FDA WARNING_LETTER - Gamucci

On September 8, 2010, the FDA issued a Warning Letter to Gamucci America, owned by Smokey Bayou, Inc., regarding their "Gamucci" electronic cigarette and cigar products. The FDA's review of the products' labeling and website (www.gamucci-america.com) indicated they are marketed as aids to quit smoking, healthier alternatives to traditional cigarettes, and safe nicotine delivery systems.

The FDA determined that these claims classify Gamucci products as unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act. Specifically, the products are considered "new drugs" under section 201(p) and 505 of the Act (21 U.S.C. § 321(p), § 355) because they are promoted as smoking deterrents and for affecting body structure/function, yet lack adequate data for general recognition of safety and effectiveness. They are also misbranded under section 502 (21 U.S.C. § 352) for not having an approved new drug application and for lacking adequate directions for their intended drug uses, including smoking deterrence.

Gamucci America was required to respond within fifteen working days, detailing corrective actions, steps to prevent recurrence, and plans for already distributed products. Failure to comply could result in legal action, including seizure and injunction. The FDA also enclosed a letter to the Electronic Cigarette Association (E