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.
--
President of The United States
Guy Ralph Perea Sr President of The United States
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