Lizard Juice LLC d/b/a New Age Distribution – FDA Warning Letter, Aug 24, 2023

The FDA issued a Warning Letter to Lizard Juice LLC d/b/a New Age Distribution on August 24, 2023, following a review of inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source.

The primary violation identified is the marketing of a "new tobacco product," LIZARD JUICE RAPTURE 3MG/ML 60ML, without the required premarket authorization. This product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is 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 notice or information.

The failure to provide a required report under section 905(j) of the FD&C Act is also cited as a prohibited act under section 301(p). The FDA has not received a marketing authorization application for the listed product.

Lizard Juice LLC is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuation of violative sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties