In the Senate of the United States, 
June 11, 2009. 
Resolved, That the bill from the House of Representa-
tives (H.R. 1256) entitled ‘‘An Act to protect the public 
health by providing the Food and Drug Administration with 
certain authority to regulate tobacco products, to amend title 
5, United States Code, to make certain modifications in the 
Thrift Savings Plan, the Civil Service Retirement System, 
and the Federal Employees’ Retirement System, and for 
other purposes.’’, do pass with the following 
AMENDMENT: 
Strike all after the enacting clause and insert the 
following: 
DIVISION A—FAMILY SMOKING 
PREVENTION AND TOBACCO 
CONTROL ACT 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This division may be cited as the 
‘‘Family Smoking Prevention and Tobacco Control Act’’.
† HR 1256 EAS 
(b) TABLE OF CONTENTS.—The table of contents of this 
division is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Findings. 
Sec. 3. Purpose. 
Sec. 4. Scope and effect. 
Sec. 5. Severability. 
Sec. 6. Modification of deadlines for Secretarial action. 
TITLE I—AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION 
Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act. 
Sec. 102. Final rule. 
Sec. 103. Conforming and other amendments to general provisions. 
Sec. 104. Study on raising the minimum age to purchase tobacco products. 
Sec. 105. Enforcement action plan for advertising and promotion restrictions. 
Sec. 106. Studies of progress and effectiveness. 
TITLE II—TOBACCO PRODUCT WARNINGS; CONSTITUENT AND 
SMOKE CONSTITUENT DISCLOSURE 
Sec. 201. Cigarette label and advertising warnings. 
Sec. 202. Authority to revise cigarette warning label statements. 
Sec. 203. State regulation of cigarette advertising and promotion. 
Sec. 204. Smokeless tobacco labels and advertising warnings. 
Sec. 205. Authority to revise smokeless tobacco product warning label statements. 
Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the public. 
TITLE III—PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS 
Sec. 301. Labeling, recordkeeping, records inspection. 
Sec. 302. Study and report. 
SEC. 2. FINDINGS. 
The Congress finds the following: 
(1) The use of tobacco products by the Nation’s 
children is a pediatric disease of considerable propor-
tions that results in new generations of tobacco-de-
pendent children and adults. 
(2) A consensus exists within the scientific and 
medical communities that tobacco products are inher-
ently dangerous and cause cancer, heart disease, and 
other serious adverse health effects.
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(3) Nicotine is an addictive drug. 
(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, comprehen-
sive restrictions on the sale, promotion, and distribu-
tion 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 tobacco prod-
ucts. 
(8) Federal and State public health officials, the 
public health community, and the public at large rec-
ognize that the tobacco industry should be subject to 
ongoing oversight. 
(9) Under article I, section 8 of the Constitution, 
the Congress is vested with the responsibility for regu-
lating interstate commerce and commerce with Indian 
tribes.
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(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 distrib-
uted 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 products. 
(12) It is in the public interest for Congress to 
enact legislation that provides the Food and Drug Ad-
ministration with the authority to regulate tobacco 
products and the advertising and promotion of such 
products. The benefits to the American people from 
enacting such legislation would be significant in 
human and economic terms. 
(13) Tobacco use is the foremost preventable 
cause of premature death in America. It causes over 
400,000 deaths in the United States each year, and 
approximately 8,600,000 Americans have chronic ill-
nesses related to smoking. 
(14) Reducing the use of tobacco by minors by 
50 percent would prevent well over 10,000,000 of to-
day’s children from becoming regular, daily smokers,
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saving over 3,000,000 of them from premature death 
due to tobacco-induced disease. Such a reduction in 
youth smoking would also result in approximately 
$75,000,000,000 in savings attributable to reduced 
health care costs. 
(15) 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 activities have 
not been successful in adequately preventing such in-
creased use. 
(16) In 2005, the cigarette manufacturers spent 
more than $13,000,000,000 to attract new users, re-
tain current users, increase current consumption, and 
generate favorable long-term attitudes toward smoking 
and tobacco use. 
(17) 
Tobacco 
product 
advertising 
often 
misleadingly portrays the use of tobacco as socially 
acceptable and healthful to minors. 
(18) Tobacco product advertising is regularly 
seen by persons under the age of 18, and persons 
under the age of 18 are regularly exposed to tobacco 
product promotional efforts.
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(19) Through advertisements during and spon-
sorship of sporting events, tobacco has become strongly 
associated with sports and has become portrayed as 
an integral part of sports and the healthy lifestyle as-
sociated with rigorous sporting activity. 
