# FDA WARNING_LETTER - Super Vape'z - April 05, 2021

Source: https://www.keypedia.com/records/warning_letter/super-vapez/d8ae8c51-b871-4a9d-bfbc-abe9e291021e

> FDA WARNING_LETTER for Super Vape'z on April 05, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Super Vape'z
- Inspection Date: 2021-04-05
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Super Vape’z, identifying that their e-liquid products, specifically "SUPER VAPE’Z Premium E-liquid Apple Mango 60ml 12mgNic," are tobacco products subject to FDA regulation. The letter states 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/or distribution of this e-liquid product without the required premarket marketing authorization order from the FDA, as mandated by 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.

Super Vape’z, a registered manufacturer with over 700 listed products, is required to ensure compliance. The FDA demands a written response within 15 working days detailing corrective actions, including the discontinuation date of violative sales/distribution, and a plan for ongoing compliance. Failure to address these violations may result in regulatory actions

## Related Officers

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

Company: https://www.keypedia.com/companies/super-vapez/39ab43ae-db37-43dc-bb96-790c303cb3f6

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