Summary
The United States Court of Appeals for the Fifth Circuit denied a petition for review challenging the FDA's refusal to approve premarket tobacco product applications for open-system electronic nicotine delivery systems. The court concluded that the FDA's denial was neither arbitrary nor capricious under the Administrative Procedure Act, as the agency properly weighed public health risks related to abuse liability and labeling comprehension. Furthermore, the court upheld the FDA's policy shift to issuing a single deficiency letter, finding the change was adequately reasoned and did not violate administrative law principles.
Topics
Practice areas
Questions Presented
- Whether FDA's denial based on the abuse‑liability deficiency was arbitrary and capricious.
- Whether FDA's change‑in‑position to issue only a single deficiency letter was arbitrary and capricious.
- Whether FDA's differential treatment of IVPS compared to similarly situated applicants violated the “like cases alike” principle.
Holdings
- The denial was not arbitrary and capricious; the petition is denied.
- The change‑in‑position was not arbitrary and capricious; FDA adequately explained the policy shift.
- The differential treatment was not arbitrary and capricious; FDA provided a permissible distinction between PMTA and substantial‑equivalence pathways.
Key quotations
“We hold FDA’s denial based on the abuse liability deficiency was not “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.””
Factual background
IVPS submitted PMTA applications for six open‑system ENDS devices. FDA issued a deficiency letter identifying three deficiencies, including insufficient abuse‑liability data. IVPS responded but did not provide label‑comprehension studies. FDA denied the applications, finding the products were not appropriate for the protection of public health.
Procedural history
IVPS filed PMTA applications for six open‑system ENDS devices. FDA issued a deficiency letter, IVPS responded, and FDA denied the applications for lack of abuse‑liability data and label‑comprehension studies. IVPS filed a petition for review in the Fifth Circuit.