[House Report 111-58, Part 1]
[From the U.S. Government Publishing Office]


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
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 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 tobacco-dependent 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 so-called ``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 Institute 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 
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:


         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.
    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 pay-as-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-as-you-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 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).

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             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

                                         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.

    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 products 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.
---------------------------------------------------------------------------
    \1\For 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.
---------------------------------------------------------------------------
    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 products 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 authorized 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 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:
           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, deposited in the Crime Victims Fund, and 
later spent. Such expenditures 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 after-tax 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 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 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 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.


             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 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.

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.

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, substances, and additives that are 
added to the tobacco, paper, filter, 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 
reduced-risk 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.

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 face-to-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 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 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 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 the product is substantially equivalent to an 
existing product. Section 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.
    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 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.

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 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.
    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 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. The Committee notes that 
this narrowly tailored sampling provision 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 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 cigarette advertising or promotion. States 
or localities may not restrict 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.
    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).

               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)[.], 515(f), 519, 564, 760, [or 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, 573[.], 704, [708, 
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 (whether or not the first sale) after 
shipment in interstate commerce and results in such article 
being adulterated or misbranded.

           *       *       *       *       *       *       *

  [(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).
  [(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 [device,] 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.
  (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 [assessed] 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 [penalty] 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 
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 
[issued.] 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, [and] (D) Any adulterated or 
misbranded [device.] 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 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 Secretary 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 [section 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 
                [section 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.
  (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 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 [section 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.

           *       *       *       *       *       *       *


                               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 [drugs 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 [drugs 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 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 content, flavoring used, size, 
        filtration, packaging, logo, registered trademark, 
        brand name, identifiable pattern of colors, or any 
        combination of such attributes.
          (3) Cigarette.--The term ``cigarette''--
                  (A) means a product that--
                          (i) is a tobacco product; and
                          (ii) meets the definition of the term 
                        ``cigarette'' in section 3(1) of the 
                        Federal Cigarette Labeling and 
                        Advertising Act; and
                  (B) includes tobacco, in any form, that is 
                functional in the product, which, because of 
                its appearance, the type of tobacco used in the 
                filler, or its packaging and labeling, is 
                likely to be offered to, or purchased by, 
                consumers as a cigarette or as roll-your-own 
                tobacco.
          (4) Cigarette tobacco.--The term ``cigarette 
        tobacco'' means any product that consists of loose 
        tobacco that is intended for use by consumers in a 
        cigarette. Unless otherwise stated, the requirements 
        applicable to cigarettes under this chapter shall also 
        apply to cigarette tobacco.
          (5) Commerce.--The term ``commerce'' has the meaning 
        given that term by section 3(2) of the Federal 
        Cigarette Labeling and Advertising Act.
          (6) Counterfeit tobacco product.--The term 
        ``counterfeit tobacco product'' means a tobacco product 
        (or the container or labeling of such a product) that, 
        without authorization, bears the trademark, trade name, 
        or other identifying mark, imprint, or device, or any 
        likeness thereof, of a tobacco product listed in a 
        registration under section 905(i)(1).
          (7) Distributor.--The term ``distributor'' as regards 
        a tobacco product means any person who furthers the 
        distribution of a tobacco product, whether domestic or 
        imported, at any 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.
          (13) Package.--The term ``package'' means a pack, 
        box, carton, or container of any kind or, if no other 
        container, any wrapping (including cellophane), in 
        which a tobacco product is offered for sale, sold, or 
        otherwise distributed to consumers.
          (14) Retailer.--The term ``retailer'' means any 
        person, government, or entity who sells tobacco 
        products to individuals for personal consumption, or 
        who operates a facility where self-service displays of 
        tobacco products are permitted.
          (15) Roll-your-own tobacco.--The term ``roll-your-own 
        tobacco'' means any tobacco product which, because of 
        its appearance, type, packaging, or labeling, is 
        suitable for use and likely to be offered to, or 
        purchased by, consumers as tobacco for making 
        cigarettes.
          (16) Small tobacco product manufacturer.--The term 
        ``small tobacco product manufacturer'' means a tobacco 
        product manufacturer that employs fewer than 350 
        employees. For purposes of determining the number of 
        employees of a manufacturer under the preceding 
        sentence, the employees of a manufacturer are deemed to 
        include the employees of each entity that controls, is 
        controlled by, or is under common control with such 
        manufacturer.
          (17) Smoke constituent.--The term ``smoke 
        constituent'' means any chemical or chemical compound 
        in mainstream or sidestream tobacco smoke that either 
        transfers from any component of the cigarette to the 
        smoke or that is formed by the combustion or heating of 
        tobacco, additives, or other component of the tobacco 
        product.
          (18) Smokeless tobacco.--The term ``smokeless 
        tobacco'' means any tobacco product that consists of 
        cut, ground, powdered, or leaf tobacco and that is 
        intended to be placed in the oral or nasal cavity.
          (19) State; territory.--The terms ``State'' and 
        ``Territory'' shall have the meanings given to such 
        terms in section 201.
          (20) Tobacco product manufacturer.--The term 
        ``tobacco product manufacturer'' means any person, 
        including any repacker or relabeler, who--
                  (A) manufactures, fabricates, assembles, 
                processes, or labels a tobacco product; or
                  (B) imports a finished tobacco product for 
                sale or distribution in the United States.
          (21) Tobacco warehouse.--
                  (A) Subject to subparagraphs (B) and (C), the 
                term ``tobacco warehouse'' includes any 
                person--
                          (i) who--
                                  (I) removes foreign material 
                                from tobacco leaf through 
                                nothing other than a mechanical 
                                process;
                                  (II) humidifies tobacco leaf 
                                with nothing other than potable 
                                water in the form of steam or 
                                mist; or
                                  (III) de-stems, dries, and 
                                packs tobacco leaf for storage 
                                and shipment;
                          (ii) who performs no other actions 
                        with respect to tobacco leaf; and
                          (iii) who provides to any 
                        manufacturer to whom the person sells 
                        tobacco all information related to the 
                        person's actions described in clause 
                        (i) that is necessary for compliance 
                        with this Act.
                  (B) The term ``tobacco warehouse'' excludes 
                any person who--
                          (i) reconstitutes tobacco leaf;
                          (ii) is a manufacturer, distributor, 
                        or retailer of a tobacco product; or
                          (iii) applies any chemical, additive, 
                        or substance to the tobacco leaf other 
                        than potable water in the form of steam 
                        or mist.
                  (C) The definition of the term ``tobacco 
                warehouse'' in subparagraph (A) shall not apply 
                to the extent to which the Secretary 
                determines, through rulemaking, that regulation 
                under this chapter of the actions described in 
                such subparagraph is appropriate for the 
                protection of the public health.
          (22) United states.--The term ``United States'' means 
        the 50 States of the United States of America and the 
        District of Columbia, the Commonwealth of Puerto Rico, 
        Guam, the Virgin Islands, American Samoa, Wake Island, 
        Midway Islands, Kingman Reef, Johnston Atoll, the 
        Northern Mariana Islands, and any other trust territory 
        or possession of the United States.

SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.

  (a) In General.--Tobacco products, including modified risk 
tobacco products for which an order has been issued in 
accordance with section 911, shall be regulated by the 
Secretary under this chapter and shall not be subject to the 
provisions of chapter V.
  (b) Applicability.--This chapter shall apply to all 
cigarettes, cigarette tobacco, roll-your-own tobacco, and 
smokeless tobacco and to any other tobacco products that the 
Secretary by regulation deems to be subject to this chapter.
  (c) Scope.--
          (1) In general.--Nothing in this chapter, or any 
        policy issued or regulation promulgated thereunder, or 
        in sections 101(a), 102, or 103 of title I, title II, 
        or title III of the Family Smoking Prevention and 
        Tobacco Control Act, shall be construed to affect, 
        expand, or limit the Secretary's authority over 
        (including the authority to determine whether products 
        may be regulated), or the regulation of, products under 
        this Act that are not tobacco products under chapter V 
        or any other chapter.
          (2) Limitation of authority.--
                  (A) In general.--The provisions of this 
                chapter shall not apply to tobacco leaf that is 
                not in the possession of a manufacturer of 
                tobacco products, or to the producers of 
                tobacco leaf, including tobacco growers, 
                tobacco warehouses, and tobacco grower 
                cooperatives, nor shall any employee of the 
                Food and Drug Administration have any authority 
                to enter onto a farm owned by a producer of 
                tobacco leaf without the written consent of 
                such producer.
                  (B) Exception.--Notwithstanding subparagraph 
                (A), if a producer of tobacco leaf is also a 
                tobacco product manufacturer or controlled by a 
                tobacco product manufacturer, the producer 
                shall be subject to this chapter in the 
                producer's capacity as a manufacturer. The 
                exception in this subparagraph shall not apply 
                to a producer of tobacco leaf who grows tobacco 
                under a contract with a tobacco product 
                manufacturer and who is not otherwise engaged 
                in the manufacturing process.
                  (C) Rule of construction.--Nothing in this 
                chapter shall be construed to grant the 
                Secretary authority to promulgate regulations 
                on any matter that involves the production of 
                tobacco leaf or a producer thereof, other than 
                activities by a manufacturer affecting 
                production.
  (d) Rulemaking Procedures.--Each rulemaking under this 
chapter shall be in accordance with chapter 5 of title 5, 
United States Code. This subsection shall not be construed to 
affect the rulemaking provisions of section 102(a) of the 
Family Smoking Prevention and Tobacco Control Act.
  (e) Center for Tobacco Products.--Not later than 90 days 
after the date of enactment of the Family Smoking Prevention 
and Tobacco Control Act, the Secretary shall establish within 
the Food and Drug Administration the Center for Tobacco 
Products, which shall report to the Commissioner of Food and 
Drugs in the same manner as the other agency centers within the 
Food and Drug Administration. The Center shall be responsible 
for the implementation of this chapter and related matters 
assigned by the Commissioner.
  (f) Office To Assist Small Tobacco Product Manufacturers.--
The Secretary shall establish within the Food and Drug 
Administration an identifiable office to provide technical and 
other nonfinancial assistance to small tobacco product 
manufacturers to assist them in complying with the requirements 
of this Act.
  (g) Consultation Prior to Rulemaking.--Prior to promulgating 
rules under this chapter, the Secretary shall endeavor to 
consult with other Federal agencies as appropriate.

