FDA WARNING_LETTER - Coastal E-Liquid Laboratory/GC Vapors LLC - January 15, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Mark LaFontaine regarding e-liquid products sold on gcvapors.com. The FDA determined that e-liquid products, specifically "Amaretto" and "Lavender," are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The key violation is that these e-liquid products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required information under section 905(j) was not provided.

The firm is a registered manufacturer with over 23,200 products listed with FDA. The letter emphasizes the firm's responsibility to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to comply may result in regulatory actions including civil money penalties, seizure, and/or injunction.