SCOTUS sides with vape company in case against FDA

The Supreme Court issued a 7-2 ruling Friday that will allow tobacco giant R.J. Reynolds to continue fighting a product rejection issued by the Food and Drug Administration. The FDA in early 2023 rejected Reynolds’ application to market a new tobacco product. Reynolds appealed the rejection, but the FDA’s attorneys argued the appeal was filed in the wrong court. The 7-2 ruling allows Reynolds’ appeal to move forward in the 5th Circuit, setting a new precedent for parties appealing FDA product rejections.

How does the appeal process work for such products? According to the 2009 Family Smoking Prevention and Tobacco Control Act, any person adversely affected by an FDA’s marketing denial may file a petition for judicial review. Individuals may appeal FDA decisions to the United States Court of Appeals for the District of Columbia, or in the circuit where the company resides or does its primary business, according to the 2009 statute.

How did this case reach the highest court in the land? Reynolds, a North Carolina-based company, opted to appeal the decision to the 5th U.S. Circuit Court of Appeals in New Orleans. Each of Reynold’s petitions filed in the 5th was joined by retailers from North Carolina, Texas, and Mississippi that sell Reynold’s products. Reynolds should have petitioned the District of Columbia Circuit or the 4th U.S. Circuit Court of Appeals, which rules over North Carolina, for its appeal, according to the FDA. However, those two circuits issued previously ruled on similar cases in a way adverse to Reynolds’ arguments, according to the FDA’s SCOTUS appeal.

The FDA argued that Reynolds joined with retailers in other states to have its appeal moved to a more favorable setting. Federal prosecutors petitioned the nine-justice panel to decide whether a product manufacturer may file an appeal in a circuit court where it neither resides nor does its primary business, so long as it is joined by a regional seller of its product. The FDA requested that the court dismiss the joint petition for improper venue or transfer the case to either the District of Columbia Circuit or the 4th Circuit.

How did the court rule? Justice Amy Coney Barrett penned the ruling opinion, joined by Chief Justice John Roberts and Justices Clarence Thomas, Samuel Alito, Elena Kagan, Neil Gorsuch, and Brett Kavanaugh. The FDA attempted to ratchet up the standard for those considered adversely affected by the FDA’s rejection, insinuating that the only person aggrieved by the application denial could be the applicant, Barrett wrote. But retailers easily fit the bill for a party adversely affected by an FDA rejection because they lose out on sales profits on a new product, she explained. Barrett argued that if Congress intended for only applicants to appeal FDA product rejections, the language of the 2009 statute would have specified that. However, the law allows any person adversely affected by the rejection to appeal it, not just the product producer, she added.

What was the dissenting opinion? Justice Ketanji Brown Jackson penned a dissenting opinion, joined by Justice Sonia Sotomayor. The court’s majority focused too heavily on the language of the law rather than its original intent with the zone of interest statute, according to the dissent. Under the 2009 law, Congress established a detailed method for manufacturers to obtain authorization to market new tobacco products, a method in which retailers play no role, Jackson argued. In the context of the appeals route laid out in the law, Congress provided a cause of action to protect manufacturers’ statutorily created interests, the dissent continued. Nothing in the law suggested that Congress meant to allow retailers to challenge FDA denials, much less bring that legal challenge to a venue outside the courts identified in the statute, Jackson added.

Dig deeper: Read Leah Savas’ report on previous arguments before SCOTUS about the FDA loosening safety precautions for the abortion drug mifepristone.