U.S. FDA Will Publish List of Accepted PMTA Applicants


The U.S. Food and Drug Administration (FDA) will release a list to help support retailers. The regulatory agency now says it will break protocol and publish the names of manufacturers and products that have accepted premarket tobacco product applications (PMTAs) on file.

In a press note on Monday, director of the FDA’s Center for Tobacco Products, Mitch Zeller, wrote that the FDA plans to make publicly available a list of the deemed new tobacco products that are subject to the Sept. 9 deadline and were on the market as of Aug. 8, 2016.

“And for which a premarket application is submitted by Sept. 9, 2020,” Zeller wrote. “However, before doing so, we will need to ensure that the publishing of any such information complies with federal disclosure laws and regulations as only certain types of product information from applications can be lawfully disclosed.”

The news comes just one week after several retail groups submitted a letter to the agency asking for a published list of applicants. The Vapor Technology Association, a vapor industry advocacy group, asked the FDA more than a month ago for a published list.

The FDA also noted that while the deadline is on September 9, 2020, it will take FDA some time for the agency to compile and confirm that the list is accurate before publication. “The fact that FDA will be publishing such a list is dramatic change from their prior practice,” wrote VTA Executive Director Tony Abboud in an email. “In the meantime, we will do our best to inform you of VTA members which are participating in the process.”

Zeller stated that the agency requests patience from stakeholders as the agency works through the appropriate processes to ensure the posted information is accurate and compliant with federal laws. In the interim, Zeller stated that retailers and other interested parties should refer to the public statements made by the companies or contact the companies directly to get information about applications they may have submitted.



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