SEC. 902. ADULTERATED TOBACCO PRODUCTS.

  A tobacco product shall be deemed to be adulterated if--
          (1) it consists in whole or in part of any filthy, 
        putrid, or decomposed substance, or is otherwise 
        contaminated by any added poisonous or added 
        deleterious substance that may render the product 
        injurious to health;
          (2) it has been prepared, packed, or held under 
        insanitary conditions whereby it may have been 
        contaminated with filth, or whereby it may have been 
        rendered injurious to health;
          (3) its package is composed, in whole or in part, of 
        any poisonous or deleterious substance which may render 
        the contents injurious to health;
          (4) the manufacturer or importer of the tobacco 
        product fails to pay a user fee assessed to such 
        manufacturer or importer pursuant to section 919 by the 
        date specified in section 919 or by the 30th day after 
        final agency action on a resolution of any dispute as 
        to the amount of such fee;
          (5) it is, or purports to be or is represented as, a 
        tobacco product which is subject to a tobacco product 
        standard established under section 907 unless such 
        tobacco product is in all respects in conformity with 
        such standard;
          (6)(A) it is required by section 910(a) to have 
        premarket review and does not have an order in effect 
        under section 910(c)(1)(A)(i); or
          (B) it is in violation of an order under section 
        910(c)(1)(A);
          (7) the methods used in, or the facilities or 
        controls used for, its manufacture, packing, or storage 
        are not in conformity with applicable requirements 
        under section 906(e)(1) or an applicable condition 
        prescribed by an order under section 906(e)(2); or
          (8) it is in violation of section 911.

SEC. 903. MISBRANDED TOBACCO PRODUCTS.

  (a) In General.--A tobacco product shall be deemed to be 
misbranded--
          (1) if its labeling is false or misleading in any 
        particular;
          (2) if in package form unless it bears a label 
        containing--
                  (A) the name and place of business of the 
                tobacco product manufacturer, packer, or 
                distributor;
                  (B) an accurate statement of the quantity of 
                the contents in terms of weight, measure, or 
                numerical count;
                  (C) an accurate statement of the percentage 
                of the tobacco used in the product that is 
                domestically grown tobacco and the percentage 
                that is foreign grown tobacco; and
                  (D) the statement required under section 
                920(a),
        except that under subparagraph (B) reasonable 
        variations shall be permitted, and exemptions as to 
        small packages shall be established, by regulations 
        prescribed by the Secretary;
          (3) if any word, statement, or other information 
        required by or under authority of this chapter to 
        appear on the label or labeling is not prominently 
        placed thereon with such conspicuousness (as compared 
        with other words, statements, or designs in the 
        labeling) and in such terms as to render it likely to 
        be read and understood by the ordinary individual under 
        customary conditions of purchase and use;
          (4) if it has an established name, unless its label 
        bears, to the exclusion of any other nonproprietary 
        name, its established name prominently printed in type 
        as required by the Secretary by regulation;
          (5) if the Secretary has issued regulations requiring 
        that its labeling bear adequate directions for use, or 
        adequate warnings against use by children, that are 
        necessary for the protection of users unless its 
        labeling conforms in all respects to such regulations;
          (6) if it was manufactured, prepared, propagated, 
        compounded, or processed in an establishment not duly 
        registered under section 905(b), 905(c), 905(d), or 
        905(h), if it was not included in a list required by 
        section 905(i), if a notice or other information 
        respecting it was not provided as required by such 
        section or section 905(j), or if it does not bear such 
        symbols from the uniform system for identification of 
        tobacco products prescribed under section 905(e) as the 
        Secretary by regulation requires;
          (7) if, in the case of any tobacco product 
        distributed or offered for sale in any State--
                  (A) its advertising is false or misleading in 
                any particular; or
                  (B) it is sold or distributed in violation of 
                regulations prescribed under section 906(d);
          (8) unless, in the case of any tobacco product 
        distributed or offered for sale in any State, the 
        manufacturer, packer, or distributor thereof includes 
        in all advertisements and other descriptive printed 
        matter issued or caused to be issued by the 
        manufacturer, packer, or distributor with respect to 
        that tobacco product--
                  (A) a true statement of the tobacco product's 
                established name as described in paragraph (4), 
                printed prominently; and
                  (B) a brief statement of--
                          (i) the uses of the tobacco product 
                        and relevant warnings, precautions, 
                        side effects, and contraindications; 
                        and
                          (ii) in the case of specific tobacco 
                        products made subject to a finding by 
                        the Secretary after notice and 
                        opportunity for comment that such 
                        action is appropriate to protect the 
                        public health, a full description of 
                        the components of such tobacco product 
                        or the formula showing quantitatively 
                        each ingredient of such tobacco product 
                        to the extent required in regulations 
                        which shall be issued by the Secretary 
                        after an opportunity for a hearing;
          (9) if it is a tobacco product subject to a tobacco 
        product standard established under section 907, unless 
        it bears such labeling as may be prescribed in such 
        tobacco product standard; or
          (10) if there was a failure or refusal--
                  (A) to comply with any requirement prescribed 
                under section 904 or 908; or
                  (B) to furnish any material or information 
                required under section 909.
  (b) Prior Approval of Label Statements.--The Secretary may, 
by regulation, require prior approval of statements made on the 
label of a tobacco product. No regulation issued under this 
subsection may require prior approval by the Secretary of the 
content of any advertisement, except for modified risk tobacco 
products as provided in section 911. No advertisement of a 
tobacco product published after the date of enactment of the 
Family Smoking Prevention and Tobacco Control Act shall, with 
respect to the language of label statements as prescribed under 
section 4 of the Federal Cigarette Labeling and Advertising Act 
and section 3 of the Comprehensive Smokeless Tobacco Health 
Education Act of 1986 or the regulations issued under such 
sections, be subject to the provisions of sections 12 through 
15 of the Federal Trade Commission Act.

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

  (a) Requirement.--Each tobacco product manufacturer or 
importer, or agents thereof, shall submit to the Secretary the 
following information:
          (1) Not later than 6 months after the date of 
        enactment of the Family Smoking Prevention and Tobacco 
        Control Act, a listing of all ingredients, including 
        tobacco, substances, compounds, and additives that are, 
        as of such date, added by the manufacturer to the 
        tobacco, paper, filter, or other part of each tobacco 
        product by brand and by quantity in each brand and 
        subbrand.
          (2) A description of the content, delivery, and form 
        of nicotine in each tobacco product measured in 
        milligrams of nicotine in accordance with regulations 
        promulgated by the Secretary in accordance with section 
        4(e) of the Federal Cigarette Labeling and Advertising 
        Act.
          (3) Beginning 3 years after the date of enactment of 
        the Family Smoking Prevention and Tobacco Control Act, 
        a listing of all constituents, including smoke 
        constituents as applicable, identified by the Secretary 
        as harmful or potentially harmful to health in each 
        tobacco product, and as applicable in the smoke of each 
        tobacco product, by brand and by quantity in each brand 
        and subbrand. Effective beginning 3 years after such 
        date of enactment, the manufacturer, importer, or agent 
        shall comply with regulations promulgated under section 
        915 in reporting information under this paragraph, 
        where applicable.
          (4) Beginning 6 months after the date of enactment of 
        the Family Smoking Prevention and Tobacco Control Act, 
        all documents developed after such date of enactment 
        that relate to health, toxicological, behavioral, or 
        physiologic effects of current or future tobacco 
        products, their constituents (including smoke 
        constituents), ingredients, components, and additives.
  (b) Data Submission.--At the request of the Secretary, each 
tobacco product manufacturer or importer of tobacco products, 
or agents thereof, shall submit the following:
          (1) Any or all documents (including underlying 
        scientific information) relating to research 
        activities, and research findings, conducted, 
        supported, or possessed by the manufacturer (or agents 
        thereof) on the health, toxicological, behavioral, or 
        physiologic effects of tobacco products and their 
        constituents (including smoke constituents), 
        ingredients, components, and additives.
          (2) Any or all documents (including underlying 
        scientific information) relating to research 
        activities, and research findings, conducted, 
        supported, or possessed by the manufacturer (or agents 
        thereof) that relate to the issue of whether a 
        reduction in risk to health from tobacco products can 
        occur upon the employment of technology available or 
        known to the manufacturer.
          (3) Any or all documents (including underlying 
        scientific or financial information) relating to 
        marketing research involving the use of tobacco 
        products or marketing practices and the effectiveness 
        of such practices used by tobacco manufacturers and 
        distributors.
An importer of a tobacco product not manufactured in the United 
States shall supply the information required of a tobacco 
product manufacturer under this subsection.
  (c) Time for Submission.--
          (1) In general.--At least 90 days prior to the 
        delivery for introduction into interstate commerce of a 
        tobacco product not on the market on the date of 
        enactment of the Family Smoking Prevention and Tobacco 
        Control Act, the manufacturer of such product shall 
        provide the information required under subsection (a).
          (2) Disclosure of additive.--If at any time a tobacco 
        product manufacturer adds to its tobacco products a new 
        tobacco additive or increases the quantity of an 
        existing tobacco additive, the manufacturer shall, 
        except as provided in paragraph (3), at least 90 days 
        prior to such action so advise the Secretary in 
        writing.
          (3) Disclosure of other actions.--If at any time a 
        tobacco product manufacturer eliminates or decreases an 
        existing additive, or adds or increases an additive 
        that has by regulation been designated by the Secretary 
        as an additive that is not a human or animal 
        carcinogen, or otherwise harmful to health under 
        intended conditions of use, the manufacturer shall 
        within 60 days of such action so advise the Secretary 
        in writing.
  (d) Data List.--
          (1) In general.--Not later than 3 years after the 
        date of enactment of the Family Smoking Prevention and 
        Tobacco Control Act, and annually thereafter, the 
        Secretary shall publish in a format that is 
        understandable and not misleading to a lay person, and 
        place on public display (in a manner determined by the 
        Secretary) the list established under subsection (e).
          (2) Consumer research.--The Secretary shall conduct 
        periodic consumer research to ensure that the list 
        published under paragraph (1) is not misleading to lay 
        persons. Not later than 5 years after the date of 
        enactment of the Family Smoking Prevention and Tobacco 
        Control Act, the Secretary shall submit to the 
        appropriate committees of Congress a report on the 
        results of such research, together with recommendations 
        on whether such publication should be continued or 
        modified.
  (e) Data Collection.--Not later than 24 months after the date 
of enactment of the Family Smoking Prevention and Tobacco 
Control Act, the Secretary shall establish, and periodically 
revise as appropriate, a list of harmful and potentially 
harmful constituents, including smoke constituents, to health 
in each tobacco product by brand and by quantity in each brand 
and subbrand. The Secretary shall publish a public notice 
requesting the submission by interested persons of scientific 
and other information concerning the harmful and potentially 
harmful constituents in tobacco products and tobacco smoke.

