b&g trading llc – FDA Warning Letter, Oct 14, 2022

On October 14, 2022, the FDA issued a Warning Letter to Ataman Bilgin and Hasmet Girgin regarding electronic nicotine delivery systems (ENDS) products offered for sale on vaportechusa.com. The FDA determined that products like Vaportech CUBE Aloe Grape and Vaportech CUBE Mango Colada are "new tobacco products" under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

These products are considered new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these ENDS products lack the required premarket authorization order 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 due to the absence of required notice or information under section 905(j).

The letter mandates a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.