricing of, 
such testing services. 
‘‘(e) EXTENSIONS FOR LIMITED LABORATORY CA-
PACITY.— 
‘‘(1) IN
GENERAL.—The regulations promul-
gated under subsection (a) shall provide that a small 
tobacco product manufacturer shall not be consid-
ered to be in violation of this section before the 
deadline applicable under paragraphs (3) and (4), 
if— 
‘‘(A) the tobacco products of such manu-
facturer are in compliance with all other re-
quirements of this chapter; and 
‘‘(B) the conditions described in paragraph 
(2) are met. 
‘‘(2) CONDITIONS.—Notwithstanding the re-
quirements of this section, the Secretary may delay 
the date by which a small tobacco product manufac-
turer must be in compliance with the testing and re-
porting required by this section until such time as 
the testing is reported if, not later than 90 days be-
fore the deadline for reporting in accordance with 
this section, a small tobacco product manufacturer
125 
provides evidence to the Secretary demonstrating 
that— 
‘‘(A) the manufacturer has submitted the 
required products for testing to a laboratory 
and has done so sufficiently in advance of the 
deadline to create a reasonable expectation of 
completion by the deadline; 
‘‘(B) the products currently are awaiting 
testing by the laboratory; and 
‘‘(C) neither that laboratory nor any other 
laboratory is able to complete testing by the 
deadline at customary, nonexpedited testing 
fees. 
‘‘(3) EXTENSION.—The Secretary, taking into 
account the laboratory testing capacity that is avail-
able to tobacco product manufacturers, shall review 
and verify the evidence submitted by a small tobacco 
product manufacturer in accordance with paragraph 
(2). If the Secretary finds that the conditions de-
scribed in such paragraph are met, the Secretary 
shall notify the small tobacco product manufacturer 
that the manufacturer shall not be considered to be 
in violation of the testing and reporting require-
ments of this section until the testing is reported or 
until 1 year after the reporting deadline has passed,
126 
whichever occurs sooner. If, however, the Secretary 
has not made a finding before the reporting dead-
line, the manufacturer shall not be considered to be 
in violation of such requirements until the Secretary 
finds that the conditions described in paragraph (2) 
have not been met, or until 1 year after the report-
ing deadline, whichever occurs sooner. 
‘‘(4) ADDITIONAL EXTENSION.—In addition to 
the time that may be provided under paragraph (3), 
the Secretary may provide further extensions of 
time, in increments of no more than 1 year, for re-
quired testing and reporting to occur if the Sec-
retary determines, based on evidence properly and 
timely submitted by a small tobacco product manu-
facturer in accordance with paragraph (2), that a 
lack of available laboratory capacity prevents the 
manufacturer from completing the required testing 
during the period described in paragraph (3). 
‘‘(f) RULE
OF CONSTRUCTION.—Nothing in sub-
section (d) or (e) shall be construed to authorize the exten-
sion of any deadline, or to otherwise affect any timeframe, 
under any provision of this Act or the Family Smoking 
Prevention and Tobacco Control Act other than this sec-
tion.
127 
‘‘SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHOR-
ITY. 
‘‘(a) IN GENERAL.— 
‘‘(1) PRESERVATION.—Except as provided in 
paragraph (2)(A), nothing in this chapter, or rules 
promulgated under this chapter, shall be construed 
to limit the authority of a Federal agency (including 
the Armed Forces), a State or political subdivision 
of a State, or the government of an Indian tribe to 
enact, adopt, promulgate, and enforce any law, rule, 
regulation, or other measure with respect to tobacco 
products that is in addition to, or more stringent 
than, requirements established under this chapter, 
including a law, rule, regulation, or other measure 
relating to or prohibiting the sale, distribution, pos-
session, exposure to, access to, advertising and pro-
motion of, or use of tobacco products by individuals 
of any age, information reporting to the State, or 
measures relating to fire safety standards for to-
bacco products. No provision of this chapter shall 
limit or otherwise affect any State, Tribal, or local 
taxation of tobacco products. 
‘‘(2) PREEMPTION
OF
CERTAIN
STATE
AND 
LOCAL REQUIREMENTS.— 
‘‘(A) IN GENERAL.—No State or political 
subdivision of a State may establish or continue
130 
‘‘(ii) 1 individual who is an officer or 
employee of a State or local government or 
of the Federal Government; 
‘‘(iii) 1 individual as a representative 
of the general public; 
‘‘(iv) 1 individual as a representative 
of the interests of the tobacco manufac-
turing industry; 
‘‘(v) 1 individual as a representative 
of the interests of the small business to-
bacco manufacturing industry, which posi-
tion may be filled on a rotating, sequential 
basis by representatives of different small 
business tobacco manufacturers based on 
areas of expertise relevant to the topics 
being considered by the Advisory Com-
mittee; and 
‘‘(vi) 1 individual as a representative 
of the interests of the tobacco growers. 
