79–006 

111TH CONGRESS REPT. 111–58 " ! HOUSE OF REPRESENTATIVES 1st Session Part 1 

FAMILY SMOKING PREVENTION AND TOBACCO CONTROL 

ACT 

MARCH 26, 2009.—Ordered to be printed 

Mr. WAXMAN, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

together with 

DISSENTING AND ADDITIONAL DISSENTING VIEWS 

[To accompany H.R. 1256] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 1256) to protect the public health by providing the 

Food and Drug Administration with certain authority to regulate 

tobacco products, having considered the same, report favorably 

thereon without amendment and recommend that the bill do pass. 

CONTENTS 

Page 

Purpose and Summary ............................................................................................ 2 

Background and Need for Legislation .................................................................... 2 

Hearings ................................................................................................................... 4 

Committee Consideration ........................................................................................ 4 

Committee Votes ...................................................................................................... 5 

Committee Oversight Findings ............................................................................... 14 

Statement of General Performance Goals and Objectives .................................... 14 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 14 

Earmarks and Tax and Tariff Benefits .................................................................. 14 

Committee Cost Estimate ....................................................................................... 14 

Congressional Budget Office Estimate ................................................................... 14 

Federal Mandates Statement ................................................................................. 27 

Advisory Committee Statement .............................................................................. 27 

Constitutional Authority Statement ...................................................................... 27 

Applicability to Legislative Branch ........................................................................ 27 

Exchange of Committee Letters ............................................................................. 28 

Section-by-Section Analysis of the Legislation ...................................................... 32 

Changes in Existing Law Made by the Bill, as Reported ..................................... 57 


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Dissenting and Additional Dissenting Views..................................................... 127, 133 

PURPOSE AND SUMMARY

The purpose of H.R. 1256, the ‘‘Family Smoking Prevention and 

Tobacco Control Act’’, is to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to grant the Food and Drug Administration 

(FDA) the authority to regulate tobacco products. 

H.R. 1256 allows the Secretary to restrict the sale and distribution of tobacco products, including advertising and promotion, if the 

Secretary determines that such regulation would be appropriate for 

the protection of the public health. The legislation also allows the 

Secretary to take specified actions, including public notification and 

recall, against unreasonably harmful products. 

H.R. 1256 requires the Secretary to establish tobacco product 

standards to protect the public health, but prohibits the Secretary 

from banning a class of tobacco products, such as all cigarettes, or 

reducing the nicotine level to zero. The legislation sets forth standards for the sale of modified-risk tobacco products and prohibits 

cigarettes from containing, as a characterizing flavor, any artificial 

or natural flavor (other than tobacco or menthol). 

H.R. 1256 sets forth provisions regarding: (1) judicial review, (2) 

coordination with the Federal Trade Commission, (3) congressional 

review of regulations, and (4) state and local authority. The legislation also requires the Secretary to establish a Tobacco Products 

Scientific Advisory Committee. 

H.R. 1256 amends the Federal Cigarette Labeling and Advertising Act to change cigarette warning label and advertising requirements. In addition, the legislation amends the Comprehensive 

Smokeless Tobacco Health Education Act of 1986 to change smokeless tobacco warning label and advertising requirements. 

BACKGROUND AND NEED FOR LEGISLATION

The prevalence of tobacco use and its toll on human lives has 

long been a public health concern. The Centers for Disease Control 

and Prevention (CDC) estimates that 19.8% of U.S. adults (approximately 43 million people) are cigarette smokers. Current trends 

suggest that the annual rate of cessation among smokers remains 

fairly low, that the decline in the initiation rate may have slowed, 

and that overall adult prevalence may be flattening out at around 

20%. In addition to the prevalence of tobacco use in the adult population, CDC estimates that 20% of U.S. high school students are 

cigarette smokers. 

Cigarette smoking is the leading preventable cause of death in 

the United States. It is responsible for about 1 in 5 deaths annually, or more than 400,000 deaths per year according to CDC. According to the Institute of Medicine, smoking-related deaths account for more deaths than AIDS, alcohol, cocaine, heroin, homicide, suicide, motor vehicle crashes, and fires combined. Smoking 

harms nearly every organ of the body, causing many diseases and 

reducing the health of smokers in general. Cancer, the second leading cause of death, was among the first diseases causally linked to 

smoking. Approximately 8.6 million Americans suffer from chronic 

illnesses related to smoking. Smoking also increases the prevalence 

of cardiovascular and respiratory disease. Smokeless tobacco use 


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also has negatively affected the health of many Americans. According to the National Cancer Institute, smokeless tobacco contains 28 

carcinogens and consumers of smokeless tobacco products increase 

their risk for certain cancers, including oral cancer. 

In addition to the lives lost to tobacco, the financial losses 

amount to billions of dollars each year. CDC estimates that cigarette smoking costs more than $193 billion annually, based on lost 

productivity ($97 billion) and healthcare expenditures ($96 billion). 

The Food and Drug Administration made its first attempt to address the harm caused by tobacco use in 1996. On August 28, 1996, 

FDA asserted jurisdiction over tobacco products under the authority of the Federal Food, Drug, and Cosmetic Act (FFDCA) and 

issued a final rule aimed at reducing underage smoking and use of 

smokeless tobacco products. The tobacco industry challenged this 

rule in court, claiming that FDA had exceeded its authority. A resulting Supreme Court decision in 2000, while acknowledging that 

tobacco use posed ‘‘perhaps the single most significant threat to 

public health in the United States,’’ found that Congress had not 

given FDA authority over tobacco products as part of the FFDCA. 

H.R. 1256 gives FDA explicit authority over tobacco products in 

a new chapter of the FFDCA relating solely to tobacco and authorizes FDA to regulate tobacco products ‘‘as appropriate for the protection of the public health.’’ This new standard is more appropriate for inherently dangerous tobacco products than the standards of ‘‘safe’’ or ‘‘safe and effective,’’ which apply to other FDA-regulated products. 

Almost 80% of new users of tobacco products began when they 

were under the minimum legal age to purchase them. The use of 

tobacco products by the nation’s children is a pediatric disease of 

considerable proportions that results in new generations of tobaccodependent children. Every day, approximately 3,500 youth try a 

cigarette for the first time, and another 1,000 will become new, regular daily smokers. One-third of these youth will eventually die 

prematurely as a result. Tobacco advertising and marketing contribute significantly to the use of tobacco products by children and 

adolescents, who are more influenced by tobacco marketing than 

adults, and are exposed to substantial and unavoidable advertising 

that leads to favorable attitudes about tobacco use. Past efforts to 

restrict the advertising and marketing of tobacco products to youth 

have failed to adequately curb tobacco use by adolescents. H.R. 

1256 provides FDA with the authority it needs to promulgate comprehensive restrictions on the sale, promotion, and distribution of 

tobacco products, actions that most public health experts agree can 

significantly reduce the number of people who start to use tobacco 

and significantly increase the number of people who quit using tobacco. 

H.R. 1256 also grants FDA the authority to strictly regulate socalled ‘‘reduced harm’’ products and to prohibit unproven health 

claims by tobacco product manufacturers. This legislation prohibits 

the use of descriptors such as ‘‘light,’’ ‘‘mild,’’ and ‘‘low’’ to characterize the level of a substance in a product in labels or in advertising. As the National Cancer Institute found, these descriptors 

have led consumers to believe mistakenly that the products are less 

harmful than other tobacco products. The National Cancer InstiVerDate Nov 24 2008 05:06 Mar 28, 2009 Jkt 079006 PO 00000 Frm 00003 Fmt 6659 Sfmt 6602 E:\HR\OC\HR058P1.XXX HR058P1

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tute also found that these mistaken beliefs can reduce the motivation to quit smoking. 

The current lack of government regulation has allowed the tobacco industry to design new products or modify existing ones in 

ways that increase their appeal to children and that contribute to 

the risk and incidence of disease. Flavors and product modification 

not only make the products more appealing to youth, but often result in exposure to additional carcinogens and other toxic constituents. The manipulation of nicotine and other chemical levels increases addictiveness and harm. H.R. 1256 grants FDA the authority to require product changes in current and future tobacco products, such as the reduction or elimination of ingredients, additives, 

and constituents (including smoke constituents). In addition, H.R. 

1256 requires manufacturers to provide detailed disclosure of ingredients, nicotine levels, and harmful smoke constituents. 

The current Surgeon General warnings on tobacco products are 

ineffective in providing adequate warnings about the dangers of tobacco products. This legislation requires stronger and more specific 

health warnings immediately upon enactment and gives FDA the 

authority to enlarge them further and to incorporate color graphics. 

For too long, the tobacco industry in the United States has escaped the type of ordinary product regulation that applies to most 

other consumer products. This legislation levels the playing field 

with respect to tobacco products so that public health may be protected and improved. 

HEARINGS

In the 110th Congress, the Subcommittee on Health held a legislative hearing on H.R. 1108, legislation similar to H.R. 1256, on 

October 3, 2007 (Printed Hearing 110–69). The Subcommittee 

heard from two panels of witnesses and experts. The first panel 

consisted of Fred Jacobs, M.D., J.D., Commissioner, New Jersey 

Department of Health and Senior Services; and Richard J. Bonnie, 

L.L.B., John S. Battle Professor of Law and Director, Institute of 

Law, Psychiatry and Public Policy, University of Virginia, Chair, 

Committee on Reducing Tobacco Use: Strategies, Barriers, and 

Consequences, Institute of Medicine. The second panel consisted of 

Risa Lavizzo-Mourey, M.D., M.B.A., President and CEO, Robert 

Wood Johnson Foundation; Scott Ballin, J.D., Steering Committee 

Member, Alliance for Health Economic and Agricultural Development; Mr. James Winkler, General Board of Church and Society, 

United Methodist Church; Mr. Henry Armour, President and CEO, 

National Association of Convenience Stores; Alan Blum, M.D., Professor, Wallace Endowed Chair, Director, Center for the Study of 

Tobacco and Society, College of Community Health Sciences, The 

University of Alabama; William Corr, Executive Director, Campaign for Tobacco Free Kids; and Jack E. Henningfield, Ph.D., Vice 

President, Research and Health Policy Pinney Associates. There 

were no legislative hearings held in the 111th Congress. 

COMMITTEE CONSIDERATION

H.R. 1256 was introduced on March 3, 2009, by Rep. Henry A. 

Waxman (D–CA) along with 124 original cosponsors. The bill was 

referred to the Subcommittee on Health on March 3, 2009, but 


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later discharged by the full Committee. On Wednesday, March 4, 

2009, the full Committee convened in open markup session and ordered H.R. 1256 favorably reported to the House by a record vote. 

Amendments offered during consideration of the bill were either 

defeated or withdrawn. 

COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the record votes on the motion 

to report legislation and amendments thereto. A motion by Mr. 

Waxman to order H.R. 1256 favorably reported to the House was 

agreed to by a record vote of 39 yeas and 13 nays. The following 

are the recorded votes taken on the motion and amendments, including the names of those members voting for and against: 


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STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

The objectives of H.R. 1256 are to provide the Secretary with the 

proper authority over tobacco products in order to protect the public health and to reduce the number of individuals under 18 years 

of age who use tobacco products. 

COMMITTEE OVERSIGHT FINDINGS

Regarding clause 3(c)(1) of rule XIII of the Rules of the House 

of Representatives, the Subcommittee on Health held a hearing in 

the 110th Congress on H.R. 1108 (Serial No. 110–69), legislation 

similar to H.R. 1256, and the oversight findings of the Committee 

regarding the bill are reflected in this report. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

Regarding compliance with clause 3(c)(2) of rule XIII of the Rules 

of the House of Representatives, the Committee adopts as its own 

the estimate of budget authority and revenues regarding H.R. 1256 

prepared by the Director of the Congressional Budget Office pursuant to section 402 of the Congressional Budget Act of 1974. The 

Committee finds that H.R. 1256 would result in no new or increased entitlement authority or tax expenditures. 

EARMARKS AND TAX AND TARIFF BENEFITS

Regarding compliance with clause 9 of rule XXI of the Rules of 

the House of Representatives, H.R. 1256 does not contain any congressional earmarks, limited tax benefits, or limited tariff benefits 

as defined in clause 9(d), 9(e), or 9(f) of rule XXI. 

COMMITTEE COST ESTIMATE

The Committee adopts as its own the cost estimate on H.R. 1256 

prepared by the Director of the Congressional Budget Office pursuant to section 402 of the Congressional Budget Act of 1974. 

CONGRESSIONAL BUDGET OFFICE ESTIMATE

Pursuant to clause 3(c)(3) of rule XIII of the Rules of the House 

of Representatives, the following is the cost estimate on H.R. 1256 

provided by the Congressional Budget Office pursuant to section 

402 of the Congressional Budget Act of 1974: 

U.S. CONGRESS, CONGRESSIONAL BUDGET OFFICE, Washington, DC, March 16, 2009. 

Hon. HENRY A. WAXMAN, 

Chairman, Committee on Energy and Commerce, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed estimate for H.R. 1256, the Family Smoking 

Prevention and Tobacco Control Act. 


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If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Julia Christensen. 

Sincerely, 

DOUGLAS W. ELMENDORF, 

Director. 

Enclosure. 

H.R. 1256—Family Smoking Prevention and Tobacco Control Act 

Summary: H.R. 1256 would authorize the Food and Drug Administration (FDA) to regulate tobacco products, and would require the 

agency to assess fees on manufacturers and importers of tobacco 

products to cover the cost of FDA’s new regulatory activities authorized by the bill. Such fees could be collected and made available for obligation only to the extent and in the amounts provided 

in advance in appropriation acts. The bill also contains provisions 

that affect direct spending and revenues associated with the retirement benefits of federal employees. 

CBO estimates that: 

• Implementing the bill would increase spending subject to appropriation, on net, by about $0.1 billion over the 2010–2014 period 

and by $0.8 billion over the 2010–2019 period, assuming annual 

appropriation actions consistent with the bill. 

• Enacting H.R. 1256 would increase direct spending by $0.1 billion over the 2010–2014 period and by $0.5 billion over the 2010– 

2019 period. 

• Federal revenues would increase by $0.3 billion over the 2010– 

2014 period and by $1.3 billion over the 2010–2019 period. 

• Considering both the revenue and direct spending effects, enacting the bill would reduce budget deficits by a total of $0.2 billion 

over the 2010–2014 period and by $0.8 billion over the 2010–2019 

period. (Those amounts exclude the effects that are subject to appropriation action.) 

The legislation’s effects on direct spending and revenues over the 

2009–2013 and 2009–2018 periods are relevant for enforcing payas-you-go rules under the current budget resolution. CBO estimates 

that enacting H.R. 1256 would increase direct spending by $0.1 billion over the 2009–2013 period and by $0.4 billion over the 2009– 

2018 period. Enacting the bill also would increase revenues by $0.2 

billion over the 2009–2013 period and by $1.0 billion over the 

2009–2018 period. Together, those changes would yield net pay-asyou-go savings of $0.1 billion over five years and $0.6 billion over 

10 years. 

H.R. 1256 contains intergovernmental mandates as defined in 

the Unfunded Mandates Reform Act (UMRA) because it would preempt certain state laws governing tobacco products and require 

tribal governments that manufacture or distribute tobacco products 

to comply with new federal regulations. CBO estimates that the 

costs to state, local, and tribal governments to comply with the 

mandates in the bill would not exceed the threshold established in 

UMRA ($69 million in 2009, adjusted annually for inflation). 

CBO also expects that the federal regulations authorized by this 

bill would result in lower consumption of tobacco products and thus 

would reduce the amount of tax revenues and settlement funds collected by state and local governments. However, those declines in 


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revenues, estimated to total over $1 billion during the 2010–2014 

period, would not result from intergovernmental mandates. 

H.R 1256 would impose a number of mandates on private-sector 

entities. Among other things, the bill would assess a fee on companies that manufacture or import tobacco products, impose new restrictions on the sale, distribution and marketing of tobacco products, mandate disclosure of product information and grant FDA authority to regulate tobacco products. CBO estimates that the aggregate direct cost of complying with those mandates would exceed the 

threshold established by UMRA for private-sector mandates ($139 

million in 2009, adjusted annually for inflation) in each year, beginning with 2010. 

Estimated cost to the Federal Government: The estimated budgetary impact of H.R. 1256 is shown in the following table. The costs 

of this legislation fall primarily within budget functions 550 

(health) and 600 (income security). 


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By fiscal year, in millions of dollars— 

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2010–2014 2010–2019 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Food and Drug Administration (FDA) Collection of New Tobacco Fees: 

Authorization Level ................................................................................................ ¥235 ¥450 ¥477 ¥505 ¥534 ¥566 ¥599 ¥635 ¥672 ¥712 ¥2,201 ¥5,385 

Estimated Outlays ................................................................................................. ¥235 ¥450 ¥477 ¥505 ¥534 ¥566 ¥599 ¥635 ¥672 ¥712 ¥2,201 ¥5,385 

Spending of Fees by FDA to Regulate Tobacco Products: 

Authorization Level ................................................................................................ 235 450 477 505 534 566 599 635 672 712 2,201 5,385 Estimated Outlays ................................................................................................. 50 275 498 610 619 627 629 631 668 708 2,052 5,315 

Net Effect on FDA Spending: 

Authorization Level ................................................................................................ 0 0 0 0 0 0 0 0 0 0 0 0 Estimated Outlays ................................................................................................. ¥185 ¥175 21 105 85 61 30 ¥4 ¥4 ¥4 ¥149 ¥70 

Thrift Savings Plan Enhancement: 

Estimated Authorization Level ............................................................................... 14 49 62 76 89 102 112 121 130 139 290 894 Estimated Outlays ................................................................................................. 13 47 62 75 88 101 111 121 130 139 285 887 Total Changes: 1

Estimated Authorization Level ..................................................................... 14 49 62 76 89 102 112 121 130 139 290 894 

Estimated Outlays ........................................................................................ ¥172 ¥128 83 180 173 162 141 117 126 135 136 817 

CHANGES IN DIRECT SPENDING 

Sick Leave Retirement Credit: 

Estimated Budget Authority .................................................................................. 8 17 27 37 48 60 72 86 100 114 137 569 Estimated Outlays ................................................................................................. 8 17 27 37 48 60 72 86 100 114 137 569 

Medicaid: Tobacco Provisions: 

Estimated Budget Authority .................................................................................. ¥1 ¥2 ¥4 ¥6 ¥9 ¥11 ¥13 ¥15 ¥18 ¥20 ¥22 ¥99 

Estimated Outlays ................................................................................................. ¥1 ¥2 ¥4 ¥6 ¥9 ¥11 ¥13 ¥15 ¥18 ¥20 ¥22 ¥99 

Total Changes: Estimated Budget Authority .................................................................................. 7 15 23 31 39 49 59 71 82 94 115 470 Estimated Outlays ................................................................................................. 7 15 23 31 39 49 59 71 82 94 115 470 

CHANGES IN REVENUES 

Thrift Savings Plan Enhancement ................................................................................. 50 79 98 122 155 198 255 330 426 550 504 2,263 Tobacco Excise Taxes and Fines .................................................................................... ¥13 ¥29 ¥40 ¥55 ¥73 ¥94 ¥117 ¥145 ¥177 ¥212 ¥210 ¥955 

Total Changes in Revenues .................................................................................. 37 50 58 67 82 107 138 185 249 338 294 1,308 


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By fiscal year, in millions of dollars— 

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2010–2014 2010–2019 

NET IMPACT ON THE DEFICIT FROM CHANGES IN DIRECT SPENDING AND REVENUES 

Estimated Deficit Impact 2 ............................................................................................. ¥30 ¥35 ¥35 ¥36 ¥43 ¥55 ¥79 ¥114 ¥167 ¥244 ¥179 ¥838 

1 In addition, H.R. 1256 would require the Government Accountability Office to conduct a study on cross-border trade in tobacco products. CBO estimates that study would cost about $1 million, assuming the availability of appropriated 

funds. 2 Negative numbers indicate a reduction in the deficit. 


