# FDA WARNING_LETTER - The Vaporium - March 19, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/the-vaporium/6a0dd92c-4533-4138-920f-a440c9c7742d

> FDA WARNING_LETTER for The Vaporium on March 19, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: The Vaporium
- Inspection Date: 2021-03-19
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to The Vaporium, identifying that their e-liquid products, specifically "The Vaporium 6mg Red White and Blue 70/30 30 ML 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 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 due to the lack of required notice or information under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The Vaporium is a registered manufacturer with 19,860 listed products. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation dates for violative sales/distribution, and a plan for sustained compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/the-vaporium/fd89e8a2-6b0a-4365-8c19-274ebe586587

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