H. R. 1256 

One Hundred Eleventh Congress 

of the 

United States of America 

AT THE FIRST SESSION 

Begun and held at the City of Washington on Tuesday, 

the sixth day of January, two thousand and nine 

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. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

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’’. 

(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: 
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(1) The use of tobacco products by the Nation’s children 

is a pediatric disease of considerable proportions that results 

in new generations of tobacco-dependent children and adults. 

(2) A consensus exists within the scientific and medical 

communities that tobacco products are inherently dangerous 

and cause cancer, heart disease, and other serious adverse 

health effects. 

(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 contribute 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 adequately to curb 

tobacco use by adolescents, comprehensive restrictions on the 

sale, promotion, and distribution of such products are needed. 

(7) Federal and State governments have lacked the legal 

and regulatory authority and resources they need to address 

comprehensively the public health and societal problems caused 

by the use of tobacco products. 

(8) Federal and State public health officials, the public 

health community, and the public at large recognize that the 

tobacco industry should be subject to ongoing oversight. 

(9) Under article I, section 8 of the Constitution, the Congress is vested with the responsibility for regulating interstate 

commerce and commerce with Indian tribes. 

(10) The sale, distribution, marketing, advertising, and use 

of tobacco products are activities in and substantially affecting 

interstate commerce because they are sold, marketed, advertised, and distributed in interstate commerce on a nationwide 

basis, and have a substantial effect on the Nation’s economy. 

(11) The sale, distribution, marketing, advertising, 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 Administration 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 illnesses related to smoking. 

(14) Reducing the use of tobacco by minors by 50 percent 

would prevent well over 10,000,000 of today’s children from 

becoming regular, daily smokers, 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 attract young persons 

to use tobacco products, and these efforts have resulted in 

increased use of such products by youth. Past efforts to oversee 
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these activities have not been successful in adequately preventing such increased use. 

(16) In 2005, the cigarette manufacturers spent more than 

$13,000,000,000 to attract new users, retain 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. 

(19) Through advertisements during and sponsorship of 

sporting events, tobacco has become strongly associated with 

sports and has become portrayed as an integral part of sports 

and the healthy lifestyle associated with rigorous sporting 

activity. 

(20) Children are exposed to substantial and unavoidable 

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 pictures 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 segment of the 

tobacco market. Children, who tend to be more price sensitive 

than adults, are influenced by advertising and promotion practices that result in drastically reduced cigarette prices. 

(25) Comprehensive advertising restrictions will have a 

positive effect on the smoking rates of young people. 

(26) Restrictions on advertising are necessary to prevent 

unrestricted tobacco advertising from undermining legislation 

prohibiting access to young people and providing for education 

about tobacco use. 

(27) International experience shows that advertising regulations that are stringent and comprehensive have a greater 

impact on overall tobacco use and young people’s use than 

weaker or less comprehensive ones. 

(28) Text only requirements, although not as stringent 

as a ban, will help reduce underage use of tobacco products 

while preserving the informational function of advertising. 

(29) It is in the public interest for Congress to adopt legislation to address the public health crisis created by actions of 

the tobacco industry. 

(30) The final regulations promulgated by the Secretary 

of Health and Human Services in the August 28, 1996, issue 

of the Federal Register (61 Fed. Reg. 44615–44618) for inclusion 
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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, including 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 Government’s 

substantial interest in reducing the number of children and 

adolescents who use cigarettes and smokeless tobacco and in 

preventing the life-threatening health consequences associated 

with tobacco use. An overwhelming majority of Americans who 

use tobacco 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 products. Less restrictive and less comprehensive approaches have not and will not be effective in 

reducing the problems addressed by such regulations. The 

reasonable restrictions on the advertising and promotion of 

tobacco products contained in such regulations will lead to 

a significant decrease in the number of minors using and 

becoming addicted to those products. 

(32) The regulations described in paragraph (30) impose 

no more extensive restrictions on communication by tobacco 

manufacturers and sellers than are necessary to reduce the 

number of children and adolescents who use cigarettes and 

smokeless tobacco and to prevent the life-threatening health 

consequences associated with tobacco use. Such regulations are 

narrowly tailored to restrict those advertising and promotional 

practices which are most likely to be seen or heard by youth 

and most likely to entice them into tobacco use, while affording 

tobacco manufacturers and sellers ample opportunity to convey 

information about their products to adult consumers. 

(33) Tobacco dependence is a chronic disease, one that 

typically requires repeated interventions to achieve long-term 

or permanent abstinence. 

(34) Because the only known safe alternative to smoking 

is cessation, interventions should target all smokers to help 

them quit completely. 

(35) Tobacco products have been used to facilitate and 

finance criminal activities both domestically and internationally. Illicit trade of tobacco products has been linked to organized crime and terrorist groups. 

(36) It is essential that the Food and Drug Administration 

review products sold or distributed for use to reduce risks 

or exposures associated with tobacco products and that it be 

empowered to review any advertising and labeling for such 

products. It is also essential that manufacturers, prior to marketing such products, be required to demonstrate that such 

products will meet a series of rigorous criteria, and will benefit 

the health of the population as a whole, taking into account 

both users of tobacco products and persons who do not currently 

use tobacco products. 
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(37) Unless tobacco products that purport to reduce the 

risks to the public of tobacco use actually reduce such risks, 

those products can cause substantial harm to the public health 

to the extent that the individuals, who would otherwise not 

consume tobacco products or would consume such products 

less, use tobacco products purporting to reduce risk. Those 

who use products sold or distributed as modified risk products 

that do not in fact reduce risk, rather than quitting or reducing 

their use of tobacco products, have a substantially increased 

likelihood of suffering disability and premature death. The 

costs to society of the widespread use of products sold or distributed as modified risk products that do not in fact reduce risk 

or that increase risk include thousands of unnecessary deaths 

and injuries and huge costs to our health care system. 

(38) As the National Cancer Institute has found, many 

smokers mistakenly believe that ‘‘low tar’’ and ‘‘light’’ cigarettes 

cause fewer health problems than other cigarettes. As the 

National Cancer Institute has also found, mistaken beliefs 

about the health consequences of smoking ‘‘low tar’’ and ‘‘light’’ 

cigarettes can reduce the motivation to quit smoking entirely 

and thereby lead to disease and death. 

(39) Recent studies have demonstrated that there has been 

no reduction in risk on a population-wide basis from ‘‘low 

tar’’ and ‘‘light’’ cigarettes, and such products may actually 

increase the risk of tobacco use. 

(40) The dangers of products sold or distributed as modified 

risk tobacco products that do not in fact reduce risk are so 

high that there is a compelling governmental interest in 

ensuring that statements about modified risk tobacco products 

are complete, accurate, and relate to the overall disease risk 

of the product. 

(41) As the Federal Trade Commission has found, consumers have misinterpreted advertisements in which one 

product is claimed to be less harmful than a comparable 

product, even in the presence of disclosures and advisories 

intended to provide clarification. 

(42) Permitting manufacturers to make unsubstantiated 

statements concerning modified risk tobacco products, whether 

express or implied, even if accompanied by disclaimers would 

be detrimental to the public health. 

(43) The only way to effectively protect the public health 

from the dangers of unsubstantiated modified risk tobacco products is to empower the Food and Drug Administration to require 

that products that tobacco manufacturers sold or distributed 

for risk reduction be reviewed in advance of marketing, and 

to require that the evidence relied on to support claims be 

fully verified. 

(44) The Food and Drug Administration is a regulatory 

agency with the scientific expertise to identify harmful substances in products to which consumers are exposed, to design 

standards to limit exposure to those substances, to evaluate 

scientific studies supporting claims about the safety of products, 

and to evaluate the impact of labels, labeling, and advertising 

on consumer behavior in order to reduce the risk of harm 

and promote understanding of the impact of the product on 

health. In connection with its mandate to promote health and 

reduce the risk of harm, the Food and Drug Administration 
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routinely makes decisions about whether and how products 

may be marketed in the United States. 

(45) The Federal Trade Commission was created to protect 

consumers from unfair or deceptive acts or practices, and to 

regulate unfair methods of competition. Its focus is on those 

marketplace practices 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 Administration 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 communications 

directed to consumers through the media or through a label, 

labeling, or advertising, that a tobacco product is approved 

or inspected by the Food and Drug Administration or complies 

with Food and Drug Administration standards, consumers are 

likely 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 consumers being misled about the harmfulness of the product 

because of such regulation, inspection, approval, or compliance. 

(47) In August 2006 a United States district court judge 

found that the major United States cigarette 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 cigarette companies 

dramatically increased their advertising and promotional 

spending in ways that encourage 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 cigarette companies have 

designed their cigarettes to precisely control nicotine delivery 

levels and provide doses of nicotine sufficient to create and 

sustain addiction while also concealing much of their nicotinerelated 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 division 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 division; 

(2) to ensure that the Food and Drug Administration has 

the authority to address issues of particular concern to public 

health officials, especially the use of tobacco by young people 

and dependence on tobacco; 
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(3) to authorize the Food and Drug Administration 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 authority 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, nicotine, and other 

harmful components of tobacco products; 

(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 underage 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 division (or an amendment made by this division) shall be construed to— 

(1) establish a precedent with regard to any other industry, 

situation, circumstance, or legal action; 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 division 

(or an amendment made by this division) which authorize 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 division (or 

an amendment made by this division) which authorize the Secretary 

to take certain actions with regard to tobacco products shall not 

be construed to affect any authority of the Secretary of the Treasury 

under chapter 52 of the Internal Revenue Code of 1986. 

SEC. 5. SEVERABILITY. 

If any provision of this division, of the amendments made 

by this division, or of the regulations promulgated under this division (or under such amendments), or the application of any such 

provision to any person or circumstance is held to be invalid, 

the remainder of this division, such amendments and such regulations, and the application of such provisions to any other person 

or circumstance shall not be affected and shall continue to be 

enforced to the fullest extent possible. 
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SEC. 6. MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION. 

(a) DELAYED COMMENCEMENT OF DATES FOR SECRETARIAL

ACTION.— 

(1) IN GENERAL.—Except as provided in subsection (c), with 

respect to any time periods specified in this division (or in 

an amendment made by this division) that begin on the date 

of enactment of this Act, within which the Secretary of Health 

and Human Services is required to carry out and complete 

specified activities, the calculation of such time periods shall 

commence on the date described in subsection (b). 

(2) LIMITATION.—Subsection (a) shall only apply with 

respect to obligations of the Secretary of Health and Human 

Services that must be completed within a specified time period 

and shall not apply to the obligations of any other person 

or to any other provision of this division (including the amendments made by this division) that do not create such obligations 

of the Secretary and are not contingent on actions by the 

Secretary. 

(b) DATE DESCRIBED.—The date described in this subsection 

is the first day of the first fiscal quarter following the initial 

2 consecutive fiscal quarters of fiscal year 2010 for which the 

Secretary of Health and Human Services has collected fees under 

section 919 of the Federal Food, Drug, and Cosmetic Act (as added 

by section 101). 

(c) EXCEPTION.—Subsection (a) shall not apply to any time 

period (or date) contained— 

(1) in section 102, except that the reference to ‘‘180 days’’ 

in subsection (a)(1) of such section shall be deemed to be 

‘‘270 days’’; and 

(2) in sections 201 through 204 (or the amendments made 

by any such sections). 

(d) ADJUSTMENT.—The Secretary of Health and Human Services 

may extend or reduce the duration of one or more time periods 

to which subsection (a) applies if the Secretary determines appropriate, except that no such period shall be extended for more than 

90 days. 

TITLE I—AUTHORITY OF THE FOOD 

AND DRUG ADMINISTRATION 

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 following: 

‘‘(rr)(1) The term ‘tobacco product’ means any product 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. 
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‘‘(4) A tobacco product shall not be marketed in combination 

with any other article or product regulated under this Act (including 

a drug, biologic, food, cosmetic, medical device, or a dietary supplement).’’. 

(b) FDA AUTHORITY OVER TOBACCO PRODUCTS.—The Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended— 

(1) by redesignating chapter IX as chapter X; 

(2) by redesignating sections 901 through 910 as sections 

1001 through 1010; and 

(3) by inserting after chapter VIII the following: 

‘‘CHAPTER IX—TOBACCO PRODUCTS 

‘‘SEC. 900. DEFINITIONS. 

‘‘In this chapter: 

‘‘(1) ADDITIVE.—The term ‘additive’ means any substance 

the intended use of which results or may reasonably be expected 

to result, directly or indirectly, in its becoming a component 

or otherwise affecting the characteristic of any tobacco product 

(including any substances intended for use as a flavoring or 

coloring or in producing, manufacturing, packing, processing, 

preparing, treating, packaging, transporting, or holding), except 

that such term does not include tobacco or a pesticide chemical 

residue in or on raw tobacco or a pesticide chemical. 

‘‘(2) BRAND.—The term ‘brand’ means a variety of tobacco 

product distinguished by the tobacco used, tar content, nicotine 

content, flavoring used, size, filtration, packaging, logo, registered trademark, brand name, identifiable pattern of colors, 

or any combination of such attributes. 

‘‘(3) CIGARETTE.—The term ‘cigarette’— 

‘‘(A) means a product that— 

‘‘(i) is a tobacco product; and 

‘‘(ii) meets the definition of the term ‘cigarette’ 

in section 3(1) of the Federal Cigarette Labeling and 

Advertising Act; and 

‘‘(B) includes tobacco, in any form, that is functional 

in the product, which, because of its appearance, the type 

of tobacco used in the filler, or its packaging and labeling, 

is likely to be offered to, or purchased by, consumers as 

a cigarette or as roll-your-own tobacco. 

‘‘(4) CIGARETTE TOBACCO.—The term ‘cigarette tobacco’ 

means any product that consists of loose tobacco that is 

intended for use by consumers in a cigarette. Unless otherwise 

stated, the requirements applicable to cigarettes under this 

chapter shall also apply to cigarette tobacco. 

‘‘(5) COMMERCE.—The term ‘commerce’ has the meaning 

given that term by section 3(2) of the Federal Cigarette Labeling 

and Advertising Act. 

‘‘(6) COUNTERFEIT TOBACCO PRODUCT.—The term ‘counterfeit tobacco product’ means a tobacco product (or the container 

or labeling of such a product) that, without authorization, bears 

the trademark, trade name, or other identifying mark, imprint, 

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 
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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, possession, 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 SelfDetermination and Education Assistance 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 cellophane), 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 making cigarettes. 

‘‘(16) SMALL TOBACCO PRODUCT MANUFACTURER.—The term 

‘small tobacco product manufacturer’ means a tobacco product 

manufacturer that employs fewer than 350 employees. For purposes of determining the number of employees of a manufacturer 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 compound in mainstream or 

sidestream tobacco smoke that either transfers from any component of the cigarette to the smoke or that is formed by the 

combustion or heating of tobacco, additives, or other component 

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. 
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‘‘(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 manufacturer 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’ excludes 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 

subparagraph 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 Commonwealth of Puerto Rico, Guam, the 

Virgin Islands, American Samoa, Wake Island, Midway Islands, 

Kingman Reef, Johnston Atoll, the Northern Mariana Islands, 

and any other trust territory or possession 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 regulated 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 thereunder, or in sections 
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101(a), 102, or 103 of title I, title II, or title III of the Family 

Smoking Prevention 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 products 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 tobacco products, or to the producers 

of tobacco leaf, including tobacco growers, tobacco warehouses, and tobacco grower cooperatives, nor shall any 

employee of the Food and Drug Administration have any 

authority to enter onto a farm owned by a producer of 

tobacco leaf without the written consent of such producer. 

‘‘(B) EXCEPTION.—Notwithstanding subparagraph (A), 

if a producer of tobacco leaf is also a tobacco product 

manufacturer or controlled by a tobacco product manufacturer, the producer shall be subject to this chapter in 

the producer’s capacity as a manufacturer. The exception 

in this subparagraph shall not apply to a producer of 

tobacco leaf who grows tobacco under a contract with a 

tobacco product manufacturer 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 production. 

‘‘(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 Secretary shall establish within the 

Food and Drug Administration the Center for Tobacco Products, 

which shall report 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 assigned 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 
H. R. 1256—13 

added poisonous or added deleterious substance that may 

render the product injurious to health; 

‘‘(2) it has been prepared, packed, or held under insanitary 

conditions whereby it may have been contaminated with filth, 

or whereby it may have been rendered 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 tobacco 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 unless such tobacco product is in 

all respects in conformity with such standard; 

‘‘(6)(A) it is required by section 910(a) to have premarket 

review and does not have an order in effect 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 storage are not in conformity 

with applicable requirements under section 906(e)(1) or an 

applicable condition 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 distributor; 

‘‘(B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; 

‘‘(C) an accurate statement of the percentage 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 variations shall 

be permitted, and exemptions as to small packages shall be 

established, by regulations prescribed by the Secretary; 

‘‘(3) if any word, statement, or other information required 

by or under authority of this chapter to appear on the label 

or labeling is not prominently placed thereon with such 

conspicuousness (as compared 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 nonproprietary name, its established name prominently printed in type as required by the 

Secretary by regulation; 
H. R. 1256—14 

‘‘(5) if the Secretary has issued regulations requiring 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 regulations; 

‘‘(6) if it was manufactured, prepared, propagated, 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 required by section 905(i), if a notice or 

other information 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 identification of tobacco 

products prescribed under section 905(e) as the Secretary by 

regulation requires; 

‘‘(7) if, in the case of any tobacco product distributed or 

offered for sale in any State— 

‘‘(A) its advertising is false or misleading in any particular; or 

‘‘(B) it is sold or distributed in violation of regulations 

prescribed under section 906(d); 

‘‘(8) unless, in the case of any tobacco product distributed 

or offered for sale in any State, the manufacturer, packer, 

or distributor thereof includes in all advertisements and other 

descriptive printed matter issued or caused to be issued by 

the manufacturer, packer, or distributor with respect to that 

tobacco product— 

‘‘(A) a true statement of the tobacco product’s established name as described in paragraph (4), printed prominently; and 

‘‘(B) a brief statement of— 

‘‘(i) the uses of the tobacco product and relevant 

warnings, precautions, side effects, and contraindications; and 

‘‘(ii) in the case of specific tobacco products made 

subject to a finding by the Secretary after notice and 

opportunity for comment that such action is appropriate to protect the public health, a full description 

of the components of such tobacco product or the formula showing quantitatively each ingredient of such 

tobacco product to the extent required in regulations 

which shall be issued by the Secretary after an opportunity for a hearing; 

‘‘(9) if it is a tobacco product subject to a tobacco product 

standard established under section 907, unless it bears such 

labeling as may be prescribed in such tobacco product standard; 

or 

‘‘(10) if there was a failure or refusal— 

‘‘(A) to comply with any requirement prescribed under 

section 904 or 908; or 

‘‘(B) to furnish any material or information required 

under section 909. 

‘‘(b) PRIOR APPROVAL OF LABEL STATEMENTS.—The Secretary 

may, by regulation, require prior approval of statements made 

on the label of a tobacco product to ensure that such statements 

do not violate the misbranding provisions of subsection (a) and 

that such statements comply with other provisions of the Family 
H. R. 1256—15 

Smoking Prevention and Tobacco Control Act (including the amendments made by such Act). No regulation issued under this subsection may require prior approval by the Secretary of the content 

of any advertisement, except for modified risk tobacco products 

as provided in section 911. No advertisement of a tobacco product 

published after the date of enactment of the Family Smoking 

Prevention and Tobacco Control Act shall, with respect to the language of label statements as prescribed under section 4 of the 

Federal Cigarette Labeling and Advertising Act and section 3 of 

the Comprehensive Smokeless Tobacco Health Education Act of 

1986 or the regulations issued under such sections, be subject 

to the provisions of sections 12 through 15 of the Federal Trade 

Commission Act. 

‘‘SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE SECRETARY. 

‘‘(a) REQUIREMENT.—Each tobacco product manufacturer or 

importer, or agents thereof, shall submit to the Secretary the following information: 

‘‘(1) Not later than 6 months after the date of enactment 

of the Family Smoking Prevention and Tobacco Control Act, 

a listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by 

the manufacturer to the tobacco, paper, filter, or other part 

of each tobacco product by brand and by quantity in each 

brand and subbrand. 

