JP Ventures LLC dba iVape – FDA Warning Letter, Feb 16, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to JP Ventures LLC, d/b/a iVape, on February 14, 2022, following a review of submissions and inspection records. The letter states that iVape manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, iVape Grape Drink Flavor 100ml 6mg, iVape Strawberry Cream Flavor 100ml 6mg, and iVape Serendipity Flavor 100ml 6mg e-liquid products were found to be commercially marketed after February 15, 2007, without 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. The failure to provide required reports under section 905(j) is also cited as a prohibited act.

The letter emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. iVape, a registered manufacturer with over 26,100 listed products, is required to submit a written