FDA Official Says Tobacco Product Reviews Are in ‘Final Stages’

(Bloomberg) — The U.S. Food and Drug Administration is close to wrapping up a sweeping review of tobacco products sold in the U.S., though it faces a round of lawsuits challenging actions it has taken. 

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“Many of the reviews are in final stages,” said Mitch Zeller, director of the agency’s Center for Tobacco Products, speaking at a virtual conference hosted by the Food and Drug Law Institute Wednesday. Zeller said the agency has already refused to allow 200,000 products to continue being sold, has authorized only three, and has around 80,000 products pending. The FDA is being sued for 46 of the refusals. 

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Zeller said that some companies seek to circumvent FDA authority by using synthetic nicotine. This complicates the agency’s efforts because the FDA has authority to regulate tobacco products, but regulations are hazier when it comes to synthetic nicotine. It’s getting harder to tell the lab-made nicotine from the plant-derived version of it, and the agency is investigating the issue, Zeller said, adding that the FDA is talking to Congress about a potential legislative fix.

See also: BAT’s Vuse gets FDA nod amid broad review of e-cigarettes

The agency has yet to issue pronouncements on popular vape products from Juul Labs Inc. or make clear its stance on menthol in e-cigarettes. Zeller said Wednesday that the agency’s denial of BAT’s flavored products hadn’t gotten as much attention as the approvals, and said the agency will continue to review menthol products on a case-by-case basis. 

The FDA plans to prohibit menthol in cigarettes and cigars. 

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