‘‘(2) A description of the content, delivery, and form of 

nicotine in each tobacco product measured in milligrams of 

nicotine in accordance with regulations promulgated by the 

Secretary in accordance with section 4(e) of the Federal Cigarette Labeling and Advertising Act. 

‘‘(3) Beginning 3 years after the date of enactment of the 

Family Smoking Prevention and Tobacco Control Act, a listing 

of all constituents, including smoke constituents as applicable, 

identified by the Secretary as harmful or potentially harmful 

to health in each tobacco product, and as applicable in the 

smoke of each tobacco product, by brand and by quantity in 

each brand and subbrand. Effective beginning 3 years after 

such date of enactment, the manufacturer, importer, or agent 

shall comply with regulations promulgated under section 915 

in reporting information under this paragraph, where 

applicable. 

‘‘(4) Beginning 6 months after the date of enactment of 

the Family Smoking Prevention and Tobacco Control Act, all 

documents developed after such date of enactment that relate 

to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including 

smoke constituents), ingredients, components, and additives. 

‘‘(b) DATA SUBMISSION.—At the request of the Secretary, each 

tobacco product manufacturer or importer of tobacco products, or 

agents thereof, shall submit the following: 

‘‘(1) Any or all documents (including underlying scientific 

information) relating to research activities, and research 

findings, conducted, supported, or possessed by the manufacturer (or agents thereof) on the health, toxicological, behavioral, 

or physiologic effects of tobacco products and their constituents 
H. R. 1256—16 

(including smoke constituents), ingredients, components, and 

additives. 

‘‘(2) Any or all documents (including underlying scientific 

information) relating to research activities, and research 

findings, conducted, supported, or possessed by the manufacturer (or agents thereof) that relate to the issue of whether 

a reduction in risk to health from tobacco products can occur 

upon the employment of technology available or known to the 

manufacturer. 

‘‘(3) Any or all documents (including underlying scientific 

or financial information) relating to marketing research 

involving the use of tobacco products or marketing practices 

and the effectiveness of such practices used by tobacco manufacturers and distributors. 

An importer of a tobacco product not manufactured in the United 

States shall supply the information required of a tobacco product 

manufacturer under this subsection. 

‘‘(c) TIME FOR SUBMISSION.— 

‘‘(1) IN GENERAL.—At least 90 days prior to the delivery 

for introduction into interstate commerce of a tobacco product 

not on the market on the date of enactment of the Family 

Smoking Prevention and Tobacco Control Act, the manufacturer 

of such product shall provide the information required under 

subsection (a). 

‘‘(2) DISCLOSURE OF ADDITIVE.—If at any time a tobacco 

product manufacturer adds to its tobacco products a new 

tobacco additive or increases the quantity of an existing tobacco 

additive, the manufacturer shall, except as provided in paragraph (3), at least 90 days prior to such action so advise 

the Secretary in writing. 

‘‘(3) DISCLOSURE OF OTHER ACTIONS.—If at any time a 

tobacco product manufacturer eliminates or decreases an 

existing additive, or adds or increases an additive that has 

by regulation been designated by the Secretary as an additive 

that is not a human or animal carcinogen, or otherwise harmful 

to health under intended conditions of use, the manufacturer 

shall within 60 days of such action so advise the Secretary 

in writing. 

‘‘(d) DATA LIST.— 

‘‘(1) IN GENERAL.—Not later than 3 years after the date 

of enactment of the Family Smoking Prevention and Tobacco 

Control Act, and annually thereafter, the Secretary shall publish in a format that is understandable and not misleading 

to a lay person, and place on public display (in a manner 

determined by the Secretary) the list established under subsection (e). 

‘‘(2) CONSUMER RESEARCH.—The Secretary shall conduct 

periodic consumer research to ensure that the list published 

under paragraph (1) is not misleading to lay persons. Not 

later than 5 years after the date of enactment of the Family 

Smoking Prevention and Tobacco Control Act, the Secretary 

shall submit to the appropriate committees of Congress a report 

on the results of such research, together with recommendations 

on whether such publication should be continued or modified. 

‘‘(e) DATA COLLECTION.—Not later than 24 months after the 

date of enactment of the Family Smoking Prevention and Tobacco 

Control Act, the Secretary shall establish, and periodically revise 
H. R. 1256—17 

as appropriate, a list of harmful and potentially harmful constituents, including smoke constituents, to health in each tobacco product 

by brand and by quantity in each brand and subbrand. The Secretary shall publish a public notice requesting the submission by 

interested persons of scientific and other information concerning 

the harmful and potentially harmful constituents in tobacco products and tobacco smoke. 

‘‘SEC. 905. ANNUAL REGISTRATION. 

‘‘(a) DEFINITIONS.—In this section: 

‘‘(1) MANUFACTURE, PREPARATION, COMPOUNDING, OR PROCESSING.—The term ‘manufacture, preparation, compounding, or 

processing’ shall include repackaging or otherwise changing 

the container, wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco product 

from the original place of manufacture to the person who makes 

final delivery or sale to the ultimate 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 incorporation. 

‘‘(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 processing of a tobacco product or 

tobacco products shall register 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 occurs 

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 OPERATORS.—Every 

person upon first engaging in the manufacture, 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 additional establishment which 

that person owns or operates in any State and in which that 

person begins the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products. 

‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYSTEM.—The Secretary may by regulation prescribe a uniform 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 tobacco products in accordance with such system. 

‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMATION.—The Secretary shall make available for inspection, to any person so 

requesting, any registration filed under this section. 

‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTABLISHMENTS.— Every establishment registered with the Secretary under this section shall be subject to inspection under section 704 or subsection 

(h), and every such establishment 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 
H. R. 1256—18 

designated by the Secretary at least once in the 2-year period 

beginning with the date of registration of such establishment under 

this section and at least once in every successive 2-year period 

thereafter. 

‘‘(h) REGISTRATION BY FOREIGN ESTABLISHMENTS.—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 promulgated 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 tobacco 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 registers 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 accompanied by— 

‘‘(A) in the case of a tobacco product contained in 

the applicable list with respect to which a tobacco product 

standard has been established 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 product 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 determined 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 statement with respect to that particular tobacco 

product. 

‘‘(2) CONSULTATION WITH RESPECT TO FORMS.—The Secretary shall consult with the Secretary 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. 
H. R. 1256—19 

‘‘(3) BIANNUAL REPORT OF ANY CHANGE IN PRODUCT LIST.— 

Each person who registers with the Secretary under this section 

shall report to the Secretary 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 introduced by the 

registrant for commercial distribution which has not been 

included in any list previously 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 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 distribution 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 established name. 

‘‘(C) If since the date the registrant reported under 

subparagraph (B) a notice of discontinuance that person 

has resumed the manufacture, preparation, compounding, 

or processing for commercial distribution of the tobacco 

product with respect to which such notice of discontinuance 

was reported, notice of such resumption, the date of such 

resumption, the identity of such tobacco product by established name, and other information required by paragraph 

(1), unless the registrant has previously reported such 

resumption to the Secretary under this subparagraph. 

‘‘(D) Any material change in any information previously 

submitted under this paragraph or paragraph (1). 

‘‘(j) REPORT PRECEDING INTRODUCTION OF CERTAIN SUBSTAN- TIALLY EQUIVALENT PRODUCTS INTO INTERSTATE 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 marketing) in the United States as of February 15, 

2007, shall, at least 90 days prior to making such introduction 

or delivery, report to the Secretary (in such form and manner 

as the Secretary shall prescribe)— 

‘‘(A) the basis for such person’s determination that— 

‘‘(i) the tobacco product is substantially equivalent, 

within the meaning of section 910, to a tobacco product 

commercially marketed (other than for test marketing) 

in the United States as of February 15, 2007, or to 

a tobacco product that the Secretary has previously 

determined, pursuant to subsection (a)(3) of section 

910, is substantially equivalent and that is in compliance with the requirements of this Act; or 

‘‘(ii) the tobacco product is modified within the 

meaning of paragraph (3), the modifications are to 

a product that is commercially 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 paragraph (3); and 
H. R. 1256—20 

‘‘(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 delivered 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 exempt from 

the requirements of this subsection relating to the demonstration that a tobacco product is substantially equivalent within the meaning of section 910, tobacco products 

that are modified by adding or deleting a tobacco additive, 

or increasing or decreasing the quantity of an existing 

tobacco additive, if the Secretary determines that— 

‘‘(i) such modification would be a minor modification of a tobacco product that can be sold under this 

Act; 

‘‘(ii) a report under this subsection is not necessary 

to ensure that permitting the tobacco product to be 

marketed would be appropriate for protection of the 

public health; and 

‘‘(iii) an exemption is otherwise appropriate. 

‘‘(B) REGULATIONS.—Not later than 15 months after 

the date of enactment of the Family Smoking Prevention 

and Tobacco Control Act, the Secretary shall issue regulations to implement this paragraph. 

‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO 

PRODUCTS. 

‘‘(a) IN GENERAL.—Any requirement established by or under 

section 902, 903, 905, or 909 applicable to a tobacco product shall 

apply to such tobacco product until the applicability of the requirement to the tobacco product has been changed by action taken 

under section 907, section 910, section 911, or subsection (d) of 

this section, and any requirement established by or under section 

902, 903, 905, or 909 which is inconsistent with a requirement 

imposed on such tobacco product under section 907, section 910, 

section 911, or subsection (d) of this section shall not apply to 

such tobacco product. 

‘‘(b) INFORMATION ON PUBLIC ACCESS AND COMMENT.—Each 

notice of proposed rulemaking or other notification under section 

907, 908, 909, 910, or 911 or under this section, any other notice 

which is published in the Federal Register with respect to any 

other action taken under any such section and which states the 

reasons for such action, and each publication of findings required 

to be made in connection with rulemaking under any such section 

shall set forth— 

‘‘(1) the manner in which interested persons may examine 

data and other information on which the notice or findings 

is based; and 
H. R. 1256—21 

‘‘(2) the period within which interested persons may present 

their comments on the notice or findings (including the need 

therefore) orally or in writing, which period shall be at least 

60 days but may not exceed 90 days unless the time is extended 

by the Secretary by a notice published in the Federal Register 

stating good cause therefore. 

‘‘(c) LIMITED CONFIDENTIALITY OF INFORMATION.—Any information reported to or otherwise obtained by the Secretary or the 

Secretary’s representative under section 903, 904, 907, 908, 909, 

910, 911, or 704, or under subsection (e) or (f) of this section, 

which is exempt from disclosure under subsection (a) of section 

552 of title 5, United States Code, by reason of subsection (b)(4) 

of that section shall be considered confidential and shall not be 

disclosed, except that the information may be disclosed to other 

officers or employees concerned with carrying out this chapter, 

or when relevant in any proceeding under this chapter. 

‘‘(d) RESTRICTIONS.— 

‘‘(1) IN GENERAL.—The Secretary may by regulation require 

restrictions on the sale and distribution of a tobacco product, 

including restrictions on the access to, and the advertising 

and promotion of, the tobacco product, if the Secretary determines that such regulation would be appropriate for the protection of the public health. The Secretary may by regulation 

impose restrictions on the advertising and promotion of a 

tobacco product consistent with and to full extent permitted 

by the first amendment to the Constitution. The finding as 

to whether such regulation would be appropriate for the protection of the public health shall be determined with respect 

to the risks and 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. 

No such regulation may require that the sale or distribution 

of a tobacco product be limited to the written or oral authorization of a practitioner licensed by law to prescribe medical 

products. 

‘‘(2) LABEL STATEMENTS.—The label of a tobacco product 

shall bear such appropriate statements of the restrictions 

required by a regulation under subsection (a) as the Secretary 

may in such regulation prescribe. 

‘‘(3) LIMITATIONS.— ‘‘(A) IN GENERAL.—No restrictions under paragraph (1) 

may— 

‘‘(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 
H. R. 1256—22 

of tobacco products, shall be considered as adult-written 

publications which shall be permitted to contain advertising. Notwithstanding the preceding sentence, if the Secretary finds that such treatment of matchbooks is not 

appropriate for the protection of the public health, the 

Secretary may determine 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 Prevention and Tobacco Control 

Act, promulgate regulations regarding the sale and 

distribution of tobacco products that occur through 

means other than a direct, face-to-face exchange 

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 products that are sold or distributed 

through means other than a direct, face-to-face 

exchange 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 REQUIREMENTS.— 

‘‘(1) METHODS, FACILITIES, AND CONTROLS TO CONFORM.— 

‘‘(A) IN GENERAL.—In applying manufacturing 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 performance 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 prescribed 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 regulation under 

subparagraph (A), afford the Tobacco Products Scientific Advisory Committee an opportunity to submit 

recommendations with respect to the regulation proposed to be promulgated; 
H. R. 1256—23 

‘‘(ii) before promulgating any regulation under 

subparagraph (A), afford opportunity for an oral 

hearing; 

‘‘(iii) provide the Tobacco Products Scientific 

Advisory Committee a reasonable time to make its 

recommendation with respect to proposed regulations 

under subparagraph (A); 

‘‘(iv) in establishing the effective date of a regulation promulgated under this subsection, take into 

account the differences in the manner in which the 

different types of tobacco products have historically 

been produced, the financial resources of the different 

tobacco product manufacturers, and the state of their 

existing manufacturing facilities, and shall provide for 

a reasonable period of time for such manufacturers 

to conform to good manufacturing practices; and 

‘‘(v) not require any small tobacco product manufacturer to comply with a regulation under subparagraph (A) for at least 4 years following the effective 

date established 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 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 exemption 

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 methods, facilities, 

and controls prescribed by the requirement; and 

‘‘(iii) contain such other information as the Secretary shall prescribe. 

‘‘(B) REFERRAL TO THE TOBACCO PRODUCTS SCIENTIFIC

ADVISORY COMMITTEE.—The Secretary may refer to the 

Tobacco Products Scientific Advisory Committee any petition submitted 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 submitted to the 

Secretary under subparagraph (A); or 

‘‘(ii) the day after the petition was referred to 

the Tobacco Products Scientific Advisory Committee, 

whichever occurs later, the Secretary shall by order either 

deny the petition or approve it. 

‘‘(C) APPROVAL.—The Secretary may approve— 

‘‘(i) a petition for an exemption for a tobacco 

product from a requirement if the Secretary determines 
H. R. 1256—24 

that compliance with such requirement is not required 

to assure that the tobacco product will be in compliance 

with this chapter; and 

‘‘(ii) a petition for a variance for a tobacco 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 compliance with this chapter. 

‘‘(D) CONDITIONS.—An order of the Secretary approving 

a petition for a variance shall prescribe such conditions 

respecting the methods used in, and the facilities and controls used for, the manufacture, packing, and storage of 

the tobacco product to be granted the variance under the 

petition as may be necessary to assure that the tobacco 

product will be in compliance with this chapter. 

‘‘(E) HEARING.—After the issuance of an order under 

subparagraph (B) respecting a petition, the petitioner shall 

have an opportunity for an informal hearing on such order. 

‘‘(3) COMPLIANCE.—Compliance with requirements under 

this subsection shall not be required before 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 demonstrations 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 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 an herb or spice, 

including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, 

or coffee, that is a characterizing flavor of the tobacco 

product or tobacco smoke. Nothing in this subparagraph 

shall be construed to limit the Secretary’s authority to 

take action under this section or other sections of this 

Act applicable to menthol or any artificial or natural flavor, 

herb, or spice not specified in this subparagraph. 

‘‘(B) ADDITIONAL SPECIAL RULE.—Beginning 2 years 

after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, a tobacco product manufacturer shall not use tobacco, including foreign grown tobacco, 

that contains a pesticide chemical residue that is at a 

level greater than is specified by any tolerance applicable 

under Federal law to domestically grown tobacco. 
H. R. 1256—25 

‘‘(2) REVISION OF TOBACCO PRODUCT STANDARDS.—The Secretary may revise the tobacco product 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 tobacco 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 CONSIDERATIONS.—In the event 

that the Secretary makes a determination, set forth 

in a proposed tobacco product standard in a proposed 

rule, that it is appropriate for the protection of public 

health to require the reduction or elimination of an 

additive, constituent (including a smoke constituent), 

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 illness or injury may provide for the Secretary’s consideration scientific evidence that demonstrates that the proposed standard will not reduce 

or eliminate the risk of illness or injury. 

‘‘(4) CONTENT OF TOBACCO PRODUCT STANDARDS.—A tobacco 

product standard established under this section for a tobacco 

product— 

‘‘(A) shall include provisions that are appropriate 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 constituents, or harmful 

components of the product; or 

‘‘(iii) relating to any other requirement under 

subparagraph (B); 

‘‘(B) shall, where appropriate for the protection of the 

public health, include— 

‘‘(i) provisions respecting the construction, 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 individual basis) of the tobacco 

product; 
H. R. 1256—26 

‘‘(iii) provisions for the measurement of the tobacco 

product characteristics of the tobacco product; 

‘‘(iv) provisions requiring that the results 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 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); 

‘‘(C) shall, where appropriate, require the use and prescribe the form and content of labeling for the proper 

use of the tobacco product; and 

‘‘(D) shall require tobacco products containing foreigngrown tobacco to meet the same standards applicable to 

tobacco products containing 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. 

‘‘(6) INVOLVEMENT OF OTHER AGENCIES; INFORMED PER- SONS.—In carrying out duties under this section, the Secretary 

shall endeavor to— 

‘‘(A) use personnel, facilities, and other technical support available in other Federal agencies; 

‘‘(B) consult with other Federal agencies concerned with 

standard setting and other nationally 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 connection with a proposed 

standard, including information concerning the countervailing 

effects of the tobacco product standard on the health of adolescent tobacco users, adult tobacco users, or nontobacco users, 

such as the creation of a significant demand for contraband 

or other tobacco products that do not meet the requirements 

of this chapter and the significance of such demand. 

‘‘(c) PROPOSED STANDARDS.— 

‘‘(1) IN GENERAL.—The Secretary shall publish in the Federal Register a notice of proposed rulemaking for the establishment, amendment, or revocation of any tobacco product 

standard. 
H. R. 1256—27 

‘‘(2) REQUIREMENTS OF NOTICE.—A notice of proposed rulemaking for the establishment or amendment of a tobacco 

product standard for a tobacco product shall— 

‘‘(A) set forth a finding with supporting justification 

that the tobacco product standard is appropriate for the 

protection of the public health; 

‘‘(B) invite interested persons to submit a draft or 

proposed tobacco product standard for consideration by the 

Secretary; 

‘‘(C) invite interested persons to submit comments on 

structuring the standard so that it does not advantage 

foreign-grown tobacco over domestically grown tobacco; and 

‘‘(D) invite the Secretary of Agriculture to provide any 

information or analysis which the Secretary of Agriculture 

believes is relevant to the proposed tobacco product 

standard. 

‘‘(3) FINDING.—A notice of proposed rulemaking for the 

revocation of a tobacco product standard shall set forth a finding 

with supporting justification that the tobacco product standard 

is no longer appropriate for the protection of the public health. 

‘‘(4) COMMENT.—The Secretary shall provide for a comment 

period of not less than 60 days. 

‘‘(d) PROMULGATION.— 

‘‘(1) IN GENERAL.—After the expiration of the period for 

comment on a notice of proposed rulemaking published under 

subsection (c) respecting a tobacco product standard and after 

consideration of comments submitted under subsections (b) and 

(c) and any report from the Tobacco Products Scientific Advisory 

Committee, the Secretary shall— 

‘‘(A) if the Secretary determines that the standard 

would be appropriate for the protection of the public health, 

promulgate a regulation establishing a tobacco product 

standard and publish in the Federal Register findings on 

the matters referred to in subsection (c); or 

‘‘(B) publish a notice terminating the proceeding for 

the development of the standard together with the reasons 

for such termination. 

