FDA WARNING_LETTER - Hells Vapors LLC

The FDA's Center for Tobacco Products issued a Warning Letter to Gavin Rydell and Kimberly Lee of Hells Vapors, based on a review of their website, http://www.hellsvapors.com. The FDA determined that Hells Vapors Lava Berry e-liquid, offered for sale to U.S. customers, is a tobacco product under section 201(rr) of the FD&C Act.

The primary violation identified is the sale of Hells Vapors Lava Berry e-liquid to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including e-liquids, to minors. The FDA's investigation confirmed a purchase by an underage individual from the website.

Hells Vapors is required to immediately correct this violation and any similar issues to ensure compliance with the FD&C Act and FDA regulations. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. The company must submit a written response within 15 working days detailing