The United States Food and Drug Administration and the United States Department of Health and Human Services, through the U.S. Justice Department, filed an appeal the decision of Judge Paul Grimm to the United States Court of Appeals for the Fourth Circuit in the case of American Academy of Pediatrics, et al. v. United States Food and Drug Administration, et al. On May 15, 2019, Judge Grimm found, in an opinion focused almost exclusively on e-cigarettes and recent increases in youth use of e-cigarettes, that the FDA lacked authority to delay compliance deadlines for the premarket review and substantial equivalence process.
Although the scope of Judge Grimm’s subsequent orders is unclear, some parties have argued that they may require substantial equivalence applications to be filed by May 2020. The Government’s appeal is an important step in bringing clarity to the appropriate compliance dates under the Rule and allowing the FDA to first complete its ongoing work to provide rules for the substantial equivalence process and to determine whether and how premium cigars should pass through that process.
The original lawsuit was filed on March 27, 2018, by 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.
FDA Appeal on Scribd
