Retailers who would sell certain R.J. Reynolds e-cigarette products were it not for the Food & Drug Administration‘s denial of the manufacturer’s requests for approval are entitled to judicial review of the agency’s denial order, the U.S. Supreme Court ruled 7-2 in affirming a decision from the 5th Circuit.
The case involves the Family Smoking Prevention & Tobacco Control Act‘s requirement that manufacturers receive approval from the FDA before marketing any “new tobacco product.” In 2016, the FDA decided that e-cigarettes and related products were subject to the TCA. Retailers challenged the FDA’s denial of R. J. Reynolds Vapor Co.’s application for continued marketing of its popular Vuse Alto products. The FDA found that RJR Vapor failed to demonstrate that marketing Vuse Alto products would be “appropriate for the protection of the public health” as required by under 28 U.S.C. §387j(c)(2)(A).
Click here to read the full text of the June 20 decision in Food & Drug Administration v. R.J. Reynolds Vapor Co.
- “Echoing the [Administrative Procedure Act], the TCA provides that ‘any person adversely affected by [the FDA’s] denial’ may petition for judicial review. The TCA’s cause of action thus extends to any petitioner ‘with an interest “arguably sought to be protected by the statute.”’ The retailers fit the bill. If the FDA denies an application, the retailers, like the manufacturer, lose the opportunity to profit from the sale of the new tobacco product — or, if they sell the product anyway, risk imprisonment and other sanctions. Given this significant, direct impact on retailers, their interests are not ‘so marginally related to or inconsistent with the purposes implicit in the statute that it cannot reasonably be assumed that Congress intended to permit the suit.’ Accordingly, the retailers are ‘adversely affected’ by a denial order and are therefore proper petitioners under [21 U.S.C.] §387l(a)(1).”
— Justice Amey Coney Barrett, opinion of the court
- “The statute at issue in this case requires tobacco manufacturers to receive permission from the Food and Drug Administration (FDA) before new tobacco products may be marketed or sold. 21 U. S. C. §387j. In deciding who falls within the zone of interest of that statute, the Court largely ignores this context. Instead, the Court directs all attention to the language of the statute’s cause of action — and then essentially nullifies the zone-of-interest test by reducing it to the near-meaningless proposition that anyone affected, or even arguably affected, by the FDA’s marketing denial can sue.
“The actual zone-of-interest inquiry, however, requires us to examine exactly whom Congress intended to protect under the relevant statutory provisions. And, here, all the usual tools of statutory interpretation point in the same direction: Congress established a detailed scheme for manufacturers to obtain authorization to market new tobacco products — a scheme within which retailers have no rights and play no role — and, in the context of that scheme, Congress provided a cause of action for the protection of the manufacturers’ statutorily created interests. Because nothing in this statute suggests that Congress meant to authorize retailers to sue to challenge the FDA’s denial of a manufacturer’s marketing application, much less bring that legal challenge in a venue that is otherwise unavailable, I respectfully dissent.”
— Justice Ketanji Brown Jackson, joined by Justice Sonia Sotomayor, dissenting
