Food and Drug Administration rules nicotine-spiked lollipops

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Posted 7:59AM on Thursday, April 11, 2002

TUCKER, Ga. - When customers came to pharmacist Jon Carr desperate for a way to quit smoking, he gave them lollipops spiked with nicotine -- a way to satisfy their cravings without the toxins of a cigarette. But the Food and Drug Administration declared the lollipops illegal Wednesday, saying the type of nicotine druggists were adding had not been tested for safety. Anti-smoking groups had urged the government to halt sales of the lollipops, arguing they could hook children on nicotine and possibly lead them to take up cigarettes later. "The quantity of nicotine could be potentially dangerous to a small child," FDA attorney David Horowitz said. The government ordered three pharmacies targeted in the crackdown to stop sales immediately and urged smokers to use FDA-approved products like gums and patches. Carr said he still believes in the lollipops, which give smokers the same hand-to-mouth motion as cigarettes. He said he would consider making them with the type of nicotine used in the FDA-approved products. "If it works, it works," Carr said. "They make an inhaler, but it tastes bad. The lollipop seems to take care of both of those things -- the manual motion and the taste." The idea -- making batches of nicotine lollipops in dozens of candy flavors -- was catching on around the country with pharmacists. Some reported selling several hundred a week, charging $3 to $4 apiece. The FDA determined that the lollipops were being promoted as smoking-cessation aids, which under federal law renders them drugs -- and the agency must approve drugs before they sell. The FDA also declared nicotine-laced lip balm illegal and said it was looking into other unconventional stop-smoking products, like nicotine lozenges and nicotine water. It also is hunting other sellers of nicotine lollipops. "This is an important first step in regulating a whole range of new nicotine-laced products that have recently been brought to the market," said Matthew Myers of the Campaign for Tobacco-Free Kids, which petitioned the FDA last November to end sales of Triax Nicotine Water but hasn't received a response. The three targeted pharmacies wrongly dispensed the products without a doctor's prescription, both in stores and over the Internet, the FDA said. Most pharmacies, including Carr's in suburban Atlanta, were requiring prescriptions and sold the lollipops only in person, adjusting their potency based on how much nicotine a smoker was getting from cigarettes. Professional Compounding Centers of America, a pharmacy supply group, said it never endorsed selling over the Internet or without prescriptions. The group had approved lollipops with salicylate -- the type of nicotine the FDA said it was concerned about -- but said it would change its recommendation immediately. Still, PCCA president David Sparks said he believed lollipops were effective, particularly for smokers who have had no success with nicotine patches, gums and inhalers. "If it wasn't getting better results than the commercially available products, there wouldn't be any reason to do it," he said. The FDA couldn't say if the lollipops posed a health risk to adult smokers because there is no data on the safety or effectiveness of this nicotine salt, called nicotine salicylate. The pharmacies ordered to stop sales or risk further legal action were Ashland Drugs in Ashland, Miss., Bird's Hill Pharmacy in Needham, Mass., and The Compounding Pharmacy in Aurora, Ill. They had been selling to a few customers a week until media attention brought a surge of orders last week -- and sudden scrutiny from anti-tobacco advocates. "I didn't know there'd be a problem" with selling the lollipops, said Larry Melton, owner of Ashland Drugs, who said he created them because customers had requested alternatives to gum or patches. He said he quit selling them Wednesday upon receiving the FDA's warning letter. ------ On the Net: Food and Drug Administration: http://www.fda.gov