Vapor Sense League City – FDA Warning Letter, Jul 13, 2023

On July 13, 2023, the FDA issued a Warning Letter to Vapor Sense LLC, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that Vapor Sense LLC manufactures and distributes e-liquid products, including "DewPearry," which are considered tobacco products under section 201(rr) of the FD&C Act, as they are made or derived from tobacco or contain nicotine from any source and are intended for human consumption.

The primary violation is that these e-liquid products are "new tobacco products" that lack the required premarket authorization. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed after this date. Since "DewPearry" was not commercially marketed by the February 15, 2007, predicate date and lacks FDA marketing authorization, it is deemed 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). The FDA requires Vapor Sense LLC to submit a written response within 15 working days detailing actions taken to address the violations