FDA WARNING_LETTER - Chrimar Enterprises LLC d/b/a VapeGeek - June 07, 2022

The FDA issued a Warning Letter to Chrimar Enterprises LLC d/b/a VapeGeek on June 7, 2022, following a review of submissions and inspection records. The FDA determined that VapeGeek manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act, making them subject to FDA jurisdiction and compliance requirements.

The primary violation identified is the manufacturing, sale, and/or distribution of "Vapegeek Prohibition 50mL HW-1.5mg/ml" e-liquid without the required premarket authorization. This product is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket notification. The introduction of adulterated or misbranded tobacco products into interstate commerce, and the failure to provide required reports, are prohibited acts under sections 301(a) and 301(p) of the FD&C Act.

VapeGeek, a registered manufacturer with over 13,500 listed products, is responsible for ensuring all products comply with the FD&C Act and