# FDA WARNING_LETTER - Lincoln Vapor LLC - June 15, 2021

Source: https://www.keypedia.com/records/warning_letter/lincoln-vapor-llc/27956d7b-900f-47f4-91ca-3bba47c697ce

> FDA WARNING_LETTER for Lincoln Vapor LLC on June 15, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Lincoln Vapor LLC
- Inspection Date: 2021-06-15
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Lincoln Vapor LLC, identifying that the company manufactures and distributes e-liquid products, specifically the "Escapades 2.0 6mg nicotine e-liquid product," which are deemed tobacco products under the FD&C Act. The FDA determined 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 the required notice or information under section 905(j) was not provided. These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Lincoln Vapor LLC, a registered manufacturer with over 1,400 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation dates for the violative product, and a plan for maintaining compliance. Failure to address these violations may result in regulatory actions such as civil money

## Related Officers

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

Company: https://www.keypedia.com/companies/lincoln-vapor-llc/bcd53ce5-a573-4bb5-8d3d-3a93c6eb886c

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