July 14 (Reuters) – A coalition of public health organizations, pediatricians and parents sued the U.S. Food and Drug Administration on Tuesday, challenging a new policy that allow some manufacturers to sell vapes and nicotine without the legally required license.
The lawsuit, filed in U.S. District Court in Maryland, targets FDA guidance issued in May. The guidance states the agency would not prioritize enforcement against certain unauthorized e-cigarettes and nicotine pouch products if the companies have marketing applications under review.
• Plaintiffs include the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, Truth Initiative and Parents Against Vaping, along with a pediatrician and a parent whose children became addicted to nicotine after using flavored e-cigarettes.
• Plaintiffs argue the policy unlawfully allows products to remain on the market without the marketing authorization required under the Tobacco Control Act.
• The group also said the guidance could permit thousands of unauthorized products, including flavored e-cigarettes and nicotine pouches popular with young people, to be sold indefinitely.
• They also contend the FDA bypassed required public notice and comment procedures under the Administrative Procedure Act and failed to justify the policy shift.
• The lawsuit also challenges the FDA’s plan to publish a list of products it does not intend to prioritize for enforcement, arguing it would facilitate sales of unauthorized products.
• The case will be heard in the same Maryland court that struck down an earlier FDA policy in 2017 that had allowed many e-cigarettes to remain on the market without authorization.
• The FDA did not immediately respond to Reuters request for comment.
(Reporting by Sanskriti Shekhar in Bengaluru; Editing by Tasim Zahid)
Comments