# FDA WARNING_LETTER - Atomic Vapor - October 07, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/atomic-vapor/a797ae12-1f0a-4079-9251-caaa0dbc9140

> FDA WARNING_LETTER for Atomic Vapor on October 07, 2021. Product: Tobacco. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Atomic Vapor
- Inspection Date: 2021-10-07
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to Atomic Vapor, identifying that their e-liquid product, ATOMIC VAPOR Tsunami 6mg, is being manufactured and distributed without the required premarket authorization. Under section 201(rr) of the FD&C Act, e-liquid products are classified as tobacco products subject to FDA jurisdiction.

The ATOMIC VAPOR Tsunami 6mg e-liquid product is deemed a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007. Consequently, it requires a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act or an exemption. Since no such authorization or exemption is in effect, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

The FDA considers new tobacco products marketed without premarket authorization unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. Atomic Vapor is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant

## Related Documents

- [WARNING_LETTER - 2025-08-28](https://www.globalkeysolutions.net/records/warning_letter/atomic-vapor/1938e54d-fc8e-4061-b879-40ca1945ddd1)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/atomic-vapor/68735493-7fe1-42ee-9c47-a9a1464b34b1

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