The Family Smoking Prevention and Tobacco Control Act of 2009 grants the FDA authority to regulate tobacco products. Key provisions include banning fruit-flavored cigarettes, graphic health warnings covering 50% of cigarette packs, limits on advertising and marketing appeals to youth. It does not preempt all state/local tobacco control laws. The act aims to reduce youth tobacco use and inform the public of health risks but was partially struck down by a Kentucky court over some marketing restrictions.

1. The Family Smoking Prevention and Tobacco
Control Act of 2009
Summary and Review for Informed Decision Making at the State and Local Level
“A cigarette is the only consumer product
which when used as directed kills its
consumer.”—Dr. Gro Harlem Brundtland
On June 22, 2009, President Barack Obama signed into law the Family Smoking
Prevention and Tobacco Control Act1. The legislation provided the Federal Food and
Drug Administration (FDA) with the authority to regulate tobacco products.
Background
 Under Commissioner David Kessler, in 1996, the FDA determined that tobacco products,
including cigarettes and smokeless, were nicotine delivery devices that fell within the scope of
the Federal Food, Drug, and Cosmetic Act2. The regulation developed under Kessler’s
administration was entitled the Youth Access and Advertising Regulation.
 In 2000, the U.S. Supreme Court ruled—in FDA v. Brown & Williamson Tobacco Corp3.—that the
FDA did not have jurisdiction over tobacco products as they were customarily marketed,
impeding the agency’s efforts to restrict these products availability and appeal to young people.
Justice O’Connor remarked in the final ruling that, “regardless of how serious the problem an
administrative agency seeks to address, however, it may not exercise its authority ‘in a manner
that is inconsistent with the administrative structure that Congress enacted into law.’"4
1 Please note, that throughout this document the Family Smoking Prevention and Tobacco Control Act may be referred to as the “Tobacco Control Act,” the
“FDA law,” or for purposes of this discussion, “the law.”
2 21 U.S.C. §§ 301-399a.
3 FDA v. Brown & Williamson Tobacco Corp., 529 US 120 (2000).
4 Ibid.
Developed by the Health Policy Partners of Maine, June 2010 [ako]

2.  On June 22, 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco
Control Act5 into law. The law is scheduled to take effect on June 22, 2010. It amends the
Federal Food, Drug, and Cosmetic Act, granting the FDA with jurisdiction to regulate the
manufacturing, marketing and sale of commercial tobacco products.
 On September 22, 2009, the FDA banned cigarettes with fruit or candy characterizing flavors.
 On March 19, 2010, the FDA adopted a rule that disallows for the use of a (tobacco) brand
name that began being marketed after January 1, 1995, if the name is also used as a brand by
another company of a nontobacco product.6 This rule was adopted to deal with concerns over
“misbranding.”
What the Tobacco Control Act Does
The Tobacco Control Act grants the FDA with authority to regulate the manufacturing, marketing and
distribution of tobacco productions in order to protect the public health and reduce youth use rates.
The law also charges the FDA with reinstating 1996 regulations restricting the sale and distribution of
cigarettes and smokeless tobacco products with some modifications. The once named Youth Access
and Advertising Regulation is currently known as Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco to Protect Children and Adolescents 7. The new regulations are
effective June 22, 2010.
The most prominent features of the Tobacco Control Act are:
 FDA may assert jurisdiction over all commercial tobacco products, while cigarettes and
smokeless tobacco products remain current priority products.
o Regulation will not be under the “safe and effective” standard of other products under
FDA review, but rather classified based on whether they are “appropriate for the
protection of public health.”
5 Pub. L. 111-131. 22 June 2009. Stat. 123.1776.
6 *In RENEGADE TOBACCO CO. et. al. v. FDA, a U.S. District Court judge in NC approved a stay on May 19, 2010, that prevents the FDA from enforcing
this rule. The court recommended that the FDA “amend” the rule. Should FDA continue with regulatory action, it must give tobacco companies 90-days notice
before taking action.
7 USC: 21 CFR Pt. 1140. 2010
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3. o FDA is currently examining whether to add cigars to their list of products to closely
regulate “but on no particular deadline.”8
o Immediate priorities include the evaluation of the public health effects of menthol in
cigarettes, which make up 1/3 of the U.S. cigarette market.
 The law:
o Creates a federal minimum age of 18 years for purchases of cigarettes and smokeless
tobacco.
o Restricts sales of tobacco to direct, face-to-face exchange, eliminating vending machines
and self-service machines from any facility, except for those where the age of patrons is
18 years or older.
