Vape Central Group, LLC – FDA Warning Letter, Sep 22, 2020

On August 17, 2020, the FDA issued a Warning Letter to Paola Goldman and Scott Goldman of Vape Central Group, following a review of their website, https://www.vapecentralgroup.com. The FDA determined that the company was offering for sale or distribution in the United States electronic nicotine delivery system (ENDS) products, which are classified as tobacco products under section 201(rr) of the FD&C Act.

The core violation identified was the sale of "new tobacco products" without the required premarket authorization. Specifically, products like Sea Pods Apple, Eonsmoke Pineapple Crush Pods, Orange Squeeze by Salteez Pods, and Zalt Mango Pods were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lacked FDA marketing authorization orders or exemptions. This renders these products 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 under section 905(j).

The letter mandates that Vape Central Group promptly correct these violations, including discontinuing the violative labeling, advertising, sale, and distribution of these products. A written response detailing corrective actions and a plan for maintaining compliance was required within 15 working days of receipt