Str8Vape, LLC – FDA Warning Letter, Apr 13, 2023

On April 13, 2023, the FDA issued a Warning Letter to STR8VAPE, LLC, following a review of submissions and inspection records. The FDA determined that STR8VAPE, LLC manufactures and distributes e-liquid products, including "American Blend" e-liquid, which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine from any source and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The "American Blend" e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notices or information were not provided.

The FDA cited prohibited acts under sections 301(k) and 301(p) of the FD&C Act for holding for sale adulterated or misbranded products and failing to provide required reports. STR8VAPE, LLC is required to submit a written response within 15 working days detailing actions taken to