FDA WARNING_LETTER - Wolfe Trading Company LLC d/b/a East Coast Vapors - November 02, 2023

On November 2, 2023, the FDA issued a Warning Letter to Wolfe Trading Company LLC d/b/a East Coast Vapors for manufacturing and distributing e-liquid products, specifically "Katy Perry," without required marketing authorization. These products are classified as "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed in the U.S. as of February 15, 2007, and contain nicotine from any source.

The FDA determined that "Katy Perry" e-liquid products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of premarket authorization or substantial equivalence reports. The failure to provide required reports under section 905(j) is a prohibited act under section 301(p).

Wolfe Trading Company LLC is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of non-compliant products, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.