Better Vapes LLC – FDA Warning Letter, Mar 8, 2024

The FDA issued a Warning Letter to BETTER VAPES LLC on March 7, 2024, following a review of inspection records. The FDA determined that BETTER VAPES LLC manufactures and distributes e-liquid products, specifically "Candy Cane," which are considered tobacco products under section 201(rr) of the FD&C Act, as amended to include products with nicotine from any source.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The "Candy Cane" e-liquid product was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization orders or exemptions. Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j).

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA requires BETTER VAPES LLC to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing the sale and distribution of the non-compliant products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and