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Basis of estimate: For this estimate, CBO assumes that H.R. 

1256 will be enacted near the start of fiscal year 2010, that the full 

amounts authorized will be collected (starting in fiscal year 2010) 

to fund FDA’s regulatory activities authorized under the bill, and 

that outlays will follow historical patterns for similar activities. 

H.R. 1256 would authorize FDA to regulate tobacco products. 

Such authority would include: 

• Setting national standards for tobacco products, including 

a ban on cigarettes that contain certain additives or flavors 

(other than tobacco or menthol) that are a characterizing flavor 

of the tobacco product or tobacco smoke; 

• Implementing new restrictions on the sale, distribution, 

and marketing of tobacco products; 

• Requiring manufacturers of certain tobacco products to 

submit a marketing application to FDA and requiring manufacturers of certain products that are ‘‘substantially equivalent’’ to ones already on the market before a particular date to 

notify FDA by submitting a report with specified information 

before entering the market; 

• Directing manufacturers and importers of tobacco products 

to adhere to new labeling requirements and to submit specific 

information, including health-related research, to the FDA 

about their products; 

• Mandating the annual registration of all establishments 

that manufacturer, prepare, compound, or process tobacco 

products and specifying certain inspection, record-keeping and 

reporting requirements for manufacturers and importers; and 

• Enforcing compliance with requirements specified in the 

bill. 

H.R. 1256 would establish the Center for Tobacco Products within the FDA. It also would require FDA to reinstate certain regulations issued in 1996 intended to limit tobacco sales and marketing, 

especially to children. (The Supreme Court ruled in 2000 that the 

FDA did not have the authority to issue such regulations.) The bill 

explicitly would prohibit FDA from banning certain tobacco products or requiring the reduction of nicotine yields of tobacco products to zero. The legislation also would require FDA to issue new 

regulations relating to the testing and reporting of tobacco product 

information. (Such regulations could also include requirements for 

public disclosure of that information.) Among other things, H.R. 

1256 would require the Secretary of Health and Human Services 

(HHS) to publish a list of the amounts of harmful and potentially 

harmful constituents of each tobacco product. 

Use of tobacco products in the United States 

At least partly as a result of efforts by the federal government, 

state governments, and the public health community, cigarette 

smoking has declined substantially over the past decade: in 2005, 

about 21 percent of adults in the United States were smokers, compared to about 25 percent in 1995. The recent increase in the federal excise tax on cigarettes as a result of the Children’s Health Insurance Program Reauthorization Act (Public Law 111–3)—from 

$0.39 to $1.01 per pack—is likely to contribute to a continuing decline in smoking. CBO expects that consumption of tobacco prodVerDate Nov 24 2008 05:06 Mar 28, 2009 Jkt 079006 PO 00000 Frm 00019 Fmt 6659 Sfmt 6602 E:\HR\OC\HR058P1.XXX HR058P1

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1For example, pursuant to a timeline specified in the bill, descriptors on a tobacco product 

such as ‘‘low,’’ ‘‘light,’’ or ‘‘mild’’ would be prohibited and certain health-related claims not allowed unless manufacturers receive FDA’s permission to market the product with that claim. 

ucts in the United States would further decline as a result of enacting H.R. 1256. 

The effect of regulatory activities authorized under the bill on the 

use of tobacco products is uncertain because ongoing initiatives to 

reduce the use of tobacco products are expected to continue under 

current law. In particular, public heath efforts by federal, state, 

and local governments and by private entities have contributed to 

a substantial reduction in underage smoking in recent years. For 

example, the proportion of 17 year-olds who smoke declined from 

19 percent in 1995 to 10 percent in 2005. Significant efforts to reduce underage smoking (the group most directly targeted by many 

of the interventions envisioned under the bill) have been taken as 

a result of the Master Settlement Agreement (MSA) in 1998 between major tobacco manufacturers and settling states. States and 

localities also continue to pursue public health initiatives independent of the MSA to reduce smoking and to limit health risks to 

the public associated with smoking. (However, funding for such activities is subject to the fiscal constraints of state and local budgets.) Public health efforts funded by federal programs and coverage 

of smoking cessation therapies (including those offered under certain public programs) also aim to reduce the use of tobacco under 

current law. 

The expected impact of the legislation on the use of tobacco products stems from a combination of regulatory and economic factors. 

The regulatory changes with the largest potential to reduce smoking include: restricting access to tobacco by youths, requiring an increase in the size of warning labels on certain tobacco packaging 

(and authorizing the Secretary of HHS to mandate further changes 

to enhance warning labels), limiting certain marketing and advertising activities (especially those that target youths), and requiring 

FDA permission before manufacturers can market tobacco products 

that suggest reduced health risks or exposure to particular substances.1 In addition, tobacco consumption would decline because 

the assessment of new fees on manufacturers and importers of tobacco products would probably result in higher prices of tobacco 

products. 

Based on information from academic and other researchers, CBO 

estimates that H.R. 1256 would result in a further reduction in the 

number of underage tobacco users of 11 percent by 2019. CBO also 

estimates that implementing H.R. 1256 would lead to a further decline in smoking by adults by about 2 percent after 10 years. CBO 

has incorporated these projected changes in U.S. tobacco consumption into its estimates of the impact of the bill on Medicaid spending and on receipts from excise taxes on tobacco products. 

Spending Subject to Appropriation 

CBO estimates that implementing H.R. 1256 would increase spending subject to appropriation, on net, by $0.1 billion over the 

2010–2014 period and by $0.8 billion over the 2010–2019 period, 

assuming the appropriation action consistent with the bill. The effect on discretionary spending by federal programs reflects the authorized funding relating to the federal regulation of tobacco prodVerDate Nov 24 2008 05:06 Mar 28, 2009 Jkt 079006 PO 00000 Frm 00020 Fmt 6659 Sfmt 6602 E:\HR\OC\HR058P1.XXX HR058P1

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ucts and federal agency costs associated with changes to the Thrift 

Savings Plan (TSP) specified in the bill. 

The costs for FDA to administer the new regulatory activities au- thorized under the legislation—$2.1 billion over the 2010–2014 period and $5.3 billion over the 2010–2019 period—would be covered 

by fees assessed on manufacturers and importers of tobacco products, resulting in a very small net impact on discretionary spending 

over the next 10 years (and no net impact over time). CBO estimates that automatic enrollment, under the bill, of new TSP participants would increase the cost for federal civilian agencies relating to their matching contributions for employees. The estimated 

TSP costs would sum to $0.9 billion over the 2010–2019 period, assuming the appropriation of the necessary amounts. 

Collection of New Fees. H.R. 1256 would establish a program to 

assess fees to fund FDA’s administrative costs for new regulatory 

activities relating to tobacco products authorized by the bill. The 

legislation would authorize the quarterly assessment of fees on 

manufacturers and importers of such products. It would authorize 

the appropriation of assessments equal to $85 million in 2009, $235 

million in 2010, $450 million in 2011, $477 million in 2012, $505 

million in 2013, $534 million in 2014, $566 million in 2015, $599 

million in 2016, $635 million in 2017, $672 million in 2018, and 

$712 million in 2019 and each subsequent year. 

Fees authorized by the bill would be collected and made available 

for obligation only to the extent and in the amounts provided in advance in appropriation acts. As a result, those collections would be 

credited as an offset to discretionary spending. 

Spending of Fees by FDA to Regulate Tobacco Products. Spending of the new fees assessed by FDA to regulate tobacco products 

also would be classified as discretionary spending because the authorized amounts would be available for obligation subject to appropriation action. Amounts collected would be available to cover 

FDA’s administrative costs to regulate tobacco products at any 

point in the future. 

Given the uncertainty surrounding how the FDA would implement such a large expansion of its regulatory activities, it is difficult to estimate the resources necessary—particularly in the early 

years—to implement the bill. We anticipate that, over the initial 

five-year period after enactment, FDA would actively develop the 

necessary infrastructure to operate the new tobacco program and 

that its ability to enter into obligations and disburse funds would 

grow rapidly. The legislation would limit the budget for the new 

program to the aggregate amount of fees collected for such purpose, 

and there would likely be some lag (at least initially) between 

when fees are collected and when they are spent. 

Assuming appropriation action consistent with the bill, CBO estimates that implementing the program to assess fees to cover new 

FDA costs associated with regulating tobacco would reduce net discretionary outlays by $149 million over the 2010–2014 period and 

by $70 million over the 2010–2019 period, because the spending of 

fees would lag behind their collection. 

Thrift Savings Plan. The bill would require that newly hired federal employees who are eligible for the TSP be automatically enrolled in that program. The automatic enrollment of participants in 

TSP would increase the matching contributions of the civilian 


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agencies that employ them (which are paid from personnel budgets 

and are usually considered spending subject to appropriation) by 

creating a greater and earlier participation rate of employees in the 

program. According to data from a 2006 survey conducted by the 

Federal Thrift Retirement Investment Board, 52 percent of employees enrolled in the Federal Employees Retirement System voluntarily contribute to the TSP in their first year of eligibility, but 86 

percent contribute by their sixth year. (Although federal employees 

covered by the Civil Service Retirement System are also eligible to 

participate in the TSP, they would not be affected by automatic enrollment.) Using information from that survey, CBO expects that 

under automatic enrollment more than 90 percent of eligible new 

entrants would contribute to the TSP in their first year and that 

a similar proportion would continue to contribute by their 10th 

year (some would opt out in the beginning and others would likely 

change their status in the future). 

For the uniformed services, the characteristics of potential participants differ. The current average rate for voluntary participation of new enlistees is approximately 25 percent, and unlike civilian employees, the uniformed services do not currently contribute 

on behalf of their members. Based on lower voluntary enrollment 

rates and the lack of agency contributions, CBO expects that under 

automatic enrollment more than 40 percent of eligible new entrants 

would contribute. 

Assuming that the bill becomes effective in October 2009 and 

that civilian agencies would not begin matching contributions for 

an additional six months, participants would receive an increase in 

matching agency contributions of 3 percent of their basic pay for 

the third quarter of fiscal year 2010 and 3 percent per year thereafter. CBO estimates that enacting H.R. 1256 would increase agency contributions by nearly $0.9 billion over the 2010–2019 period. 

Federal Trade Commission (FTC). The bill would authorize the 

FTC to enforce provisions in the bill relating to advertising that 

would be considered unfair or deceptive trade practices under the 

Federal Trade Commission Act. Currently, the FTC enforces certain laws governing warnings printed on labels of cigarettes and 

smokeless tobacco, among other things. Based on information from 

the FTC, CBO expects that the FTC’s new enforcement activities 

under H.R. 1256 would replace some of its current enforcement activities that would be transferred to FDA under the bill. CBO estimates that any additional costs to the FTC would be insignificant. 

Other Provisions. H.R. 1256 would require the Government Accountability Office to conduct a study on cross-border trade in tobacco products. CBO estimates that conducting such studies would 

cost about $1 million, assuming the availability of the necessary 

funds. CBO also anticipates that any additional costs for other federal agencies that might assist FDA with implementing certain requirements relating to the regulation of tobacco specified in the bill 

would not be significant. 

Direct Spending 

CBO estimates that enacting H.R. 1256 would increase direct 

spending, on net, by $0.1 billion over the 2010–2014 period and by 

$0.5 billion over the 2010–2019 period. That estimate reflects two 

effects of the bill: 


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• Authorizing FDA regulation of tobacco products and 

changes relating to such products required by the bill would 

lower consumption of tobacco and would generate savings to 

the Medicaid program, and • Changing the calculation of federal retirement benefits 

under the Federal Employees Retirement System to reflect accrued sick leave hours would raise average retirement benefits 

paid to individuals. 

Impact of FDA Regulation of Tobacco on Medicaid. CBO anticipates that FDA’s regulation of tobacco products will lead to a decline in smoking among pregnant women. That decline will reduce 

health care spending on pregnancies because women who refrain 

from smoking during pregnancy are less likely to give birth to children with low birth weights—such children have relatively high 

costs both at birth and afterwards—or experience other complications during pregnancy. Part of the savings from reduced complications is offset by costs associated with the additional live births resulting from a decline in miscarriages. CBO estimates federal 

spending for Medicaid would decrease by $0.1 billion over the 

2010–2019 period. (That savings is an estimated increment above 

savings previously estimated and credited to Public Law 111–3, 

which contains an increase in federal excise taxes on tobacco products.) 

A decline in smoking could affect health care spending for many 

other medical conditions. An individual who stops smoking is less 

likely to suffer a heart attack or stroke over a given period of time 

compared to one who continues to smoke, so a potential reduction 

in utilization of acute care services for those or other conditions 

could lead to cost savings. The magnitude and timing of such savings are uncertain, however. Also, a reduction in smoking may add 

to costs in many cases by increasing the lifespans of persons who 

would incur health care costs over longer periods. In those cases, 

government spending for other benefits such as Social Security, 

Medicare, and from other retirement and mandatory spending programs would also increase. CBO continues to examine the impact 

of smoking related legislation on public and private payers. This 

cost estimate does not include potential effects on federal spending 

other than the estimated impact on Medicaid of reduced smoking 

levels on pregnancies. 

Retirement Credit for Sick Leave. Currently, the retirement benefit calculation for federal employees in FERS does not incorporate 

any accrued sick leave hours. Under H.R. 1256, eligible federal employees who retire after enactment would add 100 percent of their 

remaining sick leave hours to their total years of service when calculating the retirement benefit owed. CBO estimates that an average of about three months would be added to employees’ length of 

service as a result of including sick leave hours. That addition is 

estimated to boost the average retirement benefit by about $150 

per year, increasing direct spending over the 2010–2019 period by 

$0.6 billion. 

Other Effects on Direct Spending. Under H.R. 1256, FDA would 

have the discretion to impose criminal fines on entities convicted 

of violating certain new requirements established by the bill. Collections of criminal fines are recorded in the budget as revenues, 

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penditures are classified as direct spending. CBO expects that relatively few cases would result in such criminal fines. Therefore, 

CBO estimates that enacting H.R. 1256 would not have a significant effect on revenues or direct spending from the collection of 

criminal fines over the 2010–2019 period. 

Revenues 

CBO estimates that enacting H.R. 1256 would increase federal revenues, on net, by $0.3 billion over the 2010–2014 period and by 

$1.3 billion over the 2010–2019 period. That estimate primarily reflects two effects of the bill: • Authorizing FDA oversight of tobacco products and 

changes relating to such products required by the bill would 

lower consumption of tobacco and reduce receipts of federal excise taxes on those products, and • Establishing a Roth contribution program would increase 

tax revenues because of the tax treatment of employee’s contributions. 

In addition, revenues may increase slightly from the collection of 

fines associated with violations of new requirements imposed by 

the bill. 

Excise Taxes. As noted earlier, CBO expects that enacting H.R. 

1256 would reduce the consumption of tobacco products in the 

United States, which in turn would reduce the collection of federal 

excise taxes. As a result, CBO estimates that the legislation would 

reduce federal revenues, by $0.2 billion over the 2010–2014 period 

and $1.0 billion over the 2010–2019 period, net of changes to income and payroll taxes. Over the 10–year period, the reduction in 

receipts would amount to less than 1 percent of receipts from excise 

taxes on tobacco expected under current law. 

Effects of TSP Changes on Revenues. Enacting H.R. 1256 would increase revenues by an estimated $2.3 billion over the 2010–2019 

period. Establishing a Roth contribution program (in which contributions to the retirement accounts would be made on an aftertax basis) would result in some TSP participants electing to contribute after-tax income to their retirement plan rather than contributing pre-tax amounts, thereby boosting income tax revenues 

by an estimated $3.3 billion over the 10–year period. However, because income taxes are deferred on regular TSP contributions, the 

anticipated increase in participants’ contributions from automatic 

enrollment would offset part of the revenue increase, reducing receipts by $1.0 billion over the 2010–2019 period. 

Collection of Fines. The effects on federal revenues also include 

relatively small effects from provisions that would allow the Secretary of HHS to levy fines against sponsors of misbranded and 

adulterated tobacco products, sellers of tobacco to underage individuals, and for other violations. The FTC would also be authorized 

to assess fines for certain violations of tobacco-related requirements 

enforced by the commission. We estimate that revenues associated 

with the collection of civil fines authorized under H.R. 1256 would 

be roughly $1 million annually. 

Estimated impact on state, local, and tribal governments: H.R. 

1256 contains intergovernmental mandates as defined in UMRA. 

CBO estimates that the costs of those mandates to state, local, and 

tribal governments would be small and would not exceed the 


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threshold established in UMRA ($69 million in 2009, adjusted annually for inflation). 

The bill would preempt state laws governing tobacco products 

that are different from or in addition to the federal regulations authorized by the bill, including laws governing: • Product standards • Premarket review • Adulteration • Misbranding • Labeling • Registration • Good manufacturing standards, or • Modified-risk tobacco products. 

That preemption would be an intergovernmental mandate as defined in UMRA. However, because the preemption would simply 

limit the application of state and local laws, CBO estimates that 

it would not impose significant costs on state or local governments. 

H.R. 1256 would require tobacco manufacturers to register annually with the FDA and pay fees assessed by the agency. The bill 

would require both tobacco manufacturers and distributors of tobacco products to comply with federal regulations relating to the 

content, labeling, and marketing of tobacco products. CBO has 

identified two tribal governments that manufacture and distribute 

tobacco products. Because those governments would be required to 

comply with federal regulations authorized by the bill, they would 

face intergovernmental mandates as defined in UMRA. Based on 

information from tribal and federal officials, CBO estimates that 

the costs to tribal governments to comply with the bill would be 

small and would not exceed the UMRA threshold for intergovernmental mandates. 

Other impacts 

CBO also estimates that the amount of tax revenues and settlement funds collected by state and local governments would decline 

as a result of the federal regulations authorized by this bill because 

of lower consumption of tobacco products. However, those declines 

in revenues, estimated to total over $1 billion during the 2010– 

2014 period, would not result from intergovernmental mandates. 

Rather, the decline in revenues would be an indirect effect on state 

and local governments resulting from the new federal regulations 

imposed on companies that manufacture or import tobacco products. 

In 2008, state and local governments collected about $19 billion 

in revenues from excise and general sales taxes levied on tobacco 

products. CBO estimates that this bill would lower consumption of 

those products and that excise taxes collected by state and local 

governments would fall by about $20 million in 2010, with that reduction growing to over $330 million in 2014. Similarly, CBO estimates that state and local governments would see a decline in 

sales-tax revenues of about $170 million over the 2010–2014 period. 

