Nuvo Silver Inc. – FDA Warning Letter, Aug 10, 2021

The FDA issued a Warning Letter to Nuvo Silver Inc. on August 6, 2021, for importing and distributing unauthorized electronic nicotine delivery system (ENDS) products. The FDA determined that Nuvo Silver Inc. is importing and distributing ENDS products for commercial distribution in the United States. These products are considered tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The violation stems from the sale and distribution of "new tobacco products" without the required premarket authorization. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed after this date. The listed products, including various Nuvo refill cartomizers (e.g., Traditional Tobacco High, Blueberry High, Mango High), were not commercially marketed by the February 15, 2007, predicate date and lack FDA marketing authorization orders.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The introduction of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a), and failure to provide required reports under section 905(j) is a prohibited act under section 301(