FDA WARNING_LETTER - Vapor Candy, LLC d/b/a The Vape Stop - February 01, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Ricardo and Colleen Leyba, owners of Vapor Candy USA, following a review of their website, https://vaporcandyusa.com. The FDA determined that e-liquid products, specifically "Vapor Candy Beetle Juice" and "Vapor Candy Pink Twist," are manufactured and offered for sale or distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is that these e-liquid products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although the firm is a registered manufacturer with over 10,100 products listed, their Premarket Tobacco Product Application (PMTA) STN PM0003527, covering 386 products, received a "Refuse to Accept" determination on June 29, 2021. The FDA emphasizes that all new tobacco products marketed without statutory premarket