FDA WARNING_LETTER - bestvape.com - June 27, 2025
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On June 27, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to bestvape.com (700 Louisiana St, Houston, TX 77002) for offering unauthorized electronic nicotine delivery system (ENDS) products for sale in the U.S. The FDA reviewed bestvape.com and identified "Lost Mary MT15000 Turbo Disposable Thermal Edition – Frozen White Strawberry" and "Lost Mary MT35000 Turbo Disposable – Strawberry+" as new tobacco products lacking required premarket authorization.
Under sections 201(rr), 901(b), and 910(a) of the FD&C Act, and 21 C.F.R. § 1100.1, ENDS products are tobacco products requiring premarket authorization if not commercially marketed before February 15, 2007, or if modified thereafter without substantial equivalence or exemption. The identified products are deemed "new tobacco products" without FDA marketing authorization, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to lack of required notice under section 905(j).
Bestvape.com must ensure all tobacco products comply with the FD&C Act and FDA regulations (21 C.F.R
ID · 692159a5-8288-4044-bc82-da1041b555ac
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