FDA WARNING_LETTER - FF Vapors, LLC - October 26, 2023

On October 26, 2023, the FDA issued a Warning Letter to FF Vapors, LLC, following a review of inspection records. The FDA determined that FF Vapors manufactures and distributes e-liquid products, including "Fruit Cocktail," which are considered tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, due to containing nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. "Fruit Cocktail" e-liquid was not commercially marketed in the United States as of February 15, 2007, and lacks an FDA marketing authorization order (section 910(c)(1)(A)(i) of the FD&C Act) or exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided per section 905(j).

The FDA states that the failure to obtain premarket authorization or submit required reports constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act. FF Vapors is required to submit a written response within 15 working days detailing actions taken to address violations