Supreme Court Ruling Opens Door For Vape Industry to Challenge the FDA
Supreme Court Rules E-Cigarette Sellers Can Challenge the FDA: What It Means for the Vape Industry
In a significant decision, the U.S. Supreme Court recently ruled that e-cigarette sellers and manufacturers have the right to challenge FDA decisions in court. This ruling emerged from a case involving R.J. Reynolds Vapor Company, which contested the FDA’s rejection of its marketing applications for flavored e-cigarette products.
Key Issue: Who Can Sue the FDA?
At the heart of the case was whether retailers, in addition to manufacturers, have standing to challenge Marketing Denial Orders (MDOs) issued by the FDA. The Supreme Court held that retailers who would otherwise sell a product—but for the FDA’s denial—do have legal standing to sue. This expands the pool of industry actors who can push back against regulatory decisions.
The Forum Shopping Question: Left Unresolved
The Court did not rule on the controversial issue of forum shopping—the practice of filing lawsuits in courts that are perceived to be more favorable to one’s case. R.J. Reynolds had filed its case in the Fifth Circuit Court of Appeals, a jurisdiction considered more industry-friendly. The federal government warned that allowing such choice could flood the system with strategically placed lawsuits.
Though the Court allowed R.J. Reynolds to proceed in the Fifth Circuit, it declined to decide whether forum shopping is appropriate in these FDA cases. That issue remains unresolved for now.
Background Context: Earlier Ruling on Flavored Vape Denials
Notably, the Supreme Court recently reversed a Fifth Circuit ruling that had struck down FDA marketing denial orders for flavored e-cigarettes. This shows that even with greater access to courts, vape companies still face steep challenges in overturning FDA decisions based on public health grounds.
Key Takeaways from the Ruling
1. E-Cigarette Companies Can Sue the FDA
Manufacturers and retailers now have clear legal authority to challenge FDA marketing denials and enforcement actions. This affirms their right to due process and access to judicial review.
2. Forum Shopping Remains a Gray Area
While the Court opened the door to lawsuits, it stopped short of deciding whether companies can freely choose the most favorable jurisdictions for those legal battles.
Implications for Vape Manufacturers and Vape Shops
PMTA Requirement Stands: All vape manufacturers must submit a Premarket Tobacco Product Application (PMTA) for any tobacco or nicotine product on the market. Products must remain under FDA review to be legally sold.
Scientific Burden Remains High: Each PMTA must provide compelling scientific evidence that the product is “appropriate for the protection of public health (APPH)”—a standard that is rigorous and often subjective in interpretation.
Opportunity Under New FDA Leadership: With the FDA now under the direction of Commissioner Dr. Makary, there is cautious optimism in the industry. Many believe that a more transparent, science-based, and balanced regulatory approach may emerge—potentially offering a fairer path to market authorization.
In Summary: A Mixed but Meaningful Victory
This Supreme Court decision empowers vape companies to defend their interests in court but does not guarantee success in challenging FDA rulings. The real test remains: providing robust, credible scientific data to support marketing applications.