E-CIGARETTE MANUFACTURERS FACED A DEADLINE TO SUBMIT THEIR PRODUCTS TO FDA FOR REVIEW AFTER OUR VICTORY IN COURT
On May 15, 2019, a federal judge ruled that the FDA unlawfully shirked its responsibility when delaying pre-market review of e-cigarettes. The judge ordered the agency to speed up its review of e-cigarettes. The FDA’s new deadline ultimately came on September 9, 2020 — years earlier than the FDA’s unlawfully-delayed deadline.
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 2017 U.S. Food and Drug Administration (FDA) guidance document that allowed 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 contended that the 2017 guidance left tobacco products that appeal to kids on the market, deprived the FDA and the public of critical information about the health impact of products already on the market, and relieved manufacturers of the burden to produce scientific evidence that their products have a public health benefit.
In August 2016, the FDA 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 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 argued that the FDA’s lengthy delay of product review deadlines exceeded the agency’s authority under the Family Smoking Prevention and Tobacco Control Act (the 2009 law that established FDA oversight of tobacco products) and was arbitrary and capricious. It also contended that the FDA’s decision violated 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 stated.
On May 15, 2019, a federal judge ruled that the FDA unlawfully shirked its responsibility when delaying pre-market review of e-cigarettes. The judge ordered the agency to speed up its review of e-cigarettes. E-cigarette manufacturers were required to submit applications for pre-market review of their products to the FDA by September 9, 2020, in order to receive permission to keep their products on shelves across the U.S.
After our clients’ victory, industry lobbyists engaged in a year-long campaign to overturn the victory, filing numerous motions and appeals to reverse or stay the district court’s judgment. We successfully defended against that last-ditch effort, obtaining affirmance of the district court’s rulings and dismissal of the appeals in the U.S. Court of Appeals for the Fourth Circuit.
In the news
Public health groups are challenging the FDA’s decision to delay e-cigarette regulation
CNBC / March 27, 2018
FDA sued for delaying e-cigarette, cigar regulations
The Washington Post / March 27, 2018
Judge orders FDA to speed up review of e-cigarettes
Associated Press / May 15, 2019
Ruling turns up pressure for FDA to strictly regulate e-cigarettes
CNN / May 16, 2019
Millions of Applications Could Hit FDA as E-Cig Deadline Arrives
Bloomberg / September 9, 2020
- American Academy of Pediatrics v. FDA (PDF / 1 MB)
- Plaintiffs' Motion for Summary Judgment (PDF / 407 KB)
- Plaintiffs’ Reply in Support of Summary Judgment and Supporting Declarations (PDF / 9 MB)
- District Court Memorandum Opinion (05/15/19) (PDF / 262 KB)
- District Court Injunction Opinion and Order (7/12/19) (PDF / 92 KB)
- Appellee’s Brief (02/20/20) (PDF / 475 KB)
- Fourth Circuit Court of Appeals Opinion (05/04/20) (PDF / 68 KB)
Jeffrey DubnerDeputy Legal Director
Litigating challenges to unlawful actions, abuses of power, and threats to democracy on behalf of those who are harmed.Read the Bio