 Mail order sales, excluding mail-order redemption of coupons and free samples,
are permitted.
o Cigarette packs may contain no less than 20 cigarettes.
o Supply of free samples of smokeless tobacco is prohibited, except in temporary adult-
only facilities where minors are not allowed.
o Bans brand-name sponsorship of sporting events and concerts by tobacco companies.
o Disallows the outdoor advertisement (i.e. billboards, posters) of cigarettes and
smokeless tobacco within 1,000 feet of any public playground, elementary or secondary
school.
o Prohibits the use of the terms “light,” “mild” and “low tar” as descriptors without the
express consent of the FDA, thus disallowing tobacco companies from claiming a
tobacco product is less hazardous than another.
 Tobacco manufacturers are required to submit to the FDA lists of ingredients of their products,
as well as all internal documents regarding product and ingredient safety. The FDA has the
authority and responsibility to then publish the list of ingredients and chemicals that are
potentially harmful, either through direct use of the product or through the inhalation of
smoke. Any changes to ingredient lists must be reported to the FDA.
8 David Kesmodel, “FDA Tobacco Regulator Promises Firm Approach, Open Mind,” Wall Street Journal 24 May 2010.
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4. o FDA may require manufacturers to reduce or eliminate harmful ingredients where/when
possible.
 The FDA is responsible for publishing information on why tobacco use is harmful and how to
quit using. This information is to be tailored to meet the needs of numerous subpopulations,
including young people, sexual minorities, individuals with behavioral health or substance
abuse issues, military personnel and others.
 By the end of 2010, FDA will propose new graphic health warning labels to cover 50% of the
front and back of all packs of cigarettes. These warning labels will mimic those used in Canada,
Brazil and Australia. New warning labels will also be developed for smokeless tobacco
products.
 FDA will be tasked with the evaluation and regulation of “modified-risk” tobacco products, as
the law allows for companies to seek FDA approval to market their products as “reduced harm”
from tobacco-related illnesses, as compared to other tobacco products on the market.
o The FDA may set standards for a class of tobacco products to reduce addictiveness or
harm for the protection of public health.
 FDA has the authority to bring about advisory, administrative, or judicial actions (criminal and
civil), for any violation of the law.
 FDA will contract with states to enforce the federal law.
Legal Challenge to the FDA Law
Commonwealth Brands, Inc. et al. v. U.S. FDA (1:09CV-117-M)
o In 2009, Commonwealth Brands, Inc. took the U.S. FDA to district court in Bowling
Green, Kentucky, challenging the constitutionality of restrictions outlined in the Tobacco
Control Act.
o U.S. District Court Judge Joseph H. McKinley sent down a ruling on January 5, 2010 that:
 Upheld the law to the extent that it:
Require large, graphic health warnings on cigarette packs.
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5. Prohibit tobacco companies from making health claims about tobacco
products without FDA review.
Ban several forms of tobacco marketing that appeal to children, including
brand name sponsorships, tobacco-branded merchandise, free samples
of tobacco products and free gifts with purchase.
Impose additional regulations on tobacco products and marketing
beyond those specified in the law (at the federal, state and local levels).
 Struck down two provisions in the law:
The FDA ban on the use of color and imagery in tobacco advertising (i.e.
outdoor advertisements, magazines, etc.) in locations viewed by large
numbers of youth is not allowed.
Any claims by FDA implying that a tobacco product is “safe” or “safer” by
applying FDA approval to the product is prohibited.
What the Tobacco Control Act Does NOT Do
 The law does not preempt state and local governments from enacting certain tobacco control
measures, including tobacco taxes, smoke-free workplace law and fire-safety (i.e. fire-safe
cigarettes) standards for cigarettes.
o It does not restrict the states’ ability to adopt measures related to the sale, distribution,
possession and access to tobacco, as well as exposure to secondhand smoke.
o The Tobacco Control Act actually expands state and local authority to restrict the time,
place and manner of cigarette advertising.
 FDA’s authority is limited to tobacco manufacturers and their products, distributors and
retailers. FDA does NOT have authority to regulate tobacco farming or farmers.
 FDA regulations on branding and marketing must not be in violation of the First Amendment.
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6. Limitations Placed on State and Local Governments by the Tobacco Control Act
 The FDA has jurisdiction over laws regarding tobacco product standards, premarket approval,
adulteration, misbranding, labeling, registration, good manufacturing standards and reduced
risk product claims. No state or local government may pass laws or regulations regarding these
areas.
 While the new FDA law amended the Federal Cigarette Labeling and Advertising Act (FCLAA) to
allow for more state and local control over cigarette promotion, the FCLAA still prohibits:
o The banning of certain types of tobacco products, but not others (i.e. you cannot
prohibit the promotion of smokeless tobacco, but allow for the advertisement of
cigarettes at the same time).
o Additional warning labels placed on tobacco product packaging in addition to FDA
warning labels.
 This includes the introduction of warning labels in other languages, or literacy
sensitive warnings.
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