Regenative Labs sues FDA over nearly 3-year delay in export license

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 Filed Against FDA

Regenative Labs filed a lawsuit in federal district court on Thursday, alleging that the FDA has "unlawfully withheld" a certificate that signals to foreign governments that the company's products meet U.S. regulatory standards. This certificate is a crucial step for selling American-made medical technology abroad.

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

The Regulatory Stalemate

Regenative Labs seeks to expand its market overseas and grow its American workforce—a goal it would likely have achieved already, if not for what it describes as a "bizarre regulatory limbo" imposed by the FDA.

Key details from the complaint:

• The company has made multiple attempts to obtain a Certificate to Foreign Governments (CFG)
• The FDA has refused to review these applications
• 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 the latest application, the FDA cited issues 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 (HCT/Ps) —a distinct category of health products.

Around the same time, the FDA sent similar letters to several birth tissue therapy companies, indicating their products might also face reclassification as drugs. Such a change would trigger additional testing and approval requirements.

Impact on the Company

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

The complaint argues that the FDA's refusal has caused material harm:

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

The FDA's handling of the matter is described in the lawsuit 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 someday change how it regulates that company's products?*

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 outcome, the lawsuit may be best understood as an effort to bring the issue before the Trump administration. The new administration now has an opportunity to address what the company calls a "mess" created during the Biden administration—and to 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.