How the FDA Is Prioritizing PMTA Review

Agency evaluating ENDS product applications first
ongoing applications
Photograph: Shutterstock

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) is sifting through applications for millions of tobacco products and is prioritizing applications for electronic nicotine delivery systems (ENDS) products first.

Mitch Zeller, director of the FDA’s Center for Tobacco Products (CTP), said in a Feb. 16 update the agency has completed the initial intake for all substantial equivalence requests (EX REQ) and substantial equivalence (SE) reports submitted to the agency by Sept. 9, 2020. The process is ongoing, though, for premarket tobacco product applications (PMTAs), the vast of which are applications for ENDS. Of the PMTAs that the FDA accepted for review so far, there are more than 58,000 ENDS products, the agency said.

After the initial processing step, which involves the physical or electronic intake of the submission and determining the type and number of applications it contains, there are still multiple steps before the FDA determines if it will authorize a new deemed tobacco product. Convenience-store retailers need to know which products are authorized so they can ensure they’re selling legal products.

But with thousands of submissions, how is the FDA prioritizing which applications to review first?

For SE and EX REQ applications, the FDA determined review order using randomization by manufacturer. PMTA’s review order will mostly be determined using the same randomization process; however, due to the large number of ENDS products currently marketed the FDA is dedicating a portion of its resources to reviewing the products that account for most of the current market, Zeller said.

“The continued marketing of these products has the potential to have the greatest public health impact—either positively or negatively—as they hold the largest overall market share and therefore likely used by the largest number of people,” Zeller said. “For this reason, FDA pulled several applications into a separate review queue and dedicated resources to their review. By identifying and ensuring first review of these applications, we believe we can achieve the greatest public health impact most quickly.”

If the FDA finds a widely used, currently marketed product does not meeting the standard in the law for marketing, the FDA will not grant a marketing order and the product must be removed from the market, Zeller said. If the product does meet the standards, it will receive a marketing order and may remain on the market, subject to the conditions in the order, he said.

“In either case, earlier review ensures a faster transition to a marketplace of products that have been scientifically reviewed for their impact on public health,” Zeller said.

Until the FDA makes its final decision, deemed tobacco products for which applications were filed on time for can be legally sold. The FDA is court-ordered to finish this process by Sept. 9, 2021, however the likelihood of the FDA reviewing all applications by then is low, Zeller said

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