FDA GRANTS CITIZEN'S PETITION SEEKING UNAPPROVED DRUG CLASSIFICATION FOR "NICOTINE WATER"

Today the Food and Drug Administration (FDA) issued a response to a Citizen's Petition submitted to the agency regarding the regulation of a product called "Nicotine Water." Based on several factors, including statements contained in the labeling of the product, and other evidence of intended use, FDA has determined that this product should be regarded as an unapproved new drug and cannot be legally marketed as a dietary supplement.

"FDA's decision underscores our commitment that consumers be protected from drug products that have not undergone our rigorous review process," said Dr. Lester M. Crawford, FDA Deputy Commissioner.

The petition was submitted in December of 2001, on behalf of several groups including the National Center for Tobacco-Free Kids, the American Medical Association, and the American Lung Association. The petitioners specifically requested that the FDA classify and regulate "Nicotine Water" as a drug under the Federal Food, Drug, and Cosmetic Act (the Act), or classify and regulate this product as a food containing an unapproved food additive under the Act.

FDA has concluded that "Nicotine Water" is an unapproved drug under the Act because it is intended to treat or mitigate nicotine addiction as a smoking cessation product. Because nicotine addiction is considered a disease, FDA requires safety and efficacy data to support any claims intended to treat this disease. After reviewing the claims on the manufacturer's Internet site, which were submitted with the Citizen's Petition, FDA concluded "Nicotine Water" is an unapproved drug and may not be legally sold in the United States until the manufacturer submits a new drug application to the agency and the agency approves the application.

FDA has also determined "Nicotine Water" which contains as an active ingredient nicotine or nicotine polacrilex, cannot be legally marketed as a dietary supplement. Although "Nicotine Water" is promoted by the manufacturer as a dietary supplement, this product does not meet the statutory definition of a dietary supplement. Under the Act, a "dietary supplement" does not include a product that contains an active ingredient that FDA has already approved for use in a drug. Because the nicotine and nicotine polacrilex in "Nicotine Water" are both active ingredients in FDA-approved drugs (such as Nicoderm CQ, Prostep, Habitrol, and Nicorette) "Nicotine Water" cannot be marketed as a dietary supplement.

In light of these determinations, FDA will notify manufacturers of "Nicotine Water" that this product cannot be marketed without new drug approval by the agency. FDA will continue to monitor the marketplace to ensure that consumers are protected from unapproved drug products.

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