Case Study

American Academy of Pediatrics, et al. v. Food and Drug Administration

The American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and five individual pediatricians filed suit in federal court in Maryland challenging a U.S. Food and Drug Administration (FDA) decision that allows electronic cigarettes and cigars – including candy-flavored products that appeal to kids – to stay on the market for years without being reviewed by the agency.

The lawsuit contends that the FDA’s decision leaves on the market tobacco products that appeal to kids, deprives the FDA and the public of critical information about the health impact of products already on the market, and relieves manufacturers of the burden to produce scientific evidence that their products have a public health benefit.

The FDA in August 2016 implemented a new rule (known as the “deeming rule”) extending its jurisdiction to e-cigarettes, cigars and other previously unregulated tobacco products. However, in August 2017, the FDA delayed a key provision of the rule that required manufacturers of products then on the market to provide critical information to the FDA about each product and undergo an FDA review of the product’s impact on public health, including whether it appeals to kids. The FDA delayed the deadline for filing applications until August 2021 for cigars and other newly-regulated combustible products and until August 2022 for e-cigarettes. The FDA has also said that these products will remain on the market indefinitely during the review process and did not set a deadline for completing its review.

The health groups’ lawsuit contends that the FDA’s lengthy delay of product review deadlines exceeds the agency’s authority under the Family Smoking Prevention and Tobacco Control Act (the 2009 law that established FDA oversight of tobacco products). It also contends that the FDA’s decision violates the Administrative Procedure Act because the FDA did not give the public an opportunity to comment on the change and did not articulate an adequate factual basis for this radical change from the deadlines the FDA itself established in the deeming rule.

The FDA “offered no meaningful justification for ripping a hole in the statutory framework by exempting, for more than half a decade, newly deemed products from premarket review – review FDA previously described as ‘central’ to the regulatory scheme Congress enacted for tobacco products,” the lawsuit states.

 

 

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