(20) Children are exposed to substantial and un-
avoidable tobacco advertising that leads to favorable 
beliefs about tobacco use, plays a role in leading 
young people to overestimate the prevalence of tobacco 
use, and increases the number of young people who 
begin to use tobacco. 
(21) The use of tobacco products in motion pic-
tures and other mass media glamorizes its use for 
young people and encourages them to use tobacco 
products. 
(22) Tobacco advertising expands the size of the 
tobacco market by increasing consumption of tobacco 
products including tobacco use by young people. 
(23) Children are more influenced by tobacco 
marketing than adults: more than 80 percent of youth 
smoke three heavily marketed brands, while only 54 
percent of adults, 26 and older, smoke these same 
brands. 
(24) Tobacco company documents indicate that 
young people are an important and often crucial seg-
† HR 1256 EAS 
gust 28, 1996, issue of the Federal Register (61 Fed. 
Reg. 44615–44618) for inclusion as part 897 of title 
21, Code of Federal Regulations, are consistent with 
the first amendment to the United States Constitution 
and with the standards set forth in the amendments 
made by this subtitle for the regulation of tobacco 
products by the Food and Drug Administration, and 
the restriction on the sale and distribution of, includ-
ing access to and the advertising and promotion of, 
tobacco products contained in such regulations are 
substantially related to accomplishing the public 
health goals of this division. 
(31) The regulations described in paragraph (30) 
will directly and materially advance the Federal Gov-
ernment’s substantial interest in reducing the number 
of children and adolescents who use cigarettes and 
smokeless tobacco and in preventing the life-threat-
ening health consequences associated with tobacco use. 
An overwhelming majority of Americans who use to-
bacco products begin using such products while they 
are minors and become addicted to the nicotine in 
those products before reaching the age of 18. Tobacco 
advertising and promotion play a crucial role in the 
decision of these minors to begin using tobacco prod-
ucts. Less restrictive and less comprehensive ap-
† HR 1256 EAS 
list shall be prepared in such form and manner as the 
Secretary may prescribe and shall be accompanied 
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 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 par-
ticular tobacco product; and 
‘‘(C) if the registrant filing a list has deter-
mined 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 registrant made such 
determination if the Secretary requests such a
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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 Bureau 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 pre-
viously filed by that person with the Secretary 
under this subparagraph or paragraph (1). A 
list under this subparagraph shall list a tobacco 
product by its established name and shall be ac-
companied by the other information required by 
paragraph (1).
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‘‘(B) If since the date the registrant last 
made a report under this paragraph that person 
has discontinued the manufacture, preparation, 
compounding, or processing for commercial dis-
tribution of a tobacco product included in a list 
filed under subparagraph (A) or paragraph (1), 
notice of such discontinuance, the date of such 
discontinuance, and the identity of its estab-
lished name. 
‘‘(C) If since the date the registrant reported 
under subparagraph (B) a notice of discontinu-
ance that person has resumed the manufacture, 
preparation, compounding, or processing for 
commercial distribution of the tobacco product 
with respect to which such notice of discontinu-
ance was reported, notice of such resumption, the 
date of such resumption, the identity of such to-
bacco product by established name, and other in-
formation required by paragraph (1), unless the 
registrant has previously reported such resump-
tion to the Secretary under this subparagraph. 
‘‘(D) Any material change in any informa-
tion previously submitted under this paragraph 
or paragraph (1).
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‘‘(j) REPORT PRECEDING INTRODUCTION OF CERTAIN 
SUBSTANTIALLY
EQUIVALENT
PRODUCTS
INTO
INTER-
STATE COMMERCE.— 
‘‘(1) IN GENERAL.—Each person who is required 
to register under this section and who proposes to 
begin the introduction or delivery for introduction 
into interstate commerce for commercial distribution 
of a tobacco product intended for human use that was 
not commercially marketed (other than for test mar-
keting) in the United States as of February 15, 2007, 
shall, at least 90 days prior to making such introduc-
tion or delivery, report to the Secretary (in such form 
and manner as the Secretary shall prescribe)— 
‘‘(A) the basis for such person’s determina-
tion that— 
‘‘(i) the tobacco product is substan-
tially equivalent, within the meaning of sec-
tion 910, to a tobacco product commercially 
marketed (other than for test marketing) in 
the United States as of February 15, 2007, 
or to a tobacco product that the Secretary 
has previously determined, pursuant to sub-
section (a)(3) of section 910, is substantially 
equivalent and that is in compliance with 
the requirements of this Act; or
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‘‘(ii) the tobacco product is modified 
within the meaning of paragraph (3), the 
modifications are to a product that is com-
mercially marketed and in compliance with 
the requirements of this Act, and all of the 
modifications are covered by exemptions 
granted by the Secretary pursuant to para-
graph (3); and 
‘‘(B) action taken by such person to comply 
with the requirements under section 907 that are 
applicable to the tobacco product. 
