FDA WARNING_LETTER - TX Smoke - May 06, 2024

On May 6, 2024, an FDA inspection of TX Smoke at 3090 Justin Road, Highland Village, TX 75077, revealed violations of federal tobacco laws. The establishment offered for sale electronic nicotine delivery system (ENDS) products, specifically Elfbar Gumi and Lost Mary Lemon Mint, which lack the required premarket authorization.

Under Section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)), "new tobacco products" not commercially marketed in the U.S. as of February 15, 2007, or modified products marketed after this date, require premarket authorization. The listed ENDS products are considered new tobacco products and do not have FDA marketing authorization orders or exemptions. Consequently, these products are deemed "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)) because required information was not provided per Section 905(j).

The FDA requires TX Smoke to take prompt action to address this violation. Failure to comply may result in regulatory or