SEC. 905. ANNUAL REGISTRATION.

  (a) Definitions.--In this section:
          (1) Manufacture, preparation, compounding, or 
        processing.--The term ``manufacture, preparation, 
        compounding, or processing'' shall include repackaging 
        or otherwise changing the container, wrapper, or 
        labeling of any tobacco product package in furtherance 
        of the distribution of the tobacco product from the 
        original place of manufacture to the person who makes 
        final delivery or sale to the ultimate consumer or 
        user.
          (2) Name.--The term ``name'' shall include in the 
        case of a partnership the name of each partner and, in 
        the case of a corporation, the name of each corporate 
        officer and director, and the State of incorporation.
  (b) Registration by Owners and Operators.--On or before 
December 31 of each year, every person who owns or operates any 
establishment in any State engaged in the manufacture, 
preparation, compounding, or processing of a tobacco product or 
tobacco products shall register with the Secretary the name, 
places of business, and all such establishments of that person. 
If enactment of the Family Smoking Prevention and Tobacco 
Control Act occurs in the second half of the calendar year, the 
Secretary shall designate a date no later than 6 months into 
the subsequent calendar year by which registration pursuant to 
this subsection shall occur.
  (c) Registration by New Owners and Operators.--Every person 
upon first engaging in the manufacture, preparation, 
compounding, or processing of a tobacco product or tobacco 
products in any establishment owned or operated in any State by 
that person shall immediately register with the Secretary that 
person's name, place of business, and such establishment.
  (d) Registration of Added Establishments.--Every person 
required to register under subsection (b) or (c) shall 
immediately register with the Secretary any additional 
establishment which that person owns or operates in any State 
and in which that person begins the manufacture, preparation, 
compounding, or processing of a tobacco product or tobacco 
products.
  (e) Uniform Product Identification System.--The Secretary may 
by regulation prescribe a uniform system for the identification 
of tobacco products and may require that persons who are 
required to list such tobacco products under subsection (i) 
shall list such tobacco products in accordance with such 
system.
  (f) Public Access to Registration Information.--The Secretary 
shall make available for inspection, to any person so 
requesting, any registration filed under this section.
  (g) Biennial Inspection of Registered Establishments.--Every 
establishment registered with the Secretary under this section 
shall be subject to inspection under section 704 or subsection 
(h), and every such establishment engaged in the manufacture, 
compounding, or processing of a tobacco product or tobacco 
products shall be so inspected by 1 or more officers or 
employees duly designated by the Secretary at least once in the 
2-year period beginning with the date of registration of such 
establishment under this section and at least once in every 
successive 2-year period thereafter.
  (h) Registration by Foreign Establishments.--Any 
establishment within any foreign country engaged in the 
manufacture, preparation, compounding, or processing of a 
tobacco product or tobacco products, shall register under this 
section under regulations promulgated by the Secretary. Such 
regulations shall require such establishment to provide the 
information required by subsection (i) and shall include 
provisions for registration of any such establishment upon 
condition that adequate and effective means are available, by 
arrangement with the government of such foreign country or 
otherwise, to enable the Secretary to determine from time to 
time whether tobacco products manufactured, prepared, 
compounded, or processed in such establishment, if imported or 
offered for import into the United States, shall be refused 
admission on any of the grounds set forth in section 801(a).
  (i) Registration Information.--
          (1) Product list.--Every person who registers with 
        the Secretary under subsection (b), (c), (d), or (h) 
        shall, at the time of registration under any such 
        subsection, file with the Secretary a list of all 
        tobacco products which are being manufactured, 
        prepared, compounded, or processed by that person for 
        commercial distribution and which have not been 
        included in any list of tobacco products filed by that 
        person with the Secretary under this paragraph or 
        paragraph (2) before such time of registration. Such 
        list shall be prepared in such form and manner as the 
        Secretary may prescribe and shall be accompanied by--
                  (A) in the case of a tobacco product 
                contained in the applicable list with respect 
                to which a tobacco product standard has been 
                established under section 907 or which is 
                subject to section 910, a reference to the 
                authority for the marketing of such tobacco 
                product and a copy of all labeling for such 
                tobacco product;
                  (B) in the case of any other tobacco product 
                contained in an applicable list, a copy of all 
                consumer information and other labeling for 
                such tobacco product, a representative sampling 
                of advertisements for such tobacco product, 
                and, upon request made by the Secretary for 
                good cause, a copy of all advertisements for a 
                particular tobacco product; and
                  (C) if the registrant filing a list has 
                determined that a tobacco product contained in 
                such list is not subject to a tobacco product 
                standard established under section 907, a brief 
                statement of the basis upon which the 
                registrant made such determination if the 
                Secretary requests such a statement with 
                respect to that particular tobacco product.
          (2) Consultation with respect to forms.--The 
        Secretary shall consult with the Secretary of the 
        Treasury in developing the forms to be used for 
        registration under this section to minimize the burden 
        on those persons required to register with both the 
        Secretary and the Tax and Trade Bureau of the 
        Department of the Treasury.
          (3) Biannual report of any change in product list.--
        Each person who registers with the Secretary under this 
        section shall report to the Secretary once during the 
        month of June of each year and once during the month of 
        December of each year the following:
                  (A) A list of each tobacco product introduced 
                by the registrant for commercial distribution 
                which has not been included in any list 
                previously filed by that person with the 
                Secretary under this subparagraph or paragraph 
                (1). A list under this subparagraph shall list 
                a tobacco product by its established name and 
                shall be accompanied by the other information 
                required by paragraph (1).
                  (B) If since the date the registrant last 
                made a report under this paragraph that person 
                has discontinued the manufacture, preparation, 
                compounding, or processing for commercial 
                distribution of a tobacco product included in a 
                list filed under subparagraph (A) or paragraph 
                (1), notice of such discontinuance, the date of 
                such discontinuance, and the identity of its 
                established name.
                  (C) If since the date the registrant reported 
                under subparagraph (B) a notice of 
                discontinuance that person has resumed the 
                manufacture, preparation, compounding, or 
                processing for commercial distribution of the 
                tobacco product with respect to which such 
                notice of discontinuance was reported, notice 
                of such resumption, the date of such 
                resumption, the identity of such tobacco 
                product by established name, and other 
                information required by paragraph (1), unless 
                the registrant has previously reported such 
                resumption to the Secretary under this 
                subparagraph.
                  (D) Any material change in any information 
                previously submitted under this paragraph or 
                paragraph (1).
  (j) Report Preceding Introduction of Certain 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 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--
                  (A) the increased or decreased likelihood 
                that existing users of tobacco products will 
                stop using such products; and
                  (B) the increased or decreased likelihood 
                that those who do not use tobacco products will 
                start using such products.
        No such regulation may require that the sale or 
        distribution of a tobacco product be limited to the 
        written or oral authorization of a practitioner 
        licensed by law to prescribe medical products.
          (2) Label statements.--The label of a tobacco product 
        shall bear such appropriate statements of the 
        restrictions required by a regulation under subsection 
        (a) as the Secretary may in such regulation prescribe.
          (3) Limitations.--
                  (A) In general.--No restrictions under 
                paragraph (1) may--
                          (i) prohibit the sale of any tobacco 
                        product in face-to-face transactions by 
                        a specific category of retail outlets; 
                        or
                          (ii) establish a minimum age of sale 
                        of tobacco products to any person older 
                        than 18 years of age.
                  (B) Matchbooks.--For purposes of any 
                regulations issued by the Secretary, matchbooks 
                of conventional size containing not more than 
                20 paper matches, and which are customarily 
                given away for free with the purchase of 
                tobacco products, shall be considered as adult-
                written publications which shall be permitted 
                to contain advertising. Notwithstanding the 
                preceding sentence, if the Secretary finds that 
                such treatment of matchbooks is not appropriate 
                for the protection of the public health, the 
                Secretary may determine by regulation that 
                matchbooks shall not be considered adult-
                written publications.
          (4) Remote sales.--
                  (A) In general.--The Secretary shall--
                          (i) within 18 months after the date 
                        of enactment of the Family Smoking 
                        Prevention and Tobacco Control Act, 
                        promulgate regulations regarding the 
                        sale and distribution of tobacco 
                        products that occur through means other 
                        than a direct, face-to-face exchange 
                        between a retailer and a consumer in 
                        order to prevent the sale and 
                        distribution of tobacco products to 
                        individuals who have not attained the 
                        minimum age established by applicable 
                        law for the purchase of such products, 
                        including requirements for age 
                        verification; and
                          (ii) within 2 years after such date 
                        of enactment, issue regulations to 
                        address the promotion and marketing of 
                        tobacco products that are sold or 
                        distributed through means other than a 
                        direct, face-to-face exchange between a 
                        retailer and a consumer in order to 
                        protect individuals who have not 
                        attained the minimum age established by 
                        applicable law for the purchase of such 
                        products.
                  (B) Relation to other authority.--Nothing in 
                this paragraph limits the authority of the 
                Secretary to take additional actions under the 
                other paragraphs of this subsection.
  (e) Good Manufacturing Practice Requirements.--
          (1) Methods, facilities, and controls to conform.--
                  (A) In general.--In applying manufacturing 
                restrictions to tobacco, the Secretary shall, 
                in accordance with subparagraph (B), prescribe 
                regulations (which may differ based on the type 
                of tobacco product involved) requiring that the 
                methods used in, and the facilities and 
                controls used for, the manufacture, 
                preproduction design validation (including a 
                process to assess the performance of a tobacco 
                product), packing, and storage of a tobacco 
                product conform to current good manufacturing 
                practice, or hazard analysis and critical 
                control point methodology, as prescribed in 
                such regulations to assure that the public 
                health is protected and that the tobacco 
                product is in compliance with this chapter. 
                Such regulations may provide for the testing of 
                raw tobacco for pesticide chemical residues 
                regardless of whether a tolerance for such 
                chemical residues has been established.
                  (B) Requirements.--The Secretary shall--
                          (i) before promulgating any 
                        regulation under subparagraph (A), 
                        afford the Tobacco Products Scientific 
                        Advisory Committee an opportunity to 
                        submit recommendations with respect to 
                        the regulation proposed to be 
                        promulgated;
                          (ii) before promulgating any 
                        regulation under subparagraph (A), 
                        afford opportunity for an oral hearing;
                          (iii) provide the Tobacco Products 
                        Scientific Advisory Committee a 
                        reasonable time to make its 
                        recommendation with respect to proposed 
                        regulations under subparagraph (A);
                          (iv) in establishing the effective 
                        date of a regulation promulgated under 
                        this subsection, take into account the 
                        differences in the manner in which the 
                        different types of tobacco products 
                        have historically been produced, the 
                        financial resources of the different 
                        tobacco product manufacturers, and the 
                        state of their existing manufacturing 
                        facilities, and shall provide for a 
                        reasonable period of time for such 
                        manufacturers to conform to good 
                        manufacturing practices; and
                          (v) not require any small tobacco 
                        product manufacturer to comply with a 
                        regulation under subparagraph (A) for 
                        at least 4 years following the 
                        effective date established by the 
                        Secretary for such regulation.
          (2) Exemptions; variances.--
                  (A) Petition.--Any person subject to any 
                requirement prescribed under paragraph (1) may 
                petition the Secretary for a permanent or 
                temporary exemption or variance from such 
                requirement. Such a petition shall be submitted 
                to the Secretary in such form and manner as the 
                Secretary shall prescribe and shall--
                          (i) in the case of a petition for an 
                        exemption from a requirement, set forth 
                        the basis for the petitioner's 
                        determination that compliance with the 
                        requirement is not required to assure 
                        that the tobacco product will be in 
                        compliance with this chapter;
                          (ii) in the case of a petition for a 
                        variance from a requirement, set forth 
                        the methods proposed to be used in, and 
                        the facilities and controls proposed to 
                        be used for, the manufacture, packing, 
                        and storage of the tobacco product in 
                        lieu of the methods, facilities, and 
                        controls prescribed by the requirement; 
                        and
                          (iii) contain such other information 
                        as the Secretary shall prescribe.
                  (B) Referral to the tobacco products 
                scientific advisory committee.--The Secretary 
                may refer to the Tobacco Products Scientific 
                Advisory Committee any petition submitted under 
                subparagraph (A). The Tobacco Products 
                Scientific Advisory Committee shall report its 
                recommendations to the Secretary with respect 
                to a petition referred to it within 60 days 
                after the date of the petition's referral. 
                Within 60 days after--
                          (i) the date the petition was 
                        submitted to the Secretary under 
                        subparagraph (A); or
                          (ii) the day after the petition was 
                        referred to the Tobacco Products 
                        Scientific Advisory Committee,
                whichever occurs later, the Secretary shall by 
                order either deny the petition or approve it.
                  (C) Approval.--The Secretary may approve--
                          (i) a petition for an exemption for a 
                        tobacco product from a requirement if 
                        the Secretary determines that 
                        compliance with such requirement is not 
                        required to assure that the tobacco 
                        product will be in compliance with this 
                        chapter; and
                          (ii) a petition for a variance for a 
                        tobacco product from a requirement if 
                        the Secretary determines that the 
                        methods to be used in, and the 
                        facilities and controls to be used for, 
                        the manufacture, packing, and storage 
                        of the tobacco product in lieu of the 
                        methods, facilities, and controls 
                        prescribed by the requirement are 
                        sufficient to assure that the tobacco 
                        product will be in compliance with this 
                        chapter.
                  (D) Conditions.--An order of the Secretary 
                approving a petition for a variance shall 
                prescribe such conditions respecting the 
                methods used in, and the facilities and 
                controls used for, the manufacture, packing, 
                and storage of the tobacco product to be 
                granted the variance under the petition as may 
                be necessary to assure that the tobacco product 
                will be in compliance with this chapter.
                  (E) Hearing.--After the issuance of an order 
                under subparagraph (B) respecting a petition, 
                the petitioner shall have an opportunity for an 
                informal hearing on such order.
          (3) Compliance.--Compliance with requirements under 
        this subsection shall not be required before the end of 
        the 3-year period following the date of enactment of 
        the Family Smoking Prevention and Tobacco Control Act.
  (f) Research and Development.--The Secretary may enter into 
contracts for research, testing, and demonstrations respecting 
tobacco products and may obtain tobacco products for research, 
testing, and demonstration purposes.

SEC. 907. TOBACCO PRODUCT STANDARDS.

