FDA WARNING_LETTER - Smoke and Vape Company, LLC d/b/a Smoke and Vape Co. - July 31, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Chang Ho Song, David Song, and James Kwak, associated with svcvape.com, on July 31, 2024. The letter states that the website offers for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products, specifically "Geek Bar Pulse – Frozen Blackberry Fab" and "Geek Bar Pulse – Frozen Cherry Apple."

These products are classified as tobacco products under section 201(rr) of the FD&C Act, which was amended on March 15, 2022, to include products containing nicotine from any source. The FDA determined these are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order 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 due to the absence of required marketing authorization and notice. The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil