Blackbeard Vapor LLC – FDA Warning Letter, Jan 31, 2022

On January 31, 2022, the FDA issued a Warning Letter to Blackbeard Vapor LLC, identifying violations related to the manufacturing and distribution of e-liquid products. The FDA determined that Blackbeard Vapor LLC manufactures and distributes e-liquid products, which are considered tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation cited is the marketing of a "new tobacco product," specifically "Icy Extreme 3mg e-liquid," without the required premarket authorization. Under section 910(a) of the FD&C Act, a new tobacco product is one not commercially marketed in the U.S. as of February 15, 2007, or a modified product marketed after this date. The "Icy Extreme 3mg e-liquid" was found to be a new tobacco product lacking an FDA marketing authorization order, making it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter states that the failure to provide a required report under section 905(j) of the FD&C Act is a prohibited act under section 301(p). Blackbeard Vapor LLC is a registered manufacturer with over 1,600 products listed with FDA. The FDA emphasizes that all new tobacco products