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Rules on tobacco tightened.

Certain tobacco products--including cigarettes, roll-your-own, and smokeless varieties--that were introduced or changed in the United States after Feb. 15, 2007, must be reviewed by the FDA to show that they are "substantially equivalent" to existing products, Dr. Lawrence Deyton, director of the agency's Center for Tobacco Products, said in a press briefing.

The FDA action is driven by the Family Smoking Prevention and Tobacco Control Act, which became law in June 2009. The law allows the FDA to regulate tobacco products with the goal of protecting public health.

The substantial equivalence provisions are "'meant to ensure that new tobacco products or changes to existing products are evaluated by the FDA before they enter the marketplace and are consumed by millions of people," Dr. Deyton said. "'Up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming," he said.

The Tobacco Control Act allows tobacco companies to market products that were available after Feb. 15, 2007, if the companies submit at least a preliminary report to the FDA by March 22, 2011, to show that these products are not significantly different from preexisting products. Products in existence before Feb. 15, 2007, are not subject to the new FDA review, said Ann Simoneau, director of the Center for Tobacco Products" Office of Compliance and Enforcement.

New products introduced after March 22 will follow a different regulatory pathway, Dr. Deyton said.

Physicians should know that the FDA is now examining certain tobacco products and that manufacturers are required to submit information to the FDA about the products and changes to them, "particularly if those changes might raise new questions about public health," Dr. Deyton said.

--From staff reports

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Title Annotation:NEWS FROM THE FDA
Comment:Rules on tobacco tightened.(NEWS FROM THE FDA)
Publication:Family Practice News
Geographic Code:1USA
Date:Feb 1, 2011
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