BS Vapes LLC – FDA Warning Letter, Dec 22, 2022

On December 22, 2022, the FDA issued a Warning Letter to BS Vapes LLC, identifying that the company manufactures and distributes e-liquid products, specifically "Grape Soda BS Vapes Nic 6 e-liquid," which are deemed tobacco products under the FD&C Act. The FDA determined this product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act.

Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the required notice or information under section 905(j) was not provided. The sale or distribution of such adulterated or misbranded products, and the failure to provide required reports, constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

BS Vapes LLC is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative products, and outlining a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties