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N.Y. health commissioner petitions FDA on behalf of nicotine-replacement therapies


ALBANY, N.Y. The New York State health commissioner Richard Daines is currently pursuing a citizen’s petition with the Food and Drug Administration to sell nicotine-replacement therapies in single-dose convenient packs in an effort to make NRT products more competitive with cigarettes.

“We challenge the FDA to rethink its policies regarding nicotine replacement therapy,” Daines stated. “Under the current system, a smoker generally cannot buy safe nicotine in the same store where cigarettes are sold, and, even though most smokers buy cigarettes one day at a time, those who purchase safe nicotine must buy a one- or two-week supply costing $20 to $40. New York’s petition sets in motion a process requiring the FDA to critically examine how these products are now sold to smokers and how we can make them more readily available.”

“Many smokers are confused about the safety of nicotine patches, gum and lozenges, mistakenly believing that nicotine causes cancer or that patches are more likely than cigarettes to cause a heart attack,” noted Gary Giovino, professor of Health Behavior at the University of Buffalo. “By educating consumers and making these products more widely available, smokers will begin to see them as real alternatives to cigarettes and a product they can use to quit smoking altogether.”

Specifically, New York is petitioning the FDA to allow the sale of over-the-counter NRT products in all retail locations where cigarettes are sold, including convenience stores, gas stations, tobacco specialty stores, grocery stores, and other retail businesses that sell tobacco; to allow OTC NRT to be sold in “daily” units (containing an amount of NRT that would typically be consumed in a 24-hour period) at prices competitive with one 20-count pack of cigarettes and allow OTC NRT to be advantageously positioned near cigarettes and other tobacco products to promote the sale of OTC NRT products; and to modify labeling requirements to fully disclose to smokers the benefits of OTC NRT use relative to continued cigarette use, with risks associated with OTC NRT compared to risks associated with continued cigarette use.

The FDA has until the end of July to respond.

Anti-smoking products generated $495.4 million, down 1.8 percent across food, drug and mass (minus Wal-Mart) channels, according to the Nielsen Group for the 52 weeks ending Feb. 23. New convenience-oriented NRT products would arguably help bolsters sales for the category, especially, as the New York Commissioner predicts, that the new convenience offering would attract new users to the category.

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