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    FDA Challenges Tobacco Companies

    Agency to Ban Tobacco Products Changed for Worse Since February 2007

    New or Changed Tobacco Products Could Be Banned continued...

    So what happens to tobacco products if the FDA determines they are not equivalent to grandfathered products?

    "The law allows those products not found to be equivalent to be withdrawn from the public market If the changes raise different questions of public health," Deyton said. "The intent is to assure that no new or changed tobacco products are worse for public health than those already on the market on Feb. 15, 2007."

    This doesn't mean the new products are healthier than the old products -- although Deyton says tobacco companies are encouraged to make safer products.

    How many products are affected? According to an FDA analysis of new UPC codes for tobacco products, in 2008 alone there were 233 new tobacco products, including 151 new cigarette products and 43 new chewing-tobacco products.

    It's up to tobacco companies to tell the FDA whether a product is new or changed since February 2007.

    But after March 22, 2011, any product the FDA considers new or changed will be ruled "adulterated" and banned from the market -- unless the company that makes the product has submitted a premarket application to the FDA, shown that the product is substantially equivalent to older products, or applied for an exemption from the new requirements.

    "Congress has given us the tools to bring enforcement actions: possible seizures, injunctions, and other types of enforcement against any violative product that is in U.S. commerce," Ann Simoneau, JD, director of compliance and enforcement for the FDA tobacco center, said at the news conference.

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