FDA WARNING_LETTER - Smoxygen Inc - September 14, 2023

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