FDA WARNING_LETTER - Superpuff Inc. d/b/a MyVapor - May 31, 2023

On May 31, 2023, the FDA issued a Warning Letter to Qidong Xiao regarding the sale and distribution of electronic nicotine delivery system (ENDS) products on the website https://myvaporus.com. The FDA determined that "Hyde Retro ENDS products" offered for sale are "new tobacco products" that lack the required premarket authorization order, making them adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act.

The letter clarifies that the definition of "tobacco product" under section 201(rr) of the FD&C Act was expanded on March 15, 2022, to include products containing nicotine from any source. New tobacco products, defined as those not commercially marketed in the U.S. as of February 15, 2007, generally require a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, or an exemption.

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale/distribution of the non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.