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In August, FDA issued a total of 29 warning letters to firms who manufacture and sell unauthorized electronic nicotine delivery system (ENDS) products, advising them that selling products which lack premarket authorization is illegal and therefore they cannot be sold or distributed in the U.S. The companies did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline.
While each of these 29 warning letters cites specific products as examples of tobacco products that lack the required premarket authorization, collectively these firms have listed a combined total of more than 268,000 products with the FDA.
Additionally, FDA issued two warning letters to companies for manufacturing and offering for sale or distribution ENDS products without a marketing authorization order. Both Vapor Boss, LLC, and Kaleidoscope Custom Vapor Lounge, LLC have continued to sell ENDS products after receiving “Refuse to Accept” (RTA) determinations from the agency following submission of their premarket tobacco applications. These are the first warning letters issued for an application that was submitted by the Sept. 9, 2020 deadline that subsequently received a RTA determination.
Companies who receive an RTA determination must remove any products currently on the market or risk enforcement action by FDA. Companies may resubmit a complete application for these products at any time, however the products may not be marketed unless they receive a marketing granted order.
FDA also issued the first warning letter to a company that submitted premarket applications for some, but not all, of its products. The company (Maduro Distributors d/b/a The Loon) submitted a premarket application covering 18 products, but it manufactures and sells additional products not covered by the premarket application and thus lacking premarket authorization.
From January through August 2021, FDA has issued a total of 169 warning letters to firms selling or distributing more than 17 million unauthorized electronic nicotine delivery system (ENDS) products and that did not submit premarket applications by the Sept. 9 deadline.
On FDA’s Warning Letters page, you can find all of these warning letters by entering “Center for Tobacco Products” in the “Issuing Office” box in the “Filter by” section of the search tool.
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