FDA Decision and The Fate of More than 6.5 Deemed Tobacco Products

On Sept. 9, 2021, the U.S. Food and Drug Administration (FDA) announced that it had made what it calls “significant progress” in reviewing the applications of over 6.5 million “deemed” tobacco products. Working towards a deadline of Sept. 9, 2021 deadline to review and issue judgment on the applications, the FDA revealed that it had taken action on about 93 percent of the applications that were submitted on time. It also shared that it made the decision to deny marketing orders to many e-cigarette and e-liquid products that now must be removed from the market.

Many of the Premarket Tobacco Applications (PMTA) received were for e-cigarette, e-liquid and other Electronic Nicotine Delivery System (ENDS) products. In its review of these applications, the FDA determined that many of these applications lacked sufficient evidence that demonstrated how these products were a benefit to adult smokers.

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