# FDA WARNING_LETTER - The Fog House LLC - August 26, 2021

Source: https://www.keypedia.com/records/warning_letter/the-fog-house-llc/5752315a-25ea-42b0-abfa-91f656a63998

> FDA WARNING_LETTER for The Fog House LLC on August 26, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: The Fog House LLC
- Inspection Date: 2021-08-26
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to The Fog House LLC, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that The Fog House LLC manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation cited is the marketing of a "new tobacco product," specifically "The Fog House Black Flag 3MG 60ML e-liquid product," without the required premarket authorization. This product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. 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 failure to provide required notice or information under section 905(j).

The letter emphasizes that such actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The Fog House LLC, a registered manufacturer with over 300 listed products, is responsible for ensuring compliance for all its tobacco products. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within

## Related Officers

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

Company: https://www.keypedia.com/companies/the-fog-house-llc/50a80a36-3c94-4ffe-b788-1581174b31e5

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