FDA to Prioritize Top-Selling Brands in PMTA Review
In a February 16 website update, the U.S. FDA said it is prioritizing products with the largest market share when reviewing premarket tobacco product applications (PMTAs), reducing the greatest market impact of reviews. As of mid-January, the FDA had comp
In an update posted on its website on February 16, the U.S. FDA said that in reviewing premarket tobacco product applications (PMTAs), the agency is prioritizing products with the largest market share in order to reduce the review’s impact on the market as much as possible.
As of mid-January, the FDA had completed processing applications covering more than 4.8 million products from over 230 companies. Mitch Zeller, director of the FDA’s Center for Tobacco Products, wrote: “We have accepted applications for approximately 84,000 products, but refused to accept applications for about 3,100 products submitted through the PMTA pathway.” “As of mid-January 2021, among applications submitted by September 9, we have filed applications for about 29,000 products and refused to file applications for about 1,650 products submitted through the PMTA pathway.”
Zeller believes the agency’s progress has slowed because applicants have submitted PMTAs in a wide variety of ways. To date, the FDA has issued warning letters to more than 30 companies selling ENDS products, particularly e-liquids, without receiving premarket authorization.
The agency also said it is unlikely that the FDA will review all applications by September 9, 2021. Due to the large number of applications, the agency will prioritize products with higher market share and accelerate the review of those products. Zeller wrote: “[We will] focus resources, based on market share, on products for which scientific review will have the greatest impact on public health, while still working to provide all companies with the opportunity for review.”
The FDA could not determine when it would release a list of products authorized for marketing. Zeller wrote that the agency will continue processing submissions and verifying the initial marketing dates and current marketing status of products that submitted timely PMTAs.
He wrote: “We have verified information for approximately 86,000 products received through the PMTA pathway.” “Because of the size and volume of PMTA submissions, as well as the fact that the models, formats, and presentation of these submissions vary, processing these submissions and verifying this information will take additional time.”
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