April 11, 2002
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 Ѕ 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.