Nicopure Labs, LLC v. FDA

944 F.3d 267 (2019)

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Nicopure Labs, LLC v. FDA

United States Court of Appeals for the District of Columbia Circuit
944 F.3d 267 (2019)

Facts

Under the Tobacco Control Act (the TCA), the Food and Drug Administration (FDA) (defendant) was required to conduct premarket review of all new tobacco products. The TCA required the FDA to deny permission to market any new tobacco product if the effects of the product on the population as a whole indicated that the product was not “appropriate for the protection of public health.” In 2016, acting under authority granted by the TCA, the FDA issued a rule deeming e-cigarettes (i.e., electronic nicotine-delivery systems, including e-cigs, e-hookahs, and vape pens) to be tobacco products for purposes of the TCA. The deeming rule meant that e-cigarettes would be subject to the TCA’s premarket-authorization requirements for new tobacco products. The FDA justified the deeming rule by citing evidence about e-cigarette usage and risks, including evidence that (1) nicotine is addictive and harmful, particularly for adolescent and young-adult users, (2) e-cigarette liquids and vapor also contain other risk-posing chemicals besides nicotine, (3) e-cigarette use is rising among middle-school and high-school students, (4) e-cigarettes do not stop people from smoking other traditional tobacco products, and (5) no scientific research exists about the long-term effects of e-cigarette usage. E-cigarette manufacturer Nicopure Labs, LLC and an e-cigarette industry group (collectively, the industry) (plaintiffs) challenged the FDA’s deeming rule in federal district court. The industry claimed that the FDA had violated the Administrative Procedure Act (APA) because the decision to subject e-cigarettes to the TCA’s premarket-authorization process for new tobacco products was impermissibly arbitrary. The industry asserted that e-cigarettes were less risky than traditional tobacco products, and, therefore, the FDA should have provided an easier premarket-authorization pathway for e-cigarettes. The parties cross-moved for summary judgment. The district court granted summary judgment in the FDA’s favor and sustained the FDA’s deeming rule in full. The court found that the FDA’s decision to subject e-cigarettes to the tobacco-product premarket-authorization process was supported by the evidence regarding nicotine’s risks for young users, among other things. The industry appealed. On appeal, the industry did not challenge the FDA’s decision to classify e-cigarettes as tobacco products for TCA purposes. Instead, the industry focused on whether the FDA had acted arbitrarily by imposing the TCA’s full premarket-authorization requirements for new tobacco products on e-cigarettes.

Rule of Law

Issue

Holding and Reasoning (Pillard, J.)

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