FDA stops nicotine lollipop, lip balm sales
WASHINGTON (CNN) -- The Food and Drug Administration warned three pharmacies Wednesday to stop selling nicotine lollipops and nicotine lip balm on the Internet, calling the products "illegal."
The companies' Web sites promote the products as a "convenient, tasty way" to stop smoking and treat nicotine addiction, the FDA said in a statement. The agency said the lollipops and lip balm are "unapproved drugs" that need, but do not have, FDA approval.
The FDA also said the "candy-like products present a risk of accidental use by children."
A spokesman for Ashland Drug, based in Ashland, Mississippi, said it will suspend the sale of nicotine lollipops on its Web site, nicotinelollipops.com.
A representative for The Compounder, an Aurora, Illinois-based pharmacy that customizes medications for customers, said the company received a letter from the FDA Wednesday morning and will end sales of nicotine lip balms and lollipops.
There was no immediate comment from Bird's Hill Pharmacy, of Needham, Massachusetts, which operates birdshill.com.
The FDA requested the pharmacies respond, in writing, of their intention to stop selling the products within 15 days.
The nicotine lip balms and lollipops "appear to be compounded and dispensed without a doctor's prescription," the agency said.
The products are made from natural sweeteners and flavorings in a sugar-free base combined with nicotine salicylate, a drug that pharmacists who compound drugs are not legally allowed to use. Smoking cessation products approved by the FDA use different forms of nicotine, the agency said.
The FDA also said the lip balms and lollipops' directions are inadequate and do not warn strongly enough against use by children.
Food and Drug Administration
The Compounder Pharmacy
Bird's Hill Compounding Pharmacy
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