FDA WARNING_LETTER - RPF Swedish Holdings LLC d/b/a Puffsee - May 01, 2024

The FDA's Center for Tobacco Products reviewed puffsee.com and determined that electronic nicotine delivery system (ENDS) products are offered for sale 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 FDA identified two specific ENDS products, Kangvape Onee Max, Sour Apple Ice, and EBDesign TE6000 Autumn, as "new tobacco products" that lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and do not have FDA marketing authorization or exemptions. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required information was not provided under section 905(j).

The FDA states that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for compliance. Failure to comply may