FDA Issues MDOs for 300,000 Flavored E-Cigs

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SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) denied marketing applications for about 300,000 flavored electronic-cigarette products from 31 companies.

This follows the issuance of marketing denial orders (MDOs) to three companies that had submitted premarket tobacco product applications (PMTAs) by Sept. 9, 2020.  

Companies that have received MDOs so far may have submitted PMTAs for other products—such as tobacco-flavored electronic nicotine delivery systems (ENDS) or menthol-flavored ENDS—and those products, if still pending, remain under review, the FDA said. If a product is already on the market, it must be removed or risk enforcement.

Several of the most recent round of MDOs were issued to companies that are not currently marketing their products, the agency said, and therefore, it cannot release additional information about those actions.

According to the list provided by the FDA, included in the 31 companies are: Big Time Vapes, J-Vapor LLC dba North, Shore Vapor, SS Vape Brands Inc. Dba Monster Vape Labs, Custom Vapors, The Vaping Tiger, Gothic Vapor, TrendSetters E-liquid LLC, SWT Global Supply, Diamond Vapor, American Vapor Group, MV Enterprises, Planet of the Vapes, CITTG dba Orgnx E Liquids, Vapors of Ohio Inc. dba Nostalgic Vapes, Buckshot Vapors Inc., Royalty Premium E Juice, Imperial Vapors, Midwest Vape Supply, Dominant Vapor, Mountain Vaporz, Sir Vapes -A-Lot, Loveli Design LLC dba Alice in Vapeland and Nicquid.

The FDA is continuing to review PMTA applications and intends to review as many by Sept. 9, 2021, a year from the filing date, as possible.

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