FDA WARNING_LETTER - http://www.911vape4less.com

The FDA issued a Warning Letter to Christine Cruz concerning e-liquid products offered for sale on http://www.911vape4less.com. The FDA determined these e-liquids are tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and fall under FDA jurisdiction. The primary violation identified is the distribution of free samples of e-liquid products, including Vape Girl #68 Razz Cream Cake, #73 Peanut Butter and Jelly, and #66 Snickerdoodle e-liquids. This practice violates 21 C.F.R. § 1140.16(d)(1), which prohibits retailers from distributing free samples of tobacco products. As a result, these products are considered misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). The letter requires immediate correction of this violation and similar deficiencies, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. A written response detailing corrective actions, including discontinuation dates and a compliance plan, must be submitted within 15 working days. Non-compliance may lead to further FDA actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, or refusal of admission for imported products.