‘‘(B) NONVOTING
MEMBERS.—The mem-
bers of the committee appointed under clauses 
(iv), (v), and (vi) of subparagraph (A) shall 
serve as consultants to those described in 
clauses (i) through (iii) of subparagraph (A) 
and shall be nonvoting representatives.
131 
‘‘(C) CONFLICTS OF INTEREST.—No mem-
bers of the committee, other than members ap-
pointed pursuant to clauses (iv), (v), and (vi) of 
subparagraph (A) shall, during the member’s 
tenure on the committee or for the 18-month 
period prior to becoming such a member, re-
ceive any salary, grants, or other payments or 
support from any business that manufactures, 
distributes, markets, or sells cigarettes or other 
tobacco products. 
‘‘(2) LIMITATION.—The Secretary may not ap-
point to the Advisory Committee any individual who 
is in the regular full-time employ of the Food and 
Drug Administration or any agency responsible for 
the enforcement of this Act. The Secretary may ap-
point Federal officials as ex officio members. 
‘‘(3) CHAIRPERSON.—The Secretary shall des-
ignate 1 of the members appointed under clauses (i), 
(ii), and (iii) of paragraph (1)(A) to serve as chair-
person. 
‘‘(c) DUTIES.—The Tobacco Products Scientific Ad-
visory Committee shall provide advice, information, and 
recommendations to the Secretary— 
‘‘(1) as provided in this chapter;
132 
‘‘(2) on the effects of the alteration of the nico-
tine yields from tobacco products; 
‘‘(3) on whether there is a threshold level below 
which nicotine yields do not produce dependence on 
the tobacco product involved; and 
‘‘(4) on its review of other safety, dependence, 
or health issues relating to tobacco products as re-
quested by the Secretary. 
‘‘(d) COMPENSATION; SUPPORT; FACA.— 
‘‘(1) COMPENSATION AND TRAVEL.—Members 
of the Advisory Committee who are not officers or 
employees of the United States, while attending con-
ferences or meetings of the committee or otherwise 
engaged in its business, shall be entitled to receive 
compensation at rates to be fixed by the Secretary, 
which may not exceed the daily equivalent of the 
rate in effect under the Senior Executive Schedule 
under section 5382 of title 5, United States Code, 
for each day (including travel time) they are so en-
gaged; and while so serving away from their homes 
or regular places of business each member may be 
allowed travel expenses, including per diem in lieu of 
subsistence, as authorized by section 5703 of title 5, 
United States Code, for persons in the Government 
service employed intermittently.
133 
‘‘(2) ADMINISTRATIVE
SUPPORT.—The Sec-
retary shall furnish the Advisory Committee clerical 
and other assistance. 
‘‘(3) NONAPPLICATION OF FACA.—Section 14 of 
the Federal Advisory Committee Act does not apply 
to the Advisory Committee. 
‘‘(e) PROCEEDINGS OF ADVISORY PANELS AND COM-
MITTEES.—The Advisory Committee shall make and 
maintain a transcript of any proceeding of the panel or 
committee. Each such panel and committee shall delete 
from any transcript made under this subsection informa-
tion which is exempt from disclosure under section 552(b) 
of title 5, United States Code. 
‘‘SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DE-
PENDENCE. 
‘‘(a) IN GENERAL.—The Secretary shall— 
‘‘(1) at the request of the applicant, consider 
designating products for smoking cessation, includ-
ing nicotine replacement products as fast track re-
search and approval products within the meaning of 
section 506; 
‘‘(2) consider approving the extended use of nic-
otine replacement products (such as nicotine patch-
es, nicotine gum, and nicotine lozenges) for the 
treatment of tobacco dependence; and
134 
‘‘(3) review and consider the evidence for addi-
tional indications for nicotine replacement products, 
such as for craving relief or relapse prevention. 
‘‘(b) REPORT ON INNOVATIVE PRODUCTS.— 
‘‘(1) IN
GENERAL.—Not later than 3 years 
after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, the Secretary, 
after consultation with recognized scientific, medical, 
and public health experts (including both Federal 
agencies and nongovernmental entities, the Institute 
of Medicine of the National Academy of Sciences, 
and the Society for Research on Nicotine and To-
bacco), shall submit to the Congress a report that 
examines how best to regulate, promote, and encour-
age the development of innovative products and 
treatments (including nicotine-based and non-nico-
tine-based products and treatments) to better 
achieve, in a manner that best protects and pro-
motes the public health— 
‘‘(A) total abstinence from tobacco use; 
‘‘(B) reductions in consumption of tobacco; 
and 
‘‘(C) reductions in the harm associated 
with continued tobacco use.