Students for Life of America has formally threatened to sue the Food and Drug Administration, accusing the agency of neglecting required environmental testing of mifepristone and failing to address potential risks to waterways and wildlife.

The organization, which opposes abortion, filed a notice of intent to sue the FDA on Thursday. The action came hours before Dr. Heidi Overton was scheduled to appear before the Senate for her confirmation hearing to lead the agency.

The notice focuses on the FDA’s approval of mifepristone in 2000. Students for Life of America argues that the agency never consulted two wildlife protection agencies about potentially harmful effects on federally protected species.

The group says that failure violated the Endangered Species Act. Its allegations center on the FDA’s lack of consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service before approving the drug.

“We expect these environmental concerns to be taken seriously. I know Dr. Overton is aware of these concerns. Or we expect to see the Trump FDA in court. That's where this will end,” SFLA President Kristan Hawkins told Fox News Digital on Wednesday.

Hawkins said the FDA has 60 days to respond to the notice before the organization files a lawsuit. Before sending the notice, the group had submitted 11 citizen petitions urging the agency to act.

The FDA rejected the group’s legal argument in a response to one of those petitions on Jan. 15, 2025. That response came five days before President Donald Trump began his second term.

The agency said it was not required to consult the U.S. Fish and Wildlife Service or the National Marine Fisheries Service before approving mifepristone. Students for Life of America is now challenging that position through its threatened legal action.

The notice cites six studies as part of its environmental argument. Four of those studies did not examine whether mifepristone itself was present in environmental water samples.

One cited paper, recently published in Issues in Law & Medicine, reported anti-progesterone activity in water samples collected from three U.S. cities. Students for Life of America argues that the findings support additional federal review of the drug’s environmental effects.

Mifepristone blocks progesterone receptors, preventing the hormone needed to sustain a pregnancy from performing its function. The organization contends that evidence of substances blocking progesterone suggests mifepristone has entered the U.S. water supply.

The study did not directly detect mifepristone in the sampled water. Instead, researchers looked for signs of substances that block progesterone and acknowledged that another compound could have produced the same result.

Directly confirming that mifepristone was present would generally require an analytical chemistry technique capable of identifying the substance itself. That distinction limits what the reported water findings can establish about the drug.

Hawkins has also raised questions about where the remains from abortions involving medication ultimately go. She cited an estimated 600,000 to 700,000 abortions annually involving chemical abortion pills and noted that these abortions occur outside medical facilities.

She said the organization’s legal position does not depend on any single study. Instead, Hawkins said the notice “rests on the failure of the FDA in 2000 to literally follow the law.”

Hawkins framed clean drinking water as an issue that could attract support from people with conflicting views on abortion. She said that message has resonated with students who disagree with her organization’s opposition to abortion.

Students for Life of America maintains a significant college presence, with 1,575 active student groups across nearly half of traditional four year universities in America. Hawkins said the group is using the leadership transition at the FDA to remind the agency of its responsibilities.

Overton, the deputy director of the White House Domestic Policy Council, was set to appear before the Senate as part of the confirmation process. Hawkins wants the threatened lawsuit to be among the first matters awaiting Overton if she is confirmed to lead the FDA.

“And we want to be very clear that when she gets to her desk, when she gets confirmed, and she sits down, the first thing she sees on her desk is our notice to intent to sue,” Hawkins said.