FDA WARNING_LETTER - Breeze Smoke Official - September 13, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Jessica Sons on September 12, 2024, following a review of the website https://breezesmokeoffical.us. The FDA determined that electronic nicotine delivery system (ENDS) products, specifically "Breeze Prime 6000 Puffs Strawberry Apple," were offered for sale or distribution in the United States without the required premarket authorization.

Under section 201(rr) of the FD&C Act, these products are defined as tobacco products, subject to FDA jurisdiction. The letter highlights that the definition of "tobacco product" expanded on March 15, 2022, to include products containing nicotine from any source.

The "Breeze Prime 6000 Puffs Strawberry Apple" product is identified as a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuation of sales and distribution