Ottesen v. Hi-Tech Pharmaceuticals, Inc.

Background

The case concerns the alleged use of DMHA in supplements manufactured, distributed, and sold by Hi-Tech Pharmaceuticals, Inc. In 2020, the court stayed the case on primary-jurisdiction grounds. Primary jurisdiction is a doctrine allowing a court to pause a case when an agency’s determination may help resolve an issue within the agency’s expertise. The stay was pending a Food and Drug Administration determination about DMHA’s classification.

At the time of the original stay, the FDA had issued warning letters and a public statement saying that DMHA was either a new dietary ingredient for which the FDA had not received the required notification or an unsafe food additive, and that supplements containing DMHA were adulterated. But the FDA had also stated in related litigation that its warning-letter statements were tentative and interlocutory, had not consummated its decision-making, and were not final and binding.

Motion to Lift the Stay

On August 15, 2023, the plaintiffs moved to lift the stay. They relied on an FDA webpage last updated March 6, 2023. The webpage stated that, after further research and consideration, the FDA had concluded that DMHA was an unsafe food additive and that it still considered supplements containing DMHA adulterated under the Federal Food, Drug, and Cosmetic Act.

Hi-Tech argued that the plaintiffs had failed to notify the court within seven days of the webpage update, as the stay order required for a final FDA determination. The court also noted legislative history indicating that, if the FDA sought to declare a dietary supplement adulterated, it would publish a notice in the Federal Register proposing that action and explaining the basis for its position. That process had not occurred.

Ruling

The court nonetheless concluded that there was no longer a basis for the stay. It found that the FDA webpage’s language did not appear tentative and that, unlike the earlier record, there was no indication that the FDA’s decision-making remained ongoing. The court compared the situation to a Ninth Circuit case in which a stay was denied because the FDA had issued warning letters and there was no indication that the agency was considering authorizing the conduct at issue or backing away from its determination.

The court granted the plaintiffs’ motion to lift the stay. It ordered the parties to appear for a case management conference on November 7, 2023, at 2:00 p.m., and to file a joint case management statement seven days before the conference. This order addressed whether the case should remain paused; it did not decide the underlying claims about DMHA.