The FDA has been rejecting PMTAs by the millions. Back in August 2021, the FDA announced that it would not even review 4.5 million applications from the same company, JD Nova, on grounds that they did not include an adequate Environmental Assessment.

PMTA reviewers have created a method to quickly dismiss many PMTAs without even reviewing them.
At the end of the same month, the agency issued marketing denial orders (MDOs) for applications related to flavoured vaping products (55,000 from one company and 800 from another), saying that these failed to provide “product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.”

Subsequently, in early September, the agency issued MDOs for vape company MVO, who like all other vape companies in the US, had until September 2020 to file their PMTAs. The FDA, in turn, had until September 2021 to review the PMTAs, a deadline which ironically it failed to meet. This led to MVO filing a petition for review in the Ninth Circuit Court of Appeals at the end of September, and several other vaping companies have followed suit.

A blog on Competitive Enterprise Institute’s website had highlighted that clearly the FDA was not expecting to receive as many applications as it did. “Perhaps that explains why the FDA now seems intent on coming up with excuses to issue sweeping denials and whittle that number down to a size it can handle,” reads the blog.

Infact, recent documents have revealed that PMTA reviewers have created a method to get through a backlog of millions of PMTAs, enabling them to quickly dismiss many of them without even reviewing their submitted documents.

FDA encouraged to be even more reckless about PMTAs

On the other end of the spectrum, several anti-tobacco groups have sent a letter to the FDA urging it to take action on the outstanding PMTAs and encouraging the agency to deny applications for flavoured vaping products.

“We write to urge the U.S. Food and Drug Administration (FDA) to expedite decisions on the premarket tobacco product applications (PMTAs) still pending before the agency involving the flavored e-cigarette products, including those with menthol flavoring and, based on the best available scientific evidence, deny the pending applications for all non-tobacco flavored e-cigarettes in order to protect the nation’s young people from the health harms of these products,” said the letter, which was signed by the American Academy of Pediatrics, the American Heart Association, and the Campaign for Tobacco-Free Kids among others.

In response to the action by the groups, President of the American Vaping Association (AVA) Gregory Conley, highlighted that data has been showing that youth vaping has been declining and blasted anti-tobacco groups who “continue to push for a new drug war by amping up the moral panic around safer nicotine products.”

Read Further: Fox13

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