The Food and Drug Administration has announced it has taken enforcement action against five electronic cigarette companies.
FDA alleges the electronic cigarette companies have made claims their products can help people quit smoking cigarettes. The agency also says the companies have violated the Federal food, Drug, and Cosmetic Act in various ways, including unsubstantiated claims and poor manufacturing practices.
The five companies include, E-Cigarette Direct LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc., and Johnson's Creek Enterprises LLC.
FDA issued warning letters to the companies on Sept. 9. At the same time, the FDA reported it had also sent a letter to the Electronic Cigarette Association with a statement it intends to regulate electronic cigarettes and related products.
"FDA has determined that the electronic cigarette products addressed in the warning letters to the distributors, and similar products, are subject to FDA regulation as drugs," noted FDA officials in a Sept. 9 press release. "Under the FDCA, a company cannot claim that its drug can treat or mitigate a disease, such as nicotine addiction, unless the drug's safety and effectiveness have been proven. Yet all five companies claim without FDA review of relevant evidence that the products help users quit smoking cigarettes."
For more information on the FDA's position on this issue, visit www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm