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02/19/2021

FDA Processes Premarket Tobacco Applications for 4.8M Tobacco Products

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SILVER SPRING, Md. — Through the first four months after the premarket tobacco applications (PMTA) deadline, the Food and Drug Administration (FDA) processed submissions from more than 230 companies.

According to a post from Mitch Zeller, director of the FDA's Center for Tobacco Products (CTP), as of mid-January, the agency completed the processing step of applications for more than 4.8 million products from those companies.

Tobacco companies had until Sept. 9 to file PMTAs for many newly deemed products — including electronic cigarettes, and certain cigars and hookah products. After a company submits the application, the FDA begins processing the PMTA to properly receive and prepare it for review. The steps, as Zeller outlined, include physical or electronic intake of the submission and determining the type and number of applications contained in the submission.

"During processing, FDA found that the PMTAs posed additional challenges due to the size, complexity and diversity of the submissions. For example, some firms provided separate submissions for each section of the tobacco product application, such as submitting the clinical information separately from product identification and manufacturing information, while others included up to tens of thousands of products within a submission," Zeller explained.

"One firm submitted information on more than 4 million tobacco products within a single submission. 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," he added.

The agency continues to move through the processing steps of the PMTA submissions, and once complete, will release a list of products submitted under all three pathways for FDA approval: PMTA, Substantial Equivalence (SE) and Substantial Equivalence Requests (EX REQ).

For the EX REQ pathway, the agency received applications for about 350 products from about 15 companies. For the SE pathway, it received applications for about 6,800 products from about 100 companies, according to Zeller.

To read Zeller's Feb. 16 update in full, click here.