FDA WARNING_LETTER - E-CigaretteDirect, LLC

The FDA issued a Warning Letter to E-CigaretteDirect, LLC on September 8, 2010, regarding their marketing of various electronic cigarettes and cigars (e.g., Gamucci, Smoking Everywhere, Veppo) and their components. The FDA's review of the products' labeling, promotional materials, and website (www.e-cigarettedirect.com) indicated that these products are marketed as aids to deter or cease smoking conventional tobacco products.

The FDA determined that these products are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act (the Act). Specifically, they violate Section 505 of the Act (21 U.S.C. § 355) for being unapproved new drugs and Section 502 of the Act (21 U.S.C. § 352) for being misbranded. The FDA classified them as drug/device combination products, with the primary mode of action being that of a drug, due to claims suggesting they affect body structure/function and mitigate/treat/prevent disease, particularly as smoking deterrents.

The letter cited specific promotional statements from the company's website, such as "wean yourself off of nicotine and quit smoking for good!" and claims of "reducing 400,000 American Deaths per year to 10,000," as evidence of intended drug uses. Since these