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Anti-tobacco groups appeal to FDA

21 Jan 2022. Several anti-tobacco groups have sent a letter to the FDA urging them to complete its reviews on outstanding applications e-cigarettes, reports Fox13.

The deadline for producers to hand in product applications to the US Food and Drug Administration (FDA) passed on 9 September 2020, yet the agency has yet to decide on all e-cigarette products allowed to remain on the market.

Several anti-tobacco groups including the American Academy of Pediatrics, the American Heart Association, and the Campaign for Tobacco-Free Kids have now sent a letter to the FDA pushing it to deny applications for flavoured e-cigarette products.

“We write to urge the US Food and Drug Administration (FDA) to expedite decisions on the premarket tobacco product applications (PMTAs) still pending before the agency involving the flavoured e-cigarette products, including those with menthol flavouring and, based on the best available scientific evidence, deny the pending applications for all non-tobacco flavoured e-cigarettes in order to protect the nation’s young people from the health harms of these products,” the letter stated, according to FOX13.

The FDA responded by saying, “The FDA has and continues to make significant progress on our comprehensive actions to protect the public, especially youth, from the harms of tobacco products and looks forward to continuing to work with the Administration to further these goals. When it comes to premarket review of tobacco products, an unprecedented number of products were the subject of applications submitted by the court-ordered September 9, 2020 deadline. Over the past year, the agency has taken final action on 99 per cent of the nearly 6.7 million products that were the subject of timely submitted e-cigarette applications. FDA has been devoting tremendous resources to the applications for the millions of products it has received. FDA continues to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review. The agency has around 55,000 products pending that are the subject of timely submitted PMTAs.”