‘‘(2) APPLICATION TO CERTAIN POST-FEBRUARY 
15, 2007, PRODUCTS.—A report under this subsection 
for a tobacco product that was first introduced or de-
livered for introduction into interstate commerce 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 shall be 
submitted to the Secretary not later than 21 months 
after such date of enactment. 
‘‘(3) EXEMPTIONS.— 
‘‘(A) IN GENERAL.—The Secretary may ex-
empt from the requirements of this subsection re-
lating to the demonstration that a tobacco prod-
† HR 1256 EAS 
The finding as to whether such regulation would be 
appropriate for the protection of the public health 
shall be determined with respect to the risks and bene-
fits to the population as a whole, including users and 
nonusers of the tobacco product, and taking into ac-
count— 
‘‘(A) the increased or decreased likelihood 
that existing users of tobacco products will stop 
using such products; and 
‘‘(B) the increased or decreased likelihood 
that those who do not use tobacco products will 
start using such products. 
No such regulation may require that the sale or dis-
tribution of a tobacco product be limited to the writ-
ten or oral authorization of a practitioner licensed by 
law to prescribe medical products. 
‘‘(2) LABEL STATEMENTS.—The label of a to-
bacco product shall bear such appropriate statements 
of the restrictions required by a regulation under sub-
section (a) as the Secretary may in such regulation 
prescribe. 
‘‘(3) LIMITATIONS.— 
‘‘(A) IN GENERAL.—No restrictions under 
paragraph (1) may—
† HR 1256 EAS 
‘‘(i) prohibit the sale of any tobacco 
product in face-to-face transactions by a 
specific category of retail outlets; or 
‘‘(ii) establish a minimum age of sale 
of tobacco products to any person older than 
18 years of age. 
‘‘(B) MATCHBOOKS.—For purposes of any 
regulations issued by the Secretary, matchbooks 
of conventional size containing not more than 20 
paper matches, and which are customarily given 
away for free with the purchase of tobacco prod-
ucts, shall be considered as adult-written publi-
cations which shall be permitted to contain ad-
vertising. Notwithstanding the preceding sen-
tence, if the Secretary finds that such treatment 
of matchbooks is not appropriate for the protec-
tion of the public health, the Secretary may de-
termine by regulation that matchbooks shall not 
be considered adult-written publications. 
‘‘(4) REMOTE SALES.— 
‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) within 18 months after the date of 
enactment of the Family Smoking Preven-
tion and Tobacco Control Act, promulgate 
regulations regarding the sale and distribu-
† HR 1256 EAS 
tion of tobacco products that occur through 
means other than a direct, face-to-face ex-
change between a retailer and a consumer 
in order to prevent the sale and distribution 
of tobacco products to individuals who have 
not attained the minimum age established 
by applicable law for the purchase of such 
products, including requirements for age 
verification; and 
‘‘(ii) within 2 years after such date of 
enactment, issue regulations to address the 
promotion and marketing of tobacco prod-
ucts that are sold or distributed through 
means other than a direct, face-to-face ex-
change between a retailer and a consumer 
in order to protect individuals who have not 
attained the minimum age established by 
applicable law for the purchase of such 
products. 
‘‘(B) RELATION TO OTHER AUTHORITY.— 
Nothing in this paragraph limits the authority 
of the Secretary to take additional actions under 
the other paragraphs of this subsection. 
‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE-
MENTS.—
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‘‘(1) METHODS, FACILITIES, AND CONTROLS TO 
CONFORM.— 
‘‘(A) IN GENERAL.—In applying manufac-
turing restrictions to tobacco, the Secretary shall, 
in accordance with subparagraph (B), prescribe 
regulations (which may differ based on the type 
of tobacco product involved) requiring that the 
methods used in, and the facilities and controls 
used for, the manufacture, preproduction design 
validation (including a process to assess the per-
formance of a tobacco product), packing, and 
storage of a tobacco product conform to current 
good manufacturing practice, or hazard analysis 
and critical control point methodology, as pre-
scribed in such regulations to assure that the 
public health is protected and that the tobacco 
product is in compliance with this chapter. Such 
regulations may provide for the testing of raw 
tobacco for pesticide chemical residues regardless 
of whether a tolerance for such chemical residues 
has been established. 
