Fliq Vapor LLC – FDA Warning Letter, Apr 12, 2022

On March 25, 2022, the FDA issued a Warning Letter to Haviv Arazi regarding ENDS products sold on fliqvapor.com. The FDA determined that products like "Fliq XL Grapple Berry Disposable" and "Fliq XL Menthol Disposable" are new tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction.

These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, they are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although the firm is a registered manufacturer with over 40 products listed, a Premarket Tobacco Product Application (PMTA) (STN PM0001248) covering 8 products was refused to be filed on September 2, 2021. The FDA emphasizes that all new tobacco products marketed without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction.

The firm must submit a written response within 15 working days detailing actions taken to address violations,