PMTA extension annulled

PMTA extension annulled

May 16, 2019

U.S. Judge Paul Grimm has ordered the Food and Drug Administration (FDA) to begin reviewing thousands of e-cigarettes on the U.S. market

According to Grimm, the FDA exceeded its authority when the agency in August 2017 extended the premarket tobacco application (PMTA) deadline for e-cigarettes to August 2022. The decision removes the extension granted to the industry, and essentially renders all e-cigarettes on the market illegal.

The FDA has said that both staff and manufacturers need more time to prepare for regulation.

The American Academy of Pediatrics, Campaign for Tobacco-Free Kids and other groups filed a federal lawsuit contesting the deadline extension in Maryland last year. The groups say the lack of FDA oversight has led to an explosion in underage vaping by teenagers, threatening to hook a generation of Americans on nicotine.

“It is now the FDA’s responsibility to take immediate action to protect our kids and require manufacturers to apply to the FDA if they want to keep their products on the market,” the groups said in a statement.

Grimm called the FDA’s delay “so extreme as to amount to an abdication of its statutory responsibilities.”

FDA spokesman Michael Felberbaum said in an emailed statement that the agency is reviewing the court decision and “will continue to tackle the troubling epidemic of e-cigarette use among kids.”

The court ordered plaintiffs to suggest a solution to the FDA within the next two weeks. The FDA will have the option of appealing the decision.

Category: Breaking News

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