Top Court Asked to Review Anti-FDA Ruling

The U.S. Department of Justice has asked the Supreme Court to review a lower court’s ruling rejecting the Food and Drug Administration’s reasoning in denying premarket tobacco product applications submitted by Wages and White Lion Investments.

According to the solicitor general, the 5th Circuit Court of Appeals relied upon “legal theories that have been rejected by other courts of appeals that have reviewed materially similar FDA denial orders.”

The federal government’s decision to seek Supreme Court review is unsurprising, according to Reason. However, the libertarian publication also notes that there is a circuit split on whether the FDA acted in an arbitrary and capricious fashion when it refused to consider certain materials submitted with PMTAs and departed from previous guidance it had given the industry. Most circuits to hear such claims turned them away, according to Reason.

The 5th Circuit (along with the 11th Circuit) did not. A Supreme Court review could help resolve the circuit split and remove any cloud over the FDA’s continuing ability to review (and deny) PMTAs for vaping products. Without Supreme Court review, vaping product manufacturers would be incentivized to seek review of any PMTA denials in the 5th and 11th Circuits, which could undermine the FDA’s regulatory authority.