# FDA WARNING_LETTER - Vape NV LLC - August 16, 2022

Source: https://www.keypedia.com/records/warning_letter/vape-nv-llc/59560e2f-5dc6-4e79-83a1-cf045f4754b8

> FDA WARNING_LETTER for Vape NV LLC on August 16, 2022. Product: Tobacco. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Vape NV LLC
- Inspection Date: 2022-08-16
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Vape NV LLC on August 16, 2022, following a review of submissions and inspection records. The FDA determined that Vape NV LLC manufactures and distributes "Bomberry e-liquid products" for commercial distribution in the U.S. These e-liquid products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is that Bomberry e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. Vape NV LLC is manufacturing, selling, and/or distributing these products without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j). The failure to provide such a report is a prohibited act under section 301(p), and the sale of adulterated or misbranded products is a prohibited act under section 301(k).

Vape NV LLC is required to submit a written response within 15 working days, detailing

## Related Officers

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

Company: https://www.keypedia.com/companies/vape-nv-llc/757fc1b6-3a34-473c-b9b7-59c803ed66ba

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