FDA WARNING_LETTER - Vapors Inc. d/b/a Vapors of Alabama Oneonta - February 17, 2022

On February 17, 2022, the FDA issued a Warning Letter to Vapors Inc. d/b/a Vapors of Alabama Oneonta, identifying violations related to the manufacturing and distribution of e-liquid products. The FDA determined that Vapors Inc. manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation cited is the marketing of a "new tobacco product" without the required premarket authorization. Specifically, the Krispy Kreme 3mg e-liquid product was found to be 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. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required information under section 905(j).

The letter emphasizes that marketing new tobacco products without premarket authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. Vapors Inc., a registered manufacturer with over 1,800 listed products, is required to ensure all products comply with the FD&C Act and FDA regulations. The company must submit a