3rd Rock Vapor – FDA Warning Letter, Jan 26, 2023

The FDA issued a Warning Letter to 3rd Rock Vapor Inc on January 26, 2023, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically "Blue Raspberry e-liquid products," which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the manufacturing, sale, and/or distribution of these e-liquid products without the required premarket authorization. The FDA determined these are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

Consequently, these products are cited as adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for failing to provide required notice or information under section 905(j). Prohibited acts include holding for sale after interstate shipment resulting in adulteration or misbranding (section 301(k)) and failure to provide required reports (section 301(p)).

The FDA emphasizes that unlawfully marketed new tobacco products are subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing actions to address violations, including discontinuation dates