  (a) In General.--
          (1) Special rules.--
                  (A) Special rule for cigarettes.--Beginning 3 
                months after the date of enactment of the 
                Family Smoking Prevention and Tobacco Control 
                Act, a cigarette or any of its component parts 
                (including the tobacco, filter, or paper) shall 
                not contain, as a constituent (including a 
                smoke constituent) or additive, an artificial 
                or natural flavor (other than tobacco or 
                menthol) or an herb or spice, including 
                strawberry, grape, orange, clove, cinnamon, 
                pineapple, vanilla, coconut, licorice, cocoa, 
                chocolate, cherry, or coffee, that is a 
                characterizing flavor of the tobacco product or 
                tobacco smoke. Nothing in this subparagraph 
                shall be construed to limit the Secretary's 
                authority to take action under this section or 
                other sections of this Act applicable to 
                menthol or any artificial or natural flavor, 
                herb, or spice not specified in this 
                subparagraph.
                  (B) Additional special rule.--Beginning 2 
                years after the date of enactment of the Family 
                Smoking Prevention and Tobacco Control Act, a 
                tobacco product manufacturer shall not use 
                tobacco, including foreign grown tobacco, that 
                contains a pesticide chemical residue that is 
                at a level greater than is specified by any 
                tolerance applicable under Federal law to 
                domestically grown tobacco.
          (2) Revision of tobacco product standards.--The 
        Secretary may revise the tobacco product standards in 
        paragraph (1) in accordance with subsection (c).
          (3) Tobacco product standards.--
                  (A) In general.--The Secretary may adopt 
                tobacco product standards in addition to those 
                in paragraph (1) if the Secretary finds that a 
                tobacco product standard is appropriate for the 
                protection of the public health.
                  (B) Determinations.--
                          (i) Considerations.--In making a 
                        finding described in subparagraph (A), 
                        the Secretary shall consider scientific 
                        evidence concerning--
                                  (I) the risks and benefits to 
                                the population as a whole, 
                                including users and nonusers of 
                                tobacco products, of the 
                                proposed standard;
                                  (II) the increased or 
                                decreased likelihood that 
                                existing users of tobacco 
                                products will stop using such 
                                products; and
                                  (III) the increased or 
                                decreased likelihood that those 
                                who do not use tobacco products 
                                will start using such products.
                          (ii) Additional considerations.--In 
                        the event that the Secretary makes a 
                        determination, set forth in a proposed 
                        tobacco product standard in a proposed 
                        rule, that it is appropriate for the 
                        protection of public health to require 
                        the reduction or elimination of an 
                        additive, constituent (including a 
                        smoke constituent), or other component 
                        of a tobacco product because the 
                        Secretary has found that the additive, 
                        constituent, or other component is or 
                        may be harmful, any party objecting to 
                        the proposed standard on the ground 
                        that the proposed standard will not 
                        reduce or eliminate the risk of illness 
                        or injury may provide for the 
                        Secretary's consideration scientific 
                        evidence that demonstrates that the 
                        proposed standard will not reduce or 
                        eliminate the risk of illness or 
                        injury.
          (4) Content of tobacco product standards.--A tobacco 
        product standard established under this section for a 
        tobacco product--
                  (A) shall include provisions that are 
                appropriate for the protection of the public 
                health, including provisions, where 
                appropriate--
                          (i) for nicotine yields of the 
                        product;
                          (ii) for the reduction or elimination 
                        of other constituents, including smoke 
                        constituents, or harmful components of 
                        the product; or
                          (iii) relating to any other 
                        requirement under subparagraph (B);
                  (B) shall, where appropriate for the 
                protection of the public health, include--
                          (i) provisions respecting the 
                        construction, components, ingredients, 
                        additives, constituents, including 
                        smoke constituents, and properties of 
                        the tobacco product;
                          (ii) provisions for the testing (on a 
                        sample basis or, if necessary, on an 
                        individual basis) of the tobacco 
                        product;
                          (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 
                foreign-grown 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--
                  (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) 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.
          (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--
          (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.
                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.--
          (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 
                        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;
                  (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 application and any other information 
        before the Secretary with respect to such tobacco 
        product, the Secretary finds that--
                  (A) there is a lack of a showing that 
                permitting such tobacco product to be marketed 
                would be appropriate for the protection of the 
                public health;
                  (B) the methods used in, or the facilities or 
                controls used for, the manufacture, processing, 
                or packing of such tobacco product do not 
                conform to the requirements of section 906(e);
                  (C) based on a fair evaluation of all 
                material facts, the proposed labeling is false 
                or misleading in any particular; or
                  (D) such tobacco product is not shown to 
                conform in all respects to a tobacco product 
                standard in effect under section 907, and there 
                is a lack of adequate information to justify 
                the deviation from such standard.
          (3) Denial information.--Any denial of an application 
        shall, insofar as the Secretary determines to be 
        practicable, be accompanied by a statement informing 
        the applicant of the measures required to remove such 
        application from deniable form (which measures may 
        include further research by the applicant in accordance 
        with 1 or more protocols prescribed by the Secretary).
          (4) Basis for finding.--For purposes of this section, 
        the finding as to whether the marketing of a tobacco 
        product for which an application has been submitted is 
        appropriate for the protection of the public health 
        shall be determined with respect to the risks and 
        benefits to the population as a whole, including users 
        and nonusers of the tobacco product, and taking into 
        account--
                  (A) the increased or decreased likelihood 
                that existing users of tobacco products will 
                stop using such products; and
                  (B) the increased or decreased likelihood 
                that those who do not use tobacco products will 
                start using such products.
          (5) Basis for action.--
                  (A) Investigations.--For purposes of 
                paragraph (2)(A), whether permitting a tobacco 
                product to be marketed would be appropriate for 
                the protection of the public health shall, when 
                appropriate, be determined on the basis of 
                well-controlled investigations, which may 
                include 1 or more clinical investigations by 
                experts qualified by training and experience to 
                evaluate the tobacco product.
                  (B) Other evidence.--If the Secretary 
                determines that there exists valid scientific 
                evidence (other than evidence derived from 
                investigations described in subparagraph (A)) 
                which is sufficient to evaluate the tobacco 
                product, the Secretary may authorize that the 
                determination for purposes of paragraph (2)(A) 
                be made on the basis of such evidence.
  (d) Withdrawal and Temporary Suspension.--
          (1) In general.--The Secretary shall, upon obtaining, 
        where appropriate, advice on scientific matters from 
        the Tobacco Products Scientific Advisory Committee, and 
        after due notice and opportunity for informal hearing 
        for a tobacco product for which an order was issued 
        under subsection (c)(1)(A)(i), issue an order 
        withdrawing the order if the Secretary finds--
                  (A) that the continued marketing of such 
                tobacco product no longer is appropriate for 
                the protection of the public health;
                  (B) that the application contained or was 
                accompanied by an untrue statement of a 
                material fact;
                  (C) that the applicant--
                          (i) has failed to establish a system 
                        for maintaining records, or has 
                        repeatedly or deliberately failed to 
                        maintain records or to make reports, 
                        required by an applicable regulation 
                        under section 909;
                          (ii) has refused to permit access to, 
                        or copying or verification of, such 
                        records as required by section 704; or
                          (iii) has not complied with the 
                        requirements of section 905;
                  (D) on the basis of new information before 
                the Secretary with respect to such tobacco 
                product, evaluated together with the evidence 
                before the Secretary when the application was 
                reviewed, that the methods used in, or the 
                facilities and controls used for, the 
                manufacture, processing, packing, or 
                installation of such tobacco product do not 
