FDA WARNING_LETTER - Dongguan Hengtai Biotechnology, Co., Ltd d/b/a Mr. Fog - August 02, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Chris Wei regarding electronic nicotine delivery system (ENDS) products sold on mrfog.ca. The FDA determined that ENDS products listed on the website are manufactured and offered for sale or distribution to U.S. customers. 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 primary violation is the marketing of "new tobacco products" without required premarket authorization. Specifically, "Mr. Fog Max Air 3000 Puffs – Peach Blue Raspberry Ice" and "Mr. Fog Max Air 3000 Puffs – Watermelon Kiwi Ice" were identified as new tobacco products not commercially marketed in the U.S. as of February 15, 2007, and lacking FDA marketing authorization. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction. The letter also notes that imported products appearing adulterated or misbranded may be