Posted by: audreybenenati | February 12, 2010

Groups Urge FDA To Relax Restrictions On Nicotine Patches

FEBRUARY 11, 2010, 3:40 P.M. ET

By Jared A. Favole


WASHINGTON (Dow Jones)–Two smoking-cessation groups are urging the U.S. Food and Drug Administration to relax restrictions on nicotine patches, lozenges and gums amid concerns the agency’s regulations go too far and make it harder for people to quit smoking.

The groups say nicotine-replacement therapies such as GlaxoSmithKline Plc’s (GSK) Nicoderm CQ and Nicorette gum should be available everywhere cigarettes are sold, so people who want to quit can find the products easily without having to go to a pharmacy. They also want the FDA to tone down warnings on the products that say they shouldn’t be used when people continue to smoke or in those who have heart conditions.

"It sends the message that these products are dangerous and sends the message to the smoker to just continue smoking," said Ken Wassum, former president of the Association for the Treatment of Tobacco Use and Dependence, one of two groups petitioning the FDA to relax the standards.

The petition comes at a time when the FDA is fighting to tighten its control over tobacco and nicotine products, not loosen it. The agency is also facing tough court battles over its attempts to severely restrict tobacco advertising and stop electronic cigarettes from being sold in the country.

The agency faced a similar petition in 2008 to relax its control on smoking-cessation products from New York’s commissioner of Health, Richard F. Daines. The petition had the the support of groups like the American Cancer Society.

Nicotine patches, gums and other nicotine products are approved by the FDA and deliver small amounts of nicotine generally over a period of a few minutes to a few hours. Cigarettes deliver high doses of nicotine within a few seconds. These nicotine-replacement therapies, as they are called, are sold mostly at pharmacies over the counter, while cigarettes are available at pharmacies and thousands of retail stores across the country.

The Association for the Treatment of Tobacco Use and Dependence and the Society for Research on Nicotine and Tobacco want to change that, according to a petition they plan to file with the FDA Friday. Their petition cites government statistics showing that smoking kills about 440,000 Americans annually and costs the health-care system about $157 billion a year.

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