Juice Roll Upz, Inc. – FDA Warning Letter, Oct 26, 2021

The FDA issued a Warning Letter to Joshua and Leilanie Tongco, owners of rollupz.com, after reviewing their website and determining they manufacture and offer for sale e-liquid products in the U.S. These products, including "Green Apple ICE" and "Red Razz SALT," are deemed "tobacco products" under the FD&C Act.

The core violation is the marketing of "new tobacco products" without required premarket authorization. The e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, making them "new tobacco products" requiring an FDA marketing authorization order or an exemption. Since no such order is in effect, and no exemption applies, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The firm is a registered manufacturer with over 550 products listed with FDA. While Premarket Tobacco Product Applications (PMTAs) (STNs PM0001018 and PM0001292) were submitted for 90 products, including the violative e-liquids, they received Marketing Denial Orders on September 8, 2021.

The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties,