FDA WARNING_LETTER - New Vaping US - January 24, 2023

On January 13, 2023, the FDA's Center for Tobacco Products issued a Warning Letter after reviewing https://newvaping.us and https://vapingland.com, determining that Electronic Nicotine Delivery Systems (ENDS) products were offered for sale to U.S. customers. These products are classified as 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 found that SWFT Mod Recharge Gummy Bear and Naked – American Patriots ENDS products were sold to individuals under 21 years of age, specifically from https://newvaping.us and https://vapingland.com, respectively. This constitutes a violation of section 906(d)(5) of the FD&C Act, which prohibits the sale of tobacco products to persons under 21. Consequently, these products are deemed misbranded under section 903(a)(7)(B) of the FD&C Act.

The letter emphasizes the retailer's responsibility to ensure compliance with the FD&C Act and FDA regulations, including 21 C.F.R. Parts 1140, 1141, and 1143. Failure to comply may result in regulatory actions such as civil money penalties, seizure, injunction, or refusal of import. The