FDA WARNING_LETTER - CloudXVapes Plus LLC d/b/a CloudXVapes - December 15, 2021

The FDA issued a Warning Letter to CloudXVapes Plus LLC d/b/a CloudXVapes for manufacturing and distributing an e-liquid product, "CloudXVapes Watermelon Grapeberry 30mg/ml 3 Nic," 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, 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 no notice or information was provided per section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement, including civil money penalties, seizure, and/or injunction. CloudXVapes, a registered manufacturer with 10 listed products, must ensure all its tobacco products comply with the FD&C Act and FDA regulations. The company is required to submit a written response within 15 working days, detailing corrective actions, including discontinuation dates for the violative product, and a plan for maintaining compliance