Lincoln Vapor LLC – FDA Warning Letter, Jun 15, 2021

The FDA issued a Warning Letter to Lincoln Vapor LLC, identifying that the company manufactures and distributes e-liquid products, specifically the "Escapades 2.0 6mg nicotine e-liquid product," which are deemed tobacco products under the FD&C Act. The FDA determined this product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the manufacturing, sale, and/or distribution of this e-liquid product without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the required notice or information under section 905(j) was not provided. These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Lincoln Vapor LLC, a registered manufacturer with over 1,400 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation dates for the violative product, and a plan for maintaining compliance. Failure to address these violations may result in regulatory actions such as civil money