FDA prohibits a form of artificial insemination, attempts to define relationships

WASHINGTON – Cause of Action, a nonpartisan nonprofit based in Washington, DC, filed a lawsuit today in the U.S. District Court of Northern California on behalf of a Bay-Area woman whose plans to start a family have been blocked by overregulation by the Food and Drug Administration (FDA).

Citing FDA regulations on sperm donation, Cause of Action states that the plaintiff’s ability to become pregnant through the means of her choice has been directly affected. Cause of Action argues that the right to procreate is fundamental and one that cannot be regulated by a government agency.

“We don’t think the FDA’s intentions are bad—they are trying to protect the public from communicable diseases—but this is literally stepping between two people who have agreed to have a child; the FDA should not regulate that,” said Cause of Action’s Chief Counsel for Regulatory Affairs Amber Abbasi.

Abbasi explains in Cause of Action’s complaint that the plaintiff wants to conceive a child by means of artificial insemination without a medical intermediary such as a donor bank, but is prohibited from doing so by FDA regulations.

Federal regulations set standards for manufacturing and distributing human cells, tissues, and tissue-based products, but they treat noncommercial, individual actors the same as commercial establishments, making any individual a potential human cells, tissue, and tissue-based product producer. Once an individual is labeled as a manufacturer, he is subject to the same regulatory standards as sperm banks. The FDA does exempt people engaged in sexually intimate relationships from the standard, but it is with the government’s attempt to define “relationship” that Abbasi and Cause of Action take the most issue.

“Essentially, the FDA is trying to define a personal relationship and regulate individuals’ intimate decisions,” said Abbasi. “These actions grossly exceed the reach of the FDA’s regulatory authority. If unchecked, it could set a dangerous precedent for the future.”

The lawsuit asks the federal district court to declare the FDA’s regulatory overreach unconstitutional, which will allow the plaintiff to start a family as she desires.

“This case really highlights how arbitrary regulations can take away freedom,” said Dan Epstein, executive director of Cause of Action. “Cause of Action is committed to exposing instances like these where the government is threatening freedom with rogue regulations.”

About Cause of Action:

Cause of Action is a non-partisan, non-profit organization that uses public advocacy and legal reform tools to ensure greater transparency in government, protect taxpayer interests and promote economic freedom. For more information, visit

To schedule an interview with Amber Abbasi, Cause of Action’s Chief Counsel for Regulatory Affairs, contact Mary Beth Hutchins or Briton Bennett at 202-507-5880.