The FDA has determined that a product called "nicotine water" is an unapproved drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and cannot be marketed without new drug approval by the agency.
"FDA's decision underscores our commitment that consumers be protected from drug products that have not undergone our rigorous review process," says FDA Deputy Commissioner Lester M. Crawford, D.V.M., Ph.D.
The FDA's decision was issued in response to a citizen's petition regarding the regulation of nicotine water. The petition, which was submitted to the FDA in December 2001, requested that the agency classify and regulate nicotine water as a drug or as a food containing an unapproved food additive under the FD&C Act. The petition was submitted on behalf of several groups, including the National Center for Tobacco-Free Kids, the American Medical Association, and the American Lung Association.
The FDA concluded that nicotine water is an unapproved drug under the FD&C Act because it is intended to treat or mitigate nicotine addiction as a smoking cessation product. Because nicotine addiction is considered a disease, the FDA requires safety and effectiveness data to support any claims intended to treat this disease.
The FDA also determined that the product cannot be legally marketed as a dietary supplement, as it was being promoted by the manufacturer. Under the FD&C Act, a "dietary supplement" does not include a product that contains an active ingredient that the 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 smoking cessation drugs such as Nicoderm CQ, Prostep, Habitrol, and Nicorette, nicotine water cannot be marketed as a dietary supplement.
The FDA will continue to monitor the marketplace to ensure that consumers are protected from unapproved drug products.
COPYRIGHT 2002 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group
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