Vape.com – FDA Warning Letter, Jun 12, 2024

The FDA Center for Tobacco Products issued a Warning Letter to vape.com on June 12, 2024, for offering for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) and e-liquid products without required marketing authorization. The FDA reviewed the website and determined the products are tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction.

Specifically, the products "Don’t Care Bear by Bad Drip 60ML," "Cereal Trip by Bad Drip 60ML," and "Funky Republic FI3000 Disposable 3000 Puff 5ML 4-5% - Apple Watermelon" are cited as "new tobacco products" that were not commercially marketed as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA also expressed concern that the design of the Bad Drip Labs e-liquid products imitates prescription pill bottles, potentially appealing to youth and enabling concealment. The letter requires a written response within 15 working days detailing actions to address violations, including discontinuing sales