Turning Point Brands’ PMTAs Are Back Under FDA Review

Date:

Some breaking news: TPB is withdrawing its lawsuit in a federal court of appeals.

On Friday, Turning Point Brands, which late last month petitioned a federal court to review a marketing denial order (MDO) for many of its vapor products, is withdrawing its appeal.

The company is doing so because, on Thursday, the Food and Drug Administration informed TPB the products that had been denied are now back under review.

“Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” reads a letter addressed to Brittani Cushman, TPB’s senior vice president of external affairs, and signed by Matthew Holman, the director of the office of science at the FDA’s Center for Tobacco Products.

“Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.”

“Accordingly,” it goes on, “this letter rescinds the September 14, 2021, marketing denial orders for your tobacco products.” (Full letter attached below.)

Read full article here.

Alex Norcia – The No Smoking Section – 2021-10-08.

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