# FDA WARNING_LETTER - Simply Vapour LLC - August 02, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/simply-vapour-llc/33adee4d-ff87-431a-ad99-dcb2a1a514b1

> FDA WARNING_LETTER for Simply Vapour LLC on August 02, 2022. Product: Tobacco. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Simply Vapour LLC
- Inspection Date: 2022-08-02
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On August 1, 2022, the FDA issued a Warning Letter to Simply Vapour LLC for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that Simply Vapour LLC's "SV Signature Menthol PREMIUM BLEND 6mg/mL 60mL e-liquid product" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

Under sections 910(a) and 910(c)(1)(A)(i) of the FD&C Act, new tobacco products require a premarket authorization order. Simply Vapour LLC's product lacks this order and is not exempt, rendering it 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 requires Simply Vapour LLC to submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and distribution, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.

## Related Documents

- [WARNING_LETTER - 2021-11-16](https://www.globalkeysolutions.net/records/warning_letter/simply-vapour-llc/9a28ced3-e9a4-4845-9696-edde8032f5a0)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/simply-vapour-llc/7118efcd-a7c3-4206-b10c-0a20fa7d67b9

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