FDA Issues Several Sets of Warning Letters in August

ENDS companies must remove products from market or risk enforcement
Warning stamp
Photograph: Shutterstock

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) issued several sets of warning letters in August, ordering more than 30 electronic nicotine delivery systems (ENDS) companies to pull their products from the market.

The FDA issued 29 warning letters in August to firms that manufacture and sell unauthorized ENDS. The companies did not submit premarket tobacco product applications (PMTAs) by the Sept. 9, 2020, deadline, the FDA said. The firms collectively have more than 268,000 products listed with the FDA, but each of the warning letters cites specific examples of those products that lack the required premarket authorization.

The FDA additionally issued warning letters to Vapor Boss LLC and Kaleidoscope Custom Vapor Lounge LLC. Each company continued to sell ENDS products after receiving Refuse to Accept (RTA) determinations from the FDA following the submission of their PMTAs, the agency said. These were the first warning letters issued for an application that was submitted by the PMTA deadline that later received an RTA determination.

Companies that receive an RTA determination must remove any products on the market or risk enforcement action by the FDA. Companies can resubmit a complete application for these products at any time, but the products cannot be marketed unless they receive a marketing granted order, the FDA said.

The FDA also issued a warning letter to Maduro Distributors, doing business as The Loon. While The Loon submitted a premarket application covering 18 products, it continues to manufacture and sell additional products not covered by the premarket application, the FDA said.

So far this year, the FDA issued a total of 169 warning letters to firms selling unauthorized ENDS products. A complete list of these companies can be found on the warning letters page on the FDA’s website.

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