Forty-six states, the District of Columbia, and five U.S. territories receive annual payments from tobacco manufacturers that 

are parties to the tobacco Master Settlement Agreement (MSA). In 

2008, those payments totaled over $8 billion. Under the terms of 


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the MSA, those payments are adjusted annually to account for 

changes in the volume of cigarette sales in the United States of 

participating manufacturers. Because CBO estimates that enacting 

this legislation would result in lower consumption of tobacco products, CBO estimates that the annual payments to states under the 

MSA also would decline by over $160 million over the 2010–2014 

period. 

A decline in smoking among pregnant individuals is expected to 

result in a reduction of low-weight births. As a result, state spending for Medicaid would decrease by an estimated $17 million over 

the 2010–2014 period, with additional savings in subsequent years. 

Estimated impact on the private sector: H.R. 1256 would impose 

a number of private-sector mandates, as defined in UMRA, on companies that manufacture or import tobacco products. CBO estimates that the total direct cost of these mandates would exceed the 

threshold established by UMRA ($139 million in 2009, adjusted annually for inflation) in each year, beginning with 2010. The bill 

would assess a fee on manufacturers and importers of tobacco products to cover the cost to FDA of regulating those products. The aggregate payments would sum to $235 million in 2010, and rise to 

more than $500 million a year by 2013. 

The bill would impose new requirements related to the labeling 

and advertising of cigarette and smokeless tobacco products. New 

warnings on packaging and advertisements would have to be larger. The bill would also prohibit cigarettes or any of their component 

parts from containing certain additives or flavors (other than tobacco or menthol) that are a characterizing flavor of the tobacco 

product or tobacco smoke. CBO has not been able to determine 

whether the direct cost of these provisions would be significant. 

The bill would require that FDA publish a final rule on tobacco 

products that would be similar to part 897 of the tobacco regulations promulgated by the Secretary of HHS in 1996 and subsequently invalidated by the Supreme Court. Certain restrictions 

that would be in that rule already exist under current federal and 

state law or are included in the 1998 Master Settlement Agreement 

between major tobacco manufacturers and settling states. As a result, and based on information from industry sources, CBO estimates that the incremental direct cost of these restrictions to manufacturers and importers of tobacco products would be small. 

In addition, the bill would give FDA the authority to regulate the 

sale, distribution, advertising, promotion and use of tobacco products if such actions would be in the interest of the public health. 

FDA would also have the authority to set product standards that 

reduce quantities of nicotine and other harmful constituents allowed in tobacco products or otherwise alter the composition and 

testing of such products. CBO cannot estimate the potential cost of 

these provisions because the cost would depend on future actions 

by the Secretary of HHS. 

Finally, the bill would require companies that manufacture or 

import tobacco products to disclose information about those products to the Secretary of HHS. That information, among other 

things, would include a listing of all ingredients and additives, a 

description of nicotine content, delivery, and form, and a listing of 

all potentially harmful constituents found in the tobacco product. 

At the discretion of the Secretary of HHS, those companies would 


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also be required to disclose any and all documents regarding research on risks to health of tobacco products, methods for reducing 

those risks, and the effectiveness of marketing practices used by 

companies that manufacture or distribute tobacco products. Such 

information would include both research activities and the findings 

associated with that research. CBO estimates that the direct cost 

of complying with these requirements would be small. 

Estimate prepared by: Federal Spending: Food and Drug Administration—Julia Christensen, Medicaid—Ellen Werble and Colin 

Baker, Federal Retirement—Amber Marcellino, Thrift Savings 

Plan—Jared Brewster, Federal Trade Commission—Susan Willie; 

Federal Revenues: Grant Driessen and Barbara Edwards; Impact 

on State, Local, and Tribal Governments: Lisa Ramirez-Branum; 

Impact on the Private Sector: Patrick Bernhardt. 

Estimate approved by: Peter H. Fontaine, Assistant Director for 

Budget Analysis. 

FEDERAL MANDATES STATEMENT

The Committee adopts as its own the estimate of federal mandates regarding H.R. 1256 prepared by the Director of the Congressional Budget Office pursuant to section 423 of the Unfunded Mandates Reform Act. 

ADVISORY COMMITTEE STATEMENT

Regarding section 5(b) of the Federal Advisory Committee Act, 

H.R. 1256 requires the establishment of an advisory committee regarding tobacco products. See section 917 in the chapter IX that 

section 101(b) of the bill adds to the Federal Food, Drug, and Cosmetic Act. The Committee finds that establishing the advisory committee is the most efficient way of carrying out the policies involved. 

CONSTITUTIONAL AUTHORITY STATEMENT

Pursuant to clause 3(d)(1) of rule XIII of the Rules of the House 

of Representatives, the Committee finds that the constitutional authority for H.R. 1256 is provided in Article I, section 8, clause 3, 

which grants Congress the power to regulate commerce with foreign nations, among the several states, and with the Indian Tribes, 

in the provisions of Article I, section 8, clause 1, that relate to expending funds to provide for the general welfare of the United 

States, and in the provisions of Article I, section 8, clause 18, which 

grants Congress the power to make all laws necessary and proper 

to carry into execution the powers enumerated in section 8 and all 

other powers vested by the Constitution in the government of the 

United States. 

APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that H.R. 1256 does not relate to the terms 

and conditions of employment or access to public services or accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act of 1995. 


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SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Short title; table of contents 

The short title is designated as the ‘‘Family Smoking Prevention 

and Tobacco Control Act’’. This section also includes the Act’s table 

of contents. 

Section 2. Findings 

Section 2 provides findings relating to tobacco use in the United 

States and the need for regulation. 

A number of the findings included in the legislation address the 

constitutionality of the legislation. The Committee finds that the 

legislation is fully consistent with the First Amendment of the U.S. 

Constitution. Specifically, the reasonable restrictions on advertising 

and promotion of tobacco products are both necessary and narrowly 

tailored to protect a compelling federal interest. 

In finding 31, Congress finds that the regulations promulgated 

by the Secretary of Health and Human Services in August 1996 

and described in finding 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. This is based on the evidence cited by 

FDA in support of the 1996 regulation referenced in finding 30 and 

on numerous studies that have been conducted since 1996. For example, several studies have shown that exposure to tobacco advertising substantially increases the likelihood that children and adolescents will smoke. One such study, published in 2006 in the Archives of Pediatrics and Adolescent Medicine, found that tobacco 

marketing doubles the odds that children under 18 years of age 

will become tobacco users. Additionally, a 2002 study published in 

the Archives of Pediatrics and Adolescent Medicine and a 1998 

study published in the Journal of the American Medical Association showed that the greatest impact was on influencing non-susceptible youth to become susceptible to smoking, though at least 

one study, published in 2006 in the Archives of Pediatrics and Adolescent Medicine, also showed that tobacco marketing leads children who already smoke to smoke more heavily. Even before some 

of the more recent studies were conducted, the National Cancer Institute found in 2001, based on a review of then existing research, 

that ‘‘the conclusion that there is a causal relationship between tobacco marketing and smoking initiation seems unassailable.’’ More 

recently, in August 2008, the National Cancer Institute issued a 

peer reviewed monograph that examined evidence of the relationship between tobacco marketing and youth smoking. This monograph found that ‘‘the evidence base indicates a causal relationship 

between tobacco advertising and increased levels of tobacco initiation and continued consumption’’ and that even brief exposure to 

tobacco advertising influences adolescents’ attitudes and perceptions about smoking as well as their intentions to smoke. 

In finding 31, Congress also finds that less restrictive and less 

comprehensive approaches have not been and will not be effective 

in reducing the problems addressed by the regulations described in 

finding 30. For example, the Master Settlement Agreement (MSA) 

between the states and some of the major tobacco companies has 


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been in effect since 1998. Despite the MSA, prior federal legislation, and state efforts, CDC has found that the percentage of high 

school students who smoke increased from 21.9% in 2003 to 23% 

in 2005 and remains unacceptably high. The rates are particularly 

alarming given all the state excise tax increases, prevention and 

cessation programs, and smokefree air laws, which cumulatively 

should have forced youth smoking rates down below the current 

level. Major scientific reports issued after the MSA, such as the 

2008 NCI Monograph on tobacco marketing, ‘‘The Role of the Media 

in Promoting and Reducing Tobacco Use,’’ the 2007 Report of the 

President’s Cancer Panel, ‘‘Promoting Healthy Lifestyles: Policy, 

Program and Personal Recommendations for Reducing Cancer 

Risk,’’ and the 2007 Report of the Institute of Medicine on tobacco, 

‘‘Ending the Tobacco Problem: A Blueprint for the Nation,’’ all 

found a continuing serious problem despite prior efforts and concluded that additional restrictions on tobacco marketing are essential to reduce tobacco use, especially among youth. 

In finding 31, Congress also finds that reasonable restrictions on 

the advertising and promotion of tobacco products contained in the 

1996 regulation will lead to a significant decrease in the number 

of minors using and becoming addicted to those products. This too 

is based on the evidence cited by FDA in support of the 1996 regulation and on more recent studies and findings. For example, an article in the 2007 Archives of Pediatrics and Adolescent Medicine 

concluded that the more cigarette marketing teens are exposed to 

in retail stores, the more likely they are to smoke, and that restricting these retail marketing practices would reduce youth smoking. These conclusions were reaffirmed by the 2007 Report of the 

President’s Cancer Panel and the 2007 Institute of Medicine Report. 

In finding 32, Congress finds that 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. The regulation is carefully tailored to focus on the types of advertising that will have the 

greatest impact on youth. The requirements are tailored to allow 

companies to advertise to adults in ways that provide information 

on what they are selling, for what reason, and for what price. 

There are no limits on print advertising in publications with adult 

readership and adult establishments, such as bars. 

Section 3. Purpose 

Section 3 provides the purpose of the bill, which is to provide authority to the Food and Drug Administration to regulate tobacco 

products under the Federal Food, Drug, and Cosmetic Act. FDA 

would be given authority to set national product standards; ensure 

effective oversight; regulate the levels of tar, nicotine, and other 

components of tobacco products as appropriate for the protection of 

the public health; require tobacco product manufacturers to disclose research; continue to permit the sale of tobacco products to 

adults; promote cessation; and strengthen protections against illicit 

trade in tobacco products. 


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Section 4. Scope and effect 

Section 4 states that nothing in this Act shall be construed to establish a precedent with regard to any other industry or affect any 

pending court action. This Act is also not intended to affect the authority of the Secretary of Agriculture regarding raw tobacco nor 

is it intended to affect any authority of the Secretary of the Treasury. 

Section 5. Severability 

Section 5 states that if any provision of this Act is held to be invalid, the remainder of this Act shall not be affected and shall continue to be enforced. 

Title 1—Authority of the Food and Drug Administration 

Section 101. Amendment of Federal Food, Drug, and Cosmetic Act 

Chapter IX (in the FFDCA)—Tobacco products 

The bill creates a new chapter within the FFDCA to regulate tobacco products. 

Section 900. Definitions 

Section 900 defines the following terms: additive; brand; cigarette; cigarette tobacco; commerce; counterfeit tobacco product; distributor; illicit trade; Indian tribe; Indian country; little cigar; nicotine; package; retailer; roll-your-own tobacco; small tobacco product 

manufacturer; smoke constituent; smokeless tobacco; state, territory; tobacco product manufacturer; tobacco warehouse; and United 

States. 

The Committee notes. that ‘‘small tobacco product manufacturer’’ 

(STPM) is defined. The Committee believes that an entity that 

qualifies as an STPM has access to fewer economic resources and, 

therefore, needs the special considerations provided for STPMs in 

certain portions of the Act (e.g., Sec. 901(f) and Sec. 

906(e)(1)(B)(v)). Accordingly, the term ‘‘employees’’ includes not 

only those persons considered employees under labor or tax laws, 

but also any other person working full-time for a manufacturer 

doing the work of a regular employee (e.g., under a services contract or consulting agreement). Without this understanding of the 

term ‘‘employee,’’ some manufacturers would be able to qualify 

wrongfully as STPMs by replacing a number of their formal employees with consultants or contract workers or by changing their 

relationships with existing workers from a formal employer-employee relationship to an independent contractor relationship. The 

Food and Drug Administration should review annually the documentation of any company that qualifies as a small manufacturer 

to ensure that the number of its employees, taking into account 

employees of each entity it controls, is controlled by or is under 

common control, does not exceed 350. For purposes of determining 

the number of employees under the preceding sentence, the employees of a company that owns, has a substantial ownership interest in, or is owned by such manufacturer shall be included. 


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Section 901. FDA authority over tobacco products 

Section 901(c) limits the scope of FDA’s authority to regulate 

manufacturers of tobacco products, making clear that FDA does not 

have the authority to regulate tobacco growers. If a producer of tobacco leaf, however, is also a tobacco product manufacturer, the 

producer shall be subject to regulation in the producer’s capacity as 

a manufacturer. The Committee notes that the phrase ‘‘in the producer’s capacity as a manufacturer’’ refers to the actual process of 

manufacturing a tobacco product. While it covers a tobacco cooperative that operates as a tobacco product manufacturer, it does not 

refer to a tobacco producer who merely sells raw tobacco to a tobacco cooperative which operates a tobacco product manufacturing 

facility or to a tobacco producer who merely serves on the board of 

directors of such a cooperative. 

In order to make clear the importance of tobacco regulation, as 

well as the Committee’s intent not to have FDA regulation of tobacco detract from other responsibilities of the agency, Section 

901(e) directs FDA to establish a separate Center for Tobacco Products. 

Section 901(f) directs FDA to establish an Office to Assist Small 

Manufacturers of Tobacco Products to provide technical assistance 

to small manufacturers in complying with the requirements of this 

Act. 

Section 902. Adulterated tobacco products 

Section 902 lays out guidelines for determining whether tobacco 

products are adulterated. Filthy, decomposed, or otherwise contaminated substances in tobacco products, the preparation of such 

products, or the packaging of such products will cause them to be 

deemed adulterated. Tobacco products held under unsanitary conditions or manufactured, packed, or stored in violation of good 

manufacturing practices will likewise be deemed adulterated. A tobacco product will also be deemed adulterated if the manufacturer 

of it fails to pay required user fees, if it does not meet the product 

standards established for the product, or if the product is required 

to have premarket review and an order in effect under section 910 

or to have an order in effect as a modified risk product under section 911 and does not have such an order in effect. 

Section 903. Misbranded tobacco products 

Section 903(a) states that tobacco products will be deemed misbranded if their label is false or misleading, if they are not correctly labeled (e.g., with the percentage of domestically grown 

versus foreign tobacco, proper warning labels, the name of the 

manufacturer, or in accordance with other requirements of the Secretary) or advertised, or if the manufacturing, distribution, or selling of the product does not comply with other parts of the Act. 

Section 903(b) provides that the Secretary is specifically authorized to require prior approval of statements made on the label of 

a tobacco product. 

Section 904. Submission of health information to the Secretary 

Section 904(a) requires, within six months of passage, submission 

to the Secretary by brand and quantity of ingredients, compounds, 

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ter, or other part of the tobacco product. This section also requires 

a description of the content, delivery, and form of nicotine, as well 

as documents developed after enactment that relate to health, toxicological, behavioral, or physiologic effects of tobacco products. This 

information is required of all current tobacco products as well as 

any tobacco products introduced after enactment. Further, three 

years after enactment, a list of constituents, including smoke constituents, identified by the Secretary as harmful or potentially 

harmful, is required to be submitted to the Secretary. 

Section 904(b) provides the Secretary with the authority to request documents and information on a broad range of issues, including, for example, documents and information relating to research activities and findings, scientific information on reducedrisk products and technology, the health effects of tobacco products 

and their components, and marketing research. This provision applies to both foreign and domestic manufacturers. 

Section 904(c) requires a written notice to the Secretary at least 

90 days prior to marketing if a tobacco manufacturer adds a new 

additive to their product or increases the amount of an additive. 

This section requires a written notice to the Secretary at least 60 

days prior to marketing if a tobacco manufacturer eliminates or decreases an existing additive. 

Section 904(d)(1) requires within three years of passage, and annually thereafter, the Secretary must publish in an easily available 

and understood format a list of harmful and potentially harmful 

constituents in each brand. 

Section 904(d)(2) requires the Secretary also to conduct consumer 

research to ensure that publication of the list is not misleading to 

lay persons. After 5 years, the Secretary must report to Congress 

on the results of the consumer research, and provide a recommendation on whether or not publication of the list should continue or be modified. 

Section 905. Annual registration 

Section 905 requires registration of every entity that owns or operates in any state any establishment engaged in the manufacture, 

preparation, compounding, or processing of tobacco products. The 

same requirement extends to foreign establishments. At the time 

of this registration, a listing is required of all tobacco products, 

which are being manufactured, prepared, compounded, or processed. Once registered, every establishment is subject to an inspection once every two years. 

Section 905(e) allows the Secretary to create a uniform system 

for identification of tobacco products. 

Section 905(j) requires a report to the Secretary 90 days prior to 

the introduction of a new tobacco product demonstrating that the 

product is substantially equivalent to a tobacco product already on 

the market and therefore not subject to premarket review. If the 

new product is not substantially equivalent to a product already on 

the market, the new product must be reviewed pursuant to Section 

910. Section 905(j) requires reports on products first marketed between February 16, 2007, and 21 months after enactment. Additionally, section 905(j) authorizes the Secretary to issue regulations 

creating exemptions from premarket notification for minor modifications of existing products or where otherwise appropriate. 


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Section 906. General provisions respecting control of tobacco products 

Section 906(b) provides for notice and comment rulemaking. 

Section 906(c) ensures limited confidentiality of certain information reported to the Secretary. Section 906(d) authorizes the Secretary to issue regulations restricting the sale and distribution of 

tobacco products, including access to, advertising, and promotion of 

tobacco products, if the Secretary determines that the regulations 

would be appropriate to protect the public health, taking into account factors specified in the provision. 

Advertising and promotion restrictions are permitted to the full 

extent consistent with the First Amendment. The Committee notes 

that Section 906(d) authorizes the Secretary to impose restrictions 

on the advertising and promotion of tobacco products in any venue 

used to advertise and promote tobacco products, including retail establishments that limit admittance to persons over age 18, where 

the Secretary finds that such restrictions would be ‘‘appropriate for 

the protection of the public health,’’ based on the factors laid out 

in Section 906(d)(1)(A) and (B), and where consistent with the First 

Amendment to the Constitution. 

Section 906(d) does not permit the Secretary to prohibit the faceto-face sale of any tobacco product by a specific category of retail 

outlets, or to establish a national minimum age of greater than 18 

years to purchase tobacco products. Section 906(d) requires the Secretary, however, to regulate the sale, distribution, promotion, and 

marketing of tobacco products that are sold through means other 

than a direct, face-to-face exchange. Section 906(d) permits advertising on conventional matchbooks to the extent permitted in adult 

publications, unless the Secretary determines that such treatment 

of matchbooks is not appropriate for the protection of the public 

health. 

Section 906(e) allows for regulations requiring that tobacco products conform to specified good manufacturing practices or hazard 

analysis and critical control point methodology (with input from the 

public and interested parties, and from the Tobacco Products Scientific Advisory Committee). This section exempts small tobacco 

product manufacturers from the above requirements for at least 

four years following the effective date of the Secretary’s regulation. 

Section 906(e)(2) provides for a petition process for a temporary or 

permanent exemption or variance from the regulation. 

