FDA WARNING_LETTER - T.S.V.L. LLC d/b/a Times Square Vape Lab - August 17, 2021

This FDA Warning Letter, dated August 17, 2021, addresses T.S.V.L. LLC d/b/a Times Square Vape Lab for manufacturing and distributing e-liquid products, specifically "TSVL Blue Charm 1.5 mg 60 ml e-liquid product," without required premarket authorization.

The FDA determined that this e-liquid product is a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007. The company failed to obtain a marketing authorization order under section 910(c)(1)(A)(i) or demonstrate an exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j).

The letter states that the firm is a registered manufacturer with over 4,000 listed products and emphasizes the responsibility to comply with all applicable FD&C Act provisions and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including discontinuation dates for violative sales