African American Tobacco Control Leadership Council et al. v. U.S. Dept. of Human Services et al. (2020)
Public health groups sue the FDA over its failure to prohibit the sale of menthol cigarettes.
E-cigarette manufacturers and trade group challenged the deeming rule under the Administrative Procedure Act and on Constitutional grounds.
The legal issue in this case is whether the Tobacco Control Act preempts the County of San Diego's flavored tobacco product ordinance.
Cigar and pipe tobacco trade associations filed suit against the FDA, challenging the deeming rule as it applies to cigars and pipe tobacco. The suit is ongoing, but has resulted in a suspension of warning labels for cigars and pipe tobacco and the premarket review process specifically for premium cigars.
R. J. Reynolds Tobacco Company et al. v. U.S. Food & Drug Administration et al., No. 6:20-cv-00176 (E.D. Tex. 2020)
Shortly after the FDA issued its new graphic warning label rule in the March 18, 2020 Federal Register, R.J. Reynolds Tobacco Company and several other manufacturers, distributors, and retailers filed suit against the FDA in U.S. District Court for the Eastern District of Texas.
An e-cigarette manufacturer and trade association challenged the deeming rule on Constitutional grounds.
Public health groups sued the FDA to compel the agency to require graphic warning labels on cigarette packages and advertisements. The public health groups won. FDA appealed, but dropped the appeal after it issued a new graphic warning rule in March, 2020.
American Academy of Pediatrics et al., v. U.S. Food and Drug Administration et al., Nos. 19-2130, -2132, -2198 & -2242, U.S. Court of Appeals for Fourth Circuit (2018)
Public health groups successfully challenged FDA’s 2017 guidance indefinitely extending premarket review deadlines. FDA issued updated guidance reflecting an expedited schedule. The industry appealed, but the district court’s ruling was upheld by the Fourth Circuit Court of Appeals on May 4, 2020. Due to the COVID-19 pandemic, however, the deadline to submit premarket review applications was extended to September 9, 2020.
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