Knoxville Vapor LLC – FDA Warning Letter

The FDA Center for Tobacco Products issued a Warning Letter to Knoxville Vapor LLC after reviewing their website, knoxvillevaporshop.com, which sells e-liquids containing nicotine (e.g., 3mg, 8mg, 18mg, 24mg). These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation cited is under section 301(tt) of the FD&C Act, which prohibits misleading statements implying FDA approval, safety, endorsement, or reduced harm due to FDA regulation or compliance. Knoxville Vapor's website stated their e-liquids are "tested, created and bottled in an FDA and/or AEMSA certified lab." This statement, directed at consumers, falsely conveys FDA endorsement or implies safety/reduced harm due to FDA regulation, violating the Act. Specific products listed include 555, Absolute Pin, Ambrosia, American Tobacco, Apple Brandy, Apple Pie Moonshine, and Appletini.

Knoxville Vapor must immediately correct these and similar violations, ensuring all tobacco products and promotional materials comply with the FD&C Act. Failure to comply may result in further FDA action, including civil money penalties, criminal prosecution, or injunction. A written response detailing corrective actions, including discontinuation dates of violative promotions, and a plan for maintaining compliance, is required within 15 working days.