FDA WARNING_LETTER - Lazarus Adventures LLC - August 31, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Mark Toma of Lazarus Adventures, LLC, following a review of their website, lazarusadventures.com. The FDA determined that e-liquid products, specifically "Czar Nicotine 180 Blue" and "Czar Nicotine 360 Purple," are manufactured and offered for sale or distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The key violation identified is that these e-liquid products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 2,000 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/