BAM Group LLC d/b/a VapEscape – FDA Warning Letter, May 11, 2023

The FDA issued a Warning Letter to BAM Group LLC d/b/a VapEscape on May 11, 2023, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, including "Fireball," which are deemed tobacco products under the FD&C Act.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. These e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide required reports under section 905(j) is also a prohibited act.

While a Premarket Tobacco Product Application (PMTA) (STN PM0003600) was submitted on September 9, 2020, it received a Marketing Denial Order on September 3, 2021, covering 4,000 products, including those cited.

BAM Group LLC must submit a written response within 15 working days, detailing actions taken to address violations, including discontinuation of violative sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure