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WASHINGTON -- The Food and Drug Administration launched a new initiative requiring a substantial equivalence review of all new tobacco products introduced or changed in the past four years. Under the new guidance, companies marketing the product must prove that it is "substantially equivalent" to products commercially available on Feb. 15, 2007.
According to the FDA, "substantially equivalent" means the products must be the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single predicate product or have different characteristics, but not raise different questions of public health.
"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.S.P.H., M.D., director of the agency’s Center for Tobacco Products said in a released statement. "Products that are equivalent to those which were on the market on Feb. 15, 2007, may be cleared to go to market; those that are not may be prohibited from the market, or withdrawn if they are already available, if the changes raise different questions of public health."
The new initiative is part of the Family Smoking Prevention and Tobacco Control Act, which became law in June 2009. "This piece of the Tobacco Control Act protects the health of all Americans," said Health and Human Services Secretary Kathleen Sebelius. "It does this by setting a clear deadline for tobacco companies to provide important product information to the FDA so the agency can then begin evaluating tobacco products for any potential new risks to public health."
Under the new guidance, manufacturers of tobacco products that were introduced or changed after Feb. 15, 2007 -- which include cigarettes, roll-your-own tobacco and all smokeless products -- must apply for equivalency by Mar. 22, 2011. Manufacturers intending to introduce new products into the market after that date must submit an application for the new product and obtain a marketing order from the FDA before introducing the product to market, according to the FDA.