# FDA WARNING_LETTER - The Smoker's Alternative - May 11, 2021

Source: https://www.keypedia.com/records/warning_letter/the-smokers-alternative/d9722f02-4ac1-4e0b-880a-5b7ace8b56f9

> FDA WARNING_LETTER for The Smoker's Alternative on May 11, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: The Smoker's Alternative
- Inspection Date: 2021-05-11
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to The Smoker’s Alternative after reviewing submissions and inspection records, determining the firm manufactures and distributes e-liquid products, specifically "The Smoker’s Alternative Vanilla Custard 60 ml 3mg e-liquid product," which are deemed tobacco products subject to FDA regulation. The primary violation is the sale and distribution of this e-liquid product without the required premarket marketing authorization order, as it is considered a "new tobacco product" not commercially marketed before February 15, 2007. 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 information under section 905(j). The firm's actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA requires a written response within 15 working days detailing corrective actions, including dates of discontinued sales/distribution, and a plan for maintaining compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, or injunction.

## Related Documents

- [WARNING_LETTER - 2026-05-01](https://www.keypedia.com/records/warning_letter/the-smokers-alternative/fa279435-d328-42ef-a984-815e4477875d)

## Related Officers

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

Company: https://www.keypedia.com/companies/the-smokers-alternative/6c54ec14-302a-47f8-82e2-5e8affee37a8

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