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FDA to Expand With New Tobacco Role

11 June 2009 4:31 pm
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The Senate today voted 79–17 to approve a landmark tobacco bill that President Barack Obama said he will sign once it is reconciled with a similar House of Representatives measure. The legislation will, for the first time, empower the Food and Drug Administration to regulate cigarettes and other tobacco products, creating a new FDA Center for Tobacco Products within 90 days after enactment.

A government source tells ScienceInsider that FDA is planning to hire as many as 1000 new employees—including several hundred scientists—to staff the new tobacco products center. (The agency now has six centers for drug evaluation, food safety, devices, biologics, veterinary medicine, and toxicology.) A user fee paid by tobacco companies will finance the FDA expansion required by the law, including a scientific advisory panel on tobacco-related issues. The bill follows a 2007 report by the Institute of Medicine that urged Congress to give the FDA such regulatory authority.

The bill would not allow FDA to ban nicotine, but would give the agency the power to require changes in the yields of nicotine and other chemicals in tobacco products. It would ban misleading claims such as “light” and “low-tar” as well as require manufacturers to submit claims for "reduced risk" cigarettes to FDA for analysis. Detailed lists of cigarette ingredients will also be required.

Public health researchers who study tobacco risks say the law’s impact will depend on how FDA implements the new rules and structures its tobacco research. Gregory N. Connolly of the Harvard School of Public Health says FDA should focus on reducing tobacco use, rather than regulating the industry’s efforts to develop “safer” cigarettes.

In a statement, Obama said he plans to sign the legislation because it “will make history by giving the scientists and medical experts at the FDA the power to take sensible steps that will reduce tobacco’s harmful effects and prevent tobacco companies from marketing their products to children.”

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