ktownvaporlounge.com – FDA Warning Letter, Jun 3, 2025
On May 23, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to KTown Vapor Lounge, LLC, following a review of their website, https://www.ktownvaporlounge.com. The FDA determined that the company offers for sale or distribution in the United States electronic nicotine delivery system (ENDS) products that are considered "new tobacco products" and lack the required premarket authorization.
The identified violative products are: EBDesign - BC5000 EB Designs (Formerly Elf Bar) BC5000 5000 puff 5% - Strawberry Pear Orange Ice and Lost Vape 10K Orion Disp 10K Puffs 5% - Raspberry Sour Apple. These products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and do not have FDA marketing authorization orders or exemptions.
Consequently, these products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) due to the lack of required premarket authorization and failure to provide necessary information
ID · 6b119e80-547f-4dd4-a274-89a1ceee2e04
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