Agency takes significant steps in implementation of historic new tobacco law
In a momentous effort to curtail the deadly effects of tobacco use, the U.S. Food and Drug Administration (FDA) has recently opened the doors to a new Center for Tobacco Products that will have authority to regulate the production and marketing of tobacco products.
The center will oversee the implementation of the Family Smoking Prevention and Tobacco Control Act (Adobe Acrobat Reader required) that became law just two months earlier. The historic new law empowers the agency to regulate levels of nicotine and other ingredients, as well as force greater disclosure of the contents of tobacco products and restrict false or misleading advertising.
Lawrence Deyton, M.D., M.S.P.H., an expert on veterans' health issues, public health, and tobacco use will serve as the center's first director. Deyton's appointment was praised by FDA Commissioner Margaret Hamburg who described him as a "rare combination of public health expert, administrative leader, scientist, and clinician."
On Aug. 25, 2009, FDA also announced the establishment of a Tobacco Products Scientific Advisory Committee (TPSAC), a 12-member body that will provide guidance to the commissioner. TPSAC will submit reports and recommendations on complex scientific issues such as the effects of altering nicotine yields and whether there is a threshold level at which nicotine becomes addictive. Nine of the voting members will include health care professionals, an officer or employee of a state or local government or the federal government, and a representative of the general public. Three nonvoting members will represent the tobacco-manufacturing industry, tobacco growers, and the small-business manufacturing industry.
In reaction to FDA's broad new authority, several prominent tobacco manufacturers have recently launched a legal effort to overturn portions of the new FDA tobacco law that they claim violate their constitutional right of commercial free speech. In a federal lawsuit filed in Kentucky on August 31, the plaintiffs specifically challenged the new advertising restrictions, including a requirement that tobacco products have larger, graphic warning labels covering half of the packaging. The case may eventually advance to the U.S. Supreme Court.
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