FDA to Prioritize Bestsellers’ PMTAs

In reviewing premarket tobacco product applications (PMTAs), the U.S. Food and Drug Administration is prioritizing products with the greatest market share where scientific review will have the greatest public health impact, the agency said in a Feb. 16 update on its website.

As of mid-January, the FDA had completed the processing step of applications for more than 4.8 million products from over 230 companies. “We have accepted applications for about 84,000 products and refused to accept applications for about 3,100 products submitted through the PMTA pathway,” wrote Mitch Zeller, director of the FDA Center for Tobacco Products. “As of mid-January 2021, of the applications submitted by Sept. 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.

According to Zeller, the agency’s progress has been slowed by the great variety of ways in which applicants submitted their PMTAs. For example, some applicants provided information on one product per submission while other applicants provided information for all of their products within one submission.

The FDA is prioritizing enforcement against electronic nicotine-delivery devices (ENDS) that continue to be sold and for which the agency did not receive a product application. To date, the FDA has sent warning letters to 30 firms selling ENDS products, specifically e-liquids, without premarket authorization.

The agency also stated that the likelihood of the FDA reviewing all the applications by Sept. 9, 2021, is low. Because of the sheer number of applications, the agency has set aside the products with the greatest market share and will push those products through the process more quickly. “[We will] focus resources on products where scientific review will have the greatest public health impact, based on their market share, while also committing to providing an opportunity for review to all companies,” Zeller wrote.

The FDA could not confirm when it would release a list of products that are approved to be on the market. Zeller wrote that the agency continues to work on processing submissions and verifying the dates of initial marketing and current marketing status of products that submitted a timely PMTA.

“We have already verified this information for around 86,000 products received through the PMTA pathway,” he wrote. “Due to the size and volume of the PMTA submissions and the variable quality, format and presentation of these submissions, processing these submissions and verifying this information will take more time.”