Regenative Labs sues FDA over three-year delay in issuing export certificate

An American biotech company specializing in human tissue therapy has been waiting nearly three years for the Food and Drug Administration (FDA) to process an application to sell its products overseas. Now, the company is turning to federal court—and giving the Trump administration an opportunity to resolve a situation inherited from its predecessor.

Lawsuit Alleges Unlawful Delay

Regenative Labs filed a lawsuit in federal district court on Thursday, alleging that the FDA has "unlawfully withheld" a Certificate to Foreign Governments (CFG). This certificate signals to foreign regulators that a company's products meet U.S. standards—a critical step for exporting American-made medical technology.

The Florida-based company's products already meet U.S. requirements. Regenative Labs has been lawfully operating in the American market and has been registered with the FDA since 2020. The company harvests tissue cells from donated umbilical cords to produce jellies used for repairing injured tendons and other connective tissues.

Repeated Applications, No Response

Regenative Labs wants to expand internationally and grow its U.S. workforce. It likely would have done so already, but for what it describes as a "bizarre regulatory limbo" imposed by the FDA.

According to the complaint:

• The company has submitted multiple CFG applications
• The FDA has refused to review any of them
• Federal law requires the FDA to process such applications within 20 days
• More than 10 months have passed since the company's most recent application

In response to that latest application, the FDA cited concerns raised in a 2023 letter. That letter suggested Regenative's products might need to be regulated as drugs rather than as human cell and tissue products (known as "HCT/Ps").

Broader Regulatory Uncertainty

Around the same time, the FDA sent similar letters to several birth tissue therapy companies, warning that their products might also require drug classification—a change that would trigger additional testing and approvals.

In the years since, the FDA has not officially changed its policy on human tissue therapy. However, it has used the possibility of such a change to block Regenative Labs' CFG application.

Harm to the Company

In its complaint, Regenative Labs argues that the FDA's inaction has caused material harm:

• The company has fallen behind in the global market for human tissue therapies
• It remains in a state of "regulatory purgatory" with no clear path forward

The complaint describes the FDA's handling of the matter as "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law."

Core Legal Questions

At its heart, the lawsuit raises a straightforward question: Can the FDA arbitrarily prevent an American company from operating overseas because it might change how it regulates that company's products in the future?

A second, underlying question—whether Regenative Labs' products are drugs or HCT/Ps—remains unresolved. Last year, the Supreme Court declined to review a case in which the FDA determined that products made from human tissue cells were drugs.

A Call for Administrative Action

While Regenative Labs seeks a legal remedy, the lawsuit may also be understood as an effort to bring the issue before the Trump administration. The company hopes the new administration will fix what it calls a "mess" created during the Biden era, and provide regulatory certainty to an American small business trying to expand.

Regardless of the outcome, the FDA's handling of Regenative Labs' application has been unacceptable. American businesses should not face endless delays while regulators decide what rules they might apply tomorrow.

CORRECTION: This article has been updated to clarify that Regenative Labs is involved in human tissue therapy using material drawn from umbilical cords.