FDA Deems Nicotine Candy & Lip Balm Illegal

Apr 11, 2002

The 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.

The pharmacies’ nicotine lollipops and nicotine lip balm, intended for use as “drugs,” appear to be illegal for the reasons that they are:

  • Compounded and dispensed without a doctor’s prescription.

  • Unapproved new drugs, which need, but do not have, FDA approval.

  • 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.

  • 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.

Moderator Comment: How long will it be before a pharmaceutical
company introduces smoking cessation lollipops to the market?

The FDA has to do what the FDA has to do. Still we can’t
help feeling for the independent pharmacies that had obviously hit on something
with consumers looking to quit smoking. [George
Anderson – Moderator

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