‘‘(2) EFFECTIVE DATE.—A regulation establishing a tobacco 

product standard shall set forth the date or dates upon which 

the standard shall take effect, but no such regulation may 

take effect before 1 year after the date of its publication unless 

the Secretary determines that an earlier effective date is necessary for the protection of the public health. Such date or 

dates shall be established so as to minimize, consistent with 

the public health, economic loss to, and disruption or dislocation 

of, domestic and international trade. In establishing such effective date or dates, the Secretary shall consider information 

submitted in connection with a proposed product standard by 

interested parties, including manufacturers and tobacco 

growers, regarding the technical achievability of compliance 

with the standard, and including information concerning the 

existence of patents that make it impossible to comply in the 

timeframe envisioned in the proposed standard. If the Secretary 

determines, based on the Secretary’s evaluation of submitted 

comments, that a product standard can be met only by manufacturers requiring substantial changes to the methods of farming 

the domestically grown tobacco used by the manufacturer, the 
H. R. 1256—28 

effective date of that product standard shall be not less than 

2 years after the date of publication of the final regulation 

establishing the standard. 

‘‘(3) LIMITATION ON POWER GRANTED TO THE FOOD AND

DRUG ADMINISTRATION.—Because of the importance of a decision 

of the Secretary to issue a regulation— 

‘‘(A) banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, 

all pipe tobacco, or all roll-your-own tobacco products; or 

‘‘(B) requiring the reduction of nicotine yields of a 

tobacco product to zero, 

the Secretary is prohibited from taking such actions under 

this Act. 

‘‘(4) AMENDMENT; REVOCATION.— 

‘‘(A) AUTHORITY.—The Secretary, upon the Secretary’s 

own initiative or upon petition of an interested person, 

may by a regulation, promulgated in accordance with the 

requirements of subsection (c) and paragraph (2), amend 

or revoke a tobacco product standard. 

‘‘(B) EFFECTIVE DATE.—The Secretary may declare a 

proposed amendment of a tobacco product standard to be 

effective on and after its publication in the Federal Register 

and until the effective date of any final action taken on 

such amendment if the Secretary determines that making 

it so effective is in the public interest. 

‘‘(5) REFERRAL TO ADVISORY COMMITTEE.— 

‘‘(A) IN GENERAL.—The Secretary may refer a proposed 

regulation for the establishment, amendment, or revocation 

of a tobacco product standard to the Tobacco Products 

Scientific Advisory Committee for a report and recommendation with respect to any matter involved in the 

proposed regulation which requires the exercise of scientific 

judgment. 

‘‘(B) INITIATION OF REFERRAL.—The Secretary may 

make a referral under this paragraph— 

‘‘(i) on the Secretary’s own initiative; or 

‘‘(ii) upon the request of an interested person 

that— 

‘‘(I) demonstrates good cause for the referral; 

and 

‘‘(II) is made before the expiration 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 Committee, 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 Committee shall, within 60 

days after the referral of a proposed regulation under this 

paragraph and after independent study of the data and 

information furnished to it by the Secretary and other 

data and information before it, submit to the Secretary 

a report and recommendation respecting such regulation, 

together with all underlying data and information and 

a statement of the reason or basis for the recommendation. 
H. R. 1256—29 

‘‘(E) PUBLIC AVAILABILITY.—The Secretary shall make 

a copy of each report and recommendation under subparagraph (D) publicly available. 

‘‘(e) MENTHOL CIGARETTES.— 

‘‘(1) REFERRAL; CONSIDERATIONS.—Immediately upon the 

establishment of the Tobacco Products 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 menthol in 

cigarettes on the public health, including such use among children, African-Americans, Hispanics, 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 Tobacco Product Scientific Advisory 

Committee shall submit to the Secretary the report and recommendations required 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 applicable 

to menthol. 

‘‘(f) DISSOLVABLE TOBACCO PRODUCTS.— 

‘‘(1) REFERRAL; CONSIDERATIONS.—The Secretary shall refer 

to the Tobacco Products Scientific Advisory Committee for 

report and recommendation, under section 917(c)(4), the issue 

of the nature and impact of the use of dissolvable tobacco 

products on the public health, including such use among children. In its review, the Tobacco Products Scientific Advisory 

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 required 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 dissolvable tobacco product. 

‘‘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 necessary 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 appropriate form, by 

the persons and means best suited under the circumstances 

involved, to all persons who should properly receive such notification 

in order to eliminate such risk. The Secretary may order notification 

by any appropriate means, including public service announcements. 
H. R. 1256—30 

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 product contains a manufacturing or other defect not ordinarily contained in tobacco 

products on the market that would cause serious, adverse 

health consequences or death, the Secretary shall issue an 

order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the tobacco 

product) to immediately cease distribution of such tobacco 

product. The order shall provide the person subject to the 

order with an opportunity for an informal hearing, to be held 

not later than 10 days after the date of the issuance of the 

order, on the actions 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 determines that inadequate grounds exist to support the actions required by the order, the Secretary shall 

vacate the order. 

‘‘(2) AMENDMENT OF ORDER TO REQUIRE RECALL.— ‘‘(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 recall. 

‘‘(B) NOTICE.—An amended order under subparagraph 

(A)— 

‘‘(i) shall not include recall of a tobacco product 

from individuals; and 

‘‘(ii) shall provide for notice to persons subject to 

the risks associated with the use of such tobacco 

product. 

In providing the notice required by clause (ii), the Secretary 

may use the assistance of retailers and other persons who 

distributed such tobacco product. If a significant number 

of such persons cannot be identified, the Secretary shall 

notify such persons under section 705(b). 

‘‘(3) REMEDY NOT EXCLUSIVE.—The remedy provided by this 

subsection shall be in addition to remedies provided by subsection (a). 

‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS. 

‘‘(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 reports, and provide such information, 

as the Secretary may by regulation reasonably require to assure 
H. R. 1256—31 

that such tobacco product is not adulterated or misbranded and 

to otherwise protect public health. Regulations prescribed under 

the preceding sentence— 

‘‘(1) may require a tobacco product manufacturer or 

importer to report to the Secretary whenever the manufacturer 

or importer receives or otherwise becomes aware of information 

that reasonably suggests that one of its marketed tobacco products may have caused or contributed to a serious unexpected 

adverse experience associated with the use of the product or 

any significant increase in the frequency of a serious, expected 

adverse product experience; 

‘‘(2) shall require reporting of other significant adverse 

tobacco product experiences as determined by the Secretary 

to be necessary to be reported; 

‘‘(3) shall not impose requirements unduly burdensome to 

a tobacco product manufacturer or importer, taking into account 

the cost of complying with such requirements and the need 

for the protection of the public health and the implementation 

of this chapter; 

‘‘(4) when prescribing the procedure for making requests 

for reports or information, shall require that each request made 

under such regulations for submission of a report or information 

to the Secretary state the reason or purpose for such request 

and identify to the fullest extent practicable such report 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 information and identify to the 

fullest extent practicable such report or information; and 

‘‘(6) may not require that the identity of any patient or 

user be disclosed in records, reports, or information required 

under this subsection unless required for the medical welfare 

of an individual, to determine risks to public health of a tobacco 

product, or to verify a record, report, or information submitted 

under this chapter. 

In prescribing regulations under this subsection, the Secretary 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 paragraph (2), 

the Secretary shall by regulation require a tobacco product 

manufacturer or importer of a tobacco product to report 

promptly to the Secretary any corrective action taken or 

removal from the market of a tobacco product undertaken by 

such manufacturer or importer if the removal or correction 

was undertaken— 

‘‘(A) to reduce a risk to health posed by the tobacco 

product; or 

‘‘(B) to remedy a violation of this chapter caused by 

the tobacco product which may present a risk to health. 

A tobacco product manufacturer or importer of a tobacco 

product who undertakes a corrective action or removal from 

the market of a tobacco product which is not required to be 
H. R. 1256—32 

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 required under paragraph 

(1) if a report of the corrective action or removal is required 

and has been submitted under subsection (a). 

‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO PRODUCTS. 

‘‘(a) IN GENERAL.— 

‘‘(1) NEW TOBACCO PRODUCT DEFINED.—For purposes of this 

section the term ‘new tobacco product’ means— 

‘‘(A) any tobacco product (including those products in 

test markets) that was not commercially marketed in the 

United States as of February 15, 2007; or 

‘‘(B) any modification (including a change in design, 

any component, any part, or any constituent, including 

a smoke constituent, or in the content, delivery or form 

of nicotine, or any other additive or ingredient) of a tobacco 

product where the modified product was commercially marketed in the United States after February 15, 2007. 

‘‘(2) PREMARKET REVIEW REQUIRED.— 

‘‘(A) NEW PRODUCTS.—An order under subsection 

(c)(1)(A)(i) for a new tobacco product is required unless— 

‘‘(i) the manufacturer has submitted a report under 

section 905(j); and the Secretary has issued an order 

that the tobacco product— 

‘‘(I) is substantially equivalent to a tobacco 

product commercially marketed (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 section 905(j)(3). 

‘‘(B) APPLICATION TO CERTAIN POST-FEBRUARY 15, 2007, 

PRODUCTS.—Subparagraph (A) shall not apply to a tobacco 

product— 

‘‘(i) that was first introduced or delivered 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; 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 equivalent’ or ‘substantial equivalence’ means, with respect to the tobacco product being 

compared to the predicate tobacco product, that the Secretary by order has found that the tobacco product— 
H. R. 1256—33 

‘‘(i) has the same characteristics as the predicate 

tobacco product; or 

‘‘(ii) has different characteristics and the information submitted contains information, including clinical 

data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the 

product under this section because the product does 

not raise different questions of public health. 

‘‘(B) CHARACTERISTICS.—In subparagraph (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 removed from the market at the initiative 

of the Secretary or that has been determined by a judicial 

order to be misbranded or adulterated. 

‘‘(4) HEALTH INFORMATION.— 

‘‘(A) SUMMARY.—As part of a submission under section 

905(j) respecting a tobacco product, the person required 

to file a premarket notification under such section shall 

provide an adequate summary of any health information 

related to the tobacco product or state that such information will be made available upon request by any person. 

‘‘(B) REQUIRED INFORMATION.—Any summary under 

subparagraph (A) respecting a tobacco product shall contain 

detailed information regarding data concerning adverse 

health effects and shall be made available to the public 

by the Secretary within 30 days of the issuance of a determination that such tobacco product is substantially equivalent to another tobacco product. 

‘‘(b) APPLICATION.— 

‘‘(1) CONTENTS.—An application under this section shall 

contain— 

‘‘(A) full reports of all information, published or known 

to, or which should reasonably be known to, the applicant, 

concerning investigations which have been made to show 

the health risks of such tobacco product and whether 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 product; 

‘‘(D) an identifying reference to any tobacco product 

standard under section 907 which would be applicable to 

any aspect of such tobacco product, and either adequate 

information to show that such aspect of such tobacco 

product fully meets such tobacco product standard or adequate information to justify any deviation from such 

standard; 

‘‘(E) such samples of such tobacco product and of 

components thereof as the Secretary may reasonably 

require; 
H. R. 1256—34 

‘‘(F) specimens of the labeling proposed to be used 

for such tobacco product; and 

‘‘(G) such other information relevant to the subject 

matter of the application as the Secretary may require. 

‘‘(2) REFERRAL TO TOBACCO PRODUCTS SCIENTIFIC ADVISORY

COMMITTEE.—Upon receipt of an application meeting the 

requirements set forth in paragraph (1), the Secretary— 

‘‘(A) may, on the Secretary’s own initiative; or 

‘‘(B) may, upon the request of an applicant, 

refer such application to the Tobacco Products Scientific 

Advisory Committee for reference and for submission (within 

such period as the Secretary may establish) of a report and 

recommendation respecting 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 possible, 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 subsection 

(b)(2), shall— 

‘‘(i) issue an order that the new product may be 

introduced or delivered for introduction into interstate 

commerce if the Secretary finds that none of the 

grounds specified in paragraph (2) of this subsection 

applies; or 

‘‘(ii) issue an order that the new product 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 accompanying such denial) that 1 or more grounds for denial 

specified in paragraph (2) of this subsection apply. 

‘‘(B) RESTRICTIONS ON SALE AND DISTRIBUTION.—An 

order under subparagraph (A)(i) may require that the sale 

and distribution of the tobacco product be restricted but 

only to the extent that the sale and distribution of a tobacco 

product may be restricted under a regulation under 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 permitting such 

tobacco product to be marketed would be appropriate for 

the protection of the public health; 

‘‘(B) the methods used in, or the facilities or controls 

used for, the manufacture, processing, or packing of such 

tobacco product do not conform to the requirements of 

section 906(e); 

‘‘(C) based on a fair evaluation of all material facts, 

the proposed labeling is false or misleading in any particular; or 

‘‘(D) such tobacco product is not shown to conform 

in all respects to a tobacco product standard in effect under 
H. R. 1256—35 

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 informing the applicant of 

the measures required to remove such application from deniable 

form (which measures may include further research by the 

applicant in accordance with 1 or more protocols prescribed 

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 include 1 or more 

clinical investigations by experts qualified by training and 

experience to evaluate the tobacco product. 

‘‘(B) OTHER EVIDENCE.—If the Secretary determines 

that there exists valid scientific evidence (other than evidence derived from investigations described in subparagraph (A)) which is sufficient to evaluate the tobacco 

product, the Secretary may authorize that the determination for purposes of paragraph (2)(A) be made on the basis 

of such evidence. 

‘‘(d) WITHDRAWAL AND TEMPORARY SUSPENSION.— 

‘‘(1) IN GENERAL.—The Secretary shall, upon obtaining, 

where appropriate, advice on scientific matters from the 

Tobacco Products Scientific Advisory Committee, and after due 

notice and opportunity 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 material 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 

applicable regulation under section 909; 
H. R. 1256—36 

‘‘(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 requirements of 

section 905; 

‘‘(D) on the basis of new information before 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 facilities and controls used for, the manufacture, processing, packing, or installation of such tobacco product 

do not conform with the requirements 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 before the Secretary, evaluated together with the evidence before the 

Secretary when the application was reviewed, that the 

labeling of such tobacco product, based on a fair evaluation 

of all material facts, is false or misleading in any particular 

and was not corrected within a reasonable time after receipt 

of written notice from the Secretary of such fact; or 

‘‘(F) on the basis of new information before 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 section 907, 

compliance with which was a condition 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) withdrawing 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 

receives notice of such withdrawal, obtain review thereof in 

accordance with section 912. 

‘‘(3) TEMPORARY SUSPENSION.—If, after providing 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 product. If the Secretary issues 

such an order, the Secretary 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 applicant’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 
H. R. 1256—37 

(c)(1)(A)(i) for an application filed under subsection (b) is in 

effect, the applicant 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 determination of, whether there is or may be 

grounds for withdrawing or temporarily suspending such order. 

‘‘(2) ACCESS TO RECORDS.—Each person required 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 reasonable times to have access to and copy and verify 

such records. 

‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMPTION 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 deliver for 

introduction into interstate commerce any modified 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 tobacco product that is sold 

or distributed for use to reduce harm or the risk of tobaccorelated disease associated with commercially marketed tobacco 

products. 

‘‘(2) SOLD OR DISTRIBUTED.— 

‘‘(A) IN GENERAL.—With respect to a tobacco product, 

the term ‘sold or distributed for use to reduce harm or 

the risk of tobacco-related disease associated with commercially marketed tobacco products’ means a tobacco 

product— 

‘‘(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 exposure 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 manufacturer of which 

has taken any action directed to consumers through 

the media or otherwise, other than by means of the 

tobacco product’s label, labeling, or advertising, after 

the date of enactment of the Family Smoking Prevention and Tobacco Control Act, respecting the product 
H. R. 1256—38 

that would be reasonably expected to result in consumers believing that the tobacco product or its smoke 

may present a lower risk of disease or is less harmful 

than one or more commercially marketed tobacco products, 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-related disease associated with 

commercially marketed 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 products whose label, labeling, or advertising contains 

the terms described in such paragraph on such date of enactment. The effective date shall be with respect to the date 

of manufacture, provided that, in any case, beginning 30 days 

after such effective date, a manufacturer shall not introduce 

into the domestic 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 approved as a drug or device 

by the Food and Drug Administration and is subject to the requirements of chapter V. 

‘‘(d) FILING.—Any person may file with the Secretary 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 scientific information) relating to research findings conducted, supported, or 

possessed by the tobacco product manufacturer relating to the 

effect of the product on tobacco-related diseases and healthrelated conditions, including information both favorable 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 
H. R. 1256—39 

matters in the application which are trade secrets or otherwise 

confidential, commercial information) and shall request comments 

by interested persons on the information contained in the application and on the label, labeling, and advertising accompanying such 

application. 

‘‘(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 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 section, 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 tobaccorelated disease to individual tobacco users; and 

‘‘(B) benefit the health of the population as a whole 

taking into account both users of tobacco products and 

persons who do not currently 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 

product that may not be commercially marketed under 

paragraph (1) if the Secretary makes the findings required 

under this paragraph and determines that the applicant 

has demonstrated that— 

‘‘(i) such order would be appropriate to promote 

the public health; 

‘‘(ii) any aspect of the label, labeling, and advertising for such product that would cause the tobacco 

product to be a modified risk tobacco product under 

subsection (b) is limited to an explicit or implicit representation that such tobacco product or its smoke 

does not contain or is free of a substance or contains 

a reduced level of a substance, or presents a reduced 

exposure to a substance in tobacco smoke; 

‘‘(iii) scientific evidence is not available and, using 

the best available scientific methods, cannot be made 

available without conducting long-term epidemiological 

studies for an application to meet the standards set 

forth in paragraph (1); and 

‘‘(iv) the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction 

in morbidity or mortality among individual tobacco 

users is reasonably likely in subsequent studies. 
H. R. 1256—40 

‘‘(B) ADDITIONAL FINDINGS REQUIRED.—To issue an 

order under subparagraph (A) the Secretary must also 

find that the applicant has demonstrated that— 

‘‘(i) the magnitude of the overall reductions in exposure to the substance or substances which are the 

subject of the application is substantial, such substance 

or substances are harmful, and the product as actually 

used exposes consumers to the specified reduced level 

of the substance or substances; 

‘‘(ii) the product as actually used by consumers 

will not expose them to higher levels of other harmful 

substances compared to the similar types of tobacco 

products then on the market unless such increases 

are minimal and the reasonably likely overall impact 

of use of the product remains a substantial and measurable reduction in overall morbidity and mortality 

among individual tobacco users; 

‘‘(iii) testing of actual consumer perception shows 

that, as the applicant proposes to label and market 

the product, consumers 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 demonstrated to 

present less of a risk of disease than 1 or more 

other commercially 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 products and persons who do not currently 

use tobacco products. 

‘‘(C) CONDITIONS OF MARKETING.— 

‘‘(i) IN GENERAL.—Applications subject 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 

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 consumer perception, behavior, 

and health and to enable the Secretary to review the 

accuracy of the determinations upon which the order 

was based in accordance with a protocol approved by 

the Secretary. 

‘‘(iii) ANNUAL SUBMISSION.—The results of such 

postmarket surveillance and studies described in clause 

(ii) shall be submitted annually. 

‘‘(3) BASIS.—The determinations under paragraphs (1) and 

(2) shall be based on— 

‘‘(A) the scientific evidence submitted by the applicant; 

and 
H. R. 1256—41 

‘‘(B) scientific evidence and other information that is 

made available to the Secretary. 

‘‘(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.— 

‘‘(1) MODIFIED RISK PRODUCTS.—The Secretary 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 products. 

‘‘(2) COMPARATIVE CLAIMS.— ‘‘(A) IN GENERAL.—The Secretary may require for the 

marketing of a product under this subsection that a claim 

comparing a tobacco product to 1 or more other commercially marketed tobacco products shall compare the tobacco 

product to a commercially marketed tobacco 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 established regular tobacco product). 

‘‘(B) QUANTITATIVE COMPARISONS.—The Secretary may 

also require, for purposes of subparagraph (A), that the 

percent (or fraction) of change and identity of the reference 

tobacco 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 require the 

disclosure on the label of other substances 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 conditions associated with the use of tobacco products. 

‘‘(B) CONDITIONS OF USE.—If the conditions 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. 
H. R. 1256—42 

‘‘(4) TIME.—An order issued under subsection (g)(1) shall 

be effective for a specified period of time. 

‘‘(5) ADVERTISING.—The Secretary may require, with 

respect to a product for which an applicant obtained an order 

under subsection (g)(1), that the product comply with requirements relating to advertising and promotion of the tobacco 

product. 

‘‘(i) POSTMARKET SURVEILLANCE AND STUDIES.— 

‘‘(1) IN GENERAL.—The Secretary shall require, with respect 

to a product for which an applicant 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 perception, 

behavior, and health, to enable the Secretary to review the 

accuracy of the determinations upon which the order was based, 

and to provide information that the Secretary determines is 

otherwise necessary regarding the use or health risks involving 

the tobacco product. The results of postmarket surveillance 

and studies shall be submitted to the Secretary on an annual 

basis. 

‘‘(2) SURVEILLANCE PROTOCOL.—Each applicant 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 

approval of the Secretary, a protocol for the required surveillance. The Secretary, within 60 days of the receipt of such 

protocol, shall determine if the principal investigator proposed 

to be used in the surveillance has sufficient qualifications and 

experience to conduct such surveillance and if such protocol 

will result in collection of the data or other information designated by the Secretary as necessary to protect the public 

health. 

‘‘(j) WITHDRAWAL OF AUTHORIZATION.—The Secretary, after an 

opportunity for an informal hearing, shall withdraw an order under 

subsection (g) if the Secretary determines that— 

‘‘(1) the applicant, based on new information, can no longer 

make the demonstrations required under subsection (g), or 

the Secretary can no longer make the determinations required 

under subsection (g); 

‘‘(2) the application failed to include material information 

or included any untrue statement of material fact; 

‘‘(3) any explicit or implicit representation that the product 

reduces risk or exposure is no longer valid, including if— 

‘‘(A) a tobacco product standard is established pursuant 

to section 907; 

‘‘(B) an action is taken that affects the risks presented 

by other commercially marketed tobacco products that were 

compared to the product that is the subject of the application; or 

‘‘(C) any postmarket surveillance or studies reveal that 

the order is no longer consistent with the protection of 

the public health; 

‘‘(4) the applicant failed to conduct or submit the 

postmarket surveillance and studies required under subsection 

(g)(2)(C)(ii) or subsection (i); or 

‘‘(5) the applicant failed to meet a condition imposed under 

subsection (h). 
H. R. 1256—43 

‘‘(k) CHAPTER IV OR V.—A product for which the Secretary 

has issued an order pursuant to subsection (g) shall not be subject 

to chapter IV or V. 

‘‘(l) IMPLEMENTING REGULATIONS OR GUIDANCE.— 

‘‘(1) SCIENTIFIC EVIDENCE.—Not later than 2 years after 

the date of enactment of the Family Smoking Prevention and 

Tobacco Control Act, the Secretary shall issue regulations or 

guidance (or any combination thereof) on the scientific evidence 

required for assessment and ongoing review of modified risk 

tobacco products. Such regulations or guidance shall— 

‘‘(A) to the extent that adequate scientific evidence 

exists, establish minimum standards for scientific studies 

needed prior to issuing an order under subsection (g) to 

show that a substantial reduction in morbidity or mortality 

among individual tobacco users occurs for products 

described in subsection (g)(1) or is reasonably likely for 

products described in subsection (g)(2); 

‘‘(B) include validated biomarkers, intermediate clinical 

endpoints, and other feasible outcome measures, as appropriate; 

‘‘(C) establish minimum standards for postmarket 

studies, that shall include regular and long-term assessments of health outcomes and mortality, intermediate clinical endpoints, consumer perception of harm reduction, and 

the impact on quitting behavior and new use of tobacco 

products, as appropriate; 

‘‘(D) establish minimum standards for required 

postmarket surveillance, including ongoing assessments of 

consumer perception; 

‘‘(E) require that data from the required studies and 

surveillance be made available to the Secretary prior to 

the decision on renewal of a modified risk tobacco product; 

and 

‘‘(F) establish a reasonable timetable for the Secretary 

to review an application under this section. 

‘‘(2) CONSULTATION.—The regulations or guidance issued 

under paragraph (1) shall be developed in consultation with 

the Institute of Medicine, and with the input of other appropriate scientific and medical experts, on the design and conduct 

of such studies and surveillance. 

‘‘(3) REVISION.—The regulations or guidance under paragraph (1) shall be revised on a regular basis as new scientific 

information becomes available. 

‘‘(4) NEW TOBACCO PRODUCTS.—Not later than 2 years after 

the date of enactment of the Family Smoking Prevention and 

Tobacco Control Act, the Secretary shall issue a regulation 

or guidance that permits the filing of a single application for 

any tobacco product that is a new tobacco product under section 

910 and which the applicant seeks to commercially market 

under this section. 

‘‘(m) DISTRIBUTORS.—Except as provided in this section, no 

distributor may take any action, after the date of enactment of 

the Family Smoking Prevention and Tobacco Control Act, with 

respect to a tobacco product that would reasonably be expected 

to result in consumers believing that the tobacco product or its 

smoke may present a lower risk of disease or is less harmful 
H. R. 1256—44 

than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, 

a substance or substances. 

‘‘SEC. 912. JUDICIAL REVIEW. 

‘‘(a) RIGHT TO REVIEW.— 

‘‘(1) IN GENERAL.—Not later than 30 days after— 

‘‘(A) the promulgation of a regulation under section 

907 establishing, amending, or revoking a tobacco product 

standard; or 

‘‘(B) a denial of an application under section 910(c), 

any person adversely affected by such regulation or denial 

may file a petition for judicial review of such regulation or 

denial with the United States Court of Appeals for the District 

of Columbia or for the circuit in which such person resides 

or has their principal place of business. 

‘‘(2) REQUIREMENTS.— 

‘‘(A) COPY OF PETITION.—A copy of the petition filed 

under paragraph (1) shall be transmitted by the clerk 

of the court involved to the Secretary. 

‘‘(B) RECORD OF PROCEEDINGS.—On receipt 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 published 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 advisory committee with respect to such regulation or order; 

‘‘(iv) any hearing held with respect to such regulation or order; and 

‘‘(v) any other information identified by the Secretary, in the administrative proceeding held with 

respect to such regulation 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 regulation 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 relief, including interim relief, as provided 

for in such chapter. 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. 
H. R. 1256—45 

‘‘(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 regulation 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 authority 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 violates 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 considered a violation of a rule promulgated under section 18 of 

that Act. 

‘‘(b) COORDINATION.—With respect to the requirements 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 Commission shall 

coordinate with the Secretary concerning the enforcement of 

such Act as such enforcement relates to unfair or deceptive 

acts or practices in the advertising of cigarettes or smokeless 

tobacco; and 

‘‘(2) the Secretary shall consult with the Chairman of such 

Commission in revising the label statements 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 promulgated under 

subsection (a)— 

‘‘(1) shall require testing and reporting of tobacco product 

constituents, ingredients, and additives, 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 paragraph, 
H. R. 1256—46 

tobacco products manufactured and sold by a single tobacco 

product manufacturer that are identical in all respects except 

the labels, packaging design, logo, trade dress, trademark, 

brand name, or any combination thereof, shall be considered 

as a single brand; and 

‘‘(2) may require that tobacco product manufacturers, packagers, or importers make disclosures relating to the results 

of the testing of tar and nicotine through labels or advertising 

or other appropriate 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 mislead consumers about the risk of tobaccorelated disease. 

‘‘(c) AUTHORITY.—The Secretary shall have the authority under 

this chapter to conduct or to require the testing, reporting, or 

disclosure of tobacco product constituents, including smoke constituents. 

‘‘(d) SMALL TOBACCO PRODUCT MANUFACTURERS.— 

‘‘(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 manufacturers that are not small 

tobacco product manufacturers. 

‘‘(2) TESTING AND REPORTING INITIAL COMPLIANCE PERIOD.— 

‘‘(A) 4-YEAR PERIOD.—The initial regulations 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 

promulgation of such regulations, as described in paragraph (1)(A). A small tobacco product manufacturer shall 

be required— 

‘‘(i) to conduct such testing and reporting for 25 

percent of its tobacco products during each year of 

such 4-year period; and 

‘‘(ii) to conduct such testing and reporting for its 

largest-selling tobacco products (as determined by the 

Secretary) before its other tobacco products, or in such 

other order of priority as determined by the Secretary. 

‘‘(B) CASE-BY-CASE DELAY.—Notwithstanding subparagraph (A), the Secretary may, on a case-by-case basis, 

delay the date by which an individual small tobacco product 

manufacturer must conduct testing and reporting for its 

tobacco products under this section based upon a showing 

of undue hardship to such manufacturer. Notwithstanding 

the preceding sentence, the Secretary shall not extend the 

deadline for a small tobacco product manufacturer to conduct testing and reporting for all of its tobacco products 
H. R. 1256—47 

beyond a total of 5 years after the initial date of compliance 

under this section set by the Secretary with respect to 

manufacturers that are not small tobacco product manufacturers. 

‘‘(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 reporting of tobacco products required under this 

section, such testing and reporting by a small tobacco product 

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 reporting required 

under this section, the Secretary shall require that any subsequent or additional testing 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 tobacco product manufacturers 

to join together to purchase laboratory testing services required 

by this 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 CAPACITY.— ‘‘(1) IN GENERAL.—The regulations promulgated under subsection (a) shall provide that a small tobacco product manufacturer shall not be considered to be in violation of this section 

before the deadline applicable under paragraphs (3) and (4), 

if— 

‘‘(A) the tobacco products of such manufacturer are 

in compliance with all other requirements of this chapter; 

and 

‘‘(B) the conditions described in paragraph (2) are met. 

‘‘(2) CONDITIONS.—Notwithstanding the requirements of 

this section, the Secretary may delay the date by which a 

small tobacco product manufacturer must be in compliance 

with the testing and reporting required by this section until 

such time as the testing is reported if, not later than 90 

days before the deadline for reporting in accordance with this 

section, a small tobacco product manufacturer 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 available 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 

described in such paragraph are met, the Secretary shall notify 
H. R. 1256—48 

the small tobacco product manufacturer that the manufacturer 

shall not be considered to be in violation of the testing and 

reporting requirements of this section until the testing is 

reported or until 1 year after the reporting deadline has passed, 

whichever occurs sooner. If, however, the Secretary has not 

made a finding before the reporting deadline, 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 reporting 

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 required testing and reporting to occur if the Secretary determines, based on evidence properly and timely submitted by a small tobacco product manufacturer 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 subsection (d) or (e) 

shall be construed to authorize the extension 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 section. 

‘‘SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHORITY. 

‘‘(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, possession, exposure to, access to, advertising and promotion of, or use of tobacco products by individuals of any 

age, information reporting to the State, or measures relating 

to fire safety standards for tobacco 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 in effect with respect 

to a tobacco product any requirement which is different 

from, or in addition to, any requirement under the provisions of this chapter relating to tobacco product standards, 

premarket review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk 

tobacco products. 

‘‘(B) EXCEPTION.—Subparagraph (A) does not apply to 

requirements relating to the sale, distribution, possession, 

information reporting to the State, exposure to, access to, 

the advertising and promotion of, or use of, tobacco products 
H. R. 1256—49 

by individuals of any age, or relating to fire safety standards for tobacco products. Information disclosed to a State 

under subparagraph (A) that is exempt from disclosure 

under section 552(b)(4) of title 5, United States Code, shall 

be treated as a trade secret and confidential information 

by the State. 

‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT LIABILITY.— 

No provision of this chapter relating to a tobacco product shall 

be construed to modify or otherwise affect any action or the liability 

of any person under the product liability law of any State. 

‘‘SEC. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE. 

‘‘(a) ESTABLISHMENT.—Not later than 6 months after the date 

of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall establish a 12-member advisory committee, to be known as the Tobacco Products Scientific Advisory 

Committee (in this section referred to as the ‘Advisory Committee’). 

‘‘(b) MEMBERSHIP.— 

‘‘(1) IN GENERAL.— ‘‘(A) MEMBERS.—The Secretary shall appoint as members of the Tobacco Products Scientific Advisory Committee 

individuals who are technically qualified by training and 

experience in medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of 

tobacco products, who are of appropriately diversified 

professional backgrounds. The committee shall be composed 

of— 

‘‘(i) 7 individuals who are physicians, dentists, scientists, or health care professionals practicing in the 

area of oncology, pulmonology, cardiology, toxicology, 

pharmacology, addiction, or any other relevant specialty; 

‘‘(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 manufacturing industry; 

‘‘(v) 1 individual as a representative of the interests 

of the small business tobacco manufacturing industry, 

which position 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 

Committee; and 

‘‘(vi) 1 individual as a representative of the 

interests of the tobacco growers. 

‘‘(B) NONVOTING MEMBERS.—The members 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. 

‘‘(C) CONFLICTS OF INTEREST.—No members of the committee, other than members appointed pursuant to clauses 

(iv), (v), and (vi) of subparagraph (A) shall, during the 

member’s tenure on the committee or for the 18-month 
H. R. 1256—50 

period prior to becoming such a member, receive 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 appoint to the 

Advisory Committee any individual who is in the regular fulltime employ of the Food and Drug Administration or any agency 

responsible for the enforcement of this Act. The Secretary may 

appoint Federal officials as ex officio members. 

‘‘(3) CHAIRPERSON.—The Secretary shall designate 1 of the 

members appointed under clauses (i), (ii), and (iii) of paragraph 

(1)(A) to serve as chairperson. 

‘‘(c) DUTIES.—The Tobacco Products Scientific Advisory Committee shall provide advice, information, and recommendations to 

the Secretary— 

‘‘(1) as provided in this chapter; 

‘‘(2) on the effects of the alteration of the nicotine 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 requested 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 conferences 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 engaged; 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. 

‘‘(2) ADMINISTRATIVE SUPPORT.—The Secretary 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 COMMITTEES.— 

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 information which is exempt from disclosure under section 552(b) of title 5, United States Code. 

‘‘SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE. 

‘‘(a) IN GENERAL.—The Secretary shall— 

‘‘(1) at the request of the applicant, consider designating 

products for smoking cessation, including nicotine replacement 

products as fast track research and approval products within 

the meaning of section 506; 
H. R. 1256—51 

‘‘(2) consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum, and 

nicotine lozenges) for the treatment of tobacco dependence; 

and 

‘‘(3) review and consider the evidence for additional 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 Tobacco), shall submit 

to the Congress a report that examines how best to regulate, 

promote, and encourage the development of innovative products 

and treatments (including nicotine-based and non-nicotinebased products and treatments) to better achieve, in a manner 

that best protects and promotes 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. 

‘‘(2) RECOMMENDATIONS.—The report under paragraph (1) 

shall include the recommendations of the Secretary on how 

the Food and Drug Administration should coordinate and facilitate the exchange of information on such innovative products 

and treatments among relevant offices and centers within the 

Administration and within the National Institutes of Health, 

the Centers for Disease Control and Prevention, and other 

relevant agencies. 

‘‘SEC. 919. USER FEES. 

‘‘(a) ESTABLISHMENT OF QUARTERLY FEE.—Beginning on the 

date of enactment of the Family Smoking Prevention and Tobacco 

Control Act, the Secretary shall in accordance with this section 

assess user fees on, and collect such fees from, each manufacturer 

and importer of tobacco products subject to this chapter. The fees 

shall be assessed and collected with respect to each quarter of 

each fiscal year, and the total amount assessed and collected for 

a fiscal year shall be the amount specified in subsection (b)(1) 

for such year, subject to subsection (c). 

‘‘(b) ASSESSMENT OF USER FEE.— 

‘‘(1) AMOUNT OF ASSESSMENT.—The total amount of user 

fees authorized to be assessed and collected under subsection 

(a) for a fiscal year is the following, as applicable to the fiscal 

year involved: 

‘‘(A) For fiscal year 2009, $85,000,000 (subject to subsection (e)). 

‘‘(B) For fiscal year 2010, $235,000,000. 

‘‘(C) For fiscal year 2011, $450,000,000. 

‘‘(D) For fiscal year 2012, $477,000,000. 

‘‘(E) For fiscal year 2013, $505,000,000. 

‘‘(F) For fiscal year 2014, $534,000,000. 

‘‘(G) For fiscal year 2015, $566,000,000. 

‘‘(H) For fiscal year 2016, $599,000,000. 
H. R. 1256—52 

‘‘(I) For fiscal year 2017, $635,000,000. 

‘‘(J) For fiscal year 2018, $672,000,000. 

‘‘(K) For fiscal year 2019 and each subsequent fiscal 

year, $712,000,000. 

‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS OF TOBACCO

PRODUCTS.— 

‘‘(A) IN GENERAL.—The total user fees assessed and 

collected under subsection (a) each fiscal year with respect 

to each class of tobacco products shall be an amount that 

is equal to the applicable percentage of each class for 

the fiscal year multiplied by the amount specified in paragraph (1) for the fiscal year. 

‘‘(B) APPLICABLE PERCENTAGE.— 

‘‘(i) IN GENERAL.—For purposes of subparagraph 

(A), the applicable percentage for a fiscal year for each 

of the following classes of tobacco products shall be 

determined in accordance with clause (ii): 

‘‘(I) Cigarettes. 

‘‘(II) Cigars, including small cigars and cigars 

other than small cigars. 

‘‘(III) Snuff. 

‘‘(IV) Chewing tobacco. 

‘‘(V) Pipe tobacco. 

‘‘(VI) Roll-your-own tobacco. 

‘‘(ii) ALLOCATIONS.—The applicable percentage of 

each class of tobacco product described in clause (i) 

for a fiscal year shall be the percentage determined 

under section 625(c) of Public Law 108–357 for each 

such class of product for such fiscal year. 

‘‘(iii) REQUIREMENT OF REGULATIONS.—Notwithstanding clause (ii), no user fees shall be assessed 

on a class of tobacco products unless such class of 

tobacco products is listed in section 901(b) or is deemed 

by the Secretary in a regulation under section 901(b) 

to be subject to this chapter. 

‘‘(iv) REALLOCATIONS.—In the case of a class of 

tobacco products that is not listed in section 901(b) 

or deemed by the Secretary in a regulation under section 901(b) to be subject to this chapter, the amount 

of user fees that would otherwise be assessed to such 

class of tobacco products shall be reallocated to the 

classes of tobacco products that are subject to this 

chapter in the same manner and based on the same 

relative percentages otherwise determined under 

clause (ii). 

‘‘(3) DETERMINATION OF USER FEE BY COMPANY.— 

‘‘(A) IN GENERAL.—The total user fee to be paid by 

each manufacturer or importer of a particular class of 

tobacco products shall be determined for each quarter by 

multiplying— 

‘‘(i) such manufacturer’s or importer’s percentage 

share as determined under paragraph (4); by 

‘‘(ii) the portion of the user fee amount for the 

current quarter to be assessed on all manufacturers 

and importers of such class of tobacco products as 

determined under paragraph (2). 
H. R. 1256—53 

‘‘(B) NO FEE IN EXCESS OF PERCENTAGE SHARE.—No 

manufacturer or importer of tobacco products shall be 

required to pay a user fee in excess of the percentage 

share of such manufacturer or importer. 

‘‘(4) ALLOCATION OF ASSESSMENT WITHIN EACH CLASS OF

TOBACCO PRODUCT.—The percentage share of each manufacturer or importer of a particular class of tobacco products 

of the total user fee to be paid by all manufacturers or importers 

of that class of tobacco products shall be the percentage determined for purposes of allocations under subsections (e) through 

(h) of section 625 of Public Law 108–357. 

‘‘(5) ALLOCATION FOR CIGARS.—Notwithstanding paragraph 

(4), if a user fee assessment is imposed on cigars, the percentage 

share of each manufacturer or importer of cigars shall be based 

on the excise taxes paid by such manufacturer or importer 

during the prior fiscal year. 

‘‘(6) TIMING OF ASSESSMENT.—The Secretary shall notify 

each manufacturer and importer of tobacco products subject 

to this section of the amount of the quarterly assessment 

imposed on such manufacturer or importer under this subsection for each quarter of each fiscal year. Such notifications 

shall occur not later than 30 days prior to the end of the 

quarter for which such assessment is made, and payments 

of all assessments shall be made by the last day of the quarter 

involved. 

