FDA WARNING_LETTER - Titan Premium Services, LLC d/b/a TitanVapez - July 21, 2020

On May 22, 2020, the FDA issued a Warning Letter to Charles McClung regarding e-liquid products sold on http://www.titanvapez.com/Default.asp. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that several e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). The website advertising for products like Titan Strawberry Cream Cake, Titan Blueberry Cream Cake, Titan Cookie Cheesecake, Prohibition X, and Prohibition XX fails to include the required nicotine warning statement, violating 21 CFR 1143.3(b). This regulation mandates that advertising for covered tobacco products, including e-liquids, must bear the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical."

The letter requires immediate correction of this and similar violations to ensure compliance with the FD&C Act and FDA regulations. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including dates of discontinued violative activities and a plan for maintaining compliance, is required within 15 working days.