# FDA WARNING_LETTER - Vapor Arts LLC d/b/a Main Street Vapor Co. - May 18, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/vapor-arts-llc-dba-main-street-vapor-co/96ebbcfe-57a2-4f40-b03c-5622605e0b63

> FDA WARNING_LETTER for Vapor Arts LLC d/b/a Main Street Vapor Co. on May 18, 2022. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Vapor Arts LLC d/b/a Main Street Vapor Co.
- Inspection Date: 2022-05-18
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Vapor Arts LLC d/b/a Main Street Vapor Co. on May 18, 2022, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, specifically "Main Street Vapor Co. Fire breather e-liquid," which are classified as tobacco products under the FD&C Act.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The "Fire breather e-liquid" was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order, a substantial equivalence order, or an exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Prohibited acts include holding for sale an adulterated or misbranded product (section 301(k)) and failing to provide a required report (section 301(p)).

The FDA emphasized that all new tobacco products without premarket authorization are marketed unlawfully and are subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company, a registered manufacturer with over 60 listed products, must ensure all products comply with the FD&C Act and FDA regulations. A written response detailing corrective actions, including

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/vapor-arts-llc-dba-main-street-vapor-co/5748d093-23fa-49ad-a288-038e80d55de1

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