‘‘(7) MEMORANDUM OF UNDERSTANDING.— 

‘‘(A) IN GENERAL.—The Secretary shall request the 

appropriate Federal agency to enter into a memorandum 

of understanding that provides for the regular and timely 

transfer from the head of such agency to the Secretary 

of the information described in paragraphs (2)(B)(ii) and 

(4) and all necessary information regarding all tobacco 

product manufacturers and importers required to pay user 

fees. The Secretary shall maintain all disclosure restrictions established by the head of such agency regarding 

the information provided under the memorandum of understanding. 

‘‘(B) ASSURANCES.—Beginning not later than fiscal year 

2015, and for each subsequent fiscal year, the Secretary 

shall ensure that the Food and Drug Administration is 

able to determine the applicable percentages described in 

paragraph (2) and the percentage shares described in paragraph (4). The Secretary may carry out this subparagraph 

by entering into a contract with the head of the Federal 

agency referred to in subparagraph (A) to continue to provide the necessary information. 

‘‘(c) CREDITING AND AVAILABILITY OF FEES.— ‘‘(1) IN GENERAL.—Fees authorized under subsection (a) 

shall be collected and available for obligation only to the extent 

and in the amount provided in advance in appropriations Acts, 

subject to paragraph (2)(D). Such fees are authorized to remain 

available until expended. Such sums as may be necessary may 

be transferred from the Food and Drug Administration salaries 

and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses 

with such fiscal year limitation. 

‘‘(2) AVAILABILITY.— 
H. R. 1256—54 

‘‘(A) IN GENERAL.—Fees appropriated under paragraph 

(3) are available only for the purpose of paying the costs 

of the activities of the Food and Drug Administration 

related to the regulation of tobacco products under this 

chapter and the Family Smoking Prevention and Tobacco 

Control Act (referred to in this subsection as ‘tobacco regulation activities’), except that such fees may be used for 

the reimbursement specified in subparagraph (C). 

‘‘(B) PROHIBITION AGAINST USE OF OTHER FUNDS.— 

‘‘(i) IN GENERAL.—Except as provided in clause 

(ii), fees collected under subsection (a) are the only 

funds authorized to be made available for tobacco regulation activities. 

‘‘(ii) STARTUP COSTS.—Clause (i) does not apply 

until October 1, 2009. Until such date, any amounts 

available to the Food and Drug Administration 

(excluding user fees) shall be available and allocated 

as needed to pay the costs of tobacco regulation activities. 

‘‘(C) REIMBURSEMENT OF START-UP AMOUNTS.— 

‘‘(i) IN GENERAL.—Any amounts allocated for the 

start-up period pursuant to subparagraph (B)(ii) shall 

be reimbursed through any appropriated fees collected 

under subsection (a), in such manner as the Secretary 

determines appropriate to ensure that such allocation 

results in no net change in the total amount of funds 

otherwise available, for the period from October 1, 

2008, through September 30, 2010, for Food and Drug 

Administration programs and activities (other than 

tobacco regulation activities) for such period. 

‘‘(ii) TREATMENT OF REIMBURSED AMOUNTS.— Amounts reimbursed under clause (i) shall be available 

for the programs and activities for which funds allocated for the start-up period were available, prior to 

such allocation, until September 30, 2010, notwithstanding any otherwise applicable limits on amounts 

for such programs or activities for a fiscal year. 

‘‘(D) FEE COLLECTED DURING START-UP PERIOD.—Notwithstanding the first sentence of paragraph (1), fees under 

subsection (a) may be collected through September 30, 2009 

under subparagraph (B)(ii) and shall be available for obligation and remain available until expended. Such offsetting 

collections shall be credited to the salaries and expenses 

account of the Food and Drug Administration. 

‘‘(E) OBLIGATION OF START-UP COSTS IN ANTICIPATION

OF AVAILABLE FEE COLLECTIONS.—Notwithstanding any 

other provision of law, following the enactment of an appropriation for fees under this section for fiscal year 2010, 

or any portion thereof, obligations for costs of tobacco regulation activities during the start-up period may be incurred 

in anticipation of the receipt of offsetting fee collections 

through procedures specified in section 1534 of title 31, 

United States Code. 

‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For fiscal year 

2009 and each subsequent fiscal year, there is authorized to 

be appropriated for fees under this section an amount equal 

to the amount specified in subsection (b)(1) for the fiscal year. 
H. R. 1256—55 

‘‘(d) COLLECTION OF UNPAID FEES.—In any case where the 

Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated 

as a claim of the United States Government subject to subchapter 

II of chapter 37 of title 31, United States Code. 

‘‘(e) APPLICABILITY TO FISCAL YEAR 2009.—If the date of enactment of the Family Smoking Prevention and Tobacco Control Act 

occurs during fiscal year 2009, the following applies, subject to 

subsection (c): 

‘‘(1) The Secretary shall determine the fees that would 

apply for a single quarter of such fiscal year according to 

the application of subsection (b) to the amount specified in 

paragraph (1)(A) of such subsection (referred to in this subsection as the ‘quarterly fee amounts’). 

‘‘(2) For the quarter in which such date of enactment occurs, 

the amount of fees assessed shall be a pro rata amount, determined according to the number of days remaining in the quarter 

(including such date of enactment) and according to the daily 

equivalent of the quarterly fee amounts. Fees assessed under 

the preceding sentence shall not be collected until the next 

quarter. 

‘‘(3) For the quarter following the quarter to which paragraph (2) applies, the full quarterly fee amounts shall be 

assessed and collected, in addition to collection of the pro rata 

fees assessed under paragraph (2).’’. 

(c) CONFORMING AMENDMENT.—Section 9(1) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 

4408(i)) is amended to read as follows: 

‘‘(1) The term ‘smokeless tobacco’ has the meaning given 

such term by section 900(18) of the Federal Food, Drug, and 

Cosmetic Act.’’. 

SEC. 102. FINAL RULE. 

(a) CIGARETTES AND SMOKELESS TOBACCO.— (1) IN GENERAL.—On the first day of publication of the 

Federal Register that is 180 days or more after the date of 

enactment of this Act, the Secretary of Health and Human 

Services shall publish in the Federal Register a final rule 

regarding cigarettes and smokeless tobacco, which— 

(A) is deemed to be issued under chapter 9 of the 

Federal Food, Drug, and Cosmetic Act, as added by section 

101 of this division; and 

(B) shall be deemed to be in compliance with all 

applicable provisions of chapter 5 of title 5, United States 

Code, and all other provisions of law relating to rulemaking 

procedures. 

(2) CONTENTS OF RULE.—Except as provided in this subsection, the final rule published under paragraph (1), shall 

be identical in its provisions to part 897 of the regulations 

promulgated by the Secretary of Health and Human Services 

in the August 28, 1996, issue of the Federal Register (61 

Fed. Reg. 44615–44618). Such rule shall— 

(A) provide for the designation of jurisdictional 

authority that is in accordance with this subsection in 

accordance with this division and the amendments made 

by this division; 

(B) strike Subpart C—Labels and section 897.32(c); 
H. R. 1256—56 

(C) strike paragraphs (a), (b), and (i) of section 897.3 

and insert definitions of the terms ‘‘cigarette’’, ‘‘cigarette 

tobacco’’, and ‘‘smokeless tobacco’’ as defined in section 

900 of the Federal Food, Drug, and Cosmetic Act; 

(D) insert ‘‘or roll-your-own paper’’ in section 897.34(a) 

after ‘‘other than cigarettes or smokeless tobacco’’; 

(E) include such modifications to section 897.30(b), if 

any, that the Secretary determines are appropriate in light 

of governing First Amendment case law, including the decision of the Supreme Court of the United States in Lorillard 

Tobacco Co. v. Reilly (533 U.S. 525 (2001)); 

(F) become effective on the date that is 1 year after 

the date of enactment of this Act; and 

(G) amend paragraph (d) of section 897.16 to read 

as follows: 

‘‘(d)(1) Except as provided in subparagraph (2), no manufacturer, distributor, or retailer may distribute or cause to be distributed any free samples of cigarettes, smokeless tobacco, or other 

tobacco products (as such term is defined in section 201 of the 

Federal Food, Drug, and Cosmetic Act). 

‘‘(2)(A) Subparagraph (1) does not prohibit a manufacturer, 

distributor, or retailer from distributing or causing to be distributed 

free samples of smokeless tobacco in a qualified adult-only facility. 

‘‘(B) This subparagraph does not affect the authority of a State 

or local government to prohibit or otherwise restrict the distribution 

of free samples of smokeless tobacco. 

‘‘(C) For purposes of this paragraph, the term ‘qualified adultonly facility’ means a facility or restricted area that— 

‘‘(i) requires each person present to provide to a law enforcement officer (whether on or off duty) or to a security guard 

licensed by a governmental entity government-issued identification showing a photograph and at least the minimum age 

established by applicable law for the purchase of smokeless 

tobacco; 

‘‘(ii) does not sell, serve, or distribute alcohol; 

‘‘(iii) is not located adjacent to or immediately across from 

(in any direction) a space that is used primarily for youthoriented marketing, promotional, or other activities; 

‘‘(iv) is a temporary structure constructed, designated, and 

operated as a distinct enclosed area for the purpose of distributing free samples of smokeless tobacco in accordance with 

this subparagraph; 

‘‘(v) is enclosed by a barrier that— 

‘‘(I) is constructed of, or covered with, an opaque material (except for entrances and exits); 

‘‘(II) extends from no more than 12 inches above the 

ground or floor (which area at the bottom of the barrier 

must be covered with material that restricts visibility but 

may allow airflow) to at least 8 feet above the ground 

or floor (or to the ceiling); and 

‘‘(III) prevents persons outside the qualified adult-only 

facility from seeing into the qualified adult-only facility, 

unless they make unreasonable efforts to do so; and 

‘‘(vi) does not display on its exterior— 

‘‘(I) any tobacco product advertising; 
H. R. 1256—57 

‘‘(II) a brand name other than in conjunction with 

words for an area or enclosure to identify an adult-only 

facility; or 

‘‘(III) any combination of words that would imply to 

a reasonable observer that the manufacturer, distributor, 

or retailer has a sponsorship that would violate section 

897.34(c). 

‘‘(D) Distribution of samples of smokeless tobacco under this 

subparagraph permitted to be taken out of the qualified adultonly facility shall be limited to 1 package per adult consumer 

containing no more than 0.53 ounces (15 grams) of smokeless 

tobacco. If such package of smokeless tobacco contains individual 

portions of smokeless tobacco, the individual portions of smokeless 

tobacco shall not exceed 8 individual portions and the collective 

weight of such individual portions shall not exceed 0.53 ounces 

(15 grams). Any manufacturer, distributor, or retailer who distributes or causes to be distributed free samples also shall take reasonable steps to ensure that the above amounts are limited to one 

such package per adult consumer per day. 

‘‘(3) Notwithstanding subparagraph (2), no manufacturer, distributor, or retailer may distribute or cause to be distributed any 

free samples of smokeless tobacco— 

‘‘(A) to a sports team or entertainment group; or 

‘‘(B) at any football, basketball, baseball, soccer, or hockey 

event or any other sporting or entertainment event determined 

by the Secretary to be covered by this subparagraph. 

‘‘(4) The Secretary shall implement a program to ensure compliance with this paragraph and submit a report to the Congress 

on such compliance not later than 18 months after the date of 

enactment of the Family Smoking Prevention and Tobacco Control 

Act. 

‘‘(5) Nothing in this paragraph shall be construed to authorize 

any person to distribute or cause to be distributed any sample 

of a tobacco product to any individual who has not attained the 

minimum age established by applicable law for the purchase of 

such product.’’. 

(3) AMENDMENTS TO RULE.—Prior to making amendments 

to the rule published under paragraph (1), the Secretary shall 

promulgate a proposed rule in accordance with chapter 5 of 

title 5, United States Code. 

(4) RULE OF CONSTRUCTION.—Except as provided in paragraph (3), nothing in this section shall be construed to limit 

the authority of the Secretary to amend, in accordance with 

chapter 5 of title 5, United States Code, the regulation promulgated pursuant to this section, including the provisions of such 

regulation relating to distribution of free samples. 

(5) ENFORCEMENT OF RETAIL SALE PROVISIONS.—The Secretary of Health and Human Services shall ensure that the 

provisions of this division, the amendments made by this division, and the implementing regulations (including such provisions, amendments, and regulations relating to the retail sale 

of tobacco products) are enforced with respect to the United 

States and Indian tribes. 

(6) QUALIFIED ADULT-ONLY FACILITY.—A qualified adultonly facility (as such term is defined in section 897.16(d) of 

the final rule published under paragraph (1)) that is also a 

retailer and that commits a violation as a retailer shall not 
H. R. 1256—58 

be subject to the limitations in section 103(q) and shall be 

subject to penalties applicable to a qualified adult-only facility. 

(7) CONGRESSIONAL REVIEW PROVISIONS.—Section 801 of 

title 5, United States Code, shall not apply to the final rule 

published under paragraph (1). 

(b) LIMITATION ON ADVISORY OPINIONS.—As of the date of enactment of this Act, the following documents issued by the Food 

and Drug Administration shall not constitute advisory opinions 

under section 10.85(d)(1) of title 21, Code of Federal Regulations, 

except as they apply to tobacco products, and shall not be cited 

by the Secretary of Health and Human Services or the Food and 

Drug Administration as binding precedent: 

(1) The preamble to the proposed rule in the document 

titled ‘‘Regulations Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco Products to Protect Children 

and Adolescents’’ (60 Fed. Reg. 41314–41372 (August 11, 1995)). 

(2) The document titled ‘‘Nicotine in Cigarettes and Smokeless Tobacco Products is a Drug and These Products Are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act’’ (60 Fed. Reg. 41453–41787 (August 11, 1995)). 

(3) The preamble to the final rule in the document titled 

‘‘Regulations Restricting the Sale and Distribution of Cigarettes 

and Smokeless Tobacco to Protect Children and Adolescents’’ 

(61 Fed. Reg. 44396–44615 (August 28, 1996)). 

(4) The document titled ‘‘Nicotine in Cigarettes and Smokeless Tobacco is a Drug and These Products are Nicotine Delivery 

Devices Under the Federal Food, Drug, and Cosmetic Act; Jurisdictional Determination’’ (61 Fed. Reg. 44619–45318 (August 

28, 1996)). 

SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL 

PROVISIONS. 

(a) AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC

ACT.—Except as otherwise expressly provided, whenever in this 

section an amendment is expressed in terms of an amendment 

to, or repeal of, a section or other provision, the reference is to 

a section or other provision of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 301 et seq.). 

(b) SECTION 301.—Section 301 (21 U.S.C. 331) is amended— 

(1) in subsection (a), by inserting ‘‘tobacco product,’’ after 

‘‘device,’’; 

(2) in subsection (b), by inserting ‘‘tobacco product,’’ after 

‘‘device,’’; 

(3) in subsection (c), by inserting ‘‘tobacco product,’’ after 

‘‘device,’’; 

(4) in subsection (e)— 

(A) by striking the period after ‘‘572(i)’’; and 

(B) by striking ‘‘or 761 or the refusal to permit access 

to’’ and inserting ‘‘761, 909, or 920 or the refusal to permit 

access to’’; 

(5) in subsection (g), by inserting ‘‘tobacco product,’’ after 

‘‘device,’’; 

(6) in subsection (h), by inserting ‘‘tobacco product,’’ after 

‘‘device,’’; 

(7) in subsection (j)— 

(A) by striking the period after ‘‘573’’; and 
H. R. 1256—59 

(B) by striking ‘‘708, or 721’’ and inserting ‘‘708, 721, 

904, 905, 906, 907, 908, 909, or 920(b)’’; 

(8) in subsection (k), by inserting ‘‘tobacco product,’’ after 

‘‘device,’’; 

(9) by striking subsection (p) and inserting the following: 

‘‘(p) The failure to register in accordance with section 510 

or 905, the failure to provide any information required by section 

510(j), 510(k), 905(i), or 905(j), or the failure to provide a notice 

required by section 510(j)(2) or 905(i)(3).’’; 

(10) by striking subsection (q)(1) and inserting the following: 

‘‘(q)(1) The failure or refusal— 

‘‘(A) to comply with any requirement prescribed under section 518, 520(g), 903(b), 907, 908, or 915; 

‘‘(B) to furnish any notification or other material or information required by or under section 519, 520(g), 904, 909, or 

920; or 

‘‘(C) to comply with a requirement under section 522 or 

913.’’; 

(11) in subsection (q)(2), by striking ‘‘device,’’ and inserting 

‘‘device or tobacco product,’’; 

(12) in subsection (r), by inserting ‘‘or tobacco product’’ 

after the term ‘‘device’’ each time that such term appears; 

and 

(13) by adding at the end the following: 

‘‘(oo) The sale of tobacco products in violation of a no-tobaccosale order issued under section 303(f). 

‘‘(pp) The introduction or delivery for introduction into interstate commerce of a tobacco product in violation of section 911. 

‘‘(qq)(1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp 

(including tax stamp), tag, label, or other identification device upon 

any tobacco product or container or labeling thereof so as to render 

such tobacco product a counterfeit tobacco product. 

‘‘(2) Making, selling, disposing of, or keeping in possession, 

control, or custody, or concealing any punch, die, plate, stone, or 

other item that is designed to print, imprint, or reproduce the 

trademark, trade name, or other identifying mark, imprint, or device 

of another or any likeness of any of the foregoing upon any tobacco 

product or container or labeling thereof so as to render such tobacco 

product a counterfeit tobacco product. 

‘‘(3) The doing of any act that causes a tobacco product to 

be a counterfeit tobacco product, or the sale or dispensing, or 

the holding for sale or dispensing, of a counterfeit tobacco product. 

‘‘(rr) The charitable distribution of tobacco products. 

‘‘(ss) The failure of a manufacturer or distributor to notify 

the Attorney General and the Secretary of the Treasury of their 

knowledge of tobacco products used in illicit trade. 

‘‘(tt) Making any express or implied statement or representation 

directed to consumers with respect to a tobacco product, in a label 

or labeling or through the media or advertising, that either conveys, 

or misleads or would mislead consumers into believing, that— 

‘‘(1) the product is approved by the Food and Drug Administration; 

‘‘(2) the Food and Drug Administration deems the product 

to be safe for use by consumers; 
H. R. 1256—60 

‘‘(3) the product is endorsed by the Food and Drug Administration for use by consumers; or 

‘‘(4) the product is safe or less harmful by virtue of— 

‘‘(A) its regulation or inspection by the Food and Drug 

Administration; or 

‘‘(B) its compliance with regulatory requirements set 

by the Food and Drug Administration; 

including any such statement or representation rendering the 

product misbranded under section 903.’’. 

