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

Source: https://www.keypedia.com/records/warning_letter/tsvl-llc-dba-times-square-vape-lab/45097cca-0f32-47a2-b329-63f558d8de3a

> FDA WARNING_LETTER for T.S.V.L. LLC d/b/a Times Square Vape Lab on August 17, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: T.S.V.L. LLC d/b/a Times Square Vape Lab
- Inspection Date: 2021-08-17
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)

Company: https://www.keypedia.com/companies/tsvl-llc-dba-times-square-vape-lab/1abb6752-5d2f-4495-9516-44f9e36b782c

Office: https://www.keypedia.com/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374