FDA WARNING_LETTER - Puffy Vapes - September 17, 2019

The FDA's Center for Tobacco Products issued a Warning Letter to Puffy Vapes after reviewing their website, puffyvapes.com, and determining that their e-liquid products are tobacco products subject to FDA jurisdiction under the FD&C Act. The primary violation identified is that several e-liquid products advertised and offered for sale on the website are misbranded. This misbranding stems from the failure to include the required nicotine warning statement in their labeling and/or advertising, as mandated by 21 C.F.R. § 1143.3(b).

Specifically, the e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act for violating regulations prescribed under section 906(d), including 21 C.F.R. Part 1143. Additionally, the products are misbranded under section 903(a)(1) and/or section 903(a)(7)(A) of the FD&C Act because the advertising is considered false or misleading due to the failure to reveal material facts concerning the consequences of product use, as per section 201(n). The FDA requires immediate correction of these violations and similar issues across all advertising platforms. Puffy Vapes must submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative activities, and a plan for sustained compliance. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and injunction.