By Timothy S. Donahue
Top Takeaways:
- Rule or review standard? Judges repeatedly questioned whether FDA’s comparative-efficacy requirement functions as a rule requiring notice-and-comment rulemaking.
- FDA defends PMTA process: Government attorneys argued the agency was simply applying the Tobacco Control Act’s public-health standard through adjudications.
- Glas authorization enters debate: FDA pointed to recently authorized Glas products as evidence that flavored products are not categorically barred.
On June 11, a United States Court of Appeals for the Ninth Circuit panel sharply questioned attorneys from both the U.S. Food and Drug Administration and industry during oral arguments in MH Global LSC v. FDA, a case challenging the agency’s use of its comparative-efficacy standard to deny applications for flavored vaping products.
The central issue is whether the FDA effectively created a new rule requiring flavored vaping products to demonstrate benefits beyond those of tobacco-flavored products without first conducting notice-and-comment rulemaking.
Representing MH Global, attorney Eric Heyer argued that the FDA adopted the standard through an August 2021 internal memorandum and then applied it across the board to flavored PMTAs. “FDA adopted this standard in the abstract,” Heyer told the court, adding that the agency copied the same rationale “word for word” into flavored-product denial reviews.
One judge repeatedly pressed both sides on the distinction between rulemaking and evidentiary standards developed through case-by-case review. FDA attorney Joshua Koppel countered that the agency never issued a rule and instead applied the Tobacco Control Act’s public-health standard on a case-by-case basis to applications.
“FDA was permitted to proceed by adjudication and figure out how the TCA public health standard applies to flavored e-cigarettes as it works through the applications,” Koppel argued.
The hearing also featured one of the first appellate discussions of FDA’s recent authorization of Glas flavored products. Koppel cited the Glas orders as evidence that flavored products are not automatically denied, telling the court that Glas reduced youth-access risks through age-restriction technology.
The panel did not indicate when it would rule.
