# FDA WARNING_LETTER - BloVape - January 29, 2021

Source: https://www.keypedia.com/records/warning_letter/blovape/51bd2141-2aef-41f6-9701-69d726a647b1

> FDA WARNING_LETTER for BloVape on January 29, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: BloVape
- Inspection Date: 2021-01-29
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Corey J. Stanbery regarding e-liquid products manufactured and sold via blovape.com. The FDA determined that products like "The Bakery" and "Melon Milk" are "new tobacco products" under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) because they were not commercially marketed in the U.S. as of February 15, 2007.

These e-liquid products are subject to FDA jurisdiction (section 901(b) of the FD&C Act and 21 C.F.R. § 1100.1) and require premarket authorization. The company failed to obtain the necessary marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act or demonstrate substantial equivalence or exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.

## Related Officers

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

Company: https://www.keypedia.com/companies/blovape/1312d4fb-5949-4db4-9d9c-7dbdd0611cb9

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