FDA WARNING_LETTER - Slam Cake Vapes LLC - January 04, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to Summer Kutscher on December 20, 2021, after reviewing the website https://buyslamcakevapes.com. The review determined that e-liquid products, specifically "Slam Cake Vapes Fruit Series: Heart," are manufactured and offered for sale or distribution in the United States. 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 identified is the marketing of a "new tobacco product" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. The "Slam Cake Vapes Fruit Series: Heart" e-liquid was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The firm is a registered manufacturer with over 500 products listed with FDA. A Premarket Tobacco Product Application (PMTA) (STN PM0001193) covering 471 products was submitted on September 7, 2020, but received a Marketing Denial Order