FDA: Equivalence Reviews Required for Tobacco Products

Agency to review products launched after Feb. 15, 2007; will consider questions of public health

WEDNESDAY, Jan. 5 (HealthDay News) -- The U.S. Food and Drug Administration announced today that certain tobacco products, including cigarettes, roll-your-own tobacco, and all smokeless products, introduced or changed in the United States after Feb. 15, 2007, must be reviewed by the agency. In its newly published guidance, the agency says that any company marketing a tobacco product must prove that the product is "substantially equivalent" to products commercially available on Feb. 15, 2007.

"Substantially equivalent," as defined by the FDA, means that the product must be the same regarding ingredients, composition, design, heating source, and other characteristics to an existing, single predicate product or have different traits without raising different questions of public health. On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act granted the FDA regulatory authority over tobacco products, which allowed the agency to deny applications for new products if marketing the product posed harm to public health.

Manufacturers with tobacco products changed or introduced after Feb. 15, 2007, must apply for equivalency by March 22, 2011, in order to continue to market their products. Manufacturers launching products after March 22, 2011, will need to submit an application for the new product and obtain a marketing order from the FDA before launching the product.

"This specific part of the law is meant to ensure that new tobacco products are evaluated by the FDA before they are cleared to enter the marketplace. The law requires FDA to carefully examine the impact those products may have on the public health," Lawrence R. Deyton, M.D., M.S.P.H., director of the FDA's Center for Tobacco Products, said in a statement.

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