FDA Orders Halt of Nicotine Lollipop Sales
The FDA yesterday sent "cease and desist" letters to three pharmacies ordering them to halt sales of nicotine-laced lollipops, the Chicago Tribune reports. Sold as smoking cessation products, the FDA said the lollipops are illegal because they use an untested form of nicotine called salicylate, a chemical that has not been approved by the FDA (Yates, Chicago Tribune, 4/11). Nicorette gum, nicotine patches, nasal sprays and several other smoking-cessation products have gone through testing by the FDA to prove they are safe and effective(American Health Line, 4/3). These products use nicotine polacrilex, which is FDA-approved, the Tribune reports. The lollipops are produced by compounding pharmacists and contain two or four milligrams of nicotine -- cigarettes have about 10 milligrams of nicotine. The lollipops sell for $2 to $5 and come in different flavors such as grape, watermelon and tequila sunrise (Chicago Tribune, 4/11). The flavors have raised concerns due to their potential appeal to children, as the lollipops look like regular candy (AP/Washington Post, 4/11). The FDA has said in the past that smoking cessation products cannot taste too good, for fear they will be abused (American Health Line, 4/3). Also, the FDA said pharmacies have been "wrongly dispensing" the lollipops without a prescription. The FDA has given three pharmacies -- Ashland Drugs in Ashland, Miss., Bird's Hill Pharmacy in Needham, Mass., and the Compounding Pharmacy in Aurora, Ill. -- 15 days to notify the agency that sales have been halted in order to avoid further legal action. The FDA is also investigating a Virginia company that is selling a nicotine lozenge (AP/Washington Post, 4/11).
The lollipops were developed four years ago by a pharmacist in Augusta, Ga., and by last year, they were being sold at hundreds of pharmacies. While the pharmacy in Illinois has stopped selling the lollipops, others plan to switch the active ingredient to nicotine polacrilex, the FDA-approved chemical. In response to the FDA's letter, the International Academy of Compounding Pharmacists has ordered its members to stop selling the lollipops without a prescription and to stop claiming they are more effective than the FDA-approved smoking cessation products. L.D. King, executive director of the organization, said, "It's important to keep in mind the big picture here. Pharmacists and health care professionals are looking to help people stop smoking, and the health care benefits [of the lollipops] are definitely great" (Chicago Tribune, 4/11).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.