U.S. FDA has Processed PMTAs for 4.8 Million Products
Mitch Zeller speaking at a TMA annual meeting. Photo: Taco Tuinstra
The U.S. Food and Drug Administration (FDA) said it received thousands of premarket tobacco product application (PMTA) submissions covering millions of tobacco products, the majority of which came in very close to the Sept. 9, 2020 deadline. The submissions varied substantially in number of tobacco products contained in each submission, size, format and organization, including paper submissions and even hard drives and CDs, according to a press release.
FDA Center for Tobacco Products (CTP) director Mitch Zeller stated as of mid-January 2021, the agency has 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 Zeller. “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.”
He also stated that several factors have slowed the agency’s progress in getting application’s into the system. Companies submitted PMTAs differently, for example some applicants provided information on one product per submission while other applicants provided information for all of the company’s products within one submission.
“One firm submitted information on more than 4 million tobacco products within a single submission,” Zeller wrote. “The amount of content in each submission also greatly varied, with some applications including up to 2,000,000 files where each file contains multiple pages of content for FDA to review.” The letter is part of a pledge Zeller made that the agency would keep interested stakeholders updated on the agency’s progress.
FDA is prioritizing enforcement against any ENDS product that continues 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 who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids, which lack premarket authorization, according to the letter.
The agency also stated that the likelihood of 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. This could prove positive or negative as a quick denial would force the product off the market.
The agency can still 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.”