(c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f)) is amended— 

(1) in paragraph (5)— 

(A) by striking ‘‘paragraph (1), (2), (3), or (4)’’ each 

place such appears and inserting ‘‘paragraph (1), (2), (3), 

(4), or (9)’’; 

(B) in subparagraph (A)— 

(i) by striking ‘‘assessed’’ the first time it appears 

and inserting ‘‘assessed, or a no-tobacco-sale order may 

be imposed,’’; and 

(ii) by striking ‘‘penalty’’ the second time it appears 

and inserting ‘‘penalty, or upon whom a no-tobaccosale order is to be imposed,’’; 

(C) in subparagraph (B)— 

(i) by inserting after ‘‘penalty,’’ the following: ‘‘or 

the period to be covered by a no-tobacco-sale order,’’; 

and 

(ii) by adding at the end the following: ‘‘A notobacco-sale order permanently prohibiting an individual retail outlet from selling tobacco products shall 

include provisions that allow the outlet, after a specified period of time, to request that the Secretary compromise, modify, or terminate the order.’’; and 

(D) by adding at the end the following: 

‘‘(D) The Secretary may compromise, modify, or terminate, with 

or without conditions, any no-tobacco-sale order.’’; 

(2) in paragraph (6)— 

(A) by inserting ‘‘or the imposition of a no-tobaccosale order’’ after the term ‘‘penalty’’ each place such term 

appears; and 

(B) by striking ‘‘issued.’’ and inserting ‘‘issued, or on 

which the no-tobacco-sale order was imposed, as the case 

may be.’’; and 

(3) by adding at the end the following: 

‘‘(8) If the Secretary finds that a person has committed repeated 

violations of restrictions promulgated under section 906(d) at a 

particular retail outlet then the Secretary may impose a no-tobaccosale order on that person prohibiting the sale of tobacco products 

in that outlet. A no-tobacco-sale order may be imposed with a 

civil penalty under paragraph (1). Prior to the entry of a nosale order under this paragraph, a person shall be entitled to 

a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money 

penalties, including at a retailer’s request a hearing by telephone, 

or at the nearest regional or field office of the Food and Drug 

Administration, or at a Federal, State, or county facility within 

100 miles from the location of the retail outlet, if such a facility 

is available. 
H. R. 1256—61 

‘‘(9) CIVIL MONETARY PENALTIES FOR VIOLATION OF TOBACCO

PRODUCT REQUIREMENTS.— 

‘‘(A) IN GENERAL.—Subject to subparagraph (B), any person 

who violates a requirement of this Act which relates to tobacco 

products shall be liable to the United States for a civil penalty 

in an amount not to exceed $15,000 for each such violation, 

and not to exceed $1,000,000 for all such violations adjudicated 

in a single proceeding. 

‘‘(B) ENHANCED PENALTIES.— 

‘‘(i) Any person who intentionally violates a requirement of section 902(5), 902(6), 904, 908(c), or 911(a), shall 

be subject to a civil monetary penalty of— 

‘‘(I) not to exceed $250,000 per violation, and not 

to exceed $1,000,000 for all such violations adjudicated 

in a single proceeding; or 

‘‘(II) in the case of a violation that continues after 

the Secretary provides written notice to such person, 

$250,000 for the first 30-day period (or any portion 

thereof) that the person continues to be in violation, 

and such amount shall double for every 30-day period 

thereafter that the violation continues, not to exceed 

$1,000,000 for any 30-day period, and not to exceed 

$10,000,000 for all such violations adjudicated in a 

single proceeding. 

‘‘(ii) Any person who violates a requirement of section 

911(g)(2)(C)(ii) or 911(i)(1), shall be subject to a civil monetary penalty of— 

‘‘(I) not to exceed $250,000 per violation, and not 

to exceed $1,000,000 for all such violations adjudicated 

in a single proceeding; or 

‘‘(II) in the case of a violation that continues after 

the Secretary provides written notice to such person, 

$250,000 for the first 30-day period (or any portion 

thereof) that the person continues to be in violation, 

and such amount shall double for every 30-day period 

thereafter that the violation continues, not to exceed 

$1,000,000 for any 30-day period, and not to exceed 

$10,000,000 for all such violations adjudicated in a 

single proceeding. 

‘‘(iii) In determining the amount of a civil penalty 

under clause (i)(II) or (ii)(II), the Secretary shall take into 

consideration whether the person is making efforts toward 

correcting the violation of the requirements of the section 

for which such person is subject to such civil penalty.’’. 

(d) SECTION 304.—Section 304 (21 U.S.C. 334) is amended— 

(1) in subsection (a)(2)— 

(A) by striking ‘‘and’’ before ‘‘(D)’’; and 

(B) by striking ‘‘device.’’ and inserting the following: 

‘‘device, and (E) Any adulterated or misbranded tobacco 

product.’’; 

(2) in subsection (d)(1), by inserting ‘‘tobacco product,’’ after 

‘‘device,’’; 

(3) in subsection (g)(1), by inserting ‘‘or tobacco product’’ 

after the term ‘‘device’’ each place such term appears; and 

(4) in subsection (g)(2)(A), by inserting ‘‘or tobacco product’’ 

after ‘‘device’’. 
H. R. 1256—62 

(e) SECTION 505.—Section 505(n)(2) (21 U.S.C. 355(n)(2)) is 

amended by striking ‘‘section 904’’ and inserting ‘‘section 1004’’. 

(f) SECTION 523.—Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D)) 

is amended by striking ‘‘section 903(g)’’ and inserting ‘‘section 

1003(g)’’. 

(g) SECTION 702.—Section 702(a)(1) (U.S.C. 372(a)(1)) is 

amended— 

(1) by striking ‘‘(a)(1)’’ and inserting ‘‘(a)(1)(A)’’; and 

(2) by adding at the end the following: 

‘‘(B)(i) For a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in 

connection with the enforcement of this Act. 

‘‘(ii) The Secretary shall not enter into any contract under 

clause (i) with the government of any of the several States to 

exercise enforcement authority under this Act on Indian country 

without the express written consent of the Indian tribe involved.’’. 

(h) SECTION 703.—Section 703 (21 U.S.C. 373) is amended— 

(1) by inserting ‘‘tobacco product,’’ after the term ‘‘device,’’ 

each place such term appears; and 

(2) by inserting ‘‘tobacco products,’’ after the term ‘‘devices,’’ 

each place such term appears. 

(i) SECTION 704.—Section 704 (21 U.S.C. 374) is amended— 

(1) in subsection (a)(1)— 

(A) by striking ‘‘devices, or cosmetics’’ each place it 

appears and inserting ‘‘devices, tobacco products, or cosmetics’’; 

(B) by striking ‘‘or restricted devices’’ each place it 

appears and inserting ‘‘restricted devices, or tobacco products’’; and 

(C) by striking ‘‘and devices and subject to’’ and all 

that follows through ‘‘other drugs or devices’’ and inserting 

‘‘devices, and tobacco products and subject to reporting 

and inspection under regulations lawfully issued pursuant 

to section 505 (i) or (k), section 519, section 520(g), or 

chapter IX and data relating to other drugs, devices, or 

tobacco products’’; 

(2) in subsection (b), by inserting ‘‘tobacco product,’’ after 

‘‘device,’’; and 

(3) in subsection (g)(13), by striking ‘‘section 903(g)’’ and 

inserting ‘‘section 1003(g)’’. 

(j) SECTION 705.—Section 705(b) (21 U.S.C. 375(b)) is amended 

by inserting ‘‘tobacco products,’’ after ‘‘devices,’’. 

(k) SECTION 709.—Section 709 (21 U.S.C. 379a) is amended 

by inserting ‘‘tobacco product,’’ after ‘‘device,’’. 

(l) SECTION 801.—Section 801 (21 U.S.C. 381) is amended— 

(1) in subsection (a)— 

(A) by inserting ‘‘tobacco products,’’ after the term 

‘‘devices,’’; 

(B) by inserting ‘‘or section 905(h)’’ after ‘‘section 510’’; 

and 

(C) by striking the term ‘‘drugs or devices’’ each time 

such term appears and inserting ‘‘drugs, devices, or tobacco 

products’’; 

(2) in subsection (e)(1)— 

(A) by inserting ‘‘tobacco product’’ after ‘‘drug, device,’’; 

and 
H. R. 1256—63 

(B) by inserting ‘‘, and a tobacco product intended 

for export shall not be deemed to be in violation of section 

906(e), 907, 911, or 920(a),’’ before ‘‘if it—’’; and 

(3) by adding at the end the following: 

‘‘(p)(1) Not later than 36 months after the date of enactment 

of the Family Smoking Prevention and Tobacco Control Act, and 

annually thereafter, the Secretary shall submit to the Committee 

on Health, Education, Labor, and Pensions of the Senate and the 

Committee on Energy and Commerce of the House of Representatives, a report regarding— 

‘‘(A) the nature, extent, and destination of United States 

tobacco product exports that do not conform to tobacco product 

standards established pursuant to this Act; 

‘‘(B) the public health implications of such exports, 

including any evidence of a negative public health impact; 

and 

‘‘(C) recommendations or assessments of policy alternatives 

available to Congress and the executive branch to reduce any 

negative public health impact caused by such exports. 

‘‘(2) The Secretary is authorized to establish appropriate 

information disclosure requirements to carry out this subsection.’’. 

(m) SECTION 1003.—Section 1003(d)(2)(C) (as redesignated by 

section 101(b)) is amended— 

(1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 

(2) inserting ‘‘, and tobacco products’’ after ‘‘devices’’. 

(n) SECTION 1009.—Section 1009(b) (as redesignated by section 

101(b)) is amended by striking ‘‘section 908’’ and inserting ‘‘section 

1008’’. 

(o) SECTION 409 OF THE FEDERAL MEAT INSPECTION ACT.— 

Section 409(a) of the Federal Meat Inspection Act (21 U.S.C. 679(a)) 

is amended by striking ‘‘section 902(b)’’ and inserting ‘‘section 

1002(b)’’. 

(p) RULE OF CONSTRUCTION.—Nothing in this section is 

intended or shall be construed to expand, contract, or otherwise 

modify or amend the existing limitations on State government 

authority over tribal restricted fee or trust lands. 

(q) GUIDANCE AND EFFECTIVE DATES.— (1) IN GENERAL.—The Secretary of Health and Human 

Services shall issue guidance— 

(A) defining the term ‘‘repeated violation’’, as used 

in section 303(f)(8) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 333(f)(8)) as amended by subsection (c), 

as including at least 5 violations of particular requirements 

over a 36-month period at a particular retail outlet that 

constitute a repeated violation and providing for civil penalties in accordance with paragraph (2); 

(B) providing for timely and effective notice by certified 

or registered mail or personal delivery to the retailer of 

each alleged violation at a particular retail outlet prior 

to conducting a followup compliance check, such notice 

to be sent to the location specified on the retailer’s registration or to the retailer’s registered agent if the retailer 

has provider such agent information to the Food and Drug 

Administration prior to the violation; 

(C) providing for a hearing pursuant to the procedures 

established through regulations of the Food and Drug 

Administration for assessing civil money penalties, 
H. R. 1256—64 

including at a retailer’s request a hearing by telephone 

or at the nearest regional or field office of the Food and 

Drug Administration, and providing for an expedited procedure for the administrative appeal of an alleged violation; 

(D) providing that a person may not be charged with 

a violation at a particular retail outlet unless the Secretary 

has provided notice to the retailer of all previous violations 

at that outlet; 

(E) establishing that civil money penalties for multiple 

violations shall increase from one violation to the next 

violation pursuant to paragraph (2) within the time periods 

provided for in such paragraph; 

(F) providing that good faith reliance on the presentation of a false government-issued photographic identification that contains a date of birth does not constitute a 

violation of any minimum age requirement for the sale 

of tobacco products if the retailer has taken effective steps 

to prevent such violations, including— 

(i) adopting and enforcing a written policy against 

sales to minors; 

(ii) informing its employees of all applicable laws; 

(iii) establishing disciplinary sanctions for 

employee noncompliance; and 

(iv) requiring its employees to verify age by way 

of photographic identification or electronic scanning 

device; and 

(G) providing for the Secretary, in determining whether 

to impose a no-tobacco-sale order and in determining 

whether to compromise, modify, or terminate such an order, 

to consider whether the retailer has taken effective steps 

to prevent violations of the minimum age requirements 

for the sale of tobacco products, including the steps listed 

in subparagraph (F). 

(2) PENALTIES FOR VIOLATIONS.— 

(A) IN GENERAL.—The amount of the civil penalty to 

be applied for violations of restrictions promulgated under 

section 906(d), as described in paragraph (1), shall be as 

follows: 

(i) With respect to a retailer with an approved 

training program, the amount of the civil penalty shall 

not exceed— 

(I) in the case of the first violation, $0.00 

together with the issuance of a warning letter 

to the retailer; 

(II) in the case of a second violation within 

a 12-month period, $250; 

(III) in the case of a third violation within 

a 24-month period, $500; 

(IV) in the case of a fourth violation within 

a 24-month period, $2,000; 

(V) in the case of a fifth violation within a 

36-month period, $5,000; and 

(VI) in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis. 
H. R. 1256—65 

(ii) With respect to a retailer that does not have 

an approved training program, the amount of the civil 

penalty shall not exceed— 

(I) in the case of the first violation, $250; 

(II) in the case of a second violation within 

a 12-month period, $500; 

(III) in the case of a third violation within 

a 24-month period, $1,000; 

(IV) in the case of a fourth violation within 

a 24-month period, $2,000; 

(V) in the case of a fifth violation within a 

36-month period, $5,000; and 

(VI) in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis. 

(B) TRAINING PROGRAM.—For purposes of subparagraph 

(A), the term ‘‘approved training program’’ means a training 

program that complies with standards developed by the 

Food and Drug Administration for such programs. 

(C) CONSIDERATION OF STATE PENALTIES.—The Secretary shall coordinate with the States in enforcing the 

provisions of this Act and, for purposes of mitigating a 

civil penalty to be applied for a violation by a retailer 

of any restriction promulgated under section 906(d), shall 

consider the amount of any penalties paid by the retailer 

to a State for the same violation. 

(3) GENERAL EFFECTIVE DATE.—The amendments made by 

paragraphs (2), (3), and (4) of subsection (c) shall take effect 

upon the issuance of guidance described in paragraph (1) of 

this subsection. 

(4) SPECIAL EFFECTIVE DATE.—The amendment made by 

subsection (c)(1) shall take effect on the date of enactment 

of this Act. 

(5) PACKAGE LABEL REQUIREMENTS.—The package label 

requirements of paragraphs (3) and (4) of section 903(a) of 

the Federal Food, Drug, and Cosmetic Act (as amended by 

this division) shall take effect on the date that is 12 months 

after the date of enactment of this Act. The package label 

requirements of paragraph (2) of such section 903(a) for cigarettes shall take effect on the date that is 15 months after 

the issuance of the regulations required by section 4(d) of 

the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 

1333), as amended by section 201 of this division. The package 

label requirements of paragraph (2) of such section 903(a) for 

tobacco products other than cigarettes shall take effect on the 

date that is 12 months after the date of enactment of this 

Act. The effective date shall be with respect to the date of 

manufacture, provided that, in any case, beginning 30 days 

after such effective date, a manufacturer shall not introduce 

into the domestic commerce of the United States any product, 

irrespective of the date of manufacture, that is not in conformance with section 903(a) (2), (3), and (4) and section 920(a) 

of the Federal Food, Drug, and Cosmetic Act. 

(6) ADVERTISING REQUIREMENTS.—The advertising requirements of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act (as amended by this division) shall take effect on 
H. R. 1256—66 

the date that is 12 months after the date of enactment of 

this Act. 

SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PURCHASE 

TOBACCO PRODUCTS. 

The Secretary of Health and Human Services shall— 

(1) convene an expert panel to conduct a study on the 

public health implications of raising the minimum age to purchase tobacco products; and 

(2) not later than 5 years after the date of enactment 

of this Act, submit a report to the Congress on the results 

of such study. 

SEC. 105. ENFORCEMENT ACTION PLAN FOR ADVERTISING AND PROMOTION RESTRICTIONS. 

(a) ACTION PLAN.— (1) DEVELOPMENT.—Not later than 6 months after the date 

of enactment of this Act, the Secretary of Health and Human 

Services (in this section referred to as the ‘‘Secretary’’) shall 

develop and publish an action plan to enforce restrictions 

adopted pursuant to section 906 of the Federal Food, Drug, 

and Cosmetic Act, as added by section 101(b) of this division, 

or pursuant to section 102(a) of this division, on promotion 

and advertising of menthol and other cigarettes to youth. 

(2) CONSULTATION.—The action plan required by paragraph 

(1) shall be developed in consultation with public health 

organizations and other stakeholders with demonstrated expertise and experience in serving minority communities. 

(3) PRIORITY.—The action plan required by paragraph (1) 

shall include provisions designed to ensure enforcement of the 

restrictions described in paragraph (1) in minority communities. 

(b) STATE AND LOCAL ACTIVITIES.— (1) INFORMATION ON AUTHORITY.—Not later than 3 months 

after the date of enactment of this Act, the Secretary shall 

inform State, local, and tribal governments of the authority 

provided to such entities under section 5(c) of the Federal 

Cigarette Labeling and Advertising Act, as added by section 

203 of this division, or preserved by such entities under section 

916 of the Federal Food, Drug, and Cosmetic Act, as added 

by section 101(b) of this division. 

(2) COMMUNITY ASSISTANCE.—At the request of communities seeking assistance to prevent underage tobacco use, the 

Secretary shall provide such assistance, including assistance 

with strategies to address the prevention of underage tobacco 

use in communities with a disproportionate use of menthol 

cigarettes by minors. 

SEC. 106. STUDIES OF PROGRESS AND EFFECTIVENESS. 

(a) FDA REPORT.—Not later than 3 years after the date of 

enactment of this Act, and not less than every 2 years thereafter, 

the Secretary of Health and Human Services shall submit to the 

Committee on Health, Education, Labor, and Pensions of the Senate 

and the Committee on Energy and Commerce of the House of 

Representatives, a report concerning— 

(1) the progress of the Food and Drug Administration in 

implementing this division, including major accomplishments, 

objective measurements of progress, and the identification of 

any areas that have not been fully implemented; 
H. R. 1256—67 

(2) impediments identified by the Food and Drug Administration to progress in implementing this division and to meeting 

statutory timeframes; 

(3) data on the number of new product applications received 

under section 910 of the Federal Food, Drug, and Cosmetic 

Act and modified risk product applications received under section 911 of such Act, and the number of applications acted 

on under each category; and 

(4) data on the number of full time equivalents engaged 

in implementing this division. 

(b) GAO REPORT.—Not later than 5 years after the date of 

enactment of this Act, the Comptroller General of the United States 

shall conduct a study of, and submit to the Committees described 

in subsection (a) a report concerning— 

(1) the adequacy of the authority and resources provided 

to the Secretary of Health and Human Services for this division 

to carry out its goals and purposes; and 

(2) any recommendations for strengthening that authority 

to more effectively protect the public health with respect to 

the manufacture, marketing, and distribution of tobacco products. 

(c) PUBLIC AVAILABILITY.—The Secretary of Health and Human 

Services and the Comptroller General of the United States, respectively, shall make the reports required under subsection (a) and 

(b) available to the public, including by posting such reports on 

the respective Internet websites of the Food and Drug Administration and the Government Accountability Office. 

TITLE II—TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE 

CONSTITUENT DISCLOSURE 

SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 

(a) AMENDMENT.—Section 4 of the Federal Cigarette Labeling 

and Advertising Act (15 U.S.C. 1333) is amended to read as follows: 

‘‘SEC. 4. LABELING. 

‘‘(a) LABEL REQUIREMENTS.— 

‘‘(1) IN GENERAL.—It shall be unlawful for any person to 

manufacture, package, sell, offer to sell, distribute, or import 

for sale or distribution within the United States any cigarettes 

the package of which fails to bear, in accordance with the 

requirements of this section, one of the following labels: 

‘‘WARNING: Cigarettes are addictive. 

‘‘WARNING: Tobacco smoke can harm your children. 

‘‘WARNING: Cigarettes cause fatal lung disease. 

‘‘WARNING: Cigarettes cause cancer. 

‘‘WARNING: Cigarettes cause strokes and heart disease. 

‘‘WARNING: Smoking during pregnancy can harm your 

baby. 

‘‘WARNING: Smoking can kill you. 

‘‘WARNING: Tobacco smoke causes fatal lung disease 

in nonsmokers. 
H. R. 1256—68 

‘‘WARNING: Quitting smoking now greatly reduces 

serious risks to your health. 

‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—Each label statement 

required by paragraph (1) shall be located in the upper portion 

of the front and rear panels of the package, directly on the 

package underneath the cellophane or other clear wrapping. 

Each label statement shall comprise the top 50 percent of 

the front and rear panels of the package. The word ‘WARNING’ 

shall appear in capital letters and all text shall be in conspicuous and legible 17-point type, unless the text of the label 

statement would occupy more than 70 percent of such area, 

in which case the text may be in a smaller conspicuous and 

legible type size, provided that at least 60 percent of such 

area is occupied by required text. The text shall be black 

on a white background, or white on a black background, in 

a manner that contrasts, by typography, layout, or color, with 

all other printed material on the package, in an alternating 

fashion under the plan submitted under subsection (c). 

‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBUTION.—The provisions of this subsection do not apply to a tobacco product 

manufacturer or distributor of cigarettes which does not manufacture, package, or import cigarettes for sale or distribution 

within the United States. 

‘‘(4) APPLICABILITY TO RETAILERS.—A retailer of cigarettes 

shall not be in violation of this subsection for packaging that— 

‘‘(A) contains a warning label; 

‘‘(B) is supplied to the retailer by a license- or permitholding tobacco product manufacturer, importer, or distributor; and 

‘‘(C) is not altered by the retailer in a way that is 

material to the requirements of this subsection. 

‘‘(b) ADVERTISING REQUIREMENTS.— 

‘‘(1) IN GENERAL.—It shall be unlawful for any tobacco 

product manufacturer, importer, distributor, or retailer of cigarettes to advertise or cause to be advertised within the United 

States any cigarette unless its advertising bears, in accordance 

with the requirements of this section, one of the labels specified 

in subsection (a). 

‘‘(2) TYPOGRAPHY, ETC.—Each label statement required by 

subsection (a) in cigarette advertising shall comply with the 

standards set forth in this paragraph. For press and poster 

advertisements, each such statement and (where applicable) 

any required statement relating to tar, nicotine, or other constituent (including a smoke constituent) yield shall comprise 

at least 20 percent of the area of the advertisement and shall 

appear in a conspicuous and prominent format and location 

at the top of each advertisement within the trim area. The 

Secretary may revise the required type sizes in such area 

in such manner as the Secretary determines appropriate. The 

word ‘WARNING’ shall appear in capital letters, and each 

label statement shall appear in conspicuous and legible type. 

The text of the label statement shall be black if the background 

is white and white if the background is black, under the plan 

submitted under subsection (c). The label statements shall be 

enclosed by a rectangular border that is the same color as 

the letters of the statements and that is the width of the 

first downstroke of the capital ‘W’ of the word ‘WARNING’ 
H. R. 1256—69 

in the label statements. The text of such label statements 

shall be in a typeface pro rata to the following requirements: 

45-point type for a whole-page broadsheet newspaper advertisement; 39-point type for a half-page broadsheet newspaper 

advertisement; 39-point type for a whole-page tabloid newspaper advertisement; 27-point type for a half-page tabloid newspaper advertisement; 31.5-point type for a double page spread 

magazine or whole-page magazine advertisement; 22.5-point 

type for a 28 centimeter by 3 column advertisement; and 15- 

point type for a 20 centimeter by 2 column advertisement. 

The label statements shall be in English, except that— 

‘‘(A) in the case of an advertisement that appears in 

a newspaper, magazine, periodical, or other publication 

that is not in English, the statements shall appear in 

the predominant language of the publication; and 

‘‘(B) in the case of any other advertisement that is 

not in English, the statements shall appear in the same 

language as that principally used in the advertisement. 

‘‘(3) MATCHBOOKS.—Notwithstanding paragraph (2), for 

matchbooks (defined as containing not more than 20 matches) 

customarily given away with the purchase of tobacco products, 

each label statement required by subsection (a) may be printed 

on the inside cover of the matchbook. 

‘‘(4) ADJUSTMENT BY SECRETARY.—The Secretary may, 

through a rulemaking under section 553 of title 5, United 

States Code, adjust the format and type sizes for the label 

statements required by this section; the text, format, and type 

sizes of any required tar, nicotine yield, or other constituent 

(including smoke constituent) disclosures; or the text, format, 

and type sizes for any other disclosures required under the 

Federal Food, Drug, and Cosmetic Act. The text of any such 

label statements or disclosures shall be required to appear 

only within the 20 percent area of cigarette advertisements 

provided by paragraph (2). The Secretary shall promulgate 

regulations which provide for adjustments in the format and 

type sizes of any text required to appear in such area to 

ensure that the total text required to appear by law will fit 

within such area. 

‘‘(c) MARKETING REQUIREMENTS.— 

‘‘(1) RANDOM DISPLAY.—The label statements specified in 

subsection (a)(1) shall be randomly displayed in each 12-month 

period, in as equal a number of times as is possible on each 

brand of the product and be randomly distributed in all areas 

of the United States in which the product is marketed in 

accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by the 

Secretary. 

‘‘(2) ROTATION.—The label statements specified in subsection (a)(1) shall be rotated quarterly in alternating sequence 

in advertisements for each brand of cigarettes in accordance 

with a plan submitted by the tobacco product manufacturer, 

importer, distributor, or retailer to, and approved by, the Secretary. 

‘‘(3) REVIEW.—The Secretary shall review each plan submitted under paragraph (2) and approve it if the plan— 
H. R. 1256—70 

‘‘(A) will provide for the equal distribution and display 

on packaging and the rotation required in advertising 

under this subsection; and 

‘‘(B) assures that all of the labels required under this 

section will be displayed by the tobacco product manufacturer, importer, distributor, or retailer at the same time. 

‘‘(4) APPLICABILITY TO RETAILERS.—This subsection and subsection (b) apply to a retailer only if that retailer is responsible 

for or directs the label statements required under this section 

except that this paragraph shall not relieve a retailer of liability 

if the retailer displays, in a location open to the public, an 

advertisement that does not contain a warning label or has 

been altered by the retailer in a way that is material to the 

requirements of this subsection and subsection (b). 

‘‘(d) GRAPHIC LABEL STATEMENTS.—Not later than 24 months 

after the date of enactment of the Family Smoking Prevention 

and Tobacco Control Act, the Secretary shall issue regulations that 

require color graphics depicting the negative health consequences 

of smoking to accompany the label statements specified in subsection (a)(1). The Secretary may adjust the type size, text and 

format of the label statements specified in subsections (a)(2) and 

(b)(2) as the Secretary determines appropriate so that both the 

graphics and the accompanying label statements are clear, conspicuous, legible and appear within the specified area.’’. 

(b) EFFECTIVE DATE.—The amendment made by subsection (a) 

shall take effect 15 months after the issuance of the regulations 

required by subsection (a). Such effective date shall be with respect 

to the date of manufacture, provided that, in any case, beginning 

30 days after such effective date, a manufacturer shall not introduce 

into the domestic commerce of the United States any product, 

irrespective of the date of manufacture, that is not in conformance 

with section 4 of the Federal Cigarette Labeling and Advertising 

Act (15 U.S.C. 1333), as amended by subsection (a). 

SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING LABEL STATEMENTS. 

(a) PREEMPTION.—Section 5(a) of the Federal Cigarette Labeling 

and Advertising Act (15 U.S.C. 1334(a)) is amended by striking 

‘‘No’’ and inserting ‘‘Except to the extent the Secretary requires 

additional or different statements on any cigarette package by 

a regulation, by an order, by a standard, by an authorization 

to market a product, or by a condition of marketing a product, 

pursuant to the Family Smoking Prevention and Tobacco Control 

Act (and the amendments made by that Act), or as required under 

section 903(a)(2) or section 920(a) of the Federal Food, Drug, and 

Cosmetic Act, no’’. 

(b) CHANGE IN REQUIRED STATEMENTS.—Section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333), as 

amended by section 201, is further amended by adding at the 

end the following: 

‘‘(d) CHANGE IN REQUIRED STATEMENTS.—The Secretary 

through a rulemaking conducted under section 553 of title 5, United 

States Code, may adjust the format, type size, color graphics, and 

text of any of the label requirements, or establish the format, 

type size, and text of any other disclosures required under the 

Federal Food, Drug, and Cosmetic Act, if the Secretary finds that 
H. R. 1256—71 

such a change would promote greater public understanding of the 

risks associated with the use of tobacco products.’’. 

SEC. 203. STATE REGULATION OF CIGARETTE ADVERTISING AND PROMOTION. 

Section 5 of the Federal Cigarette Labeling and Advertising 

Act (15 U.S.C. 1334) is amended by adding at the end the following: 

‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a State or 

locality may enact statutes and promulgate regulations, based on 

smoking and health, that take effect after the effective date of 

the Family Smoking Prevention and Tobacco Control Act, imposing 

specific bans or restrictions on the time, place, and manner, but 

not content, of the advertising or promotion of any cigarettes.’’. 

SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING 

WARNINGS. 

(a) AMENDMENT.—Section 3 of the Comprehensive Smokeless 

Tobacco Health Education Act of 1986 (15 U.S.C. 4402) is amended 

to read as follows: 

‘‘SEC. 3. SMOKELESS TOBACCO WARNING. 

‘‘(a) GENERAL RULE.— 

‘‘(1) It shall be unlawful for any person to manufacture, 

package, sell, offer to sell, distribute, or import for sale or 

distribution within the United States any smokeless tobacco 

product unless the product package bears, in accordance with 

the requirements of this Act, one of the following labels: 

‘‘WARNING: This product can cause mouth cancer. 

‘‘WARNING: This product can cause gum disease and 

tooth loss. 

‘‘WARNING: This product is not a safe alternative 

to cigarettes. 

‘‘WARNING: Smokeless tobacco is addictive. 

‘‘(2) Each label statement required by paragraph (1) shall 

be— 

‘‘(A) located on the 2 principal display panels of the 

package, and each label statement shall comprise at least 

30 percent of each such display panel; and 

‘‘(B) in 17-point conspicuous and legible type and in 

black text on a white background, or white text on a 

black background, in a manner that contrasts by typography, layout, or color, with all other printed material 

on the package, in an alternating fashion under the plan 

submitted under subsection (b)(3), except that if the text 

of a label statement would occupy more than 70 percent 

of the area specified by subparagraph (A), such text may 

appear in a smaller type size, so long as at least 60 percent 

of such warning area is occupied by the label statement. 

‘‘(3) The label statements required by paragraph (1) shall 

be introduced by each tobacco product manufacturer, packager, 

importer, distributor, or retailer of smokeless tobacco products 

concurrently into the distribution chain of such products. 

‘‘(4) The provisions of this subsection do not apply to a 

tobacco product manufacturer or distributor of any smokeless 

tobacco product that does not manufacture, package, or import 

smokeless tobacco products for sale or distribution within the 

United States. 
H. R. 1256—72 

‘‘(5) A retailer of smokeless tobacco products shall not be 

in violation of this subsection for packaging that— 

‘‘(A) contains a warning label; 

‘‘(B) is supplied to the retailer by a license- or permitholding tobacco product manufacturer, importer, or distributor; and 

‘‘(C) is not altered by the retailer in a way that is 

material to the requirements of this subsection. 

‘‘(b) REQUIRED LABELS.— 

‘‘(1) It shall be unlawful for any tobacco product manufacturer, packager, importer, distributor, or retailer of smokeless 

tobacco products to advertise or cause to be advertised within 

the United States any smokeless tobacco product unless its 

advertising bears, in accordance with the requirements of this 

section, one of the labels specified in subsection (a). 

‘‘(2)(A) Each label statement required by subsection (a) 

in smokeless tobacco advertising shall comply with the standards set forth in this paragraph. 

‘‘(B) For press and poster advertisements, each such statement and (where applicable) any required statement relating 

to tar, nicotine, or other constituent yield shall comprise at 

least 20 percent of the area of the advertisement. 

‘‘(C) The word ‘WARNING’ shall appear in capital letters, 

and each label statement shall appear in conspicuous and legible type. 

‘‘(D) The text of the label statement shall be black on 

a white background, or white on a black background, in an 

alternating fashion under the plan submitted under paragraph 

(3). 

‘‘(E) The label statements shall be enclosed by a rectangular 

border that is the same color as the letters of the statements 

and that is the width of the first downstroke of the capital 

‘W’ of the word ‘WARNING’ in the label statements. 

‘‘(F) The text of such label statements shall be in a typeface 

pro rata to the following requirements: 45-point type for a 

whole-page broadsheet newspaper advertisement; 39-point type 

for a half-page broadsheet newspaper advertisement; 39-point 

type for a whole-page tabloid newspaper advertisement; 27- 

point type for a half-page tabloid newspaper advertisement; 

31.5-point type for a double page spread magazine or wholepage magazine advertisement; 22.5-point type for a 28 centimeter by 3 column advertisement; and 15-point type for a 

20 centimeter by 2 column advertisement. 

‘‘(G) The label statements shall be in English, except that— 

‘‘(i) in the case of an advertisement that appears in 

a newspaper, magazine, periodical, or other publication 

that is not in English, the statements shall appear in 

the predominant language of the publication; and 

‘‘(ii) in the case of any other advertisement that is 

not in English, the statements shall appear in the same 

language as that principally used in the advertisement. 

‘‘(3)(A) The label statements specified in subsection (a)(1) 

shall be randomly displayed in each 12-month period, in as 

equal a number of times as is possible on each brand of the 

product and be randomly distributed in all areas of the United 

States in which the product is marketed in accordance with 
H. R. 1256—73 

a plan submitted by the tobacco product manufacturer, 

importer, distributor, or retailer and approved by the Secretary. 

‘‘(B) The label statements specified in subsection (a)(1) 

shall be rotated quarterly in alternating sequence in 

advertisements for each brand of smokeless tobacco product 

in accordance with a plan submitted by the tobacco product 

manufacturer, importer, distributor, or retailer to, and approved 

by, the Secretary. 

‘‘(C) The Secretary shall review each plan submitted under 

subparagraphs (A) and (B) and approve it if the plan— 

‘‘(i) will provide for the equal distribution and display 

on packaging and the rotation required in advertising 

under this subsection; and 

‘‘(ii) assures that all of the labels required under this 

section will be displayed by the tobacco product manufacturer, importer, distributor, or retailer at the same time. 

‘‘(D) This paragraph applies to a retailer only if that retailer 

is responsible for or directs the label statements under this 

section, unless the retailer displays, in a location open to the 

public, an advertisement that does not contain a warning label 

or has been altered by the retailer in a way that is material 

to the requirements of this subsection. 

‘‘(4) The Secretary may, through a rulemaking under section 553 of title 5, United States Code, adjust the format 

and type sizes for the label statements required by this section; 

the text, format, and type sizes of any required tar, nicotine 

yield, or other constituent disclosures; or the text, format, and 

type sizes for any other disclosures required under the Federal 

Food, Drug, and Cosmetic Act. The text of any such label 

statements or disclosures shall be required to appear only 

within the 20 percent area of advertisements provided by paragraph (2). The Secretary shall promulgate regulations which 

provide for adjustments in the format and type sizes of any 

text required to appear in such area to ensure that the total 

text required to appear by law will fit within such area. 

‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is unlawful to 

advertise smokeless tobacco on any medium of electronic communications subject to the jurisdiction of the Federal Communications 

Commission.’’. 

(b) EFFECTIVE DATE.—The amendment made by subsection (a) 

shall take effect 12 months after the date of enactment of this 

Act. Such effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such 

effective date, a manufacturer shall not introduce into the domestic 

commerce of the United States any product, irrespective of the 

date of manufacture, that is not in conformance with section 3 

of the Comprehensive Smokeless Tobacco Health Education Act 

of 1986 (15 U.S.C. 4402), as amended by subsection (a). 

SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT 

WARNING LABEL STATEMENTS. 

(a) IN GENERAL.—Section 3 of the Comprehensive Smokeless 

Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as amended 

by section 204, is further amended by adding at the end the following: 

‘‘(d) AUTHORITY TO REVISE WARNING LABEL STATEMENTS.— 

The Secretary may, by a rulemaking conducted under section 553 
H. R. 1256—74 

of title 5, United States Code, adjust the format, type size, and 

text of any of the label requirements, require color graphics to 

accompany the text, increase the required label area from 30 percent 

up to 50 percent of the front and rear panels of the package, 

or establish the format, type size, and text of any other disclosures 

required under the Federal Food, Drug, and Cosmetic Act, if the 

Secretary finds that such a change would promote greater public 

understanding of the risks associated with the use of smokeless 

tobacco products.’’. 

(b) PREEMPTION.—Section 7(a) of the Comprehensive Smokeless 

Tobacco Health Education Act of 1986 (15 U.S.C. 4406(a)) is 

amended by striking ‘‘No’’ and inserting ‘‘Except as provided in 

the Family Smoking Prevention and Tobacco Control Act (and the 

amendments made by that Act), no’’. 

SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLOSURE TO THE PUBLIC. 

Section 4 of the Federal Cigarette Labeling and Advertising 

Act (15 U.S.C. 1333), as amended by sections 201 and 202, is 

further amended by adding at the end the following: 

‘‘(e) TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLOSURE.— 

‘‘(1) IN GENERAL.—The Secretary shall, by a rulemaking 

conducted under section 553 of title 5, United States Code, 

determine (in the Secretary’s sole discretion) whether cigarette 

and other tobacco product manufacturers shall be required 

to include in the area of each cigarette advertisement specified 

by subsection (b) of this section, or on the package label, or 

both, the tar and nicotine yields of the advertised or packaged 

brand. Any such disclosure shall be in accordance with the 

methodology established under such regulations, shall conform 

to the type size requirements of subsection (b) of this section, 

and shall appear within the area specified in subsection (b) 

of this section. 

‘‘(2) RESOLUTION OF DIFFERENCES.—Any differences 

between the requirements established by the Secretary under 

paragraph (1) and tar and nicotine yield reporting requirements 

established by the Federal Trade Commission shall be resolved 

by a memorandum of understanding between the Secretary 

and the Federal Trade Commission. 

‘‘(3) CIGARETTE AND OTHER TOBACCO PRODUCT CONSTITUENTS.—In addition to the disclosures required by paragraph 

(1), the Secretary may, under a rulemaking conducted under 

section 553 of title 5, United States Code, prescribe disclosure 

requirements regarding the level of any cigarette or other 

tobacco product constituent including any smoke constituent. 

Any such disclosure may be required if the Secretary determines that disclosure would be of benefit to the public health, 

or otherwise would increase consumer awareness of the health 

consequences of the use of tobacco products, except that no 

such prescribed disclosure shall be required on the face of 

any cigarette package or advertisement. Nothing in this section 

shall prohibit the Secretary from requiring such prescribed 

disclosure through a cigarette or other tobacco product package 

or advertisement insert, or by any other means under the 

Federal Food, Drug, and Cosmetic Act. 
H. R. 1256—75 

‘‘(4) RETAILERS.—This subsection applies to a retailer only 

if that retailer is responsible for or directs the label statements 

required under this section.’’. 

TITLE III—PREVENTION OF ILLICIT 

TRADE IN TOBACCO PRODUCTS 

SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPECTION. 

Chapter IX of the Federal Food, Drug, and Cosmetic Act, as 

added by section 101, is further amended by adding at the end 

the following: 

‘‘SEC. 920. LABELING, RECORDKEEPING, RECORDS INSPECTION. 

‘‘(a) ORIGIN LABELING.— 

‘‘(1) REQUIREMENT.—Beginning 1 year after the date of 

enactment of the Family Smoking Prevention and Tobacco Control Act, the label, packaging, and shipping containers of tobacco 

products other than cigarettes for introduction or delivery for 

introduction into interstate commerce in the United States 

shall bear the statement ‘sale only allowed in the United 

States’. Beginning 15 months after the issuance of the regulations required by section 4(d) of the Federal Cigarette Labeling 

and Advertising Act (15 U.S.C. 1333), as amended by section 

201 of Family Smoking Prevention and Tobacco Control Act, 

the label, packaging, and shipping containers of cigarettes for 

introduction or delivery for introduction into interstate commerce in the United States shall bear the statement ‘Sale 

only allowed in the United States’. 

‘‘(2) EFFECTIVE DATE.—The effective date specified in paragraph (1) shall be with respect to the date of manufacture, 

provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic 

commerce of the United States any product, irrespective of 

the date of manufacture, that is not in conformance with such 

paragraph. 

‘‘(b) REGULATIONS CONCERNING RECORDKEEPING FOR TRACKING

AND TRACING.— 

‘‘(1) IN GENERAL.—The Secretary shall promulgate regulations regarding the establishment and maintenance of records 

by any person who manufactures, processes, transports, distributes, receives, packages, holds, exports, or imports tobacco products. 

‘‘(2) INSPECTION.—In promulgating the regulations 

described in paragraph (1), the Secretary shall consider which 

records are needed for inspection to monitor the movement 

of tobacco products from the point of manufacture through 

distribution to retail outlets to assist in investigating potential 

illicit trade, smuggling, or counterfeiting of tobacco products. 

