Nicopure Labs LLC – FDA Warning Letter, May 12, 2020

The FDA issued a Warning Letter to Nicopure Labs, LLC on April 16, 2020, following a review of submissions and inspection records. The company manufactures, imports, and distributes Electronic Nicotine Delivery System (ENDS) products, specifically identified as tobacco products under the FD&C Act.

The core violation is the marketing of "new tobacco products" without required premarket authorization. The specific products cited are "Halo G6 Belgian Cocoa Cartomizer" and "Halo G6 Kringle’s Curse Cartomizer." These products are deemed "new" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

Consequently, these products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket notification (section 905(j)). The introduction of adulterated or misbranded tobacco products into interstate commerce, and the failure to provide required reports, are prohibited acts under sections 301(a) and 301(p) of the FD&C Act.

Nicopure Labs, LLC is required to submit a written response within 15 working days detailing corrective actions, including discontinuation dates for violative sales/distribution, and a plan for maintaining compliance