FDA WARNING_LETTER - Hype City Vapors, LLC - June 07, 2019

The FDA and FTC issued a joint Warning Letter to Hype City Vapors, LLC, following a review of their Facebook account and website, which advertised and offered e-liquid products for sale. These e-liquids are classified as tobacco products under the FD&C Act. The FDA determined that two e-liquid products, Hype City Vapors Mango Candy and Berry Lemonade, are misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act. This misbranding stems from the failure of their labeling and/or advertising in social media posts to include the mandatory nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as required by 21 C.F.R. § 1143.3(a) and/or (b).

Concurrently, the FTC reviewed the social media postings and expressed concerns that the failure to disclose the presence and risks associated with nicotine could be unfair or misleading to consumers, potentially violating Section 5 of the FTC Act. The FTC also provided guidance on the importance of clearly and conspicuously disclosing any material connections between endorsers and the company, referencing 16 C.F.R. Part 255.5. Hype City Vapors is required to submit separate written responses to both the FDA and FTC within 15 working days, detailing corrective actions, discontinuation of violative activities, and plans for future compliance. Failure to comply could lead to severe consequences, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and injunctions.