American Academy of Pediatrics, et al. v. U.S. Food & Drug Administration, et al.

The Campaign for Tobacco-Free Kids, in conjunction with other public health and medical organizations and several individual pediatricians, challenged the U.S. Food and Drug Administration (FDA) decision to allow e-cigarettes to remain on the market until 2022 before applying for FDA authorization and permitting products to remain on the market during review. The FDA also delayed the deadline for cigar manufacturers to file such applications until 2021. The court found that the FDA had exceeded its legal authority and the FDA’s delay had played a role in the skyrocketing youth use of e-cigarettes. The court gave the plaintiffs 14 days to submit additional briefing regarding a remedy and the FDA 14 days to respond.


American Academy of Pediatrics, et al. v. Food and Drug Administration, et al., No. PWG-18-883 (D. Md. 2019).

  • United States
  • May 15, 2019
  • U.S. District Court for the District of Maryland



  • American Academy of Pediatrics
  • American Cancer Society Cancer Action Network
  • American Heart Association
  • American Lung Association
  • Campaign for Tobacco-Free Kids
  • Dr. Cynthia Fishman, MD
  • Dr. David Myles, MD
  • Dr. Leah Brash, MD
  • Dr. Linda Goldstein, MD
  • Dr. Steven Hirsch, MD
  • Maryland Chapter of the American Academy of Pediatrics
  • Truth Initiative


  • Commissioner of Food and Drugs Scott Gottlieb
  • Secretary of Health and Human Services Alex M. Azar II
  • U.S. Department of Health and Human Services
  • U.S. Food and Drug Administration

Legislation Cited

Related Documents

Type of Litigation

Tobacco Control Topics


Substantive Issues


Type of Tobacco Product