FDA WARNING_LETTER - NAKV Enterprises, Inc. d/b/a Fat Puff Wholesale - May 31, 2023

On May 31, 2023, the FDA issued a Warning Letter to Karsten B. Vaeth, regarding the sale and distribution of electronic nicotine delivery system (ENDS) products on the website https://www.fatpuffwholesale.com. The FDA determined that products like "Puff Plus Disposable – Fruit Fusion" and "Puff Plus Disposable – Grape" are offered for sale to U.S. customers.

These ENDS products are classified as "tobacco products" under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include products containing nicotine from any source. The FDA found these products to be "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

A key violation is the lack of required premarket authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. 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 mandates a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/