# FDA WARNING_LETTER - Bogart Enterprises LLC d/b/a The Vapor Shop - June 03, 2021

Source: https://www.keypedia.com/records/warning_letter/bogart-enterprises-llc-dba-the-vapor-shop/d82d3a92-57f4-4fce-9540-c1795285e52c

> FDA WARNING_LETTER for Bogart Enterprises LLC d/b/a The Vapor Shop on June 03, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Bogart Enterprises LLC d/b/a The Vapor Shop
- Inspection Date: 2021-06-03
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to The Vapor Shop, identifying that their e-liquid products, specifically "vapor Smooth Tobacco 6 e-liquid," are tobacco products subject to FDA jurisdiction. The inspection and review of submissions revealed that this product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the manufacturing, sale, and/or distribution of this e-liquid product without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The Vapor Shop, a registered manufacturer with over 600 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuation dates for violative sales and distribution, and a plan for maintaining compliance.

## Related Documents

- [WARNING_LETTER - 2021-12-27](https://www.keypedia.com/records/warning_letter/bogart-enterprises-llc-dba-the-vapor-shop/f330f57c-85e3-4685-a999-c24e4021e2a1)

## Related Officers

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

Company: https://www.keypedia.com/companies/bogart-enterprises-llc-dba-the-vapor-shop/4512dd43-17eb-4918-8524-d4d0bf4eda5e

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