FDA v. R.J. Reynolds Vapor Co.

Under the State Farm arbitrary and capricious standard, the FDA must articulate a rational basis for its balancing of competing public health interests and respond meaningfully to significant evidence presented by the applicant. R.J. Reynolds argued that the FDA's denial failed this test by either ignoring or inadequately addressing the company's evidence regarding adult smoking cessation benefits—evidence the FDA had specifically requested as part of its information-gathering process. The court examined whether the FDA's public health framework—weighing youth initiation risk against adult smoking cessation benefits—was applied consistently across applications or whether the agency had shifted its criteria in ways that rendered R.J. Reynolds' denial arbitrary. Ultimately, the case turns on whether an agency applying a discretionary balancing test can deny an application while omitting reasoned discussion of factual evidence directly supporting one side of that balance.