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FDA Launches Review of Tobacco Products
Date:1/5/2011

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, Jan. 5 (HealthDay News) -- Tobacco products introduced or altered since February 2007 must be reviewed by the U.S. Food and Drug Administration if they are to remain on the market, the agency announced Wednesday.

This effort, one aspect of the 2009 Family Smoking Prevention and Tobacco Control Act, is meant to keep more addictive products from the hands of consumers. Any new or revised tobacco products must be substantially equivalent to products sold on or before Feb. 15, 2007, the agency said.

"Up to now tobacco products have been the only mass-consumed products for which users do not know what they are consuming," Dr. Lawrence R. Deyton, director of FDA's Center for Tobacco Products, said during a Wednesday morning news conference.

The law -- which applies to cigarettes, roll-your-own tobacco and all smokeless products -- requires the FDA to examine the impact any changes to existing products could have on public health, Deyton said.

"No longer will changes to products consumed by millions of Americans be made without anyone knowing," he said.

"Substantially equivalent" means the products have the same ingredients, design, composition and heating source, among other characteristics, as an existing product, or they have different properties that don't raise new questions of public health.

Products that don't meet those criteria will have to be withdrawn from the market, Deyton said.

Anti-smoking advocates praised the FDA's move.

"As a result of the bright spotlight of FDA scrutiny, tobacco companies will no longer be able to secretly manipulate their products in ways that make them more addictive and appealing," Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a news release issued Wednesday.

"We applaud the FDA for diligently implementing this important requirement of the new law. The agency has done exactly what the law requires," said Myers.

To continue to market recently introduced or altered products, manufacturers must apply for review by March 22. The tobacco companies must also pay for the review.

Also, manufacturers trying to introduce a new product must first apply for a marketing order from the FDA, the agency said.

About 230 new tobacco products are introduced every year, according to published reports, but the FDA said tighter regulation could cut into that number.

The 2009 tobacco control act allows the FDA to regulate tobacco products and reduce their nicotine content, regulate marketing, and prohibit label claims such as "low tar" and "light."

According to the U.S. Centers for Disease Control and Prevention, tobacco use in the United States causes about 443,000 deaths annually.

More information

For more information on the FDA and tobacco, visit the U.S. Food and Drug Administration.

SOURCES: Jan. 5, 2011, teleconference with Lawrence R. Deyton, M.D., director, Center for Tobacco Products, U.S. Food and Drug Administration; Campaign for Tobacco-Free Kids, news release, Jan. 5, 2011


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