FDA Launches Review of Tobacco Products01/05/11
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withdrawn from the market, Deyton said.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
For more information on the FDA and tobacco, visit the
U.S. Food and Drug Administration.
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