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Nicotine Pops Illegally Sold on Net, U.S. Says

April 11, 2002|From Reuters

WASHINGTON — Nicotine lollipops and lip balms sold by three Internet pharmacies as aids to quit smoking are illegal, U.S. regulators said Wednesday as they warned the firms to stop selling the products.

The Food and Drug Administration ruled that the products are unapproved drugs because they contain a type of nicotine that has not passed safety and effectiveness tests for smoking cessation.

The FDA sent letters to Bird's Hill Pharmacy in Needham, Mass.; Ashland Drug of Ashland, Miss.; and the Compounding Pharmacy of Aurora, Ill. Owners of Ashland Drug and the Compounding Pharmacy said they had complied with the FDA's order. Bird's Hill Pharmacy could not be reached for comment.

Pharmacists had asserted the right to sell the products at stores and over the Internet under federal rules that permit them to make medicines easier to take, a practice known as compounding.

The FDA determined that the lollipops and lip balms violated those rules because some were being sold without a doctor's prescription. The type of nicotine typically used, nicotine salicylate, is not permitted in compounding, the FDA said. It is different from the nicotine used in approved gums and patches that help smokers quit.

Regulators said the products did not have proper directions for use and failed to carry adequate warnings against use by children.

Rep. Henry A. Waxman (D-Los Angeles), who last week urged the FDA to stop sales of nicotine lollipops, called the action "an important precedent for further action involving nicotine and other unapproved products."

The lollipops, sold in a variety of flavors, are promoted as a tasty way to give up cigarettes, or a means for smokers to get a nicotine fix in locations where they cannot light up a cigarette.

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