[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.