Section 907. Tobacco product standards 

Consistent with the overall intent of the bill to protect the public 

health, including by reducing the number of children and adolescents who smoke cigarettes, section 907(a)(1) is intended to prohibit 

the manufacture and sale of cigarettes with certain ‘‘characterizing 

flavors’’ that appeal to youth. Examples of these products include, 

but are not limited to, those introduced in recent years such as 

‘‘Mandalay Lime,’’ ‘‘Warm Winter Toffee,’’ ‘‘Mocha Taboo,’’ and 

‘‘Midnight Berry,’’ which were the subject of an investigation and 

subsequent settlement agreement between one cigarette manufacturer and the attorneys general of 40 states in October 2006. 

Accordingly, this section prohibits the use of any constituent or 

additive that causes a cigarette or its smoke to have a characterizing flavor other than menthol or tobacco. Section 907(a)(1) is not 


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intended to prohibit the use of specific ingredients, including those 

found in some American blend cigarettes, so long as those additives 

or constituents are not a characterizing flavor (other than tobacco 

or menthol) of the cigarette or its smoke. A cigarette (including any 

component of the cigarette) or its smoke should not be determined 

to have a prohibited characterizing flavor based solely on the presence of an ingredient in the product or its smoke. 

The Committee has reviewed the products that will be banned 

after 90 days under this section and has concluded that the ban 

will not lead to negative public health effects, because of how the 

affected products generally are used and because of their low overall use by adult smokers. Specifically, none of the cigarettes covered by the ban—including those with the characterizing flavors of 

fruit, chocolate, and clove—is used regularly by a large number of 

addicted adult smokers. Instead, these cigarettes tend to be used 

only occasionally, either by regular users of other products, by individuals who are experimenting with tobacco use, or by those who 

smoke only in certain social settings. Given that few adult smokers 

ever use the flavored cigarettes that will be banned and that most 

adult smokers name other products as their regular brand, it is 

likely that regular use of these products by heavily addicted adult 

smokers is negligible. 

All of these factors—irregular, experimental, and social setting 

use and low overall use within the U.S. population—support the 

Committee’s conclusion that precipitous removal of these products 

from the market will not result in a large number of heavily addicted smokers facing the sudden withdrawal of the products to 

which they are addicted, with unknown consequences for the 

health of the individual users or the overall population. The Committee notes that prohibition of a product that is used regularly by 

a large number of heavily addicted adult users would pose different 

questions of public health than those posed by the ban in section 

907(a)(1). For example, the health care system might not be capable of handling the sudden increased demand for cessation assistance in the case of a more broadly used product, leaving millions 

of smokers without medical support. In addition, the sudden removal of a legal source for such a product without the type of consideration and review that FDA will be able to conduct might unnecessarily increase the illegal black market risk, which could also 

pose a health hazard to users. 

The Committee recognizes the unique issues surrounding menthol cigarettes and urges the Secretary to address these issues as 

quickly as practicable. The Committee is especially concerned 

about proportionately higher rates of menthol cigarette use among 

African American smokers, as well as the historic targeting of African Americans for menthol cigarette use by tobacco companies. 

While it is unclear what effect the presence of menthol in cigarettes 

may have on addictiveness, toxicity, or other qualities of cigarettes, 

the Committee recognizes that menthol cigarettes may pose unique 

health risks to those who smoke them. Given the high rates of use 

among African American smokers, including African American 

youth, as well as higher rates of lung cancer documented among 

African American smokers as compared to non-African American 

smokers, the Committee believes that it is critical for the Secretary 


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to move quickly to address the unique public health issues posed 

by menthol cigarettes. 

Menthol cigarettes currently represent over one quarter of all 

cigarettes smoked in the United States, representing more than 12 

million individual smokers. Additionally, nearly 7 in 10 African 

Americans who smoke choose to smoke menthol cigarettes. Given 

the number of open questions related to menthol cigarettes, the 

legislation authorizes the Secretary to ban or modify the use of 

menthol in cigarettes based on scientific evidence. Given the large 

number of Americans who smoke menthol, the disproportionate 

prevalence of menthol cigarettes among African Americans, the racial and ethnic differences in lung cancer incidence, and the uncertainty about the potentially negative consequences of an immediate 

menthol ban, the Committee believes that this approach ensures 

that FDA has the scientific evidence necessary to make the best decisions to protect the public health. 

Section 907 allows the Secretary to adopt, through notice and 

comment rulemaking, a product standard for tobacco products if 

the Secretary determines that such standard is appropriate for the 

protection of the public health. ‘‘Appropriate for the protection of 

public health’’ is used because tobacco products are not ‘‘safe’’ or 

‘‘safe and effective,’’ the standards used by FDA for foods, drugs, 

and medical devices. The public health standard is intended to be 

a flexible standard that focuses on the overall goal of reducing the 

number of individuals who die or are harmed by tobacco products. 

Standard(s) could include provisions to alter nicotine yields, to reduce or eliminate other constituents, including smoke constituents, 

or components, or other aspects of the construction, constituents, 

properties, and labeling of the tobacco product. 

J Section 907(a)(3) provides that the Secretary may adopt a tobacco product standard if the Secretary finds that it is appropriate 

for the protection of the public health. Section 907(a)(3)(B) sets 

forth certain considerations with respect to that finding and additional considerations with respect to a standard that would reduce 

or eliminate an additive, constituent (including a smoke constituent), or other component of a tobacco product. In the event 

that the Secretary has proposed the adoption of such a standard 

because the Secretary has found that the additive, constituent, or 

other component is or may be harmful, an objecting party may, in 

response to such finding, 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. In issuing 

a final standard as with any rulemaking, the Secretary shall review and consider all information and scientific evidence and data, 

presented by any party that comments on the proposed standard, 

including any information, evidence, or other documentation that is 

submitted concerning the population impact or any other matter 

related to the proposed standard. The Committee intends the Secretary will base his or her determinations on sound information 

and scientific evidence and data when issuing the proposed standard that is appropriate for the protection of the public health. 

The Committee also intends for the agency to have authority to 

establish product standards regarding the testing and measurement of products, nicotine yields, constituents, construction, components, ingredients, additives, and all other properties of the tobacco 


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product, including the form and content of the labeling. This authority is limited only by 907(d)(3), which prohibits FDA from banning all cigarettes, all smokeless tobacco products, all little cigars, 

all cigars, all pipe tobacco, or all ‘‘roll your own’’ tobacco products, 

or requiring the reduction of nicotine levels to zero. 

It is the Committee’s intent that there be a level playing field between domestic tobacco growers and foreign tobacco growers with 

regard to the development and implementation of any tobacco product standard. Beginning two years after enactment, no tobacco 

product manufacturer shall 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. 

The Secretary is required to review periodically the product 

standards, taking into consideration new medical, scientific, or 

other technological data. In creating rules, the Secretary is required to consult with other federal agencies and invite appropriate 

persons to provide their input before issuing a rule. The Secretary 

may also refer a proposed rule to the Tobacco Products Scientific 

Advisory Committee for collecting additional data and creating a 

report on the issue, which would then be made public. 

Section 908. Notification and other remedies 

Section 908(a) provides authority for the Secretary to give notice 

(e.g., through public service announcements) if a tobacco product 

presents an ‘‘unreasonable risk of substantial harm’’, and notification is necessary and the most practicable means available to eliminate the unreasonable risk. 

Section 908(c) authorizes the Secretary to recall a tobacco product, after an opportunity for an informal hearing, if the product 

contains a manufacturing or other defect that would cause serious 

adverse health consequences or death and is not ordinarily contained in tobacco products on the market. 

Section 909. Records and reports on tobacco products 

Section 909(a) requires tobacco manufacturers and importers to 

establish and maintain records and submit them to the Secretary, 

if required by the Secretary by regulation, to ensure that tobacco 

products are not adulterated or misbranded and to otherwise protect the public health. 

Section 909(a) allows the Secretary also to require manufacturers 

and importers to report serious unexpected adverse reactions 

caused by the use of a tobacco product. The Secretary also may require the reporting of other significant adverse reactions, if necessary, and of actions taken to correct or remove products from the 

market when undertaken to reduce a health risk. 

Section 909(a) states that reports required under this section 

shall not be unduly burdensome, nor require the disclosure of the 

identity of patients or users unless required for reasons specified 

in the provision. 

Section 910. Application for review of certain tobacco products 

Section 910(a) requires premarket review for all new tobacco 

products entering the market, unless the Secretary determines that 

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tion 910(a) defines substantial equivalence to mean that the product has the same characteristics as a marketed product, or has different characteristics, but does not raise different public health 

questions. Section 910(a)(4) specifies information that must be provided under section 905(j) to establish substantial equivalence, including detailed information on adverse health effects, and provides 

that such information be made public within 30 days of a determination of substantial equivalence. 

Section 910(b) requires an application for premarket review to 

contain all information published, known, or which should reasonably be known, to the applicant concerning studies on the health 

risks of the product. The application also must contain a listing of 

components, ingredients, and composition of products; how the 

product is operated or used; a description of the methods used to 

manufacture or produce the product; and samples of the product 

and the product’s proposed labeling. The Secretary may refer the 

application to the Tobacco Products Advisory Committee. 

Section 910(c) requires the Secretary, within 180 days after receipt of an application, to make a determination of whether to 

allow the new product to enter the market or deny the application. 

The Secretary may deny the application if the Secretary finds that 

the applicant has not shown that marketing of the product would 

be appropriate for the protection of the public health, or if the Secretary finds that the making and handling of the product do not 

conform to good manufacturing practices, the labeling is false or 

misleading, or the product fails to conform to an applicable product 

standard promulgated under section 907 without justification. 

Section 910(d) provides the Secretary authority to withdraw or 

suspend an order pertaining to a new product for a number of reasons, including that continued marketing is no longer appropriate 

for the protection of public health; the application contained a materially false statement; the applicant has failed to maintain 

records or make reports; the labeling becomes false or misleading; 

or the product does not conform to a tobacco standard without appropriate justification. Section 910(f) authorizes the Secretary to require the maintenance of records and the making of reports as necessary to permit the Secretary to determine whether to withdraw 

or suspend the order pertaining to a new product. 

Section 911. Modified risk tobacco products 

Section 911 prohibits a person from selling or distributing a 

modified-risk tobacco product without having obtained an order 

pertaining to the product from FDA. Section 911(b) specifically limits the sale, distribution, and promotion of new or existing products 

for which the label, labeling, or advertising states or implies that 

the product presents a reduced risk of harm or of tobacco-related 

disease, or that there is reduced exposure to a substance, or that 

uses the words ‘‘light,’’ ‘‘mild,’’ or ‘‘low,’’ or similar descriptors. This 

definition also includes any products with respect to which the 

manufacturer takes any action after passage of the legislation directed to consumers through the media or otherwise, other than by 

means of the tobacco product’s label, labeling, or advertising, which 

would be reasonably expected to result in consumers believing that 

the tobacco product or its smoke may present a lower risk of disease or lower exposure to a substance, or that it is less harmful. 


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Section 911(b)(2)(C) makes clear that the use of the following 

phrases on the label or advertising for a product do not constitute 

a reduced-harm claim: ‘‘smokeless tobacco’’; ‘‘smokeless tobacco 

product’’; ‘‘not consumed by smoking’’; ‘‘does not produce smoke’’; 

‘‘smokefree’’; ‘‘smoke-free’’; ‘‘without smoke’’; ‘‘no smoke’’; or ‘‘not 

smoke’’. Products intended for use in the treatment of tobacco dependence are not modified-risk tobacco products and are subject to 

Chapter V of the FFDCA. 

Section 911(d) also outlines the specific requirements that tobacco manufacturers must meet before receiving an order permitting the sale or distribution of modified-risk tobacco products. For 

example, an application for such an order must include a description of the product; the conditions for using the product with respect to the claim; formulation of the product; sample labels; all 

documents relating to research regarding the product (e.g., the effect on tobacco-related diseases and other health-related conditions); data on how consumers actually use the product; and any 

other information required by the Secretary. Section 911(e) requires the Secretary to make the application and all of its contents 

(except trade secrets and confidential commercial information) public and seek public comment. The application must be referred to 

the Tobacco Products Advisory Committee for its recommendations. 

Section 911(g)(1) states that the Secretary shall issue an order 

that a product may be commercially marketed as a modified risk 

product only if the Secretary determines that the applicant has 

demonstrated that the product will significantly reduce harm and 

the risk of tobacco-related disease to individual users, and benefit 

the health of the population as a whole, taking into account the impact on both users and nonusers of tobacco products. 

Section 911(g)(2) creates a special rule for allowing the sale and 

distribution of certain products, if the Secretary determines that (1) 

it would be appropriate for the protection of the public health; (2) 

the product’s label, labeling, or advertising explicitly or implicitly 

claims only that the product contains a reduced level of a substance, or presents a reduced exposure to a substance; (3) scientific 

evidence of reduced harm is not, or cannot be made, available, 

using the best available scientific methods and cannot be made 

available without conducting long-term epidemiological studies; (4) 

such data as currently exists predicts substantially reduced morbidity or mortality among individual tobacco users; (5) the magnitude of the overall reductions in exposure to such substances is 

substantial and will not expose users to higher levels of other 

harmful substances; and (6) testing of actual consumer perceptions 

shows that consumers will not be misled into believing that the 

product is or has been demonstrated to be less harmful or presents 

less of a risk than one or more other commercially marketed tobacco products. These products are limited to a distribution term 

of 5 years, but that term may be renewed. 

Section 911(h) states that the Secretary may require a manufacturer of a modified-risk product subject to an order under this section to comply with requirements relating to labeling, advertising, 

and promotion of the tobacco product, and the Secretary must require postmarket surveillance. 

Section 911(h) states that the Secretary has discretion to require 

that a modified-risk tobacco product making a comparative claim 


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compare the tobacco product to a commercially marketed tobacco 

product that is representative of that type of tobacco product on the 

market (e.g., the average value of the top three brands). The Secretary also may require quantitative comparisons of the amount of 

the substance reduced. This information must be placed near the 

most prominent claim. 

Section 911(j) states that the Secretary may withdraw the order 

pertaining to a modified risk product if: he or she can no longer 

make the findings on which the order was based; the application 

contained a material false statement; product representations 

about reduced risk or exposure are no longer valid; the applicant 

failed to conduct required postmarket studies and surveillance; or 

the applicant failed to meet any other condition of the order. 

Section 911(l) requires the Secretary, within 2 years after enactment, to issue guidance or regulations on the scientific evidence required for assessment and ongoing review of modified-risk tobacco 

products. The regulations or guidance shall be developed by the 

Secretary in consultation with the Institute of Medicine (IOM). 

Section 912. Judicial review 

Section 912 states that any person adversely affected by an FDA 

regulation relating to performance standards or premarket review 

may, within 30 days, file a petition for judicial review of such regulation with a United States Court of Appeals. The remedies provided shall be in addition to, not in lieu of, any other remedies provided by law. Judgment by the appellate court shall be final, subject to review by the Supreme Court. 

Section 913. Equal treatment of retail outlets 

Section 913 seeks to ensure a level playing field among all retailers, and requires the Secretary to issue regulations requiring that 

retail establishments whose predominant business is the sale of tobacco products comply with any advertising restriction applicable 

to retail establishments accessible to individuals under the age of 

18. This provision is necessary because the final rule promulgated 

by FDA on tobacco products, which is required to be reinstated 

under section 102 of the Committee’s bill, exempted adult-only establishments from advertising restrictions applicable to retail outlets where persons younger than 18 years of age are allowed. This 

section is intended to level the playing field for all retailers, applying the restrictions on advertising equally across the board. 

Section 914. Jurisdiction of and coordination with the Federal 

Trade Commission 

Section 914(a) clarifies that the Federal Trade Commission’s 

(FTC) authority regarding the advertising, sale, or distribution of 

tobacco products is not limited or diminished by the Act, and that 

violations of this Act related to advertising will also be considered 

unfair or deceptive practices under the Federal Trade Commission 

Act. 

Section 914(b) states that the Secretary and the Chairman of the 

FTC are to coordinate enforcement of section 4 of the Federal Cigarette Labeling and Advertising Act and section 3 of the Comprehensive Smokeless Tobacco Health Education Act. 


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Section 915. Regulation requirement 

Section 915 requires the Secretary, within 36 months of enactment, to issue regulations that require the testing and reporting of 

tobacco product smoke constituents, ingredients, and additives that 

the Secretary determines should be tested in order to protect public 

health. Regulations may require disclosure of test results relating 

to tar and nicotine in labeling or advertising, and may require disclosure of test results relating to other constituents that the Secretary determines should be disclosed to the public, if such disclosures would be appropriate for the protection of the public health 

and would not mislead consumers. 

Section 915(d) states that for small tobacco product manufacturers, the compliance times are delayed by at least 2 years and the 

testing and reporting requirements are delayed for 4 years. Additionally, two or more small tobacco product manufacturers may join 

together to purchase laboratory testing services. The Secretary also 

may delay the deadline for testing and reporting on a case-by-case 

basis. 

Section 915(d)(2)(A) of the Act provides that testing regulations 

promulgated by FDA under Section 915 only shall provide an extended time period for small tobacco product manufacturers to complete product testing required by FDA. FDA regulations shall provide for such testing by small manufacturers to be conducted over 

a 4-year period, with each manufacturer testing 25% of its products 

per year. If, however, product testing is necessary due to the actions of a small manufacturer in seeking to market a new product 

within the definition of section 910(a)(1)(B), or modifying an existing product within the definition of section 910(a)(1)(B), that testing must be conducted within the same time frame applicable to 

non-small manufacturers under FDA rules. The Committee believes that commonly occurring natural variations in the tobacco 

leaf—meaning only those variations that result directly from geological, meteorological, or similar factors not under the control of 

and not the result of decisions by the tobacco grower, processor, or 

manufacturer—should not constitute a new product or a product 

modification for purposes of determining what time frames to apply 

for completion of testing. 

Section 915(e) states that FDA regulations are required to provide an extension to a small tobacco product manufacturer for testing and reporting in the event that the manufacturer demonstrates 

an inability to gain access to an independent testing laboratory to 

conduct product testing in time to meet regulatory deadlines. This 

delay is conditioned, in part, on evidence provided to FDA that: (1) 

the products were submitted sufficiently in advance to meet regulatory deadlines; (2) the products are currently awaiting testing; 

and (3) neither that laboratory, nor any other laboratory, is able to 

complete testing by the deadline at customary, non-expedited testing fees. 

The Committee believes that, in seeking an extension of time 

under this subsection, a small manufacturer should be required 

only to consult laboratories that are legitimate and that possess the 

expertise to produce meaningful and reliable testing reports. Therefore, we anticipate that FDA will assist small manufacturers in 

this regard through its Office to Assist Small Tobacco Product 

Manufacturers. The Committee expects that the Office will produce 


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a list of testing laboratories with which a small manufacturer can 

check for testing capacity and availability. The list should include 

a description of testing services, an address, and known contact information for each laboratory. While FDA’s production of this list 

will not eliminate the duty of each small manufacturer to use its 

best efforts to identify such laboratories on its own, the list will 

provide great assistance to small manufacturers in fulfilling that 

duty. 

As stated in this subsection, FDA’s authority to extend deadlines 

based on a demonstrated lack of laboratory capacity extends only 

to testing and reporting required under Section 915. 

