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FDA sued for allowing unauthorised vaping products

The US Food & Drug Administration (FDA) is being sued by a group comprising public health organisations, paediatricians and parents, who are challenging its new policy permitting some manufacturers to sell vapes and nicotine without the legally required licence, reports Reuters.

The lawsuit targets FDA guidance issued in May which stated that the agency would not prioritise enforcement against certain unauthorised e-cigarettes and nicotine pouch products if the companies have marketing applications under review.

The plaintiffs include the Campaign for Tobacco-Free Kids, the American Academy of Paediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, Truth Initiative and Parents Against Vaping, along with a paediatrician and a parent whose children became addicted to nicotine after using flavoured e-cigarettes.

They argue that the policy unlawfully allows products to remain on the market without the marketing authorisation required under the Tobacco Control Act, and will allow the indefinite sale of thousands of unauthorised products.

The case will be heard in the same Maryland court that struck down an FDA ⁠policy in 2017 that had allowed many e-cigarettes to remain on the market without authorisation.

 

Reuters article – US FDA sued for allowing unauthorised vaping products (Open access)

 

See more from MedicalBrief archives:

 

Supreme Court rules for FDA in flavoured vapes dispute

 

FDA defends denial of flavoured vapes in legal tussle

 

Ban flavoured vapes, says EU as as e-cigarette use rises

 

Confusion clouds FDA’s approach to e-cigarettes – POLITICO analysis

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