FDA WARNING_LETTER - Jojo's Smokeless World Inc. d/b/a: Mod Shield - February 12, 2021

The FDA issued a Warning Letter to Maan Yousef on February 12, 2021, after reviewing the website https://www.themodshield.com. The FDA determined that e-liquid products listed on the website are manufactured and offered for sale or distribution in the United States. These e-liquids are considered tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the e-liquid products OH-10 Jojo Juice E-Liquid Salted Caramel, OH-10 Jojo Juice E-Liquid Blackberry, and OH-10 Jojo Juice E-Liquid Vanilla Cupcake were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 10,700 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in civil money penalties, seizure, and/or injunction. The firm is required