Section 916. Preservation of state and local authority 

Section 916(a) states that state authority is preserved, with no 

federal preemption, with regard to enacting, adopting, promulgating, and enforcing any law, rule, or regulation in critical areas 

with respect to tobacco products that is in addition to or more 

stringent than required under this Act, including measures 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 cigarettes. State, 

tribal, and local taxation of tobacco products also is unaffected. 

Section 916(a)(2)(A) states that states are generally preempted 

from establishing or continuing in effect any requirement that is 

different from or in addition to any FDA requirement relating to 

specified and limited areas, including tobacco product standards, 

premarket review, adulteration, misbranding, labeling, registration, 

reporting, good anufacturing standards, and modified risk tobacco 

products. 

Section 916(b) also states that product liability actions under 

state law are not modified or otherwise affected by this bill. 

Section 917. Tobacco Products Scientific Advisory Committee 

Section 917 establishes a 12-member advisory committee of relevant medical, scientific, and technological experts, with representatives of the public, tobacco growers, the health community, and tobacco manufacturers, as well, including one member solely and specifically representing the interests of small manufacturers of tobacco products. The small manufacturers’ position may be filled by 

different persons, one at a time, based on different areas of expertise relevant to the topics being discussed. Representatives of the 

tobacco industry and growers will be on the Committee to provide 

technical input, but they will be non-voting. 

Section 917(c) states that this Committee will provide advice and 

guidance to the Secretary on the effects of alteration of the nicotine 

yields from tobacco products; the threshold level at which nicotine 

becomes addictive; and any other health issues as requested by the 

Secretary. 

Section 918. Drug products used to treat tobacco dependence 

Section 918 requires the Secretary to consider designating nicotine replacement products, regulated under title V of the FFDCA, 

as fast-track research and approval products. 


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Section 918(a) requires the Commissioner of Food and Drugs to 

consider approving the extended use of over-the-counter nicotine 

replacement products, and to consider other issues relating to the 

approval of nicotine replacement therapies. 

The Committee notes that the fees collected under section 919 of 

this Act shall not be used for the purposes of designating nicotine 

replacement products as fast-track research and approval products, 

or approving the extended use of over-the-counter nicotine replacement products, or to consider other issues relating to the approval 

of nicotine replacement therapies. The Committee notes that these 

activities are regulated under the authority of title V of the 

FFDCA. 

The Committee has found that public health officials and other 

interested parties are not widely aware that FDA does not currently prohibit the sales of over-the-counter smoking cessation 

products—such as certain nicotine replacement products—in retail 

settings where age verification takes place. The Committee urges 

FDA to communicate its policy on such sales to the regulated community and public health officials through simple and effective 

means, such as through posting a statement of policy on the FDA’s 

web site. 

Section 918(b) requires the Secretary to report to Congress within 3 years on how best to regulate, promote, and encourage development of innovative products and treatments to promote abstinence from tobacco use, reductions in consumption, and reductions 

in the harm associated with tobacco use. Cessation assistance is a 

critical component of the fight against the tobacco epidemic. Accordingly, the Committee believes that it is important for health insurers—public and private—to cover effective cessation treatments 

for those addicted to tobacco, including both medications and counseling. While it is clear to the Committee that the benefits of such 

coverage greatly outweigh the costs both in terms of human health 

and in terms of financial savings, private and public insurer coverage of such services remains less than comprehensive. For example, as CDC reported in 2006, only 38 of 50 state Medicaid programs provided coverage for any cessation benefits to tobacco 

users, with only one state providing all benefits recommended 

under applicable Public Health Service treatment guidelines. In addition, it is unknown to what extent private insurers are choosing 

to cover such benefits. 

In light of the critical importance of insurer coverage of cessation 

treatment for those suffering from nicotine addiction, the Committee urges the Secretary to examine this issue and to review the 

extent to which private insurers are covering effective cessation 

treatment for tobacco users. In conducting this examination, the 

Secretary should consider the potential cost savings of such coverage, taking into account not only the reduction of healthcare 

costs that would result, but also the gain in individual life years, 

improvements in quality of life, and increased productivity that 

would be achieved by such coverage. 

Section 919. User fee 

Section 919(a) requires the Secretary to assess a quarterly fee 

from tobacco product manufacturers and importers to cover the 

costs of the activities of the Food and Drug Administration related 


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to the regulation of tobacco products under the Act. Section 

919(b)(4) makes clear that only the funds provided for in this chapter will be used to pay for FDA tobacco regulation. While section 

919(c)(2)(B)(ii) allows for FDA to use other funds for startup costs 

during the first two quarters of the program only, any such funds 

must be repaid in full. In addition, none of the funds provided for 

in this chapter may be used to pay for activities not related to 

FDA’s regulation of tobacco. The method of assessing fees shall be 

the same as that currently used by United States Department of 

Agriculture for all tobacco manufacturers and importers to fund the 

2004 legislation providing transitional payments to tobacco grower 

quota holders. 

Section 919(c)(3)(B) states that no manufacturer or importer 

shall be required to pay a user fee in excess of their percentage 

market share. Section 919(c)(2)(B) also limits the imposition of user 

fees to cigarettes, smokeless tobacco products, and roll-your-own tobacco until the Secretary exercises jurisdiction over other tobacco 

products. 

Section 919(g) requires a report by the Government Accountability Office, within 3 years of enactment, that studies the prevalence of youth tobacco use and the brands that individuals under 

the age of 18 consume; the feasibility of structuring a user fee 

based on youth market share of a manufacturer; and the potential 

effects of tobacco marketing to youth if user fees were calculated 

based on youth market share. 

Section 102. Final rule 

Section 102 states that on the first day of publication of the Federal Register that is six months or more after the enactment of this 

Act, the Secretary shall publish a final rule on the advertising of, 

and access to, tobacco products, which shall become effective one 

year after passage of the bill. 

The final rule is deemed to be in compliance with the Administrative Procedure Act. The final rule shall be identical in its provisions to the advertising and access regulations promulgated by 

FDA in 1996, except where specifically provided in this Act. Prior 

to making any future amendments to the published rule, the Secretary will be required to promulgate a proposed rule. 

The final rule also includes a provision that allows the restricted 

distribution of smokeless tobacco products in qualified, adult-only 

facilities. In 1996, the Food and Drug Administration concluded 

that teens obtain free samples of tobacco products despite laws that 

prohibit the free distribution to minors. In the August 1996 rule, 

FDA wrote that ‘‘free samples represent a ‘risk-free and cost-free’ 

way for young people to obtain and possibly use cigarettes or 

smokeless tobacco and that, when free samples are distributed at 

cultural or social events, peer pressure may lead some young people to accept and to use the free samples.’’ The Committee’s intent 

in section 102 (a)(2) is to modify the final rule to allow free sampling of smokeless tobacco products only to adults in secured, enclosed, adult-only facilities or areas. The Committee expects FDA 

to monitor aggressively smokeless free-sampling facilities to assure 

that all requirements are being followed and that youth do not obtain the samples of smokeless tobacco that are being distributed. 

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sion does not preclude the Secretary from taking further action related to the regulation or prohibition of free sampling of smokeless 

tobacco products. 

The Secretary shall ensure that this Act, amendments made by 

the Act, 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. 

Section 103. Conforming and other amendments to general provisions 

Section 103 includes a number of export provisions and retailer/ 

licensing provisions. Section 103 contains retailer procedural protections and requires FDA, to the extent feasible, to contract with 

the states for retailer enforcement. 

As reflected in its findings, the Committee is concerned that, depending on the particular language, communications directed to 

consumers by tobacco manufacturers about the impact of the authority granted to FDA under this legislation could confuse or mislead consumers. The Committee recognizes that unlike most products regulated by FDA, tobacco products will remain harmful. 

Therefore, section 103(b)(13) of the bill, in a new subsection (tt) of 

Section 301 of the FFDCA, prohibits statements directed to consumers through the media or through the label, labeling, or advertising that would reasonably be expected to result in a consumer 

believing that the product is regulated, inspected, or approved by 

FDA, or that the product complies with requirements imposed by 

FDA, and that could result in consumers believing that the product 

is endorsed for use by FDA or that otherwise could result in consumers being misled about the harmfulness of the product because 

of the authority given to FDA by this legislation. The Committee 

did not attempt to identify every situation in which such specific 

statements would reasonably be expected to mislead consumers, instead giving FDA the authority to analyze any specific examples 

presented to it. This section was carefully written so that it involves only communications directed to consumers and does not 

therefore, for example, involve communications to government 

agencies, such as reports to the Securities and Exchange Commission, or as part of judicial or congressional proceedings, in formal 

documents that companies provide to shareholders in the ordinary 

course of business, or in scientific articles that appear in scientific 

journals. 

Section 103(q)(2)(C) is designed to protect retailers against the 

imposition of double penalties based on a single violation of any restriction under section 906(d) by directing the Secretary to consider 

the amount of penalties paid to a state by a retailer for the same 

violation. This provision is not meant to change the system of setting penalties in any other area within the jurisdiction of the Food 

and Drug Administration. 

Section 104. Study on raising the minimum age to purchase tobacco 

products 

Section 104 requires the Secretary to submit to Congress, within 

5 years after enactment of this Act, a report on the public health 


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implications of raising the minimum age to purchase tobacco products. 

Section 105. Enforcement Action Plan for Advertising and Promotion Restrictions 

Section 105(a) requires the Secretary, within six months of enactment, to develop, in consultation with public health organizations 

and others with expertise and experience in serving minority communities, and publish an action plan to enforce restrictions adopted 

pursuant to section 906 or pursuant to section 102(a) on the promotion and advertising of menthol and other cigarettes to youth. 

The action plan shall include provisions specifically designed to ensure enforcement of these restrictions in minority communities. 

Section 105(b)(2) directs the Secretary also to provide assistance to 

communities seeking to prevent underage tobacco use, including assistance with strategies to prevent underage tobacco use in communities with a disproportionate use of menthol cigarettes by minors. 

Section 105(b) requires the Secretary, within three months of enactment, to inform state, local, and Tribal governments of the authority newly provided to such entities pursuant to section 203 of 

this Act or preserved under section 101(b) of this Act. 

Title II. Tobacco Product Warnings; Constituent and Smoke 

Constituent Disclosure 

Section 201. Cigarette label and advertising warnings 

Section 201(a) amends section 4 of the Federal Cigarette Labeling and Advertising Act to specify nine new required warning labels, one of which must appear on cigarette packages and advertisements within 1 year of enactment of this Act. The warning 

must comprise at least the top 30% of the front and rear panels of 

the package, and at least 20% of the related advertisements. Retailers will not be held responsible for packages and advertisements bearing a warning label that they do not create or alter. 

Section 201(c) requires that all warnings be displayed on all 

brands and be randomly distributed in all areas of the United 

States where the product is distributed and requires that a plan be 

submitted to the Secretary to ensure that the statements in product advertising are equally distributed and rotated quarterly and 

that all required label statements be displayed at the same time. 

Section 202. Authority to revise cigarette warning label statements 

Section 202 amends section 4 of the Federal Cigarette Labeling 

and Advertising Act to provide the Secretary with authority, by 

rulemaking, to adjust format, type size, and text of any label requirements, and to require that warning labels contain graphics, as 

well as to increase the required label area from 30% up to 50% of 

the front and rear panels. 

Section 203. State regulation of cigarette advertising and promotion 

Section 203 amends section 5 of the Federal Cigarette Labeling 

and Advertising Act to allow states or localities to enact statutes 

and promulgate regulations based on smoking and health, imposing specific bans or restrictions on the time, place, and manner of 

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strict the content of advertisements or promotions of any cigarettes 

based on smoking and health. 

Section 204. Smokeless tobacco labels and advertising warnings 

Section 204(a) amends section 3 of the Comprehensive Smokeless 

Tobacco Health Education Act of 1986 to specify the required warning labels that must appear on smokeless tobacco product labels 

and advertisements, and imposes minimum size and text requirements. 

Section 204(b) requires that all warnings be displayed on all 

brands and be randomly distributed in all areas of the United 

States where the product is distributed and requires that a plan be 

submitted to the Secretary to ensure that the statements in product advertising are equally distributed and rotated quarterly, and 

that all required label statements are displayed at the same time. 

Section 205. Authority to revise smokeless tobacco warning label 

statements 

Section 205 amends section 3 of the Comprehensive Smokeless 

Tobacco Health Education Act of 1986 to provide the Secretary 

with authority, by rulemaking, to adjust format, type size, and text 

of any label requirements, and to require that warning labels contain graphics, as well as to increase the required label area from 

30% up to 50% of the front and rear panels. 

Section 206. Tar, nicotine, and other smoke constituent disclosure to 

the public 

Section 206 amends section 4 of the Federal Cigarette Labeling 

and Advertising Act to require the Secretary to determine, using 

his or her sole discretion, whether cigarette and other tobacco product manufacturers should be required to include in each advertisement, package, label, or both, the tar and nicotine yields of a tobacco product, and whether the yields of other constituents will be 

required to be disclosed by appropriate means. 

This section requires that any differences between the requirements established by the Secretary and tar and nicotine disclosure 

reporting requirements established by the Federal Trade Commission be resolved by a memorandum of understanding. 

Title III.—Prevention of Illicit Trade in Tobacco Products 

Section 301. Labeling, recordkeeping, records inspection 

Section 301 further amends new title IX of the Federal Food, 

Drug, and Cosmetic Act by adding a new section 920. 

Section 920(a) requires the label, packaging, and shipping containers of tobacco products to bear a statement ‘‘sale only allowed 

in the United States.’’ 

Section 920(b) directs the Secretary to issue regulations regarding the establishment and maintenance of records by any person 

who manufacturers, processes, transports, distributes, receives, 

packages, holds, exports, or imports tobacco products. These 

records will be used to track and assist in the investigation of illicit 

trade, smuggling, or counterfeiting of tobacco products. Retailers 

will not be required to maintain records of sales made to consumers. 


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Section 920(c) authorizes the Secretary to inspect and copy all 

records, including financial records, of each person who manufacturers, processes, transports, distributes, receives, holds, packages, 

exports, or imports a tobacco product that the Secretary has a reasonable belief is part of illicit trade, or smuggling, or is counterfeit. 

Section 920(d) requires manufacturers and distributors to report 

to the Attorney General any knowledge that a tobacco product it 

manufactures or distributes has been imported, exported, distributed, or offered for sale (1) without payment of duties or taxes, or 

(2) for possible illicit marketing. 

Section 302. Study and report 

Section 302 requires the Comptroller General to conduct a study 

of cross-border trade in tobacco products, including illicit trade, 

cross-border advertising, and the health effects resulting from 

cross-border trade. This section also requires the Comptroller General to 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 this section no later than 18 months after enactment. 

Section 302(c) provides a definition for ‘‘cross-border trade,’’ and 

states that the terms ‘‘Indian country,’’ ‘‘state,’’ and ‘‘territory’’ 

share the same definitions found in current law. 

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, 

existing law in which no change is proposed is shown in roman): 

FEDERAL FOOD, DRUG, AND COSMETIC ACT 

* * * * * * * 

CHAPTER II—DEFINITIONS 

SEC. 201. For the purposes of this Act— 

(a) * * * 

* * * * * * * 

(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. 

(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). 


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CHAPTER III—PROHIBITED ACTS AND PENALTIES 

PROHIBITED ACTS

SEC. 301. The following acts and the causing thereof are hereby 

prohibited: 

(a) The introduction or delivery for introduction into interstate 

commerce of any food, drug, device, tobacco product, or cosmetic 

that is adulterated or misbranded. 

(b) The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce. 

(c) The receipt in interstate commerce of any food, drug, device, 

tobacco product, or cosmetic that is adulterated or misbranded, and 

the delivery or proffered delivery thereof for pay or otherwise. 

* * * * * * * 

(e) The refusal to permit access to or copying of any record as required by section 412, 414, 417(g), 416, 504, 564, 703, 704(a), 760, 

or 761; or the failure to establish or maintain any record, or make 

any report, required under section 412, 414(b), 417, 416, 504, 505 

(i) or (k), 512(a)(4)(C), 512 (j), (l) or (m), 572(i)ø.¿, 515(f), 519, 564, 

760, øor 761 or the refusal to permit access to¿ 761, 909, or 920 

or the refusal to permit access to or verification or copying of any 

such required record. 

* * * * * * * 

(g) The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded. 

(h) The giving of a guaranty or undertaking referred to in section 

303(c)(2), which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect 

signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith 

the food, drug, device, tobacco product, or cosmetic; or the giving 

of a guaranty or undertaking referred to in section 303(c)(3), which 

guaranty or undertaking is false. 

* * * * * * * 

(j) The using by any person to his own advantage, or revealing, 

other than to the Secretary or officers or employees of the Department, or to the courts when relevant in any judicial proceeding 

under this Act, any information acquired under authority of section 

404, 409, 412, 414, 505, 510, 512, 513, 514, 515, 516, 518, 519, 520, 

571, 572, 573ø.¿, 704, ø708, or 721¿ 708, 721, 904, 905, 906, 907, 

908, 909, or 920(b) concerning any method or process which as a 

trade secret is entitled to protection; or the violating of section 

408(i)(2) or any regulation issued under that section.. This paragraph does not authorize the withholding of information from either House of Congress or from, to the extent of matter within its 

jurisdiction, any committee or subcommittee of such committee or 

any joint committee of Congress or any subcommittee of such joint 

committee. 

(k) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of 

any other act with respect to, a food, drug, device, tobacco product, 

or cosmetic, if such act is done while such article is held for sale 


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(whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded. 

* * * * * * * 

ø(p) The failure to register in accordance with section 510, the 

failure to provide any information required by section 510(j) or 

510(k); or the failure to provide a notice required by section 

510(j)(2). 

ø(q)(1) The failure or refusal to (A) comply with any requirement 

prescribed under section 518 or 520(g), (B) furnish any notification 

or other material or information required by or under section 519 

or 520(g), or (C) comply with a requirement under section 522.¿ 

(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). 

(q)(1) The failure or refusal— 

(A) to comply with any requirement prescribed under section 

518, 520(g), 903(b), 907, 908, or 916; 

(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. 

(2) With respect to any ødevice,¿ device or tobacco product, the 

submission of any report that is required by or under this Act that 

is false or misleading in any material respect. 

(r) The movement of a device or tobacco product in violation of 

an order under section 304(g) or the removal or alteration of any 

mark or label required by the order to identify the device or tobacco 

product as detained. 

* * * * * * * 

(oo) The sale of tobacco products in violation of a no-tobacco-sale 

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. 


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(tt) With respect to a tobacco product, any statement directed to 

consumers through the media or through the label, labeling, or advertising that would reasonably be expected to result in consumers 

believing that the product is regulated, inspected or approved by the 

Food and Drug Administration, or that the product complies with 

the requirements of the Food and Drug Administration, including 

a statement or implication in the label, labeling, or advertising of 

such product, and that could result in consumers believing that the 

product is endorsed for use by the Food and Drug Administration 

or in consumers being misled about the harmfulness of the product 

because of such regulation, inspection, or compliance. 

* * * * * * * 

PENALTIES

SEC. 303. (a) * * * 

* * * * * * * 

(f)(1)(A) Except as provided in subparagraph (B), any person who 

violates a requirement of this Act which relates to devices or 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. For purposes of the preceding sentence, a person accredited under paragraph (2) of section 704(g) who is substantially not in compliance with the standards of accreditation 

under such section, or who poses a threat to public health or fails 

to act in a manner that is consistent with the purposes of such section, shall be considered to have violated a requirement of this Act 

that relates to devices or tobacco products. 