                conform with the requirements of section 906(e) 
                and were not brought into conformity with such 
                requirements within a reasonable time after 
                receipt of written notice from the Secretary of 
                nonconformity;
                  (E) on the basis of new information before 
                the Secretary, evaluated together with the 
                evidence before the Secretary when the 
                application was reviewed, that the labeling of 
                such tobacco product, based on a fair 
                evaluation of all material facts, is false or 
                misleading in any particular and was not 
                corrected within a reasonable time after 
                receipt of written notice from the Secretary of 
                such fact; or
                  (F) on the basis of new information before 
                the Secretary, evaluated together with the 
                evidence before the Secretary when such order 
                was issued, that such tobacco product is not 
                shown to conform in all respects to a tobacco 
                product standard which is in effect under 
                section 907, compliance with which was a 
                condition to the issuance of an order relating 
                to the application, and that there is a lack of 
                adequate information to justify the deviation 
                from such standard.
          (2) Appeal.--The holder of an application subject to 
        an order issued under paragraph (1) withdrawing an 
        order issued pursuant to subsection (c)(1)(A)(i) may, 
        by petition filed on or before the 30th day after the 
        date upon which such holder receives notice of such 
        withdrawal, obtain review thereof in accordance with 
        section 912.
          (3) Temporary suspension.--If, after providing an 
        opportunity for an informal hearing, the Secretary 
        determines there is reasonable probability that the 
        continuation of distribution of a tobacco product under 
        an order would cause serious, adverse health 
        consequences or death, that is greater than ordinarily 
        caused by tobacco products on the market, the Secretary 
        shall by order temporarily suspend the authority of the 
        manufacturer to market the product. If the Secretary 
        issues such an order, the Secretary shall proceed 
        expeditiously under paragraph (1) to withdraw such 
        application.
  (e) Service of Order.--An order issued by the Secretary under 
this section shall be served--
          (1) in person by any officer or employee of the 
        department designated by the Secretary; or
          (2) by mailing the order by registered mail or 
        certified mail addressed to the applicant at the 
        applicant's last known address in the records of the 
        Secretary.
  (f) Records.--
          (1) Additional information.--In the case of any 
        tobacco product for which an order issued pursuant to 
        subsection (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;
                                  (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--
          (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 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.
                          (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).
                  (B) Quantitative comparisons.--The Secretary 
                may also require, for purposes of subparagraph 
                (A), that the percent (or fraction) of change 
                and identity of the reference tobacco product 
                and a quantitative comparison of the amount of 
                the substance claimed to be reduced shall be 
                stated in immediate proximity to the most 
                prominent claim.
          (3) Label disclosure.--
                  (A) In general.--The Secretary may require 
                the disclosure on the label of other substances 
                in the tobacco product, or substances that may 
                be produced by the consumption of that tobacco 
                product, that may affect a disease or health-
                related condition or may increase the risk of 
                other diseases or health-related conditions 
                associated with the use of tobacco products.
                  (B) Conditions of use.--If the conditions of 
                use of the tobacco product may affect the risk 
                of the product to human health, the Secretary 
                may require the labeling of conditions of use.
          (4) Time.--An order issued under subsection (g)(1) 
        shall be effective for a specified period of time.
          (5) Advertising.--The Secretary may require, with 
        respect to a product for which an applicant obtained an 
        order under subsection (g)(1), that the product comply 
        with requirements relating to advertising and promotion 
        of the tobacco product.
  (i) Postmarket Surveillance and Studies.--
          (1) In general.--The Secretary shall require, with 
        respect to a product for which an applicant obtained an 
        order under subsection (g)(1), that the applicant 
        conduct postmarket surveillance and studies for such a 
        tobacco product to determine the impact of the order 
        issuance on consumer perception, behavior, and health, 
        to enable the Secretary to review the accuracy of the 
        determinations upon which the order was based, and to 
        provide information that the Secretary determines is 
        otherwise necessary regarding the use or health risks 
        involving the tobacco product. The results of 
        postmarket surveillance and studies shall be submitted 
        to the Secretary on an annual basis.
          (2) Surveillance protocol.--Each applicant required 
        to conduct a surveillance of a tobacco product under 
        paragraph (1) shall, within 30 days after receiving 
        notice that the applicant is required to conduct such 
        surveillance, submit, for the approval of the 
        Secretary, a protocol for the required surveillance. 
        The Secretary, within 60 days of the receipt of such 
        protocol, shall determine if the principal investigator 
        proposed to be used in the surveillance has sufficient 
        qualifications and experience to conduct such 
        surveillance and if such protocol will result in 
        collection of the data or other information designated 
        by the Secretary as necessary to protect the public 
        health.
  (j) Withdrawal of Authorization.--The Secretary, after an 
opportunity for an informal hearing, shall withdraw an order 
under subsection (g) if the Secretary determines that--
          (1) the applicant, based on new information, can no 
        longer make the demonstrations required under 
        subsection (g), or the Secretary can no longer make the 
        determinations required under subsection (g);
          (2) the application failed to include material 
        information or included any untrue statement of 
        material fact;
          (3) any explicit or implicit representation that the 
        product reduces risk or exposure is no longer valid, 
        including if--
                  (A) a tobacco product standard is established 
                pursuant to section 907;
                  (B) an action is taken that affects the risks 
                presented by other commercially marketed 
                tobacco products that were compared to the 
                product that is the subject of the application; 
                or
                  (C) any postmarket surveillance or studies 
                reveal that the order is no longer consistent 
                with the protection of the public health;
          (4) the applicant failed to conduct or submit the 
        postmarket surveillance and studies required under 
        subsection (g)(2)(C)(ii) or subsection (i); or
          (5) the applicant failed to meet a condition imposed 
        under subsection (h).
  (k) Chapter IV or V.--A product for which the Secretary has 
issued an order pursuant to subsection (g) shall not be subject 
to chapter IV or V.
  (l) Implementing Regulations or Guidance.--
          (1) Scientific evidence.--Not later than 2 years 
        after the date of enactment of the Family Smoking 
        Prevention and Tobacco Control Act, the Secretary shall 
        issue regulations or guidance (or any combination 
        thereof) on the scientific evidence required for 
        assessment and ongoing review of modified risk tobacco 
        products. Such regulations or guidance shall--
                  (A) to the extent that adequate scientific 
                evidence exists, establish minimum standards 
                for scientific studies needed prior to issuing 
                an order under subsection (g) to show that a 
                substantial reduction in morbidity or mortality 
                among individual tobacco users occurs for 
                products described in subsection (g)(1) or is 
                reasonably likely for products described in 
                subsection (g)(2);
                  (B) include validated biomarkers, 
                intermediate clinical endpoints, and other 
                feasible outcome measures, as appropriate;
                  (C) establish minimum standards for 
                postmarket studies, that shall include regular 
                and long-term assessments of health outcomes 
                and mortality, intermediate clinical endpoints, 
                consumer perception of harm reduction, and the 
                impact on quitting behavior and new use of 
                tobacco products, as appropriate;
                  (D) establish minimum standards for required 
                postmarket surveillance, including ongoing 
                assessments of consumer perception;
                  (E) require that data from the required 
                studies and surveillance be made available to 
                the Secretary prior to the decision on renewal 
                of a modified risk tobacco product; and
                  (F) establish a reasonable timetable for the 
                Secretary to review an application under this 
                section.
          (2) Consultation.--The regulations or guidance issued 
        under paragraph (1) shall be developed in consultation 
        with the Institute of Medicine, and with the input of 
        other appropriate scientific and medical experts, on 
        the design and conduct of such studies and 
        surveillance.
          (3) Revision.--The regulations or guidance under 
        paragraph (1) shall be revised on a regular basis as 
        new scientific information becomes available.
          (4) New tobacco products.--Not later than 2 years 
        after the date of enactment of the Family Smoking 
        Prevention and Tobacco Control Act, the Secretary shall 
        issue a regulation or guidance that permits the filing 
        of a single application for any tobacco product that is 
        a new tobacco product under section 910 and which the 
        applicant seeks to commercially market under this 
        section.
  (m) Distributors.--Except as provided in this section, no 
distributor may take any action, after the date of enactment of 
the Family Smoking Prevention and Tobacco Control Act, with 
respect to a tobacco product that would reasonably be expected 
to result in consumers believing that the tobacco product or 
its smoke may present a lower risk of disease or is less 
harmful than one or more commercially marketed tobacco 
products, or presents a reduced exposure to, or does not 
contain or is free of, a substance or substances.

