FDA WARNING_LETTER - AT Vapors LLC - February 01, 2024

On January 31, 2024, the FDA issued a Warning Letter to the operator of atvapors.com after reviewing their website and determining that electronic nicotine delivery system (ENDS) products were offered for sale or distribution in the U.S. These products are considered tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The FDA identified that the "Cali Bars V2 6000 Puffs, Gummy" ENDS product was offered for sale without the required premarket authorization order. This product is deemed a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, this product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required 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 a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction. The firm is responsible for ensuring all tobacco products and related advertising comply with the FD