ROCKVILLE, Maryland—The Food and Drug Administration has warned three Internet pharmacies selling nicotine(Drug information on nicotine)-laced lollipops and lip balms as smoking cessation aids that the products appear to be illegal and ordered them pulled from the marketplace.
The agency said the products are compounded and sold without a physician’s prescription and are intended for use as "drugs." It also expressed concerns that the candy-like products pose a risk of accidental use by children.
The FDA’s concerns arose from statements posted on the pharmacies’ websites. These included claims that the products help alleviate the "hand to mouth fixation" associated with smoking and are a "convenient, tasty way" to replace the cigarette habit, the agency said.
The lollipops and lip balms contain nicotine salicylate (which is not FDA approved for use by pharmacists in compounding drugs), natural sweeteners, and flavorings in a sugar-free base and are available in 0.5 mg to 4 mg dosages.
