(Silver Spring, MD, June 30, 2006) -- The Food and Drug Administration yesterday informed a marketer of a product containing nicotine and labeled as a dietary supplement that the product “does not meet the definition of a dietary supplement [and] is an unapproved new drug whose marketing violates the [Federal Food, Drug, and Cosmetic Act].”
The company, Nico Worldwide, Inc., Oxnard, California, had submitted a notification under Title 21 of the Code of Federal Regulation, Section 101.93 last October to inform FDA of a structure-function claim it intended to make for its product, Nic Lite™, containing 2–4 mg of nicotine per 16 ounces. The company stated that its product would bear the following labeling:
Nicotine is a naturally occurring compound in many vegetables including cauliflower, eggplant, potatoes, and tomatoes… Dietary nicotine may help maintain a healthy smoke free lifestyle.
The staff of the American Herbal Products Association (AHPA) became aware of Nic Lite™ last Monday when Mark Ullman of Ullman, Shapiro & Ullman provided a link to a recent ABC News story on the product. ABC identified the product as “a lemon-flavored drink laced with nicotine,” sold in an 8-ounce bottle which “contains the same amount of nicotine as two cigarettes.”
But AHPA staff is also aware that the federal definition of dietary supplements uses the words “other than tobacco” in describing this class of goods, and that FDA had, on July 2, 2002, expressly stated that products described as “nicotine water” should be “regarded as an unapproved new drug and cannot be legally marketed as a dietary supplement.” This policy on nicotine water can be found at http://www.fda.gov/bbs/topics/NEWS/2002/NEW00818.html.
AHPA therefore promptly wrote to FDA to ask, “if this July 2, 2002, statement by the agency still accurately expresses FDA’s position on this issue, or if, on the other hand, FDA has modified its policy and believes that products containing nicotine may be legally marketed as dietary supplements.”
Yesterday’s letter from FDA was addressed to the company’s CEO, Joseph R. Knight, and was signed by Vasilios H. Frankos, PhD, Acting Director of FDA’s Division of Dietary Supplement Programs. The letter stated that nicotine “is an article authorized for investigation as a new drug” and cited the language in the Dietary Supplement Health and Education Act that specifically excludes any such article from use in dietary supplements. The letter also stated, “The mere presence of nicotine in foods such as cauliflower, eggplant, potatoes, and tomatoes, without any evidence that these foods were promoted for their nicotine content, does not constitute ‘marketing’ nicotine as a food or dietary supplement” under the law.
FDA’s letter to Nico Worldwide, Inc. is posted at AHPA’s website at http://www.ahpa.org/Portals/0/pdfs/06_0629_FDA_NicLite_ltr.pdf.
The American Herbal Products Association (AHPA) represents the core of the botanical trade -- comprised of the finest growers, processors, manufacturers and marketers of herbal products -- AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbs are manufactured, labeled, and sold. Website: www.ahpa.org.