SEC. 912. JUDICIAL REVIEW.

  (a) Right To Review.--
          (1) In general.--Not later than 30 days after--
                  (A) the promulgation of a regulation under 
                section 907 establishing, amending, or revoking 
                a tobacco product standard; or
                  (B) a denial of an application under section 
                910(c), any person adversely affected by such 
                regulation or denial may file a petition for 
                judicial review of such regulation or denial 
                with the United States Court of Appeals for the 
                District of Columbia or for the circuit in 
                which such person resides or has their 
                principal place of business.
          (2) Requirements.--
                  (A) Copy of petition.--A copy of the petition 
                filed under paragraph (1) shall be transmitted 
                by the clerk of the court involved to the 
                Secretary.
                  (B) Record of proceedings.--On receipt of a 
                petition under subparagraph (A), the Secretary 
                shall file in the court in which such petition 
                was filed--
                          (i) the record of the proceedings on 
                        which the regulation or order was 
                        based; and
                          (ii) a statement of the reasons for 
                        the issuance of such a regulation or 
                        order.
                  (C) Definition of record.--In this section, 
                the term ``record'' means--
                          (i) all notices and other matter 
                        published in the Federal Register with 
                        respect to the regulation or order 
                        reviewed;
                          (ii) all information submitted to the 
                        Secretary with respect to such 
                        regulation or order;
                          (iii) proceedings of any panel or 
                        advisory committee with respect to such 
                        regulation or order;
                          (iv) any hearing held with respect to 
                        such regulation or order; and
                          (v) any other information identified 
                        by the Secretary, in the administrative 
                        proceeding held with respect to such 
                        regulation or order, as being relevant 
                        to such regulation or order.
  (b) Standard of Review.--Upon the filing of the petition 
under subsection (a) for judicial review of a regulation or 
order, the court shall have jurisdiction to review the 
regulation or order in accordance with chapter 7 of title 5, 
United States Code, and to grant appropriate relief, including 
interim relief, as provided for in such chapter. A regulation 
or denial described in subsection (a) shall be reviewed in 
accordance with section 706(2)(A) of title 5, United States 
Code.
  (c) Finality of Judgment.--The judgment of the court 
affirming or setting aside, in whole or in part, any regulation 
or order shall be final, subject to review by the Supreme Court 
of the United States upon certiorari or certification, as 
provided in section 1254 of title 28, United States Code.
  (d) Other Remedies.--The remedies provided for in this 
section shall be in addition to, and not in lieu of, any other 
remedies provided by law.
  (e) Regulations and Orders Must Recite Basis in Record.--To 
facilitate judicial review, a regulation or order issued under 
section 906, 907, 908, 909, 910, or 916 shall contain a 
statement of the reasons for the issuance of such regulation or 
order in the record of the proceedings held in connection with 
its issuance.

SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS.

  The Secretary shall issue regulations to require that retail 
establishments for which the predominant business is the sale 
of tobacco products comply with any advertising restrictions 
applicable to retail establishments accessible to individuals 
under the age of 18.

SEC. 914. JURISDICTION OF AND COORDINATION WITH THE FEDERAL TRADE 
                    COMMISSION.

  (a) Jurisdiction.--
          (1) In general.--Except where expressly provided in 
        this chapter, nothing in this chapter shall be 
        construed as limiting or diminishing the authority of 
        the Federal Trade Commission to enforce the laws under 
        its jurisdiction with respect to the advertising, sale, 
        or distribution of tobacco products.
          (2) Enforcement.--Any advertising that violates this 
        chapter or a provision of the regulations referred to 
        in section 102 of the Family Smoking Prevention and 
        Tobacco Control Act, is an unfair or deceptive act or 
        practice under section 5(a) of the Federal Trade 
        Commission Act and shall be considered a violation of a 
        rule promulgated under section 18 of that Act.
  (b) Coordination.--With respect to the requirements of 
section 4 of the Federal Cigarette Labeling and Advertising Act 
and section 3 of the Comprehensive Smokeless Tobacco Health 
Education Act of 1986--
          (1) the Chairman of the Federal Trade Commission 
        shall coordinate with the Secretary concerning the 
        enforcement of such Act as such enforcement relates to 
        unfair or deceptive acts or practices in the 
        advertising of cigarettes or smokeless tobacco; and
          (2) the Secretary shall consult with the Chairman of 
        such Commission in revising the label statements and 
        requirements under such sections.

SEC. 915. REGULATION REQUIREMENT.

