Tobacco

FDA Clarifies Purpose of Deficiency Letters

Notices are part of PMTA review process, aim to fill gaps in applications submitted for new tobacco products
FDA approval
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SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) is processing and acting on as many premarket tobacco product applications (PMTAs) as it can before Sept. 9, 2021. While applications from tobacco companies with new deemed tobacco products had to be submitted by Sept. 9, 2020, the FDA now has a year to review those submissions.

The agency on June 3 made an announcement to clarify part of that process—the purpose of deficiency letters.

The longest and most thorough phase of this review process is the substantive review phase because it includes evaluation of the scientific information and data in an application and often includes follow-up questions of the applicant. The FDA generally sends a deficiency letter before it makes a final decision on a product based on substantive review.

A deficiency letter allows the FDA to ask applicants to provide additional information that it needs to continue its scientific review. The purpose of the letter is to communicate gaps in information identified during the review and is not intended to convey a list of concerns about the product, the FDA said; however, a complete response to the deficiency letter does not guarantee the applicant will receive a positive marketing order.

The FDA will make a final decision on any product at the end of the FDA’s scientific review, and the FDA will base that final decision on the applicable public health standard in the Federal Food, Drug and Cosmetic Act after reviewing the whole application and amendments, the agency said.

More than 41,000 of the PMTAs the FDA accepted for review as of April 1 have been filed and entered the substantive review phase.

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