FDA WARNING_LETTER - Blue Eyed Vapor - May 25, 2021

The FDA issued a Warning Letter to Laurie Ashburn after reviewing the website https://blueeyedvapor.square.site, determining that e-liquid products offered for sale are tobacco products subject to FDA regulation under section 201(rr) and 901(b) of the FD&C Act and 21 C.F.R. § 1100.1. The identified e-liquid products, including "Blue Eyed Vapor - Shiner" and "Jelly Bear," are considered "new tobacco products" as they were not commercially marketed in the U.S. before February 15, 2007. The primary violation is the firm's failure to obtain required premarket marketing authorization orders 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 due to the lack of required notices or information per section 905(j). The FDA stressed the firm's responsibility to ensure all tobacco products and related labeling/advertising comply with the FD&C Act and implementing regulations. Failure to address these violations may lead to regulatory actions, including civil money penalties, seizure, or injunction. The firm is required to submit a written response within 15 working days detailing corrective actions, discontinuation dates for violative activities, and a plan for maintaining compliance.