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.
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.
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.
E-Cigarette manufacturers and distributors challenge the deeming rule under the Administrative Procedure Act (APA) and the First Amendment.
The Tobacco Control Act’s premarket authorization pathway does not violate the APA. Additionally, neither the pre-marketing authorization requirement applicable to modified risk products nor the free sample ban violate the First Amendment.
Jennifer Hochstatter v. John Arntz, Superior Ct. of State of Calif., County of San Francisco, No. CPF-19-516813 (2019)
The legal issue in this case is whether San Francisco’s ballot measure, Proposition C – supported by JUUL Labs and purportedly a youth access law – would allow flavored e-cigarettes back onto store shelves in San Francisco, overturning city laws passed in 2019 and 2017 that were intended to ban e-cigarettes not regulated by the FDA and to keep products like Juul’s mango and cucumber nicotine pods out of the hands of teens.
The legal issue in this case is whether the Town of Yarmouth’s multi-step review process based on smelling, tasting, and physically examining tobacco products, including “concept flavors” such as Jazz, meets the evidentiary standard required by law to identify these products as flavored.