  (a) Testing, Reporting, and Disclosure.--Not later than 36 
months after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, the Secretary shall 
promulgate regulations under this Act that meet the 
requirements of subsection (b).
  (b) Contents of Rules.--The regulations promulgated under 
subsection (a)--
          (1) shall require testing and reporting of tobacco 
        product constituents, ingredients, and additives, 
        including smoke constituents, by brand and subbrand 
        that the Secretary determines should be tested to 
        protect the public health, provided that, for purposes 
        of the testing requirements of this paragraph, 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--
                          (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 
        tobacco product manufacturer provides evidence to the 
        Secretary demonstrating that--
                  (A) the manufacturer has submitted the 
                required products for testing to a laboratory 
                and has done so sufficiently in advance of the 
                deadline to create a reasonable expectation of 
                completion by the deadline;
                  (B) the products currently are awaiting 
                testing by the laboratory; and
                  (C) neither that laboratory nor any other 
                laboratory is able to complete testing by the 
                deadline at customary, nonexpedited testing 
                fees.
          (3) Extension.--The Secretary, taking into account 
        the laboratory testing capacity that is available to 
        tobacco product manufacturers, shall review and verify 
        the evidence submitted by a small tobacco product 
        manufacturer in accordance with paragraph (2). If the 
        Secretary finds that the conditions described in such 
        paragraph are met, the Secretary shall notify the small 
        tobacco product manufacturer that the manufacturer 
        shall not be considered to be in violation of the 
        testing and reporting requirements of this section 
        until the testing is reported or until 1 year after the 
        reporting deadline has passed, whichever occurs sooner. 
        If, however, the Secretary has not made a finding 
        before the reporting deadline, the manufacturer shall 
        not be considered to be in violation of such 
        requirements until the Secretary finds that the 
        conditions described in paragraph (2) have not been 
        met, or until 1 year after the reporting deadline, 
        whichever occurs sooner.
          (4) Additional extension.--In addition to the time 
        that may be provided under paragraph (3), the Secretary 
        may provide further extensions of time, in increments 
        of no more than 1 year, for required testing and 
        reporting to occur if the Secretary determines, based 
        on evidence properly and timely submitted by a small 
        tobacco product manufacturer in accordance with 
        paragraph (2), that a lack of available laboratory 
        capacity prevents the manufacturer from completing the 
        required testing during the period described in 
        paragraph (3).
  (f) Rule of Construction.--Nothing in subsection (d) or (e) 
shall be construed to authorize the extension of any deadline, 
or to otherwise affect any timeframe, under any provision of 
this Act or the Family Smoking Prevention and Tobacco Control 
Act other than this section.

SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHORITY.

  (a) In General.--
          (1) Preservation.--Except as provided in paragraph 
        (2)(A), nothing in this chapter, or rules promulgated 
        under this chapter, shall be construed to limit the 
        authority of a Federal agency (including the Armed 
        Forces), a State or political subdivision of a State, 
        or the government of an Indian tribe to enact, adopt, 
        promulgate, and enforce any law, rule, regulation, or 
        other measure with respect to tobacco products that is 
        in addition to, or more stringent than, requirements 
        established under this chapter, including a law, rule, 
        regulation, or other measure relating to or prohibiting 
        the sale, distribution, possession, exposure to, access 
        to, advertising and promotion of, or use of tobacco 
        products by individuals of any age, information 
        reporting to the State, or measures relating to fire 
        safety standards for tobacco products. No provision of 
        this chapter shall limit or otherwise affect any State, 
        Tribal, or local taxation of tobacco products.
          (2) Preemption of certain state and local 
        requirements.--
                  (A) In general.--No State or political 
                subdivision of a State may establish or 
                continue in effect with respect to a tobacco 
                product any requirement which is different 
                from, or in addition to, any requirement under 
                the provisions of this chapter relating to 
                tobacco product standards, premarket review, 
                adulteration, misbranding, labeling, 
                registration, good manufacturing standards, or 
                modified risk tobacco products.
                  (B) Exception.--Subparagraph (A) does not 
                apply to requirements relating to the sale, 
                distribution, possession, information reporting 
                to the State, exposure to, access to, the 
                advertising and promotion of, or use of, 
                tobacco products by individuals of any age, or 
                relating to fire safety standards for tobacco 
                products. Information disclosed to a State 
                under subparagraph (A) that is exempt from 
                disclosure under section 552(b)(4) of title 5, 
                United States Code, shall be treated as a trade 
                secret and confidential information by the 
                State.
  (b) Rule of Construction Regarding Product Liability.--No 
provision of this chapter relating to a tobacco product shall 
be construed to modify or otherwise affect any action or the 
liability of any person under the product liability law of any 
State.

SEC. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.

  (a) Establishment.--Not later than 6 months after the date of 
enactment of the Family Smoking Prevention and Tobacco Control 
Act, the Secretary shall establish a 12-member advisory 
committee, to be known as the Tobacco Products Scientific 
Advisory Committee (in this section referred to as the 
``Advisory Committee'').
  (b) Membership.--
          (1) In general.--
                  (A) Members.--The Secretary shall appoint as 
                members of the Tobacco Products Scientific 
                Advisory Committee individuals who are 
                technically qualified by training and 
                experience in medicine, medical ethics, 
                science, or technology involving the 
                manufacture, evaluation, or use of tobacco 
                products, who are of appropriately diversified 
                professional backgrounds. The committee shall 
                be composed of--
                          (i) 7 individuals who are physicians, 
                        dentists, scientists, or health care 
                        professionals practicing in the area of 
                        oncology, pulmonology, cardiology, 
                        toxicology, pharmacology, addiction, or 
                        any other relevant specialty;
                          (ii) 1 individual who is an officer 
                        or employee of a State or local 
                        government or of the Federal 
                        Government;
                          (iii) 1 individual as a 
                        representative of the general public;
                          (iv) 1 individual as a representative 
                        of the interests of the tobacco 
                        manufacturing industry;
                          (v) 1 individual as a representative 
                        of the interests of the small business 
                        tobacco manufacturing industry, which 
                        position may be filled on a rotating, 
                        sequential basis by representatives of 
                        different small business tobacco 
                        manufacturers based on areas of 
                        expertise relevant to the topics being 
                        considered by the Advisory Committee; 
                        and
                          (vi) 1 individual as a representative 
                        of the interests of the tobacco 
                        growers.
                  (B) Nonvoting members.--The members of the 
                committee appointed under clauses (iv), (v), 
                and (vi) of subparagraph (A) shall serve as 
                consultants to those described in clauses (i) 
                through (iii) of subparagraph (A) and shall be 
                nonvoting representatives.
                  (C) Conflicts of interest.--No members of the 
                committee, other than members appointed 
                pursuant to clauses (iv), (v), and (vi) of 
                subparagraph (A) shall, during the member's 
                tenure on the committee or for the 18-month 
                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.
          (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 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 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 
        tobacco product.--The percentage share of each 
        manufacturer or importer of a particular class of 
        tobacco products of the total user fee to be paid by 
        all manufacturers or importers of that class of tobacco 
        products shall be the percentage determined for 
        purposes of allocations under subsections (e) through 
        (h) of section 625 of Public Law 108-357.
          (5) Allocation for cigars.--Notwithstanding paragraph 
        (4), if a user fee assessment is imposed on cigars, the 
        percentage share of each manufacturer or importer of 
        cigars shall be based on the excise taxes paid by such 
        manufacturer or importer during the prior fiscal year.
          (6) Timing of assessment.--The Secretary shall notify 
        each manufacturer and importer of tobacco products 
        subject to this section of the amount of the quarterly 
        assessment imposed on such manufacturer or importer 
        under this subsection for each quarter of each fiscal 
        year. Such notifications shall occur not later than 30 
        days prior to the end of the quarter for which such 
        assessment is made, and payments of all assessments 
        shall be made by the last day of the quarter involved.
          (7) Memorandum of understanding.--
                  (A) In general.--The Secretary shall request 
                the appropriate Federal agency to enter into a 
                memorandum of understanding that provides for 
                the regular and timely transfer from the head 
                of such agency to the Secretary of the 
                information described in paragraphs (2)(B)(ii) 
                and (4) and all necessary information regarding 
                all tobacco product manufacturers and importers 
                required to pay user fees. The Secretary shall 
                maintain all disclosure restrictions 
                established by the head of such agency 
                regarding the information provided under the 
                memorandum of understanding.
                  (B) Assurances.--Beginning not later than 
                fiscal year 2015, and for each subsequent 
                fiscal year, the Secretary shall ensure that 
                the Food and Drug Administration is able to 
                determine the applicable percentages described 
                in paragraph (2) and the percentage shares 
                described in paragraph (4). The Secretary may 
                carry out this subparagraph by entering into a 
                contract with the head of the Federal agency 
                referred to in subparagraph (A) to continue to 
                provide the necessary information.
  (c) Crediting and Availability of Fees.--
          (1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to 
        the extent and in the amount provided in advance in 
        appropriations Acts. 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 (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 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 [IX] X--MISCELLANEOUS

                          SEPARABILITY CLAUSE

  Sec. [901.] 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. [902.] 1002. (a) * * *

           *       *       *       *       *       *       *


SEC. [903.] 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--
                  (A) * * *

           *       *       *       *       *       *       *

                  (C) research relating to foods, drugs, 
                cosmetics, [and] devices, and tobacco products 
                in carrying out this Act;

           *       *       *       *       *       *       *


SEC. [904.] 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. [905.] 1005. LOAN REPAYMENT PROGRAM.

  (a) * * *

           *       *       *       *       *       *       *


SEC. [906.] 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. [907.] 1007. CONTRACTS FOR EXPERT REVIEW.

  (a) * * *

           *       *       *       *       *       *       *


SEC. [908.] 1008. NOTICES TO STATES REGARDING IMPORTED FOOD.

  (a) * * *

           *       *       *       *       *       *       *


SEC. [909.] 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 [section 908] section 1008, including planning and 
otherwise preparing to take such action.

           *       *       *       *       *       *       *


SEC. [910.] 1010. OFFICE OF THE CHIEF SCIENTIST.