‘‘(B) 
REQUIREMENTS.—The 
Secretary 
shall— 
‘‘(i) before promulgating any regula-
tion under subparagraph (A), afford the To-
† HR 1256 EAS 
bacco Products Scientific Advisory Com-
mittee an opportunity to submit rec-
ommendations with respect to the regulation 
proposed to be promulgated; 
‘‘(ii) before promulgating any regula-
tion under subparagraph (A), afford oppor-
tunity for an oral hearing; 
‘‘(iii) provide the Tobacco Products 
Scientific Advisory Committee a reasonable 
time to make its recommendation with re-
spect to proposed regulations under sub-
paragraph (A); 
‘‘(iv) in establishing the effective date 
of a regulation promulgated under this sub-
section, take into account the differences in 
the manner in which the different types of 
tobacco products have historically been pro-
duced, the financial resources of the dif-
ferent tobacco product manufacturers, and 
the state of their existing manufacturing fa-
cilities, and shall provide for a reasonable 
period of time for such manufacturers to 
conform to good manufacturing practices; 
and
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‘‘(v) not require any small tobacco 
product manufacturer to comply with a reg-
ulation under subparagraph (A) for at least 
4 years following the effective date estab-
lished by the Secretary for such regulation. 
‘‘(2) EXEMPTIONS; VARIANCES.— 
‘‘(A) PETITION.—Any person subject to any 
requirement prescribed under paragraph (1) 
may petition the Secretary for a permanent or 
temporary exemption or variance from such re-
quirement. Such a petition shall be submitted to 
the Secretary in such form and manner as the 
Secretary shall prescribe and shall— 
‘‘(i) in the case of a petition for an ex-
emption from a requirement, set forth the 
basis for the petitioner’s determination that 
compliance with the requirement is not re-
quired to assure that the tobacco product 
will be in compliance with this chapter; 
‘‘(ii) in the case of a petition for a 
variance from a requirement, set forth the 
methods proposed to be used in, and the fa-
cilities and controls proposed to be used for, 
the manufacture, packing, and storage of 
the tobacco product in lieu of the methods,
† HR 1256 EAS 
facilities, and controls prescribed by the re-
quirement; and 
‘‘(iii) contain such other information 
as the Secretary shall prescribe. 
‘‘(B) REFERRAL TO THE TOBACCO PROD-
UCTS
SCIENTIFIC
ADVISORY
COMMITTEE.—The 
Secretary may refer to the Tobacco Products Sci-
entific Advisory Committee any petition sub-
mitted under subparagraph (A). The Tobacco 
Products Scientific Advisory Committee shall re-
port its recommendations to the Secretary with 
respect to a petition referred to it within 60 days 
after the date of the petition’s referral. Within 60 
days after— 
‘‘(i) the date the petition was sub-
mitted to the Secretary under subparagraph 
(A); or 
‘‘(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—
† HR 1256 EAS 
‘‘(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 prescribed 
by the requirement are sufficient to assure 
that the tobacco product will be in compli-
ance with this chapter. 
‘‘(D) CONDITIONS.—An order of the Sec-
retary approving a petition for a variance shall 
prescribe such conditions respecting the methods 
used in, and the facilities and controls used for, 
the manufacture, packing, and storage of the to-
bacco product to be granted the variance under 
the petition as may be necessary to assure that 
the tobacco product will be in compliance with 
this chapter.
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‘‘(E) HEARING.—After the issuance of an 
order under subparagraph (B) respecting a peti-
tion, the petitioner shall have an opportunity for 
an informal hearing on such order. 
‘‘(3) COMPLIANCE.—Compliance with require-
ments under this subsection shall not be required be-
fore the end of the 3-year period following the date of 
enactment of the Family Smoking Prevention and To-
bacco Control Act. 
‘‘(f) RESEARCH AND DEVELOPMENT.—The Secretary 
may enter into contracts for research, testing, and dem-
onstrations respecting tobacco products and may obtain to-
bacco products for research, testing, and demonstration pur-
poses. 
‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 
‘‘(a) IN GENERAL.— 
‘‘(1) SPECIAL RULES.— 
‘‘(A) SPECIAL RULE FOR CIGARETTES.—Be-
ginning 3 months after the date of enactment 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 (including a 
smoke constituent) or additive, an artificial or 
natural flavor (other than tobacco or menthol) or
† HR 1256 EAS 
‘‘(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 tobacco 
products will stop using such products; 
and 
‘‘(III) the increased or decreased 
likelihood that those who do not use to-
bacco products will start using such 
products. 
