The Vapor Spot, LLC – FDA Warning Letter, Feb 12, 2021

The FDA issued a Warning Letter to John Jenkins on February 12, 2021, following a review of the website https://www.thevaporspot.com. The FDA determined that e-liquid products manufactured and offered for sale or distribution on the website are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the e-liquid products "Mother Nature Vapor Blueberry Acai," "Mother Nature Vapor Strawberry Rhubarb," and "The Vapor Spot Classics Clapton" were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes that the firm, a registered manufacturer with over 450 listed products, is responsible for ensuring compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to address these violations may result in enforcement actions, including civil money penalties, seizure, and/or injunction. The firm is