* * * * * * * 

(5)(A) A civil penalty under paragraph (1), (2), (3), or (4) shall be 

øassessed¿ assessed, or a no-tobacco-sale order may be imposed, by 

the Secretary by an order made on the record after opportunity for 

a hearing provided in accordance with this subparagraph and section 554 of title 5, United States Code. Before issuing such an 

order, the Secretary shall give written notice to the person to be 

assessed a civil øpenalty¿ penalty, or upon whom a no-tobacco-sale 

order is to be imposed, under such order of the Secretary’s proposal 

to issue such order and provide such person an opportunity for a 

hearing on the order. In the course of any investigation, the Secretary may issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to 

the matter under investigation. 

(B) In determining the amount of a civil penalty, or the period 

to be covered by a no-tobacco-sale order, the Secretary shall take 

into account the nature, circumstances, extent, and gravity of the 

violation or violations and, with respect to the violator, ability to 

pay, effect on ability to continue to do business, any history of prior 

such violations, the degree of culpability, and such other matters 

as justice may require. A no-tobacco-sale order permanently prohibiting an individual retail outlet from selling tobacco products shall 

include provisions that allow the outlet, after a specified period of 


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time, to request that the Secretary compromise, modify, or terminate 

the order. 

* * * * * * * 

(D) The Secretary may compromise, modify, or terminate, with or 

without conditions, any no-tobacco-sale order. 

(6) Any person who requested, in accordance with paragraph 

(5)(A), a hearing respecting the assessment of a civil penalty or the 

imposition of a no-tobacco-sale order and who is aggrieved by an 

order assessing a civil penalty or the imposition of a no-tobacco-sale 

order may file a petition for judicial review of such order with the 

United States Court of Appeals for the District of Columbia Circuit 

or for any other circuit in which such person resides or transacts 

business. Such a petition may only be filed within the 60-day period beginning on the date the order making such assessment was 

øissued.¿ issued, or on which the no-tobacco-sale order was imposed, as the case may be. 

* * * * * * * 

(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-tobacco-sale 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 no-sale 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. 

* * * * * * * 

SEIZURE

SEC. 304. (a)(1) * * * 

(2) The following shall be liable to be proceeded against at any 

time on libel of information and condemned in any district court of 

the United States or United States court of a Territory within the 

jurisdiction of which they are found: (A) Any drug that is a counterfeit drug, (B) Any container of a counterfeit drug, (C) Any 

punch, die, plate, stone, labeling, container, or other thing used or 

designed for use in making a counterfeit drug or drugs, øand¿ (D) 

Any adulterated or misbranded ødevice.¿ device, and (E) Any adulterated or misbranded tobacco product. 

* * * * * * * 

(d)(1) Any food, drug, device, tobacco product, or cosmetic condemned under this section shall, after entry of the decree, be disposed of by destruction or sale as the court may, in accordance with 

the provisions of this section, direct and the proceeds thereof, if 

sold, less the legal costs and charges, shall be paid into the Treasury of the United States; but such article shall not be sold under 

such decree contrary to the provisions of this Act or the laws of the 

jurisdiction in which sold. After entry of the decree and upon the 


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payment of the costs of such proceedings and the execution of a 

good and sufficient bond conditioned that such article shall not be 

sold or disposed of contrary to the provisions of this Act or the laws 

of any State or Territory in which sold, the court may by order direct that such article be delivered to the owner thereof to be destroyed or brought into compliance with the provisions of this Act 

under the supervision of an officer or employee duly designated by 

the Secretary, and the expenses of such supervision shall be paid 

by the person obtaining release of the article under bond. If the article was imported into the United States and the person seeking 

its release establishes (A) that the adulteration, misbranding, or 

violation did not occur after the article was imported, and (B) that 

he had no cause for believing that it was adulterated, misbranded, 

or in violation before it was released from customs custody, the 

court may permit the article to be delivered to the owner for exportation in lieu of destruction upon a showing by the owner that all 

of the conditions of section 801(e) can and will be met. The provisions of this sentence shall not apply where condemnation is based 

upon violation of section 402(a) (1), (2), or (6), section 501(a)(3), section 502(j), or section 601 (a) or (d). Where such exportation is 

made to the original foreign supplier, then subparagraphs (A) and 

(B) of section 801(e)(1) and the preceding sentence shall not be applicable; and in all cases of exportation the bond shall be conditioned that the article shall not be sold or disposed of until the applicable conditions of section 801(e) have been met. Any person 

seeking to export an imported article pursuant to any of the provisions of this subsection shall establish that the article was intended for export at the time the article entered commerce. Any article condemned by reason of its being an article which may not, 

under section 404 or 505, be introduced into interstate commerce, 

shall be disposed of by destruction. 

* * * * * * * 

(g)(1) If during an inspection conducted under section 704 of a facility or a vehicle, a device or tobacco product which the officer or 

employee making the inspection has reason to believe is adulterated or misbranded is found in such facility or vehicle, such officer 

or employee may order the device or tobacco product detained (in 

accordance with regulations prescribed by the Secretary) for a reasonable period which may not exceed twenty days unless the Secretary determines that a period of detention greater than twenty 

days is required to institute an action under subsection (a) or section 302, in which case he may authorize a detention period of not 

to exceed thirty days. Regulations of the Secretary prescribed 

under this paragraph shall require that before a device or tobacco 

product may be ordered detained under this paragraph the Secretary or an officer or employee designated by the Secretary approve such order. A detention order under this paragraph may require the labeling or marking of a device or tobacco product during 

the period of its detention for the purpose of identifying the device 

or tobacco product as detained. Any person who would be entitled 

to claim a device or tobacco product if it were seized under subsection (a) may appeal to the Secretary a detention of such device 

or tobacco product under this paragraph. Within five days of the 

date an appeal of a detention is filed with the Secretary, the SecVerDate Nov 24 2008 05:06 Mar 28, 2009 Jkt 079006 PO 00000 Frm 00056 Fmt 6659 Sfmt 6601 E:\HR\OC\HR058P1.XXX HR058P1

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retary shall after affording opportunity for an informal hearing by 

order confirm the detention or revoke it. 

(2)(A) Except as authorized by subparagraph (B), a device or tobacco product subject to a detention order issued under paragraph 

(1) shall not be moved by any person from the place at which it 

is ordered detained until— 

(i) * * * 

* * * * * * * 

CHAPTER V—DRUGS AND DEVICES 

SUBCHAPTER A—DRUGS AND DEVICES

* * * * * * * 

NEW DRUGS

SEC. 505. (a) * * * 

* * * * * * * 

(n)(1) * * * 

(2) The Secretary may delegate the appointment and oversight 

authority granted under øsection 904¿ section 1004 to a director of 

a center or successor entity within the Food and Drug Administration. 

* * * * * * * 

SEC. 523. ACCREDITED PERSONS. 

(a) * * * 

(b) ACCREDITATION.— (1) * * * 

(2) ACCREDITATION.— (A) * * * 

* * * * * * * 

(D) ANNUAL REPORT.—The Secretary shall include in the 

annual report required under øsection 903(g)¿ section 

1003(g) the names of all accredited persons and the particular activities under subsection (a) for which each such 

person is accredited and the name of each accredited person whose accreditation has been withdrawn during the 

year. 

* * * * * * * 

CHAPTER VII—GENERAL AUTHORITY 

SUBCHAPTER A—GENERAL ADMINISTRATIVE PROVISIONS

* * * * * * * 

EXAMINATIONS AND INVESTIGATIONS

SEC. 702. (a)(1)(A) The Secretary is authorized to conduct examinations and investigations for the purposes of this Act through officers and employees of the Department or through any health, food, 

or drug officer or employee of any State, Territory, or political subdivision thereof, duly commissioned by the Secretary as an officer 

of the Department. 


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(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. 

* * * * * * * 

SEC. 703. RECORDS. 

(a) IN GENERAL.—For the purpose of enforcing the provisions of 

this Act, carriers engaged in interstate commerce, and persons receiving food, drugs, devices, tobacco products, or cosmetics in interstate commerce or holding such articles so received, shall, upon the 

request of an officer or employee duly designated by the Secretary, 

permit such officer or employee, at reasonable times, to have access 

to and to copy all records showing the movement in interstate commerce of any food, drug, device, tobacco product, or cosmetic, or the 

holding thereof during or after such movement, and the quantity, 

shipper, and consignee thereof; and it shall be unlawful for any 

such carrier or person to fail to permit such access to and copying 

of any such record so requested when such request is accompanied 

by a statement in writing specifying the nature or kind of food, 

drug, device, tobacco product, or cosmetic to which such request relates, except that evidence obtained under this section, or any evidence which is directly or indirectly derived from such evidence, 

shall not be used in a criminal prosecution of the person from 

whom obtained, and except that carriers shall not be subject to the 

other provisions of this Act by reason of their receipt, carriage, 

holding, or delivery of food, drugs, devices, tobacco products, or cosmetics in the usual course of business as carriers, except as provided in subsection (b). 

* * * * * * * 

FACTORY INSPECTION

SEC. 704. (a)(1) For purposes of enforcement of this Act, officers 

or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, 

or agent in charge, are authorized (A) to enter, at reasonable times, 

any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, 

packed, or held, for introduction into interstate commerce or after 

such introduction, or to enter any vehicle, being used to transport 

or hold such food, drugs, devices, tobacco products, or cosmetics in 

interstate commerce; and (B) to inspect, at reasonable times and 

within reasonable limits and in a reasonable manner, such factory, 

warehouse, establishment, or vehicle and all pertinent equipment, 

finished and unfinished materials, containers, and labeling therein. 

In the case of any person (excluding farms and restaurants) who 

manufactures, processes, packs, transports, distributes, holds, or 

imports foods, the inspection shall extend to all records and other 

information described in section 414 when the Secretary has a reasonable belief that an article of food is adulterated and presents a 


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threat of serious adverse health consequences or death to humans 

or animals, subject to the limitations established in section 414(d). 

In the case of any factory, warehouse, establishment, or consulting 

laboratory in which prescription drugs, nonprescription drugs intended for human use, or restricted devices or tobacco products are 

manufactured, processed, packed, or held, inspection shall extend 

to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, nonprescription drugs intended for human use, or restricted devices or 

tobacco products which are adulterated or misbranded within the 

meaning of this Act, or which may not be manufactured, introduced 

into interstate commerce, or sold, or offered for sale by reason of 

any provision of this Act, have been or are being manufactured, 

processed, packed, transported, or held in any such place, or otherwise bearing on violation of this Act. No inspection authorized by 

the preceding sentence or by paragraph (3) shall extend to financial 

data, sales data other than shipment data, pricing data, personnel 

data (other than data as to qualifications of technical and professional personnel performing functions subject to this Act), and research data (other than data relating to new drugs, antibiotic 

drugs, and devices and subject to reporting and inspection under 

regulations lawfully issued pursuant to section 505(i) or (k) section 

519, or 520(g), and data relating to other drugs or devices which 

in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to section 505(j)). A 

separate notice shall be given for each such inspection, but a notice 

shall not be required for each entry made during the period covered 

by the inspection. Each such inspection shall be commenced and 

completed with reasonable promptness. 

* * * * * * * 

(b) Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to 

leaving the premises, the officer or employee making the inspection 

shall give to the owner, operator, or agent in charge a report in 

writing setting forth any conditions or practices observed by him 

which, in his judgment, indicate that any food, drug, device, tobacco product, or cosmetic in such establishment (1) consists in 

whole or in part of any filthy, putrid, or decomposed substance, or 

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

whereby it may have become contaminated with filth, or whereby 

it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary. 

* * * * * * * 

(g)(1) * * * 

* * * * * * * 

(13) The Secretary shall include in the annual report required 

under øsection 903(g)¿ section 1003(g) the names of all accredited 

persons and the particular activities under this subsection for 

which each such person is accredited and the name of each accredited person whose accreditation has been withdrawn during the 

year. 

* * * * * * * 


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PUBLICITY

SEC. 705. (a) * * * 

(b) The Secretary may also cause to be disseminated information 

regarding food, drugs, devices, tobacco products, or cosmetics in situations involving, in the opinion of the Secretary, imminent danger 

to health, or gross deception of the consumer. Nothing in this section shall be construed to prohibit the Secretary from collecting, reporting, and illustrating the results of the investigations of the Department. 

* * * * * * * 

PRESUMPTION

SEC. 709. In any action to enforce the requirements of this Act 

respecting a device, tobacco product, food, drug, or cosmetic the 

connection with interstate commerce required for jurisdiction in 

such action shall be presumed to exist. 

* * * * * * * 

CHAPTER VIII—IMPORTS AND EXPORTS 

IMPORTS AND EXPORTS

SEC. 801. (a) The Secretary of the Treasury shall deliver to the 

Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, tobacco products, and cosmetics which 

are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the 

right to introduce testimony. The Secretary of Health and Human 

Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 510 or 

section 905(h) and shall request that if any ødrugs or devices¿ 

drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, 

samples of such ødrugs or devices¿ drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, 

with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have 

the right to introduce testimony. If it appears from the examination 

of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in 

the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of 

the device do not conform to the requirements of section 520(f), or 

(2) such article is forbidden or restricted in sale in the country in 

which it was produced or from which it was exported, or (3) such 

article is adulterated, misbranded, or in violation of section 505, or 

prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll), then such article shall be refused admission, except as provided in subsection (b) of this section. If such article is subject to a requirement under section 760 

or 761 and if the Secretary has credible evidence or information indicating that the responsible person (as defined in such section 760 


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or 761) has not complied with a requirement of such section 760 

or 761 with respect to any such article, or has not allowed access 

to records described in such section 760 or 761, then such article 

shall be refused admission, except as provided in subsection (b) of 

this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations. Clause (2) of the third sentence of this paragraph shall 

not be construed to prohibit the admission of narcotic drugs the importation of which is permitted under the Controlled Substances 

Import and Export Act. 

* * * * * * * 

(e)(1) A food, drug, device, tobacco product, or cosmetic intended 

for export shall not be deemed to be adulterated or misbranded 

under this Act if it— 

(A) * * * 

* * * * * * * 

(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. 

* * * * * * * 

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 

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istered 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 

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 Self-Determination 

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. 


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(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 selfservice 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. 

(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 perVerDate Nov 24 2008 05:06 Mar 28, 2009 Jkt 079006 PO 00000 Frm 00063 Fmt 6659 Sfmt 6603 E:\HR\OC\HR058P1.XXX HR058P1

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son’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 

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 


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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 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); 


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(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; 

(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 deVerDate Nov 24 2008 05:06 Mar 28, 2009 Jkt 079006 PO 00000 Frm 00066 Fmt 6659 Sfmt 6603 E:\HR\OC\HR058P1.XXX HR058P1

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scriptive 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. 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 


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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 (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. 


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(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 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 PROC- ESSING.—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. 


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(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 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— 


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(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. 

(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). 


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(j) REPORT PRECEDING INTRODUCTION OF CERTAIN SUBSTANTIALLY 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 

(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 


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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 

(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— 


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(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 faceto-face transactions by a specific category of retail outlets; or 

(ii) establish a minimum age of sale of tobacco products to any person older than 18 years of age. 

(B) MATCHBOOKS.—For purposes of any regulations 

issued by the Secretary, matchbooks of conventional size 

containing not more than 20 paper matches, and which are 

customarily given away for free with the purchase of tobacco 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. 


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(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; 

(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; 


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(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 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. 


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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. 

(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 


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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; 

(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 PERSONS.— 

In carrying out duties under this section, the Secretary shall endeavor to— 


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(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. 

(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) 


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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 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. 


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(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. 

(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 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. 

SEC. 908. NOTIFICATION AND OTHER REMEDIES. 

(a) NOTIFICATION.—If the Secretary determines that— 


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(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. 

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. 


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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 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.— 


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(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 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 


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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— 

(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; 


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(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; 

(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 appliVerDate Nov 24 2008 05:06 Mar 28, 2009 Jkt 079006 PO 00000 Frm 00086 Fmt 6659 Sfmt 6603 E:\HR\OC\HR058P1.XXX HR058P1

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cation 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 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 


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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; 

(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 


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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 

(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 tobacco-related 

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; 


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(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 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— 


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(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 health-related 

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 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 tobacco-related 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 


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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. 

(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. 


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(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 

(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). 


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(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 healthrelated 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. 

(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); 


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(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). 

(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 


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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 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 


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(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. 

(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 


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(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, 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 tobacco-related 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— 


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(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 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 toVerDate Nov 24 2008 05:06 Mar 28, 2009 Jkt 079006 PO 00000 Frm 00099 Fmt 6659 Sfmt 6603 E:\HR\OC\HR058P1.XXX HR058P1

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bacco 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 

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 


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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 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; 


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(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 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 full-time 

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. 


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(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; 

(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-nicotine-based 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 


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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. 

(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 


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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). 

(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 TO- BACCO 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 


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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. 

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.— 

(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. 

No fees collected under subsection (a) may be used for any 

other costs. 

(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 the purpose described in subparagraph (A). 

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

the date on which the Secretary has collected fees 

under subsection (a) for 2 fiscal year quarters. Until 

such date, other amounts available to the Food and 

Drug Administration (excluding fees collected under 

subsection (a)) are authorized to be made available to 

pay the costs described in subparagraph (A), provided 

that such amounts are reimbursed through fees collected under subsection (a). 

(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. 

(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 


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(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). 

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 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. 

(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 


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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. 

Chapter øIX¿ X—MISCELLANEOUS 

SEPARABILITY CLAUSE

SEC. ø901.¿ 1001. If any provision of this Act is declared unconstitutional, or the applicability thereof to any person or circumstances is held invalid, the constitutionality of the remainder 

of the Act and the applicability thereof to other persons and circumstances shall not be affected thereby. 

EFFECTIVE DATE AND REPEALS

SEC. ø902.¿ 1002. (a) * * * 

* * * * * * * 

SEC. ø903.¿ 1003. FOOD AND DRUG ADMINISTRATION. 

(a) * * * 

* * * * * * * 

(d) COMMISSIONER.— (1) * * * 

(2) GENERAL POWERS.—The Secretary, through the Commissioner, shall be responsible for executing this Act and for— 


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109 

(A) * * * 

* * * * * * * 

(C) research relating to foods, drugs, cosmetics, øand¿ 

devices, and tobacco products in carrying out this Act; 

* * * * * * * 

SEC. ø904.¿ 1004. SCIENTIFIC REVIEW GROUPS. 

Without regard to the provisions of title 5, United States Code, 

governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 

53 of such title relating to classification and General Schedule pay 

rates, the Commissioner of Food and Drugs may— 

(1) * * * 

* * * * * * * 

SEC. ø905.¿ 1005. LOAN REPAYMENT PROGRAM. 

(a) * * * 

* * * * * * * 

SEC. ø906.¿ 1006. PRACTICE OF MEDICINE. 

Nothing in this Act shall be construed to limit or interfere with 

the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or 

disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the 

Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of 

approval, or promulgated through regulations. Further, this section 

shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices. 

SEC. ø907.¿ 1007. CONTRACTS FOR EXPERT REVIEW. 

