FDA requires review of new tobacco products

NEWS IN BRIEF — Posted Jan. 17, 2011

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Tobacco products that entered the market or were changed after Feb. 15, 2007, must be evaluated by the Food and Drug Administration or risk being pulled from the shelves.

The new federal regulation, announced Jan. 5, requires manufacturers of tobacco products to prove that their products are "substantially equivalent" to those available before the February cut-off date to continue marketing them. "Substantially equivalent," according to the FDA, refers to products of the same ingredients, design, composition and heating source to existing products. The products may have different characteristics but must not raise any "different questions of public health" beyond their older counterparts.

Manufacturers of products introduced or altered after the 2007 cut-off date -- including cigarettes, roll-your-own tobacco and all smokeless products -- must apply for "equivalency" with the FDA by March 22. The agency also asks that tobacco companies planning to introduce products after the March date submit an application and obtain a marketing order form before proceeding.

The recent regulation stems from the Tobacco Control Act, which became law in 2009 and grants the FDA regulatory authority over tobacco products.

Note: This item originally appeared at

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