FDA WARNING_LETTER - Jam Vapes

The FDA's Center for Tobacco Products issued a Warning Letter to David Tomes regarding the website http://www.jamvapes.com, which manufactures and sells e-liquid products in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of One Hit Wonder Rocket Man 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. This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products, including e-liquids, to minors. The FDA's investigation confirmed a purchase by an underage individual from the website.

The letter requires immediate corrective actions for this violation and similar issues, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all platforms. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates of violative sales and a compliance plan, is required within 15 working days.