Tasty Cloud Vape Co., LLC d/b/a Tasty Cloud Vape Co. – FDA Warning Letter, Oct 22, 2024

The FDA issued a Warning Letter to Tasty Cloud Vape Co. after reviewing their website, identifying e-liquid products, including FIXX-E Liquid Lemon Cheesecrank 120ml and The Cakery Buttercream Dream 120ml, as unlawfully marketed. These products are classified as "new tobacco products" under section 201(rr) of the FD&C Act, which now includes nicotine from any source, and require premarket authorization. The firm failed to obtain the necessary marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these unauthorized 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 notices under section 905(j). The FDA mandates a written response within 15 working days, detailing corrective actions, including discontinuing violative sales and a plan for maintaining compliance. Failure to address these violations may lead to regulatory actions such as civil money penalties, seizure, or injunction, and imported products may be detained or refused admission.