Monday, April 15, 2002		Article

NICOTINE lollipops and lip balms sold by three Internet pharmacies as aids to quit smoking are illegal, US regulators said last week as they warned the firms to stop selling the products.

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

Two pharmacies said they halted sales immediately after receiving the FDA's written warning.

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. Also, the type of nicotine typically used, nicotine salicylate, is not permitted in compounding. It is different from the nicotine used in approved gums and patches that help smokers quit.

Regulators also said the lollipops and lip balms did not have proper directions for use and failed to carry adequate warnings against use by children, the FDA said.

"Because they are candy products, there's certainly a risk of accidental use by children. These products are of unknown safety and effectiveness and could be potentially dangerous to small children," said David Horowitz, acting director of the FDA drug division's compliance office.

Rep. Henry Waxman, a California Democrat who last week urged the FDA to stop sales of nicotine lollipops, welcomed the FDA's action. "This is an important precedent for further action involving nicotine and other unapproved products," Waxman said.

The FDA sent warning letters to Bird's Hill Pharmacy based in Needham, Massachusetts; Ashland Drug of Ashland, Mississippi; and The Compounding Pharmacy of Aurora, Illinois.

The FDA asked the firms to respond within 15 days. Failure to stop selling the products could lead to further regulatory action, such as seizure or an injunction.

Larry Frieders, owner of The Compounding Pharmacy, said he stopped selling the lollipops and lip balms as soon as he received the FDA's warning.

"I'm disappointed because I think the product we were making was helping people," he said in an interview.

The lollipops, sold in flavours including watermelon and eggnog, are promoted as a tasty way to give up cigarettes, or a means for smokers to get a nicotine fix in places where they cannot light up a cigarette. Brand names include NicoPop and Likatine.

Larry Melton, owner of Ashland Drug, said he had been filling up to 50 orders a day since last week when the lollipops were publicized in news reports. He said he stopped sales last week.

Officials at Bird's Hill Pharmacy could not immediately be reached for comment.

—Reuters