‘‘(3) CODES.—The Secretary may require codes on the labels 

of tobacco products or other designs or devices for the purpose 

of tracking or tracing the tobacco product through the distribution system. 

‘‘(4) SIZE OF BUSINESS.—The Secretary shall take into 

account the size of a business in promulgating regulations 

under this section. 
H. R. 1256—76 

‘‘(5) RECORDKEEPING BY RETAILERS.—The Secretary shall 

not require any retailer to maintain records relating to individual purchasers of tobacco products for personal consumption. 

‘‘(c) RECORDS INSPECTION.—If the Secretary has a reasonable 

belief that a tobacco product is part of an illicit trade or smuggling 

or is a counterfeit product, each person who manufactures, processes, transports, distributes, receives, holds, packages, exports, 

or imports tobacco products shall, at the request of an officer 

or employee duly designated by the Secretary, permit such officer 

or employee, at reasonable times and within reasonable limits and 

in a reasonable manner, upon the presentation of appropriate 

credentials and a written notice to such person, to have access 

to and copy all records (including financial records) relating to 

such article that are needed to assist the Secretary in investigating 

potential illicit trade, smuggling, or counterfeiting of tobacco products. The Secretary shall not authorize an officer or employee 

of the government of any of the several States to exercise authority 

under the preceding sentence on Indian country without the express 

written consent of the Indian tribe involved. 

‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.— 

‘‘(1) NOTIFICATION.—If the manufacturer or distributor of 

a tobacco product has knowledge which reasonably supports 

the conclusion that a tobacco product manufactured or distributed by such manufacturer or distributor that has left the 

control of such person may be or has been— 

‘‘(A) imported, exported, distributed, or offered for sale 

in interstate commerce by a person without paying duties 

or taxes required by law; or 

‘‘(B) imported, exported, distributed, or diverted for 

possible illicit marketing, 

the manufacturer or distributor shall promptly notify the 

Attorney General and the Secretary of the Treasury of such 

knowledge. 

‘‘(2) KNOWLEDGE DEFINED.—For purposes of this subsection, 

the term ‘knowledge’ as applied to a manufacturer or distributor 

means— 

‘‘(A) the actual knowledge that the manufacturer or 

distributor had; or 

‘‘(B) the knowledge which a reasonable person would 

have had under like circumstances or which would have 

been obtained upon the exercise of due care. 

‘‘(e) CONSULTATION.—In carrying out this section, the Secretary 

shall consult with the Attorney General of the United States and 

the Secretary of the Treasury, as appropriate.’’. 

SEC. 302. STUDY AND REPORT. 

(a) STUDY.—The Comptroller General of the United States shall 

conduct a study of cross-border trade in tobacco products to— 

(1) collect data on cross-border trade in tobacco products, 

including illicit trade and trade of counterfeit tobacco products 

and make recommendations on the monitoring of such trade; 

(2) collect data on cross-border advertising (any advertising 

intended to be broadcast, transmitted, or distributed from the 

United States to another country) of tobacco products and make 

recommendations on how to prevent or eliminate, and what 

technologies could help facilitate the elimination of, cross-border 

advertising; and 
H. R. 1256—77 

(3) collect data on the health effects (particularly with 

respect to individuals under 18 years of age) resulting from 

cross-border trade in tobacco products, including the health 

effects resulting from— 

(A) the illicit trade of tobacco products and the trade 

of counterfeit tobacco products; and 

(B) the differing tax rates applicable to tobacco products. 

(b) REPORT.—Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States 

shall submit to the Committee on Health, Education, Labor, and 

Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the study 

described in subsection (a). 

(c) DEFINITION.—In this section: 

(1) The term ‘‘cross-border trade’’ means trade across a 

border of the United States, a State or Territory, or Indian 

country. 

(2) The term ‘‘Indian country’’ has the meaning given to 

such term in section 1151 of title 18, United States Code. 

(3) The terms ‘‘State’’ and ‘‘Territory’’ have the meanings 

given to those terms in section 201 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 321). 

DIVISION B—FEDERAL RETIREMENT 

REFORM ACT 

SEC. 100. SHORT TITLE; TABLE OF CONTENTS. 

(a) SHORT TITLE.—This division may be cited as the ‘‘Federal 

Retirement Reform Act of 2009’’. 

(b) TABLE OF CONTENTS.—The table of contents for this division 

is as follows: 

DIVISION B—FEDERAL RETIREMENT REFORM ACT 

Sec. 100. Short title; table of contents. 

TITLE I—PROVISIONS RELATING TO FEDERAL EMPLOYEES RETIREMENT 

Sec. 101. Short title. 

Sec. 102. Automatic enrollments and immediate employing agency contributions. 

Sec. 103. Qualified Roth contribution program. 

Sec. 104. Authority to establish mutual fund window. 

Sec. 105. Reporting requirements. 

Sec. 106. Acknowledgment of risk. 

Sec. 107. Subpoena authority. 

Sec. 108. Amounts in Thrift Savings Funds subject to legal proceedings. 

Sec. 109. Accounts for surviving spouses. 

Sec. 110. Treatment of members of the uniformed services under the Thrift Savings 

Plan. 

TITLE II—SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR SURVIVING 

SPOUSES OF ARMED FORCES MEMBERS 

Sec. 201. Increase in monthly amount of special survivor indemnity allowance for 

widows and widowers of deceased members of the Armed Forces affected 

by required Survivor Benefit Plan annuity offset for dependency and indemnity compensation. 
H. R. 1256—78 

TITLE I—PROVISIONS RELATING TO 

FEDERAL EMPLOYEES RETIREMENT 

SEC. 101. SHORT TITLE. 

This title may be cited as the ‘‘Thrift Savings Plan Enhancement Act of 2009’’. 

SEC. 102. AUTOMATIC ENROLLMENTS AND IMMEDIATE EMPLOYING 

AGENCY CONTRIBUTIONS. 

(a) IN GENERAL.—Section 8432(b) of title 5, United States Code, 

is amended by striking paragraphs (2) through (4) and inserting 

the following: 

‘‘(2)(A) The Executive Director shall by regulation provide for 

an eligible individual to be automatically enrolled to make contributions under subsection (a) at the default percentage of basic pay. 

‘‘(B) For purposes of this paragraph, the default percentage 

shall be equal to 3 percent or such other percentage, not less 

than 2 percent nor more than 5 percent, as the Board may prescribe. 

‘‘(C) The regulations shall include provisions under which any 

individual who would otherwise be automatically enrolled in accordance with subparagraph (A) may— 

‘‘(i) modify the percentage or amount to be contributed 

pursuant to automatic enrollment, effective not later than the 

first full pay period following receipt of the election by the 

appropriate processing entity; or 

‘‘(ii) decline automatic enrollment altogether. 

‘‘(D)(i) Except as provided in clause (ii), for purposes of this 

paragraph, the term ‘eligible individual’ means any individual who, 

after any regulations under subparagraph (A) first take effect, 

is appointed, transferred, or reappointed to a position in which 

that individual becomes eligible to contribute to the Thrift Savings 

Fund. 

‘‘(ii) Members of the uniformed services shall not be eligible 

individuals for purposes of this paragraph. 

‘‘(E) Sections 8351(a)(1), 8440a(a)(1), 8440b(a)(1), 8440c(a)(1), 

8440d(a)(1), and 8440e(a)(1) shall be applied in a manner consistent 

with the purposes of this paragraph.’’. 

(b) TECHNICAL AMENDMENT.—Section 8432(b)(1) of title 5, 

United States Code, is amended by striking the parenthetical matter 

in subparagraph (B). 

SEC. 103. QUALIFIED ROTH CONTRIBUTION PROGRAM. 

(a) IN GENERAL.—Subchapter III of chapter 84 of title 5, United 

States Code, is amended by inserting after section 8432c the following: 

‘‘§ 8432d. Qualified Roth contribution program 

‘‘(a) DEFINITIONS.—For purposes of this section— 

‘‘(1) the term ‘qualified Roth contribution program’ means 

a program described in paragraph (1) of section 402A(b) of 

the Internal Revenue Code of 1986 which meets the requirements of paragraph (2) of such section; and 

‘‘(2) the terms ‘designated Roth contribution’ and ‘elective 

deferral’ have the meanings given such terms in section 402A 

of the Internal Revenue Code of 1986. 
H. R. 1256—79 

‘‘(b) AUTHORITY TO ESTABLISH.—The Executive Director shall 

by regulation provide for the inclusion in the Thrift Savings Plan 

of a qualified Roth contribution program, under such terms and 

conditions as the Board may prescribe. 

‘‘(c) REQUIRED PROVISIONS.—The regulations under subsection 

(b) shall include— 

‘‘(1) provisions under which an election to make designated 

Roth contributions may be made— 

‘‘(A) by any individual who is eligible to make contributions under section 8351, 8432(a), 8440a, 8440b, 8440c, 

8440d, or 8440e; and 

‘‘(B) by any individual, not described in subparagraph 

(A), who is otherwise eligible to make elective deferrals 

under the Thrift Savings Plan; 

‘‘(2) any provisions which may, as a result of enactment 

of this section, be necessary in order to clarify the meaning 

of any reference to an ‘account’ made in section 8432(f), 8433, 

8434(d), 8435, 8437, or any other provision of law; and 

‘‘(3) any other provisions which may be necessary to carry 

out this section.’’. 

(b) CLERICAL AMENDMENT.—The analysis for chapter 84 of title 

5, United States Code, is amended by inserting after the item 

relating to section 8432c the following: 

‘‘8432d. Qualified Roth contribution program.’’. 

SEC. 104. AUTHORITY TO ESTABLISH MUTUAL FUND WINDOW. 

(a) IN GENERAL.—Section 8438(b)(1) of title 5, United States 

Code, is amended— 

(1) in subparagraph (D), by striking ‘‘and’’ at the end; 

(2) in subparagraph (E), by striking the period and 

inserting ‘‘; and’’; and 

(3) by adding after subparagraph (E) the following: 

‘‘(F) a service that enables participants to invest in 

mutual funds, if the Board authorizes the mutual fund 

window under paragraph (5).’’. 

(b) REQUIREMENTS.—Section 8438(b) of title 5, United States 

Code, is amended by adding at the end the following: 

‘‘(5)(A) The Board may authorize the addition of a mutual 

fund window under the Thrift Savings Plan if the Board determines 

that such addition would be in the best interests of participants. 

‘‘(B) The Board shall ensure that any expenses charged for 

use of the mutual fund window are borne solely by the participants 

who use such window. 

‘‘(C) The Board may establish such other terms and conditions 

for the mutual fund window as the Board considers appropriate 

to protect the interests of participants, including requirements 

relating to risk disclosure. 

‘‘(D) The Board shall consult with the Employee Thrift Advisory 

Council (established under section 8473) before authorizing the 

addition of a mutual fund window or establishing a service that 

enables participants to invest in mutual funds.’’. 

(c) TECHNICAL AND CONFORMING AMENDMENT.—Section 

8438(d)(1) of title 5, United States Code, is amended by inserting 

‘‘and options’’ after ‘‘investment funds’’. 
H. R. 1256—80 

SEC. 105. REPORTING REQUIREMENTS. 

(a) ANNUAL REPORT.—The Board shall, not later than June 

30 of each year, submit to Congress an annual report on the 

operations of the Thrift Savings Plan. Such report shall include, 

for the prior calendar year, information on the number of participants as of the last day of such prior calendar year, the median 

balance in participants’ accounts as of such last day, demographic 

information on participants, the percentage allocation of amounts 

among investment funds or options, the status of the development 

and implementation of the mutual fund window, the diversity demographics of any company, investment adviser, or other entity 

retained to invest and manage the assets of the Thrift Savings 

Fund, and such other information as the Board considers appropriate. A copy of each annual report under this subsection shall 

be made available to the public through an Internet website. 

(b) REPORTING OF FEES AND OTHER INFORMATION.— 

(1) IN GENERAL.—The Board shall include in the periodic 

statements provided to participants under section 8439(c) of 

title 5, United States Code, the amount of the investment 

management fees, administrative expenses, and any other fees 

or expenses paid with respect to each investment fund and 

option under the Thrift Savings Plan. Any such statement 

shall also provide a statement notifying participants as to how 

they may access the annual report described in subsection 

(a), as well as any other information concerning the Thrift 

Savings Plan that might be useful. 

(2) USE OF ESTIMATES.—For purposes of providing the 

information required under this subsection, the Board may 

provide a reasonable and representative estimate of any fees 

or expenses described in paragraph (1) and shall indicate any 

such estimate as being such an estimate. Any such estimate 

shall be based on the previous year’s experience. 

(c) DEFINITIONS.—For purposes of this section— 

(1) the term ‘‘Board’’ has the meaning given such term 

by 8401(5) of title 5, United States Code; 

(2) the term ‘‘participant’’ has the meaning given such 

term by section 8471(3) of title 5, United States Code; and 

(3) the term ‘‘account’’ means an account established under 

section 8439 of title 5, United States Code. 

SEC. 106. ACKNOWLEDGMENT OF RISK. 

(a) IN GENERAL.—Section 8439(d) of title 5, United States Code, 

is amended— 

(1) by striking the matter after ‘‘who elects to invest in’’ 

and before ‘‘shall sign an acknowledgment’’ and inserting ‘‘any 

investment fund or option under this chapter, other than the 

Government Securities Investment Fund,’’; and 

(2) by striking ‘‘either such Fund’’ and inserting ‘‘any such 

fund or option’’. 

(b) COORDINATION WITH PROVISIONS RELATING TO FIDUCIARY

RESPONSIBILITIES, LIABILITIES, AND PENALTIES.—Section 

8477(e)(1)(C) of title 5, United States Code, is amended— 

(1) by redesignating subparagraph (C) as subparagraph 

(C)(i); and 

(2) by adding at the end the following: 

‘‘(ii) A fiduciary shall not be liable under subparagraph (A), 

and no civil action may be brought against a fiduciary— 
H. R. 1256—81 

‘‘(I) for providing for the automatic enrollment of a participant in accordance with section 8432(b)(2)(A); 

‘‘(II) for enrolling a participant in a default investment 

fund in accordance with section 8438(c)(2); or 

‘‘(III) for allowing a participant to invest through the 

mutual fund window or for establishing restrictions applicable 

to participants’ ability to invest through the mutual fund 

window.’’. 

SEC. 107. SUBPOENA AUTHORITY. 

(a) IN GENERAL.—Chapter 84 of title 5, United States Code, 

is amended by inserting after section 8479 the following: 

‘‘§ 8480. Subpoena authority 

‘‘(a) In order to carry out the responsibilities specified in this 

subchapter and subchapter III of this chapter, the Executive 

Director may issue subpoenas commanding each person to whom 

the subpoena is directed to produce designated books, documents, 

records, electronically stored information, or tangible materials in 

the possession or control of that individual. 

‘‘(b) Notwithstanding any Federal, State, or local law, any person, including officers, agents, and employees, receiving a subpoena 

under this section, who complies in good faith with the subpoena 

and thus produces the materials sought, shall not be liable in 

any court of any State or the United States to any individual, 

domestic or foreign corporation or upon a partnership or other 

unincorporated association for such production. 

‘‘(c) When a person fails to obey a subpoena issued under 

this section, the district court of the United States for the district 

in which the investigation is conducted or in which the person 

failing to obey is found, shall on proper application issue an order 

directing that person to comply with the subpoena. The court may 

punish as contempt any disobedience of its order. 

‘‘(d) The Executive Director shall prescribe regulations to carry 

out subsection (a).’’. 

(b) TECHNICAL AND CONFORMING AMENDMENT.—The table of 

sections for chapter 84 of title 5, United States Code, is amended 

by inserting after the item relating to section 8479 the following: 

‘‘8480. Subpoena authority.’’. 

SEC. 108. AMOUNTS IN THRIFT SAVINGS FUNDS SUBJECT TO LEGAL 

PROCEEDINGS. 

Section 8437(e)(3) of title 5, United States Code, is amended 

in the first sentence by striking ‘‘or relating to the enforcement 

of a judgment for the physically, sexually, or emotionally abusing 

a child as provided under section 8467(a)’’ and inserting ‘‘the 

enforcement of an order for restitution under section 3663A of 

title 18, forfeiture under section 8432(g)(5) of this title, or an obligation of the Executive Director to make a payment to another person 

under section 8467 of this title’’. 

SEC. 109. ACCOUNTS FOR SURVIVING SPOUSES. 

Section 8433(e) of title 5, United States Code, is amended— 

(1) by inserting ‘‘(1)’’ after ‘‘(e)’’; and 

(2) by adding at the end the following: 

‘‘(2) Notwithstanding section 8424(d), if an employee, Member, 

former employee, or former Member dies and has designated as 
H. R. 1256—82 

sole or partial beneficiary his or her spouse at the time of death, 

or, if an employee, Member, former employee, or former Member, 

dies with no designated beneficiary and is survived by a spouse, 

the spouse may maintain the portion of the employee’s or Member’s 

account to which the spouse is entitled in accordance with the 

following terms: 

‘‘(A) Subject to the limitations of subparagraph (B), the 

spouse shall have the same withdrawal options under subsection (b) as the employee or Member were the employee 

or Member living. 

‘‘(B) The spouse may not make withdrawals under subsection (g) or (h). 

‘‘(C) The spouse may not make contributions or transfers 

to the account. 

‘‘(D) The account shall be disbursed upon the death of 

the surviving spouse. A beneficiary or surviving spouse of a 

deceased spouse who has inherited an account is ineligible 

to maintain the inherited spousal account. 

‘‘(3) The Executive Director shall prescribe regulations to carry 

out this subsection.’’. 

SEC. 110. TREATMENT OF MEMBERS OF THE UNIFORMED SERVICES 

UNDER THE THRIFT SAVINGS PLAN. 

(a) SENSE OF CONGRESS.—It is the sense of Congress that— 

(1) members of the uniformed services should have a retirement system that is at least as generous as the one which 

is available to Federal civilian employees; and 

(2) Federal civilian employees receive matching contributions from their employing agencies for their contributions to 

the Thrift Savings Fund, but the costs of requiring such a 

matching contribution from the Department of Defense could 

be significant. 

(b) REPORTING REQUIREMENT.—Not later than 180 days after 

the date of the enactment of this Act, the Secretary of Defense 

shall report to Congress on— 

(1) the cost to the Department of Defense of providing 

a matching payment with respect to contributions made to 

the Thrift Savings Fund by members of the Armed Forces; 

(2) the effect that requiring such a matching payment 

would have on recruitment and retention; and 

(3) any other information that the Secretary of Defense 

considers appropriate. 

TITLE II—SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR SURVIVING 

SPOUSES OF ARMED FORCES MEMBERS 

SEC. 201. INCREASE IN MONTHLY AMOUNT OF SPECIAL SURVIVOR 

INDEMNITY ALLOWANCE FOR WIDOWS AND WIDOWERS OF 

DECEASED MEMBERS OF THE ARMED FORCES AFFECTED 

BY REQUIRED SURVIVOR BENEFIT PLAN ANNUITY OFFSET 

FOR DEPENDENCY AND INDEMNITY COMPENSATION. 

(a) PAYMENT AMOUNT PER FISCAL YEAR.—Paragraph (2) of 

section 1450(m) of title 10, United States Code, is amended— 
H. R. 1256—83 

(1) in subparagraph (E), by striking ‘‘and’’ after the semicolon; and 

(2) by striking subparagraph (F) and inserting the following 

new subparagraphs: 

‘‘(F) for months during fiscal year 2014, $150; 

‘‘(G) for months during fiscal year 2015, $200; 

‘‘(H) for months during fiscal year 2016, $275; and 

‘‘(I) for months during fiscal year 2017, $310.’’. 

(b) DURATION.—Paragraph (6) of such section is amended— 

(1) by striking ‘‘February 28, 2016’’ and inserting ‘‘September 30, 2017’’; and 

(2) by striking ‘‘March 1, 2016’’ both places it appears 

and inserting ‘‘October 1, 2017’’. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.