(a) * * * 

* * * * * * * 

SEC. ø908.¿ 1008. NOTICES TO STATES REGARDING IMPORTED FOOD. 

(a) * * * 

* * * * * * * 

SEC. ø909.¿ 1009. GRANTS TO STATES FOR INSPECTIONS. 

(a) * * * 

(b) NOTICES REGARDING ADULTERATED IMPORTED FOOD.—The 

Secretary may make grants to the States for the purpose of assisting the States with the costs of taking appropriate action to protect 

the public health in response to notification under øsection 908¿ 

section 1008, including planning and otherwise preparing to take 

such action. 

* * * * * * * 

SEC. ø910.¿ 1010. OFFICE OF THE CHIEF SCIENTIST. 

(a) * * * 

* * * * * * * 


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110 

FEDERAL MEAT INSPECTION ACT 

* * * * * * * 

TITLE IV—AUXILIARY PROVISIONS 

* * * * * * * 

SEC. 409.(a) Notwithstanding any other provisions of law, including øsection 902(b)¿ section 1002(b) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 392(a)), the provisions of this Act shall not 

derogate from any authority conferred by the Federal Food, Drug, 

and Cosmetic Act prior to enactment of the Wholesome Meat Act. 

* * * * * * * 

FEDERAL CIGARETTE LABELING AND ADVERTISING 

ACT 

* * * * * * * 

øLABELING

øSEC. 4. (a)(1) It shall be unlawful for any person to manufacture, package, 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: 

øSURGEON GENERAL’S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May Complicate Pregnancy. 

øSURGEON GENERAL’S WARNING: Quitting Smoking Now 

Greatly Reduces Serious Risks to Your Health. 

øSURGEON GENERAL’S WARNING: Smoking by Pregnant 

Women May Result in Fetal Injury, Premature Birth, And Low 

Birth Weight. 

øSURGEON GENERAL’S WARNING: Cigarette Smoke Contains 

Carbon Monoxide. 

ø(2) It shall be unlawful for any manufacturer or importer of 

cigarettes to advertise or cause to be advertised (other than 

through the use of outdoor billboards) within the United States any 

cigarette unless the advertising bears, in accordance with the requirements of this section, one of the following labels: 

øSURGEON GENERAL’S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May Complicate Pregnancy. 

øSURGEON GENERAL’S WARNING: Quitting Smoking Now 

Greatly Reduces Serious Risks to Your Health. 

øSURGEON GENERAL’S WARNING: Smoking by Pregnant 

Women May Result in Fetal Injury, Premature Birth, And Low 

Birth Weight. 

øSURGEON GENERAL’S WARNING: Cigarette Smoke Contains 

Carbon Monoxide. 

ø(3) It shall be unlawful for any manufacturer or importer of 

cigarettes to advertise or cause to be advertised within the United 

States through the use of outdoor billboards any cigarette unless 

the advertising bears, in accordance with the requirements of this 

section, one of the following labels: 

øSURGEON GENERAL’S WARNING: Smoking Causes Lung Cancer, Heart Disease, And Emphysema. 


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øSURGEON GENERAL’S WARNING: Quitting Smoking Now 

Greatly Reduces Serious Health Risks. 

øSURGEON GENERAL’S WARNING: Pregnant Women Who 

Smoke Risk Fetal Injury, And Premature Birth. 

øSURGEON GENERAL’S WARNING: Cigarette Smoke Contains 

Carbon Monoxide. 

ø(b)(1) Each label statement required by paragraph (1) of subsection (a) shall be located in the place label statements were 

placed on cigarete packages as of the date of the enactment of this 

subsection. The phrase ‘‘Surgeon General’s Warning’’ shall appear 

in capital letters and the size of all other lettes in the label shall 

be the same as the size of such letters as of such date of enactment. All the letters in the label shall appear in conspicuous and 

legible type in contrast by typography, layout, or color with all 

other printed material on the package. 

ø(2) The format of each label statement required by paragaph (2) 

of subsection (a) shall be the format required for label statements 

in cigarette advertising as of the date of the enactment of this subsection, except that the phrase ‘‘Surgeon General’s Warning’’ shall 

appear in capital letters, the area of the rectangle enclosing the 

label shall be 50 per centum larger in size with a corresponding increase in the size of the type in the label, the width of the rule 

forming the border around the label shall be twice that in effect on 

such date, and the label may be placed at a distance from the other 

edge of the advertisement which is one-half the distance permitted 

on such date. Each label statement shall appear in conspicuous and 

legible type in contrast by typography, layout, or color with all 

other printed material in the advertisement. 

ø(3) The format and type style of each label statement required 

by paragraph (3) of subsection (a) shall be the format and type 

style required in outdoor billboard advertising as of the date of the 

enactment of this subsection. Each such label statement shall be 

printed in capital letters of the height of the tallest letter in a label 

statement on outdoor advertising of the same dimension on such 

date of enactment. Each such label statement shall be enclosed by 

a black border which is located within the perimeter of the format 

required in outdoor billboard advertising of the same dimension on 

such date of enactment and the width of which is twice the width 

of the vertical element of any letter in the label statement within 

the border. 

ø(c)(1) Except as provided in paragraph (2), the label statements 

specified in paragraphs (1), (2), and (3) of subsection (a) shall be 

rotated by each manufacturer or importer of cigarettes quarterly in 

alternating sequence on packages of each brand of cigarettes manufactured by the manufacturer or importer and in the advertisements for each such brand of cigarettes in accordance with a plan 

submitted by the manufacturer or importer and approved by the 

Federal Trade Commission. The Federal Trade Commission shall 

approve a plan submitted by a manufacturer or importer of cigarettes which will provide the rotation required by this subsection 

and which assures that all of the labels required by paragraphs (1), 

(2), and (3) will be displayed by the manufacturer or importer at 

the same time. 

ø(2)(A) A manufacturer or importer of cigarettes may apply to 

the Federal Trade Commission to have the label rotation described 


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112 

in subparagraph (C) apply with respect to a brand style of cigarettes manufactured or imported by such manufacturer or importer 

if— 

ø(i) the number of cigarettes of such brand style sold in the 

fiscal year of the manufacturer or importer preceding the submission of the application is less than one-fourth of 1 percent 

of all the cigarettes sold in the United States in such year, and 

ø(ii) more than one-half of the cigarettes manufactured or 

imported by such manufacturer or importer for sale in the 

United States are packaged into brand styles which meet the 

requirements of clause (i). 

If an application is approved by the Commission, the label rotation 

described in subparagraph (C) shall apply with respect to the applicant during the one-year period beginning on the date of the application approval. 

ø(B) An applicant under subparagraph (A) shall include in its application a plan under which the label statements specified in paragraph (1) of subsection (a) will be rotated by the applicant manufacturer or importer in accordance with the label rotation described 

in subparagraph (C). 

ø(C) Under the label rotation which the manufacturer or importer with an approved application may put into effect each of the 

labels specified in paragraph (1) of subsection (a) shall appear on 

the packages of each brand style of cigarettes with respect to which 

the application was approved an equal number of times within the 

twelve-month period beginning on the date of the approval by the 

Commission of the application. 

ø(d) Subsection (a) does not apply to a distributor a retailer of 

cigarettes who does not manufacture, package, or import cigarettes 

for sale or distribution within the United States.¿ 

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. 

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 at least the top 30 percent of the 

front and rear panels of the package. The word ‘‘WARNING’’ 

shall appear in capital letters and all text shall be in conVerDate Nov 24 2008 05:06 Mar 28, 2009 Jkt 079006 PO 00000 Frm 00112 Fmt 6659 Sfmt 6603 E:\HR\OC\HR058P1.XXX HR058P1

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spicuous 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 permit-holding 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’’ 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- 


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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— 

(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 adVerDate Nov 24 2008 05:06 Mar 28, 2009 Jkt 079006 PO 00000 Frm 00114 Fmt 6659 Sfmt 6603 E:\HR\OC\HR058P1.XXX HR058P1

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vertisement 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) CHANGE IN REQUIRED STATEMENTS.—The Secretary may, by 

a rulemaking conducted under section 553 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 tobacco products. 

(e) TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLO- SURE.— 

(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 CONSTITU- ENTS.—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. 

(4) RETAILERS.—This subsection applies to a retailer only if 

that retailer is responsible for or directs the label statements required under this section. 

PREEMPTION

SEC. 5. (a) øNo¿ Except to the extent the Secretary requires additional or different statements on any cigarette package by a regulaVerDate Nov 24 2008 05:06 Mar 28, 2009 Jkt 079006 PO 00000 Frm 00115 Fmt 6659 Sfmt 6601 E:\HR\OC\HR058P1.XXX HR058P1

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tion, 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 statement relating to smoking and health, other than the 

statement required by section 4 of this Act, shall be required on 

any cigarette package. 

* * * * * * * 

(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. 

* * * * * * * 

COMPREHENSIVE SMOKELESS TOBACCO HEALTH 

EDUCATION ACT OF 1986 

* * * * * * * 

øSEC. 3. SMOKELESS TOBACCO WARNING. 

ø(a) GENERAL RULE.— ø(1) It shall be unlawful for any person to manufacture, 

package, 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 MAY 

CAUSE MOUTH CANCERWARNING: THIS PRODUCT MAY 

CAUSE GUM DISEASE AND TOOTH LOSSWARNING: THIS 

PRODUCT IS NOT A SAFE ALTERNATIVE TO CIGARETTES’. 

ø(2) It shall be unlawful for any manufacturer, packager, or 

importer of smokeless tobacco products to advertise or cause to 

be advertised (other than through the use of outdoor billboard 

advertising) within the United States any smokeless tobacco 

product unless the advertising bears, in accordance with the 

requirements of this Act, one of the labels required by paragraph (1). 

ø(b) LABEL FORMAT.—The Federal Trade Commission shall issue 

regulations requiring the label statement required by subsection (a) 

to appear— 

ø(1) in the case of the smokeless tobacco product package— 

ø(A) in a conspicuous and prominent place on the package, and 

ø(B) in a conspicuous format and in conspicuous and legible type in contrast with all other printed material on the 

package, and 

ø(2) in the case of advertising subject to subsection (a)(2)— 

ø(A) in a conspicuous and prominent location in the advertisement and in conspicuous and legible type in contrast with all other printed material in the advertisement, 

ø(B) in the following format: 


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ø(C) the label statement shall appear in capital letters 

and the area of the circle and arrow shall be determined 

by the Federal Trade Commission. 

ø(c) LABEL DISPLAY.—The Federal Trade Commission shall issue 

regulations requiring each label statement required by subsection 

(a) to— 

ø(1) in the case of a smokeless tobacco product package, be 

randomly displayed by each manufacturer, packager, or importer of a smokeless tobacco product 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 parts of the 

United States in which such product is marketed, and 

ø(2) in the case of any advertisement of a smokeless tobacco 

product, be rotated every 4 months by each manufacturer, 

packager, or importer of a smokeless tobacco product in an alternating sequence in the advertisement for each brand of the 

product. 

ø(d) PLAN.—(1) Each manufacturer, packager, or importer of a 

smokeless tobacco product shall submit a plan to the Federal Trade 

Commission which specifies the method such manufacturer, packager, or importer will use to rotate, display, and distribute the 

statements required by subsection (a) in accordance with the requirements of subsections (b) and (c). 

ø(2) The Federal Trade Commission shall approve a plan submitted by a manufacturer, packager, or importer of a smokeless tobacco product under paragraph (1) if such plan provides for the rotation, display, and distribution on smokeless tobacco product packages and advertisements of the statements required by subsection 

(a) in a manner which complies with this section and the regulations promulgated pursuant to this section. 


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118 

ø(e) APPLICATION.—This section does not apply to a distributor or 

a retailer of any smokeless tobacco product which does not manufacture, package, or import smokeless tobacco products for sale or 

distribution within the United States. 

ø(f) TELEVISION AND RADIO ADVERTISING.—Effective 6 months 

after the date of the enactment of this Act, it shall be unlawful to 

advertise smokeless tobacco on any medium of electronic communications subject to the jurisdiction of the Federal Communications 

Commission.¿ 

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. 

(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 permit-holding 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.— 


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(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 wholepage 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. 

(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 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— 


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(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. 

(d) AUTHORITY TO REVISE WARNING LABEL STATEMENTS.—The 

Secretary may, by a rulemaking conducted under section 553 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. 

* * * * * * * 

SEC. 7. PREEMPTION. 

(a) FEDERAL ACTION.—øNo¿ Except as provided in the Family 

Smoking Prevention and Tobacco Control Act (and the amendments 

made by that Act), no statement relating to the use of smokeless 

tobacco products and health, other than the statements required by 

section 3, shall be required by any Federal agency to appear on any 

package or in any advertisement (unless the advertisement is an 

outdoor billboard advertisement) of a smokeless tobacco product. 

* * * * * * * 

TITLE 5, UNITED STATES CODE 

* * * * * * * 


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PART III—EMPLOYEES 

* * * * * * * 

SUBPART G—INSURANCE AND ANNUITIES 

* * * * * * * 

CHAPTER 84—FEDERAL EMPLOYEES’ RETIREMENT 

SYSTEM 

Sec 

8401. Definitions. 

* * * * * * * 

SUBCHAPTER III—THRIFT SAVINGS PLAN 

* * * * * * * 

8432d. Qualified Roth contribution program. 

* * * * * * * 

SUBCHAPTER II—BASIC ANNUITY 

* * * * * * * 

§ 8415. Computation of basic annuity 

(a) * * * 

* * * * * * * 

ø(k)¿ (l)(1) In computing an annuity under this subchapter, the 

total service of an employee who retires from the position of a registered nurse with the Veterans Health Administration on an immediate annuity, or dies while employed in that position leaving 

any survivor entitled to an annuity, includes the days of unused 

sick leave to the credit of that employee under a formal leave system, except that such days shall not be counted in determining average pay or annuity eligibility under this subchapter. 

(2) Except as provided in paragraph (1), in computing an annuity 

under this subchapter, the total service of an employee who retires 

on an immediate annuity or who dies leaving a survivor or survivors entitled to annuity includes the days of unused sick leave to 

his credit under a formal leave system, except that these days will 

not be counted in determining average pay or annuity eligibility 

under this subchapter. For purposes of this subsection, in the case 

of any such employee who is excepted from subchapter I of chapter 

63 under section 6301(2)(x)-(xiii), the days of unused sick leave to 

his credit include any unused sick leave standing to his credit when 

he was excepted from such subchapter. 

ø(l)¿ (m) In the case of any annuity computation under this section that includes, in the aggregate, at least 2 months of credit 

under section 8411(d) for any period while receiving benefits under 

subchapter I of chapter 81, the percentage otherwise applicable 

under this section for that period so credited shall be increased by 

1 percentage point. 

* * * * * * * 


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§ 8422. Deductions from pay; contributions for other service 

(a) * * * 

* * * * * * * 

(d)(1) * * * 

(2) Deposit may not be required for days of unused sick leave 

credited under øsection 8415(k)¿ paragraph (1) or (2) of section 

8415(l). 

* * * * * * * 

SUBCHAPTER III—THRIFT SAVINGS PLAN 

* * * * * * * 

§ 8432. Contributions 

(a) * * * 

(b)(1)(A) * * * 

(B) The amount to be contributed pursuant to an election under 

subparagraph (A) ø(or any election allowable by virtue of paragraph (4))¿ shall be the percentage of basic pay or amount designated by the employee or Member. 

ø(2) Under the regulations— 

ø(A) an employee or Member who has not previously been eligible to make an election under this subsection shall not become so eligible until the date (described in paragraph (1)) beginning after the date of commencing service as an employee 

or Member; 

ø(B) an employee or Member whose appointment or election 

to a position or office in the Federal Government follows a previous period of service during which that individual met the requirements of subparagraph (A) shall be eligible to make an 

election under this subsection notwithstanding any period of 

separation; 

ø(C) an employee or Member who elects under subparagraph 

(D) to terminate contributions shall not again become eligible 

to make an election under this subsection until the date (described in paragraph (1)) commencing after the election to terminate; and 

ø(D) an election to terminate may be made under this subparagraph at any time as provided under paragraph (1). 

ø(3) An employee or Member who elects to become subject to this 

chapter under section 301 of the Federal Employees’ Retirement 

System Act of 1986 may make the first election for the purpose of 

subsection (a) during the period prescribed for such purpose by the 

Executive Director. The period prescribed by the Executive Director 

shall commence on the date on which the employee or Member 

makes the election to become subject to this chapter. 

ø(4) The Executive Director shall prescribe such regulations as 

may be necessary to carry out the following: 

ø(A) Notwithstanding subparagraph (A) of paragraph (2), an 

employee or Member described in such subparagraph shall be 

afforded a reasonable opportunity to first make an election 

under this subsection beginning on the date of commencing 

service or, if that is not administratively feasible, beginning on 

the earliest date thereafter that such an election becomes adVerDate Nov 24 2008 05:06 Mar 28, 2009 Jkt 079006 PO 00000 Frm 00122 Fmt 6659 Sfmt 6601 E:\HR\OC\HR058P1.XXX HR058P1

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ministratively feasible, as determined by the Executive Director. 

ø(B) An employee or Member described in subparagraph (B) 

of paragraph (2) shall be afforded a reasonable opportunity to 

first make an election under this subsection (based on the appointment or election described in such subparagraph) beginning on the date of commencing service pursuant to such appointment or election or, if that is not administratively feasible, beginning on the earliest date thereafter that such an 

election becomes administratively feasible, as determined by 

the Executive Director. 

ø(C)(i) Notwithstanding the preceding provisions of this 

paragraph, contributions under paragraphs (1) and (2) of subsection (c) shall not be payable with respect to any pay period 

before the earliest pay period for which such contributions 

would otherwise be allowable under this subsection if this 

paragraph had not been enacted. 

ø(ii) Notwithstanding subparagraph (A) or (B), contributions 

under paragraphs (1) and (2) of subsection (c) shall not begin 

to be made with respect to an employee or Member described 

under paragraph (2)(A) or (B) until the date that such contributions would have begun to be made in accordance with 

this paragraph as administered on the date preceding the date 

of enactment of the Thrift Savings Plan Open Elections Act of 

2004. 

ø(D) Sections 8351(a)(2), 8440a(a)(2), 8440b(a)(2), 

8440c(a)(2), and 8440d(a)(2) shall be applied in a manner consistent with the purposes of subparagraphs (A) and (B), to the 

extent those subparagraphs can be applied with respect thereto. 

ø(E) Nothing in this paragraph shall affect paragraph (3).¿ 

(2)(A) The Board 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 by regulation 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 from the start of such enrollment; or 

(ii) decline automatic enrollment altogether. 

(D) 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 is eligible to contribute to the 

Thrift Savings Fund. 

(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. 

* * * * * * * 


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§ 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. 

(b) AUTHORITY TO ESTABLISH.—The Board 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. 

* * * * * * * 

§ 8438. Investment of Thrift Savings Fund 

(a) * * * 

(b)(1) The Board shall establish— 

(A) * * * 

* * * * * * * 

(D) a Small Capitalization Stock Index Investment Fund as 

provided in paragraph (3); øand¿ 

(E) an International Stock Index Investment Fund as provided in paragraph (4)ø.¿; and 

(F) a self-directed investment window, if the Board authorizes 

such window under paragraph (5). 

