The Food and Drug Administration sent warning letters on September 8, 2010, to five makers of electronic cigarettes, cautioning them that marketing claims suggesting the devices help people quit smoking are illegal.
The agency also sent a letter to the Electronic Cigarette Association, warning it that the agency intends to regulate electronic cigarettes and related products “in a manner consistent with its mission of protecting the public health,” and reminding the makers of e-cigarettes that they must comply with the provisions of the Federal Food, Drug, and Cosmetic Act (FDCA).
E-cigarettes are drug-delivery devices, the agency said in the letters, which makes it illegal for the manufacturers to claim that the products can be used as a smoking cessation treatment without first receiving approval from the FDA. The five companies receiving letters – E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America, E-Cig Technology Inc., and Johnson’s Creek Enterprises LLC – have all run ads making such claims but haven’t conducted any clinical trials or shown any scientific evidence to support their claims, the letters stated.
In the letter to E-CigaretteDirect LLC, the agency said claims made on the manufacturer’s Web site, such as “If you’ve tried the patch, gum and other methods that haven’t worked for you, try the electronic cigarette” and “E-Cigarettes Reducing 400,000 American Deaths per year to 10,000,” violate the FDCA.
Specifically, the claims are marketed as a product “intended both to affect the structure or function of the body and to mitigate, treat, or prevent disease,” which makes it a “new drug” under the FDCA that requires the approval of an application with the FDA.
To read the FDA’s warning letter to E-CigaretteDirect LLC, click here.
To read the FDA’s letter to the Electronic Cigarette Association, click here.
Why it matters: While cigarette manufacturers face additional regulatory hurdles, advertisers should always be careful when making health-related claims.