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FDA WARNS SELLERS OF NICOTINE LOLLIPOPS &
LIP BALM THAT THEIR PRODUCTS ARE ILLEGAL

Today FDA issued warning letters to three pharmacies that are selling "nicotine lollipops" and/or nicotine "lip balm" over the Internet. The letters inform the pharmacies that FDA has found their nicotine lollipops and lip balm to be illegal. Based on statements from the pharmacies' Internet sites, the products are promoted as aids for smoking cessation or to treat nicotine addiction.

FDA is concerned about the health risk of these products because the appear to be compounded and dispensed without a doctor's prescription, contain a form of nicotine that is not used in FDA-approved smoking cessation products, and because these candy-like products present a risk of accidental use by children.

The products cited in the letters include compounds incorporating nicotine salicylate, natural sweeteners, and flavorings in a sugar-free base and are available in ½ mg., 1 mg., 2 mg., and 4 mg. dosages. The claims on the websites include that the products help alleviate the "hand to mouth fixation" associated with smoking and are a "convenient, tasty way" to replace the cigarette habit. After investigating and carefully assessing these websites, FDA has determined that the pharmacies' nicotine lollipops and nicotine lip balm are intended for use as "drugs" and appear to be illegal for the following reasons:

• They are compounded and dispensed without a doctor's prescription.
• They are unapproved new drugs which need, but do not have, FDA approval.
• They are made from a drug substance, nicotine salicylate, which is not permitted for use by pharmacists in compounding drugs. The FDA-approved smoking cessation products are made from different forms of nicotine.
• They are misbranded because their labeling does not have adequate directions for the uses for which they are being offered and does not have adequate warnings against use by children.

FDA is requesting a response from the pharmacies in writing within 15 days of receipt of the warning letters stating the action the firms will take to discontinue marketing of these drug products. Failure to do so may result in further regulatory action, potentially including a seizure or injunction action. FDA will take appropriate action to protect the public health.

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