The Juice Machine – FDA Warning Letter, Aug 23, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Muhammad Amirun regarding ENDS products offered for sale on tjmvape.com to U.S. customers. The FDA determined that specific electronic nicotine delivery system (ENDS) products, including 'Game Puff 6000 Puffs Disposable Pod- Strawberry' and 'VapeCam 12000 Puff Starter Kit Disposable Pod – Blueberry Jam,' are new tobacco products lacking the required premarket authorization. These products are considered new tobacco products as they were not commercially marketed in the U.S. as of February 15, 2007, and do not have an FDA marketing authorization order. Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) due to the absence of required information under section 905(j). The FDA expressed particular concern that the product labeling and advertising imitate children’s gaming devices, cameras, cassette tapes, and desserts, potentially promoting youth use and concealing the products' nature. The firm must submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing violative sales and outlining a compliance plan. Failure to comply may result in regulatory actions such as civil money penalties, seizure, injunction, or refusal of import.