Students for Life of America, a national pro-life advocacy group, has formally notified the U.S. Food and Drug Administration of its intent to sue, alleging the agency violated the Endangered Species Act by failing to address environmental risks from the abortion pill mifepristone. The group’s letter, sent Thursday to top federal health officials, gives the FDA 60 days to pull mifepristone from the market and initiate a review under the Act.

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The dispute centers on claims that pharmaceutical waste from mifepristone, used in chemical abortions, is contaminating U.S. waterways and may threaten endangered species, raising legal and environmental stakes for the FDA’s regulation of the drug.

The move follows months of pressure from Students for Life of America (SFLA), which in July announced a peer-reviewed study published in Issues in Law & Medicine that found significant levels of mifepristone in water samples from three U.S. cities, including some tap water. The group argues that the FDA failed to consult with wildlife agencies as required under Section 7 of the Endangered Species Act when approving mifepristone and establishing its Risk Evaluation and Mitigation Strategy (REMS).

According to the Issues in Law & Medicine study cited by SFLA, researchers detected anti-progesterone activity consistent with mifepristone in eight out of nine water sampling classes collected in Austin, Texas; Blacksburg, Virginia; and Carbondale, Illinois. Concentrations reached up to 0.041 micrograms per liter, and the study concluded that conventional water treatment did not reliably remove the contaminant.

SFLA’s letter states that animals protected under the Endangered Species Act, such as the Balcones spike, Texas fawnsfoot, fatmucket, and pimpleback freshwater mussels, are particularly vulnerable to chemical pollution from wastewater effluent. The group claims that more than 50 tons of blood and placental tissue contaminated with mifepristone are expelled into U.S. waterways each year as a result of federal policy.

"As a result of federal policy, more than 50 tons of chemically tainted blood and placenta tissue, along with human remains and waste, go into our waterway each year. Hospitals and outpatient medical facilities can’t flush pathological medical waste."

— Kristi Hamrick, Students for Life of America vice president of media and policy

SFLA vice president Kristi Hamrick told the Daily Signal that the FDA’s compliance forms show Endangered Species Act review is a regular checkpoint, and argued that the agency’s failure to conduct such a review is a serious legal lapse. "A short letter from the FDA claiming that the law does not apply will not cut it, legally or practically. The ESA is a serious law and we have serious concerns," Hamrick said.

Scope of Alleged Impact

The group’s letter, addressed to Health and Human Services Secretary Robert F. Kennedy Jr., acting FDA Commissioner Kyle Diamantas, and acting Center for Drug Evaluation and Research Director Michael Davis, asserts that endangered or threatened species exist in all 50 states and that a progesterone blocker like mifepristone could affect more than 1,500 protected species. SFLA said it named some of these species in its notice and circulated a broader list to state attorneys general.

Hamrick emphasized that the risk to endangered species should be a concern regardless of one’s stance on abortion. "You don’t have to be pro-life to want clean drinking water. And you don’t have to be pro-life to want endangered species to be protected," she said.

FDA Response and Next Steps

The letter gives the FDA 60 days to resolve the alleged violations by pulling mifepristone from the market and beginning an Endangered Species Act review. If the agency does not act, SFLA says it will pursue litigation. The FDA and other named officials have not publicly responded to the notice or addressed the group’s claims regarding environmental risk and endangered species.

SFLA’s action comes amid ongoing national debate over the regulation of abortion drugs and their broader impacts. The group maintains that, under the law, it only needs to show risk—not proven harm—to endangered species to trigger federal review.