No Go On Nicotine Lollipop & Lipstick

The FDA issued warning letters to three pharmacies that are selling "nicotine lollipops" and/or nicotine "lip balm" over the Internet.

Frederick Hecht, MD, FAAP
Associate Chief Medical Editor, MedicineNet.com


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

April 10, 2002 -- 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: