# FDA WARNING_LETTER - The Clean Vape - March 12, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/the-clean-vape/894fc9c9-b62c-4f9c-aa91-a77570f1abb1

> FDA WARNING_LETTER for The Clean Vape on March 12, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: The Clean Vape
- Inspection Date: 2021-03-12
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to Raffy Tasmajian, operating TheCleanVape.com, after determining that e-liquid products listed on the website are manufactured and offered for sale or distribution in the U.S. These e-liquids, including "Loops," "Dragonberry Kiwi," and "Gramberry," are considered "new tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA regulation. The firm failed to obtain the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering these products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) because the required notice or information under section 905(j) was not provided. Despite being a registered manufacturer with over 800 listed products, the firm did not comply with these critical regulatory requirements. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative activities and a plan for future compliance. Failure to address these violations may result in civil money penalties, product seizure, injunction, and refusal of admission for imported products.

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Raffy Tasmajian](https://www.globalkeysolutions.net/people/raffy-tasmajian/ae386c04-6c43-46e4-8171-fa7d12fcf21b)

Company: https://www.globalkeysolutions.net/companies/the-clean-vape/39529907-05f1-4ead-aa95-767be598a42b

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