  (a) * * *

           *       *       *       *       *       *       *

                              ----------                              


                      FEDERAL MEAT INSPECTION ACT



           *       *       *       *       *       *       *
TITLE IV--AUXILIARY PROVISIONS

           *       *       *       *       *       *       *


  Sec. 409.(a) Notwithstanding any other provisions of law, 
including [section 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



           *       *       *       *       *       *       *
                               [LABELING

  [Sec. 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:
[SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart 
Disease, Emphysema, And May Complicate Pregnancy.
[SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly 
Reduces Serious Risks to Your Health.
[SURGEON GENERAL'S WARNING: Smoking by Pregnant Women May 
Result in Fetal Injury, Premature Birth, And Low Birth Weight.
[SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon 
Monoxide.
  [(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:
[SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart 
Disease, Emphysema, And May Complicate Pregnancy.
[SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly 
Reduces Serious Risks to Your Health.
[SURGEON GENERAL'S WARNING: Smoking by Pregnant Women May 
Result in Fetal Injury, Premature Birth, And Low Birth Weight.
[SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon 
Monoxide.
  [(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:
[SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart 
Disease, And Emphysema.
[SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly 
Reduces Serious Health Risks.
[SURGEON GENERAL'S WARNING: Pregnant Women Who Smoke Risk Fetal 
Injury, And Premature Birth.
[SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon 
Monoxide.
  [(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.
  [(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.
  [(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.
  [(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.
  [(2)(A) A manufacturer or importer of cigarettes may apply to 
the Federal Trade Commission to have the label rotation 
described in subparagraph (C) apply with respect to a brand 
style of cigarettes manufactured or imported by such 
manufacturer or importer if--
          [(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
          [(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.
  [(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).
  [(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.
  [(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 
        conspicuous and legible 17-point type, unless the text 
        of the label statement would occupy more than 70 
        percent of such area, in which case the text may be in 
        a smaller conspicuous and legible type size, provided 
        that at least 60 percent of such area is occupied by 
        required text. The text shall be black on a white 
        background, or white on a black background, in a manner 
        that contrasts, by typography, layout, or color, with 
        all other printed material on the package, in an 
        alternating fashion under the plan submitted under 
        subsection (c).
          (3) Does not apply to foreign distribution.--The 
        provisions of this subsection do not apply to a tobacco 
        product manufacturer or distributor of cigarettes which 
        does not manufacture, package, or import cigarettes for 
        sale or distribution within the United States.
          (4) Applicability to retailers.--A retailer of 
        cigarettes shall not be in violation of this subsection 
        for packaging that--
                  (A) contains a warning label;
                  (B) is supplied to the retailer by a license- 
                or 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-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 advertisement that does not contain a 
        warning label or has been altered by the retailer in a 
        way that is material to the requirements of this 
        subsection and subsection (b).
  (d) 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 Disclosure.--
          (1) In general.--The Secretary shall, by a rulemaking 
        conducted under section 553 of title 5, United States 
        Code, determine (in the Secretary's sole discretion) 
        whether cigarette and other tobacco product 
        manufacturers shall be required to include in the area 
        of each cigarette advertisement specified by subsection 
        (b) of this section, or on the package label, or both, 
        the tar and nicotine yields of the advertised or 
        packaged brand. Any such disclosure shall be in 
        accordance with the methodology established under such 
        regulations, shall conform to the type size 
        requirements of subsection (b) of this section, and 
        shall appear within the area specified in subsection 
        (b) of this section.
          (2) Resolution of differences.--Any differences 
        between the requirements established by the Secretary 
        under paragraph (1) and tar and nicotine yield 
        reporting requirements established by the Federal Trade 
        Commission shall be resolved by a memorandum of 
        understanding between the Secretary and the Federal 
        Trade Commission.
          (3) Cigarette and other tobacco product 
        constituents.--In addition to the disclosures required 
        by paragraph (1), the Secretary may, under a rulemaking 
        conducted under section 553 of title 5, United States 
        Code, prescribe disclosure requirements regarding the 
        level of any cigarette or other tobacco product 
        constituent including any smoke constituent. Any such 
        disclosure may be required if the Secretary determines 
        that disclosure would be of benefit to the public 
        health, or otherwise would increase consumer awareness 
        of the health consequences of the use of tobacco 
        products, except that no such prescribed disclosure 
        shall be required on the face of any cigarette package 
        or advertisement. Nothing in this section shall 
        prohibit the Secretary from requiring such prescribed 
        disclosure through a cigarette or other tobacco product 
        package or advertisement insert, or by any other means 
        under the Federal Food, Drug, and Cosmetic Act.
          (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) [No] Except to the extent the Secretary requires 
additional or different statements on any cigarette package by 
a regulation, by an order, by a standard, by an authorization 
to market a product, or by a condition of marketing a product, 
pursuant to the Family Smoking Prevention and Tobacco Control 
Act (and the amendments made by that Act), or as required under 
section 903(a)(2) or section 920(a) of the Federal Food, Drug, 
and Cosmetic Act, no 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



           *       *       *       *       *       *       *
[SEC. 3. SMOKELESS TOBACCO WARNING.

  [(a) General Rule.--
          [(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'.
          [(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).
  [(b) Label Format.--The Federal Trade Commission shall issue 
regulations requiring the label statement required by 
subsection (a) to appear--
          [(1) in the case of the smokeless tobacco product 
        package--
                  [(A) in a conspicuous and prominent place on 
                the package, and
                  [(B) in a conspicuous format and in 
                conspicuous and legible type in contrast with 
                all other printed material on the package, and
          [(2) in the case of advertising subject to subsection 
        (a)(2)--
                  [(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,
                  [(B) in the following format:
                
                
                  [(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.
  [(c) Label Display.--The Federal Trade Commission shall issue 
regulations requiring each label statement required by 
subsection (a) to--
          [(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
          [(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.
  [(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).
  [(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.
  [(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.
  [(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.--
          (1) It shall be unlawful for any tobacco product 
        manufacturer, packager, importer, distributor, or 
        retailer of smokeless tobacco products to advertise or 
        cause to be advertised within the United States any 
        smokeless tobacco product unless its advertising bears, 
        in accordance with the requirements of this section, 
        one of the labels specified in subsection (a).
          (2)(A) Each label statement required by subsection 
        (a) in smokeless tobacco advertising shall comply with 
        the standards set forth in this paragraph.
          (B) For press and poster advertisements, each such 
        statement and (where applicable) any required statement 
        relating to tar, nicotine, or other constituent yield 
        shall comprise at least 20 percent of the area of the 
        advertisement.
          (C) The word ``WARNING'' shall appear in capital 
        letters, and each label statement shall appear in 
        conspicuous and legible type.
          (D) The text of the label statement shall be black on 
        a white background, or white on a black background, in 
        an alternating fashion under the plan submitted under 
        paragraph (3).
          (E) The label statements shall be enclosed by a 
        rectangular border that is the same color as the 
        letters of the statements and that is the width of the 
        first downstroke of the capital ``W'' of the word 
        ``WARNING'' in the label statements.
          (F) The text of such label statements shall be in a 
        typeface pro rata to the following requirements: 45-
        point type for a whole-page broadsheet newspaper 
        advertisement; 39-point type for a half-page broadsheet 
        newspaper advertisement; 39-point type for a whole-page 
        tabloid newspaper advertisement; 27-point type for a 
        half-page tabloid newspaper advertisement; 31.5-point 
        type for a double page spread magazine or 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--
                  (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.--[No] 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



           *       *       *       *       *       *       *
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

           *       *       *       *       *       *       *


Sec. 8415. Computation of basic annuity

  (a) * * *

           *       *       *       *       *       *       *

  [(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.
  [(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.

           *       *       *       *       *       *       *


Sec. 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 [section 8415(k)] paragraph (1) or (2) of 
section 8415(l).

           *       *       *       *       *       *       *


SUBCHAPTER III--THRIFT SAVINGS PLAN

           *       *       *       *       *       *       *


Sec. 8432. Contributions

  (a) * * *
  (b)(1)(A) * * *
  (B) The amount to be contributed pursuant to an election 
under subparagraph (A) [(or any election allowable by virtue of 
paragraph (4))] shall be the percentage of basic pay or amount 
designated by the employee or Member.
  [(2) Under the regulations--
          [(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;
          [(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;
          [(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
          [(D) an election to terminate may be made under this 
        subparagraph at any time as provided under paragraph 
        (1).
  [(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.
  [(4) The Executive Director shall prescribe such regulations 
as may be necessary to carry out the following:
          [(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 
        administratively feasible, as determined by the 
        Executive Director.
          [(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.
          [(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.
          [(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.
          [(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.
          [(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.

           *       *       *       *       *       *       *


Sec. 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.

           *       *       *       *       *       *       *


Sec. 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); [and]
          (E) an International Stock Index Investment Fund as 
        provided in paragraph (4)[.]; 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.
  (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.

           *       *       *       *       *       *       *


Sec. 8439. Accounting and information

  (a) * * *

           *       *       *       *       *       *       *

  [(d)] (d)(1) Each employee, Member, former employee, or 
former Member who elects to invest in [the 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 
[either 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

           *       *       *       *       *       *       *


Sec. 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.

           *       *       *       *       *       *       *


                            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 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 smoking-related 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 riskfor 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 tobacco-related deaths while doing nothing of significance 
to reduce the number of teens who would initiate tobacco use 
with no bill at all.''
    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 
in1996 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.
    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 wouldhave 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:

          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 following 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.

                      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.

                                  
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