# FDA WARNING_LETTER - Wise Guys Vapes - February 09, 2022

Source: https://www.keypedia.com/records/warning_letter/wise-guys-vapes/0f38dc12-e87a-42ea-b124-703bfe429326

> FDA WARNING_LETTER for Wise Guys Vapes on February 09, 2022. Product: Tobacco. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Wise Guys Vapes
- Inspection Date: 2022-02-09
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Wise Guys Vapes on February 9, 2022, after reviewing submissions and inspection records. The FDA determined that Wise Guys Vapes manufactures and distributes e-liquid products, specifically "Wise Guys Whitey Bulger 3mg e-liquid," which are deemed tobacco products under the FD&C Act.

The primary violation is that this e-liquid product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide 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. The FDA emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement, including civil money penalties, seizure, and injunction. Wise Guys Vapes must submit a written response within 15 working days detailing actions to address violations, including discontinuing sales/distribution and a plan for future compliance.

## Related Documents

- [WARNING_LETTER - 2025-05-16](https://www.keypedia.com/records/warning_letter/wise-guys-vapes/bebffdc7-a666-4f7e-9b84-fea892026cbe)

## Related Officers

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

Company: https://www.keypedia.com/companies/wise-guys-vapes/06203f23-2faa-44c0-a0e3-1c0c6c3101e0

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