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    Senate Begins Debate on FDA Tobacco Regulation

    Opponents, including the former FDA commissioner, say the agency is not prepared.

    WASHINGTON -- The Senate Health, Education, Labor and Pensions committee began work yesterday on a proposal that would give the U.S. Food and Drug Administration (FDA) authority to regulate the sale of tobacco, in an effort to curb youth smoking, the Richmond Times Dispatch reported.

    The committee began weighing amendments to the proposal, but did not finish work on the bill before pausing to resume its discussions today.

    The bill would allow the FDA to restrict tobacco advertising; prevent cigarette sales to minors; mandate stronger warning labels; bar misrepresentation of tobacco's dangers; and order removal of dangerous ingredients from cigarettes, an Associated Press report stated. Specifically, it would let the FDA regulate the levels of tar, nicotine and other harmful components of tobacco products.

    "We're going to get the bill [approved] as sure as I'm sitting here," said Sen. Edward Kennedy (D-Ma.), who introduced the bill and is also the panel's chairman.

    Opponents of the bill, including former FDA commissioner Dr. Mark McClellan, believe the FDA is not prepared to take on tobacco regulation, reported Reuters.

    "I think there is some potential for regulation of tobacco. I'm a little bit nervous about putting it in FDA," McClellan said. He now co-chairs an organization called the Coalition for a Stronger FDA, a group that tries to increase public support for the FDA.

    McClellan, who was appointed to his former role by President George W. Bush, said he did not think the FDA was the right agency to regulate tobacco. "Having been at FDA, the agency doesn't have any staff that's used to thinking about how you make an unsafe product relatively more safe," he told Reuters.

    In addition, the agency is already limited by its resources. "It has way more to do than it has manpower or resources to do," he added.
    However, McClellan agreed that tobacco should be better regulated.
    "Hopefully, this discussion in the Senate health committee will help trigger some ideas about a new regulatory structure that could actually work to do it," he said.

    Opponents also criticized a 2.5-cent per pack "user fee" that would be instated to pay for the FDA regulation, stating that separate legislation -- to expand children's health insurance programs with a 61-cent per pack federal excise tax increase -- might be adversely affected by the 2.5-cent fee, the Dispatch reported.

    The bill has broad bipartisan support. However, President Bush, FDA commissioner Dr. Andrew von Eschenbach and Health and Human Services Secretary Mike Leavitt oppose the legislation, the AP reported.

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