FDA WARNING_LETTER - Marina Technology LLC - March 21, 2023

The FDA issued a Warning Letter to Nicholas Gollust and Robert Sunderland of Marina Technology, LLC, on March 16, 2023, following a review of their website, https://www.marinatech.co. The review determined that the company manufactures and offers for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products, which are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Specifically, the products Aquabar Berry Blast, Aquabar Peach Ice, and Aquabar Rainbow Ice were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j).

The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company is required to submit a written response within 15 working days detailing actions taken to address the violations,