FDA WARNING_LETTER - Any Cig - July 09, 2019

The FDA's Center for Tobacco Products reviewed the website anycig.com and determined that its e-liquid products are tobacco products subject to FDA jurisdiction. The company is in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for two primary reasons.

First, the "Hangda Highway" e-liquid product was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b) and rendering the product misbranded under section 903(a)(7)(B) of the FD&C Act.

Second, several e-liquid products, including "Hangsen 555" and "Kingw Apple," are misbranded because their labeling and/or advertising on the website fail to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(a) and/or (b), and sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act.

The FDA requires immediate corrective actions, including discontinuing the violative sales, labeling, and advertising, and submitting a written response within 15 working days detailing the corrective actions