Last year, lawmakers reintroduced bipartisan, bicameral legislation
(H.R. 1108, S. 625) to give the Food and Drug Administration (FDA)
broad new authority to regulate the manufacture, distribution,
advertising, promotion, sale, and use of cigarettes and smokeless
tobacco products. Amended versions of both bills have been reported
out of committee and await floor action in their respective
chambers. The Secretary of Health and Human Services has stated in
a July 21, 2008, letter that the Bush Administration "would
strongly oppose this legislation." The Family Smoking Prevention
and Tobacco Control Act was first introduced in the 108th Congress,
the product of lengthy negotiations in which lawmakers sought to
balance the competing interests of public health groups and Philip
Morris, the nation's leading cigarette company. While these
organisations support the legislation, the FDA Commissioner, other
tobacco manufacturers, and tobacco industry and convenience store
associations have expressed concerns about the bills, which would
create a new Chapter IX in the Federal Food, Drug, and Cosmetic Act
(FFDCA) solely for the regulation of tobacco products. Among their
many provisions, the measures would authorise FDA to: restrict
tobacco advertising and promotions, especially to children; develop
standards that require changes in tobacco product composition and
design, such as the reduction or elimination of toxic chemicals;
and require manufacturers to obtain agency approval in order to
make reduced-risk and reduced-exposure claims for their products.
In the mid-1990s, FDA claimed authority under the FFDCA to regulate
cigarettes and smokeless tobacco products as delivery devices for
nicotine, an addictive drug. The agency's 1996 tobacco regulation
was invalidated by the U.S. Supreme Court in March 2000. The Court
concluded that Congress had clearly intended to preclude FDA from
regulating tobacco products. It found that because the FFDCA
prohibits the marketing of products that have not been found to be
safe and effective, the statute would have required FDA to ban such
manifestly harmful products as cigarettes and smokeless tobacco if
the agency had jurisdiction over them. Such a ban, argued the
Court, would plainly contradict congressional intent. The Supreme
Court's decision made it clear the Congress would have to enact
legislation giving FDA statutory authority over tobacco products in
order for the agency to assert jurisdiction. Lawmakers first
drafted such language in the 105th Congress as part of legislation
to implement the 1997 proposed national tobacco settlement.
General
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