# FDA WARNING_LETTER - Smoxygen Inc - September 14, 2023

Source: https://www.keypedia.com/records/warning_letter/smoxygen-inc/11b95636-af76-49a5-95ae-3910c0de8470

> FDA WARNING_LETTER for Smoxygen Inc on September 14, 2023. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Smoxygen Inc
- Inspection Date: 2023-09-14
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On September 14, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to the entity operating smoxygen.com. The FDA's review of the website found that electronic nicotine delivery system (ENDS) products, specifically "Lava Plus Disposable – Peach Ice," were offered for sale or distribution in the United States.

The "Lava Plus Disposable – Peach Ice" product was identified as a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007. This product was found to be adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act, as it lacked the required premarket authorization order or exemption.

Furthermore, the FDA's investigation revealed a sale of an ENDS product to an individual under the age of 21, which is a violation of section 906(d)(5) of the FD&C Act. This sale rendered the product misbranded under section 903(a)(7)(B) of the FD&C Act.

The letter requires a written response within 15 working days detailing actions taken to address the violations, including discontinuation of violative sales and a plan for maintaining compliance. Failure to comply may result in regulatory or legal actions, such as

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Bryan Hills](https://www.keypedia.com/people/bryan-hills/84003171-a4c0-4e0c-af1f-5b7f9fba080f)

Company: https://www.keypedia.com/companies/smoxygen-inc/fc3d50e2-f2c7-423a-88db-389f429e9216

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