FDA WARNING_LETTER - American Smoking Cessation Corp d/b/a Yeti Vape - September 08, 2022

The FDA issued a Warning Letter to American Smoking Cessation Corp d/b/a Yeti Vape on September 8, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act.

The primary violation identified is the marketing of the "SQUATCH DROP BEAST CAKE" e-liquid product 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, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided under section 905(j). The failure to provide such a report is also a prohibited act under section 301(p).

The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and a plan for future compliance.