‘‘(ii) ADDITIONAL CONSIDERATIONS.— 
In the event that the Secretary makes a de-
termination, set forth in a proposed tobacco
† HR 1256 EAS 
product standard in a proposed rule, that it 
is appropriate for the protection of public 
health to require the reduction or elimi-
nation of an additive, constituent (includ-
ing a smoke constituent), or other compo-
nent of a tobacco product because the Sec-
retary has found that the additive, con-
stituent, or other component is or may be 
harmful, any party objecting to the pro-
posed standard on the ground that the pro-
posed standard will not reduce or eliminate 
the risk of illness or injury may provide for 
the Secretary’s consideration scientific evi-
dence that demonstrates that the proposed 
standard 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-
† HR 1256 EAS 
stituents, or harmful components of the 
product; or 
‘‘(iii) relating to any other require-
ment under subparagraph (B); 
‘‘(B) shall, where appropriate for the protec-
tion of the public health, include— 
‘‘(i) provisions respecting the construc-
tion, components, ingredients, additives, 
constituents, including smoke constituents, 
and properties of the tobacco product; 
‘‘(ii) provisions for the testing (on a 
sample basis or, if necessary, on an indi-
vidual basis) of the tobacco product; 
‘‘(iii) provisions for the measurement 
of the tobacco product characteristics of the 
tobacco product; 
‘‘(iv) provisions requiring that the re-
sults of each or of certain of the tests of the 
tobacco product required to be made under 
clause (ii) show that the tobacco product is 
in conformity with the portions of the 
standard for which the test or tests were re-
quired; and 
‘‘(v) a provision requiring that the sale 
and distribution of the tobacco product be
† HR 1256 EAS 
restricted but only to the extent that the sale 
and distribution of a tobacco product may 
be restricted under a regulation under sec-
tion 906(d); 
‘‘(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 med-
ical, scientific, or other technological data. The Sec-
retary may provide for testing under paragraph 
(4)(B) by any person. 
‘‘(6) INVOLVEMENT
OF
OTHER
AGENCIES; IN-
FORMED PERSONS.—In carrying out duties under this 
section, the Secretary shall endeavor to— 
‘‘(A) use personnel, facilities, and other 
technical support available in other Federal 
agencies;
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‘‘(B) consult with other Federal agencies 
concerned with standard setting and other na-
tionally or internationally recognized standard- 
setting entities; and 
‘‘(C) 
invite 
appropriate 
participation, 
through joint or other conferences, workshops, or 
other means, by informed persons representative 
of scientific, professional, industry, agricultural, 
or consumer organizations who in the Secretary’s 
judgment can make a significant contribution. 
‘‘(b) CONSIDERATIONS BY SECRETARY.— 
‘‘(1) TECHNICAL ACHIEVABILITY.—The Secretary 
shall consider information submitted in connection 
with a proposed standard regarding the technical 
achievability of compliance with such standard. 
‘‘(2) OTHER
CONSIDERATIONS.—The Secretary 
shall consider all other information submitted in con-
nection with a proposed standard, including informa-
tion concerning the countervailing effects of the to-
bacco product standard on the health of adolescent to-
bacco users, adult tobacco users, or nontobacco 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.
† HR 1256 EAS 
In its review, the Tobacco Products Scientific Advi-
sory Committee shall address the considerations listed 
in subsection (a)(3)(B)(i). 
‘‘(2) REPORT AND RECOMMENDATION.—Not later 
than 2 years after its establishment, the Tobacco 
Product Scientific Advisory Committee shall submit 
to the Secretary the report and recommendations re-
quired pursuant to paragraph (1). 
‘‘(3) RULE OF CONSTRUCTION.—Nothing in this 
subsection shall be construed to limit the Secretary’s 
authority to take action under this section or other 
sections of this Act at any time applicable to any dis-
solvable tobacco product. 
‘‘SEC. 908. NOTIFICATION AND OTHER REMEDIES. 
‘‘(a) NOTIFICATION.—If the Secretary determines 
that— 
‘‘(1) a tobacco product which is introduced or de-
livered for introduction into interstate commerce for 
commercial distribution presents an unreasonable risk 
of substantial harm to the public health; and 
‘‘(2) notification under this subsection is nec-
essary to eliminate the unreasonable risk of such 
harm and no more practicable means is available 
under the provisions of this chapter (other than this 
section) to eliminate such risk,