* * * * * * * 

(5)(A) The Board may authorize the addition of a self-directed investment window under the Thrift Savings Plan if the Board determines that such addition would be in the best interests of participants. 

(B) The self-directed investment window shall be limited to— 

(i) low-cost, passively-managed index funds that offer diversification benefits; and 

(ii) other investment options, if the Board determines the options to be appropriate retirement investment vehicles for participants. 


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(C) The Board shall ensure that any administrative expenses related to use of the self-directed investment window are borne solely 

by the participants who use such window. 

(D) The Board may establish such other terms and conditions for 

the self-directed investment window as the Board considers appropriate to protect the interests of participants, including requirements 

relating to risk disclosure. 

(E) The Board shall consult with the Employee Thrift Advisory 

Council (established under section 8473) before establishing any 

self-directed investment window. 

* * * * * * * 

§ 8439. Accounting and information 

(a) * * * 

* * * * * * * 

ø(d)¿ (d)(1) Each employee, Member, former employee, or former 

Member who elects to invest in øthe Common Stock Index Investment Fund, the Fixed Income Investment Fund, the International 

Stock Index Investment Fund, or the Small Capitalization Stock 

Index Investment Fund, defined in paragraphs (1), (3), (5), and 

(10), respectively, of section 8438(a) of this title¿ any investment 

fund or option under this chapter, other than the Government Securities Investment Fund, shall sign an acknowledgement prescribed 

by the Executive Director which states that the employee, Member, 

former employee, or former Member understands that an investment in øeither such Fund¿ any such fund or option is made at the 

employee’s, Member’s, former employee’s, or former Member’s risk, 

that the employee, Member, former employee, or former Member is 

not protected by the Government against any loss on such investment, and that a return on such investment is not guaranteed by 

the Government. 

(2)(A) In the case of an investment made under section 8438(c)(2) 

in any fund or option to which paragraph (1) would otherwise 

apply, the participant involved shall, for purposes of this subsection, 

be deemed— 

(i) to have elected to invest in such fund or option; and 

(ii) to have executed the acknowledgement required under 

paragraph (1). 

(B)(i) The Executive Director shall prescribe regulations under 

which written notice shall be provided to a participant whenever an 

investment is made under section 8438(c)(2)(B) on behalf of such 

participant in the absence of an affirmative election described in 

section 8438(c)(1). 

(ii) The regulations shall ensure that any such notice shall be provided to the participant within 7 calendar days after the effective 

date of the default election. 

(C) For purposes of this paragraph, the term ‘‘participant’’ has the 

meaning given such term by section 8471(3). 

* * * * * * * 

SUBCHAPTER VII—FEDERAL RETIREMENT THRIFT 

INVESTMENT MANAGEMENT SYSTEM 

* * * * * * * 


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§ 8477. Fiduciary responsibilities; liability and penalties 

(a) * * * 

* * * * * * * 

(e)(1)(A) * * * 

* * * * * * * 

(C)(i) A fiduciary shall not be liable under subparagraph (A) with 

respect to a breach of fiduciary duty under subsection (b) committed before becoming a fiduciary or after ceasing to be a fiduciary. 

(ii) A fiduciary shall not be liable under subparagraph (A), and 

no civil action may be brought against a fiduciary— 

(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)(B); or 

(III) for allowing a participant to invest through the self-directed investment window or for establishing restrictions applicable to participants’ ability to invest through the self-directed 

investment window. 

* * * * * * * 


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DISSENTING VIEWS 

Forcing the Food and Drug Administration (FDA) to regulate tobacco products—products that will never qualify as ‘‘safe and effective’’—could have significant negative impacts on all Americans. 

This Committee has spent a great deal of time investigating the 

ways in which the FDA has been unable to fulfill its core mission. 

Therefore, we are concerned that burdening the FDA with added 

responsibilities outside of the agency’s expertise and core missions 

at this time will have dire consequences for the American people 

and the FDA’s ability to ensure the safety and efficacy of our nation’s food, drugs, and medical devices. We are also concerned that 

effectively giving the FDA stamp of approval on cigarettes will improperly lead people to believe these products are safer than they 

truly are. 

H.R. 1256 also allows the use of FDA general funds for ‘‘startup 

costs’’ associated with the bill’s new tobacco regulation activities. 

The bill allows the FDA to divert resources from its core mission, 

including funds from food safety inspections and drug and device 

approvals. While the bill specifies these funds must be reimbursed 

by manufacturer user fees, it does not provide a timeline for reimbursement, further straining FDA’s limited resources. Regardless 

of how quickly FDA is able to collect manufacturer user fees, the 

bill requires use of general funds for tobacco startup costs for at 

least six months. Depending on the timing of user fee collection, 

additional resources would have to be diverted from FDA general 

funds as the agency awaits annual appropriations. At a time when 

FDA is struggling to perform many of its core functions, diversion 

of its limited resources will negatively impact the safety of the 

American public. 

In order to rectify the concerns about H.R. 1256 outlined below, 

the Committee considered a substitute amendment offered by Congressman Steve Buyer to establish the Tobacco Harm Reduction 

Center under the Department of Health and Human Services 

(HHS). The substitute would have protected the already overburdened FDA from carrying out significant new tobacco regulations. 

The substitute was based on public health policies that acknowledge a continuum of risk among all tobacco products and referenced scientific literature which shows that smokeless tobacco 

products are 90–99% less hazardous than cigarettes in their risk of 

causing tobacco-related illness and death. The substitute would 

have ensured adult tobacco users are given complete, accurate and 

truthful information about the risks and relative risks of all tobacco products so that they can make informed health decisions. 

The substitute incentivized the development of reduced-risk tobacco 

products. Additionally, the substitute expressly prohibited regulations affecting tobacco growers, strengthened preventions against 

minors’ tobacco use, was funded through the normal appropriations 


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process instead of new user fees, and protected American jobs. All 

Republican members present at the markup voted in favor of this 

substitute. 

H.R. 1256 purports to utilize a science-based approach to the regulation of tobacco products but ignores accepted scientific evidence 

that harm reduction strategies for moving people to less dangerous 

tobacco products will in fact lead to lower incidences of smokingrelated illnesses. This is especially troublesome given the legislation’s lack of incentives for States to use Master Settlement funds 

for smoking cessation and other public health programs. 

If enacted, this legislation significantly curtails, if not entirely 

eliminates, incentives to develop and market products that reduce 

exposure to tobacco toxicants. In order to obtain approval of a 

modified-risk product, an applicant must demonstrate that the 

marketing and labeling of the product will not mislead consumers 

into believing that the product is or has been demonstrated to be 

less harmful. Further, it has to be demonstrated that the product 

reduces risk for both the individual and for the population as a 

whole. It is unlikely that such a standard could ever be proven. 

The legislation provides no incentives to manufacturers to research 

and develop reduced-risk products, and the requirement forcing 

companies to turn over all research to the FDA—whether used in 

reduced-risk product development or not—is a significant hindrance to the development of modified-risk products. 

The standard for approval of modified-risk products is unclear in 

H.R. 1256, which will create, at best, ambiguities for applicants in 

the standards that must be met or, at worst, product standards 

that can never be achieved, thus eliminating modified-risk products 

coming to market. We are concerned that such disincentives will effectively freeze the current tobacco market and prevent innovation 

which could lead to significantly less harmful tobacco products and 

improve our nation’s health. 

It is important to note that in 2001 the Institute of Medicine 

noted, ‘‘The potential for reduction in morbidity and mortality that 

could result from the use of less toxic products by those who do not 

stop using tobacco justifies inclusion of harm reduction as a component in a broad program of tobacco control.’’ 

Additionally, the Royal College of Physicians has stated, ‘‘The 

fundamental argument of this report is that this current situation 

is perverse, unjust, and acts against the rights and best interests 

of smokers and the public health. Harm reduction has the potential 

to play a major part in preventing death and disability in the millions of people who currently smoke and who, in the context of exposure to currently available drivers and supports to cessation, either cannot or will not otherwise quit smoking. These smokers 

have a right to be able to obtain and choose from a range of safer 

nicotine products, and they have a right to accurate and unbiased 

information to guide that choice.’’ 

The American Association of Public Health Physicians wrote on 

March 3, 2009, in regard to H.R. 1256, ‘‘the current bill [H.R. 

1256], in its current form, would assure current levels of tobaccorelated deaths while doing nothing of significance to reduce the 

number of teens who would initiate tobacco use with no bill at all.’’ 


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We are also opposed to the annual tax assessments placed on 

manufacturers. If Congress deems this regulation necessary for the 

protection of the public health then it should be important enough 

to appropriate funds for these activities. Manufacturers will be assessed $712 million by 2018. Claiming that a tax is a user fee does 

not change the fact that it is a tax. This is a dangerous precedent 

that grows the size of government and taxes the American people 

through secrecy and synonyms. 

H.R. 1256 will limit competition and provide essentially a monopoly to the largest companies operating today. In doing so, smaller 

companies will be denied competitive opportunities within the market because the barriers to entry are just too high. This legislation 

has the unintended consequence of creating monopolies within the 

market. Section 906 could allow the FDA to create a virtual monopoly in the tobacco market by creating tobacco product standards 

that only a few of the well-capitalized companies have the resources to achieve. The regressive nature of excise taxes, as well 

as the price increases that accompany monopolistic behavior, will 

impact low-income Americans the hardest. 

If the FDA is forced to regulate tobacco products, this legislation 

calls for the immediate codification of regulations that were drafted 

over twelve years ago. The regulations issued in 1996 were promulgated under the premise that cigarettes were medical devices. H.R. 

1256 would not regulate cigarettes as medical devices but rather 

creates a new category of tobacco products with separate regulatory 

requirements. Since 1996, the Master Settlement Agreement has 

been executed and various other State regulations have been enacted with respect to marketing, advertising, and tobacco use. We 

believe that it is poor public policy to not revisit the regulations 

and take the time to better understand the current regulations 

those manufacturers are operating under and then update the language as necessary. 

We also believe that the marketing provisions of H.R. 1256 are 

violative of the First Amendment. Section 102 of the bill directs the 

Secretary of Health and Human Services to publish an interim 

final rule that is ‘‘identical in its provisions’’ to the proposed rule 

promulgated by the FDA in 1996. Numerous legal experts have 

stated that the broad restrictions in that proposal are in effect a 

de facto ban on tobacco advertising, and violate the First Amendment. In fact, the U.S. Supreme Court held in Lorillard Tobacco 

Co. v. Thomas Reilly, Attorney General of Massachusetts, 533 U.S. 

525 (2001) that a Massachusetts tobacco regulation that was virtually identical to one part of the FDA 1996 proposal was unconstitutional. 

The effect of the various provisions in H.R. 1256 is a suspension 

of the ability to advertise tobacco products to adults, violating the 

First Amendment protections for commercial speech. The U.S. Supreme Court has emphasized repeatedly, including the landmark 

Central Hudson case, Central Hudson Gas & Electric v. Public 

Service Commission, 447 U.S. 557 (1980) that truthful, nondeceptive commercial speech cannot be banned or restricted unless the 

restriction ‘‘directly and materially advances’’ a ‘‘substantial governmental interest’’ and is ‘‘narrowly tailored’’ to ‘‘reasonably fit’’ 

that interest. 


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Finding 30 in the legislation states that the final regulations 

issued on August 20, 1996, are consistent with the First Amendment. Finding 31 states the regulations described in Finding 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.’’ 

These findings attempt to address the Constitutional test of the 

Supreme Court for determining if restrictions on commercial 

speech violate the First Amendment. One prong of the test is the 

restriction must be to advance a compelling government interest. 

The test also has a prong that states the restrictions be ‘‘narrowly 

tailored’’ to ‘‘reasonably fit’’ that interest. Finding 31 states that 

‘‘less restricting and less comprehensive approaches have not and 

will not be effective in reducing the problems addressed by such 

regulations.’’ Again, the authors of the bill try to preempt Constitutional questions regarding the legislation by reciting findings designed to answer the Constitutional test for restricting free speech. 

However, Finding 31 is not based in fact and clearly ignores the 

fact that youth smoking has declined dramatically since the Master 

Settlement Agreement. A 2006 University of Michigan study has 

shown youth smoking rates have declined from over 28% in 1997 

to less than 15% in 2006. Additionally, the rate of youths able to 

purchase cigarettes in stores has dropped dramatically since the 

imposition of the Synar Amendment in 1996. 

It is important to note that aside from the bill’s findings, H.R. 

1256 does not include any other provisions designed to protect minors from tobacco use. Many members of the Committee would 

have supported further steps to require States to use more of their 

Master Settlement Agreement funds to combat underage smoking 

and promote smoking cessation while also strengthening the Synar 

Amendment on the underage purchasing of cigarettes. Such steps 

would have been narrowly tailored to achieve the government interest without imposing clearly unconstitutional restrictions of 

First Amendment rights. In addition to these provisions being narrowly tailored, they would have also proved much more effective in 

addressing youth smoking rates and helping people to quit smoking. Unfortunately, H.R. 1256 was drafted in a manner that would 

have made such amendments non-germane during Committee consideration of the legislation. 

The Majority understands the violative nature of many of the 

provisions in the legislation and thus included a severability clause 

to allow some parts of the bill to stand with the presumption that 

others would be struck down by the courts. In fact, in the Lorillard 

case, the Supreme Court struck down a regulation promulgated by 

the Attorney General of Massachusetts that was similar in many 

respects to the FDA’s proposed rule. The Massachusetts regulation 

banned outdoor ads within 1,000 feet of schools, parks and playgrounds and also restricted point-of-sale advertising for tobacco 

products. 

In finding that the Massachusetts regulation was not narrowly 

tailored, Justice Sandra Day O’Connor actually noted a similar 

problem with the FDA regulation: 


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First, the Attorney General did not seem to consider the 

impact of the 1,000-foot restriction on commercial speech 

in major metropolitan areas. The Attorney General apparently selected the 1,000-foot distance based on the FDA’s 

decision to impose an identical 1,000-foot restriction when 

it attempted to regulate cigarette and smokeless tobacco 

advertising. The FDA’s regulations would have had widely 

disparate effects nationwide. Even in Massachusetts, the 

effect of the Attorney General’s speech regulations will 

vary based on whether a locale is rural, suburban, or 

urban. The uniformly broad sweep of the geographical limitation demonstrates a lack of tailoring. 

In more recent commercial speech cases, the Supreme Court has 

substantially raised the bar government regulators need to hurdle 

to impose restrictions on advertising. Justice O’Connor, speaking 

for the majority of the Court, for example, in Thompson v. Western 

States Medical Center, 535 U.S. 357 (2002), stated, ‘‘If the First 

Amendment means anything, it means that regulating speech must 

be a last—not first—resort.’’ 

The government has a legitimate interest in protecting minors 

from the use of tobacco products. The proposed advertising regulations in H.R. 1256, however, are overbroad and impermissibly restrictive. They are clearly unconstitutional. 

Additionally, we remain concerned about provisions in H.R. 1256 

which will affect our nation’s tobacco growers. While the bill purports to have no effect on tobacco growers, regulation regarding 

leaf cultivation and curing are inevitable under the bill and might 

lead the FDA to require tobacco manufacturers to buy only certain 

types of tobacco which are grown or cured in specific ways. Pesticide provisions in H.R. 1256 could also increase farmers’ fixed 

costs and increase liability exposure. FDA and EPA will impose 

regulations on what pesticides can be used, how much can be used, 

and when they can be applied. This will be true of imported and 

domestic leaf, and the requirements can be initiated at the FDA’s 

discretion. The bill leaves significant uncertainty concerning future 

pesticide requirements to which tobacco growers will be subject. 

H.R. 1256 also gives FDA the authority to regulate product blends 

and product design which will indirectly affect growers by requiring tobacco manufacturers to regulate all aspects of the growing 

and curing of tobacco in order to produce ingredients that are satisfactory to FDA. 

H.R. 1256 also includes significant inconsistencies with regard to 

the treatment of tobacco exports. In Section 103, the bill amends 

Section 801(e)(1) of the Food, Drug and Cosmetic Act (FDCA) by 

adding the words ‘‘tobacco product’’ and in doing so exempts tobacco products from the requirements of H.R. 1256. However, Section 103 contains a handful of other amendments to Section 301 of 

the FDCA that could bring exports back within the jurisdiction of 

the FDA for violating certain sections of the bill. For example, in 

Section 103(a)(10), the bill states that it would be a violation of 

H.R. 1256 if a manufacturer did not comply with tobacco product 

standards set forth in Section 907 of the FDCA. This provision arguably puts exports under the same product standards applicable 

to domestic and imported tobacco products. Additionally, the folVerDate Nov 24 2008 05:06 Mar 28, 2009 Jkt 079006 PO 00000 Frm 00131 Fmt 6604 Sfmt 6602 E:\HR\OC\HR058P1.XXX HR058P1

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lowing sections may also be applicable to tobacco exports: use of tobacco product warnings; ingredient, nicotine, and constituent reporting; general provisions respecting control of tobacco products; 

notification and other remedies; records and reports on tobacco 

products; modified-risk products; preservation of State and local 

authority; and tracking and tracing regulations. 

In the absence of proper Committee evaluation of H.R. 1256 and 

without the stated concerns addressed, we oppose the legislation. 

Sincerely, 

JOE BARTON, Ranking Member, Committee 

on Energy and Commerce. 

NATHAN DEAL, Ranking Member, Subcommittee on Health. 

STEVE BUYER. JOSEPH R. PITTS. MIKE ROGERS. JOHN SULLIVAN. MICHAEL C. BURGESS. MARSHA BLACKBURN. STEVE SCALISE. 


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(133) 

ADDITIONAL DISSENTING VIEWS 

The incapacity of the FDA to fully implement their current responsibilities is without question. Over 16 hearings on FDA related 

matters alone came before this committee’s Oversight and Investigations Subcommittee on the 110th Congress, and already in the 

111th we have held a hearing on the ineffectiveness of CFSAN and 

their roles in food safety outbreaks. Now, we as a Committee are 

proposing to advance a bill to give to the FDA one of the largest 

increases in regulatory power by allowing their control over an inherently dangerous product like tobacco. 

In should be intuitively obvious to the casual observer this action 

would be both illogical and harmful. The FDA’s resources are already strained given the agency’s current mission intersecting with 

the rapid changes in the global marketplace. More and more supervision is required of the drugs and medical device departments 

simply by the sheer increase in volume—as opposed to deleterious 

actions by individual bad actors—not to mention the need for FDA 

to have more supervision in their other departments as well. 

Furthermore, even if we were to concede that the FDA should 

regulate tobacco—which we clearly do not—it is extremely hypocritical to allow a science-based agency like the FDA to regulate 

this inherently dangerous drug without giving to them the power 

and ability to take nicotine levels down to zero milligrams. Under 

the bill language as it currently stands, the FDA could take nicotine levels down to 0.00000001—or any number just short of absolutely zero milligrams of nicotine—but the FDA can not take the 

level of nicotine all the way to zero. This is hypocritical. If we are 

truly concerned with the marketing and manufacturing of the safety and efficacy of this inherently dangerous drug is scientifically 

measured, then we should allow the FDA’s evidence-based review 

to determine whether science requires a mandate of zero milligrams of nicotine in cigarettes. Any handicapping of scientific review by a body who is not inherently scientific—such as Congress— 

makes no sense. 

Sincerely, 

MICHAEL C. BURGESS. 

Æ 


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