Opinion ID: 768530
Heading Depth: 3
Heading Rank: 4

Heading: Pragmatic Concerns

Text: 28 In arguing that the arbitrary and capricious standard of review does not apply, Snoring Relief implicitly suggests that the district court should have reviewed FDA's decision de novo. Snoring Relief contends that as a defense to the seizure action, it has the burden of proving by a preponderance of the evidence that it was exempt from FDA regulations. This argument, however, conflates the standard of review with the burden of proof. The arbitrary and capricious standard of review cannot be replaced by the preponderance of the evidence burden of proof. What Snoring Relief really wants is for the district court (and this court) to review FDA's decision de novo. But, as the government said, the issue is an agency decision not to exercise its enforcement discretion to waive the premarket notification requirement for SnorBan. FDA is entitled to decide how to exercise its discretion, and the Court only reviews that decision under the arbitrary and capricious standard. We agree. As a practical matter, Snoring Relief's argument is unpersuasive. Agency decisions, even if accompanied by a seizure action, should be reviewed under the arbitrary and capricious standard.