FDA WARNING_LETTER - puff21.com

On June 27, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to puff21.com (6801 Rufe Snow Dr Ste 400, Watauga, TX 76148) for offering unapproved electronic nicotine delivery system (ENDS) products for sale in the United States. The FDA reviewed the website https://puff21.com and determined that products like "Lost Mary MT15000 Turbo Disposable - Frozen White Strawberry" and "RAZ LTX 25K Disposable Vape – Strawberry Peach Gush" are "new tobacco products" as defined by section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)), meaning they were not commercially marketed in the U.S. as of February 15, 2007.

These products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) and are not otherwise exempt. Consequently, they are deemed adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. §387b(6)(A)) and misbranded