eCigPros Inc. – FDA Warning Letter

The FDA issued a Warning Letter to Mr. Branum regarding the sale of e-liquid products on http://ecigpros.com. The FDA determined that e-liquid products are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified was the sale of "30ml 100% VG Watermelon e-liquid" to a person younger than 18 years of age. This constitutes a misbranding violation under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because it violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products to minors. A "covered tobacco product" includes e-liquids as defined by 21 C.F.R. § 1140.3 and 21 C.F.R. § 1100.2.

The letter requires immediate correction of this violation and similar issues to ensure compliance with the FD&C Act and FDA's implementing regulations across all sales and advertising platforms. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response