FDA WARNING_LETTER - Kuegel Enterprise LLC d/b/a America's Choice E-Cigarettes - December 15, 2021

The FDA issued a Warning Letter to Kuegel Enterprise LLC d/b/a America’s Choice E-Cigarettes for manufacturing and distributing an e-liquid product, America’s Choice Mint Chill 4mg 60ml, without required premarket authorization. This product is deemed a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007.

The violation stems from the absence of an FDA marketing authorization order (section 910(c)(1)(A)(i)) or an exemption. Consequently, the product is considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the lack of required notice or information under section 905(j). Prohibited acts include holding for sale an adulterated/misbranded product (section 301(k)) and failing to provide a required report (section 301(p)).

The FDA emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement, including civil money penalties, seizure, and injunction. The company, a registered manufacturer with over 40 listed products, must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance.