E-Cig Technology Inc. – FDA Warning Letter

The FDA issued a Warning Letter to E-Cig Technology Inc. on September 8, 2010, regarding their electronic cigarettes, cigars, USB cigarettes, and related components and liquids. The FDA determined these products are unapproved new drugs, misbranded, and adulterated under the Federal Food, Drug, and Cosmetic Act.

The products are considered drug-device combination products with a drug primary mode of action due to labeling and promotional claims on their website (www.e-cig.com) indicating intended uses such as helping to reduce or quit smoking, relieving suffering of quitting, painless smoking abstention, weight loss, and improving sexual capacity (e.g., E-Cialis for ED, E-Rimonabant for weight loss/smoking addiction). These claims classify them as "new drugs" requiring FDA approval, which they lack, violating Section 505 of the Act.

Furthermore, the products are misbranded under Section 502 because their labeling fails to declare the quantity of active ingredients for Cialis, Rimonabant, and E-liquid products, and they lack adequate directions for their intended drug uses.

Adulteration issues under Section 501 include the detection of Diethylene Glycol (DEG) in the Vitamin C E-Liquid at five times the USP upper limit, rendering it adulterated and subject to import refusal. Additionally, FDA testing revealed inconsistencies between labeled and actual active ingredient amounts in Rimonab