# FDA WARNING_LETTER - MadTown Vapor LLC - April 21, 2020

Source: https://www.keypedia.com/records/warning_letter/madtown-vapor-llc/feab6232-ec94-4815-8e90-638aa2bdf227

> FDA WARNING_LETTER for MadTown Vapor LLC on April 21, 2020. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: MadTown Vapor LLC
- Inspection Date: 2020-04-21
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to MadTown Vapor LLC after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically Berry Splash, which are deemed tobacco products. The letter identifies multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. Firstly, MadTown Vapor LLC failed to provide an ingredient listing for its Berry Splash e-liquid to the FDA as required by section 904(a)(1) of the FD&C Act. This failure renders the product misbranded under section 903(a)(10)(A) and constitutes a prohibited act under sections 301(k) and 301(q)(1)(B). Secondly, packages for the Berry Splash e-liquid product do not include the required nicotine warning statement as mandated by 21 C.F.R. § 1143.3(a). This omission causes the product to be misbranded under sections 903(a)(7)(B) and 903(a)(1) of the FD&C Act, and also constitutes a prohibited act under section 301(k). The FDA requires prompt corrective action, including discontinuing violative sales and distribution, and submitting a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may result in regulatory actions such as civil money penalties, seizure, injunction, and refusal of admission for imported products.

## Related Documents

- [WARNING_LETTER - 2021-08-17](https://www.keypedia.com/records/warning_letter/madtown-vapor-llc/5a618293-6f0c-4fce-bdf4-952a093893fe)

## Related Officers

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

Company: https://www.keypedia.com/companies/madtown-vapor-llc/9003f2d6-6a21-4b10-8a0d-909bcf87146d

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