Regenative Labs sues FDA for unlawfully delaying export license for stem cell therapies

An American biotech company specializing in stem cell 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 regulatory issue inherited from its predecessor.

Lawsuit Filed Against FDA

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

Company Background

• Location: Florida-based
• Product: Stem cell jellies harvested from donated umbilical cords, marketed as treatments for injured tendons and other connective tissues
• Regulatory status: Lawfully operating in the U.S. market and registered with the FDA since 2020

The company seeks to expand overseas and grow its American workforce but has been unable to do so due to what it describes as a "bizarre regulatory limbo" imposed by the FDA.

Regulatory Delays

According to the complaint:

• Regenative Labs 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 the latest application, the FDA cited issues raised in a 2023 warning letter. In that letter, the agency suggested that Regenative's products might need to be regulated as drugs rather than as human cell and tissue products (HCT/Ps).

Broader Regulatory Uncertainty

Around the same time, the FDA sent similar letters to other stem cell therapy companies, raising the possibility that their products could be reclassified as drugs—a change that would trigger additional testing and approval requirements.

In the years since, the FDA has not officially changed its policy toward stem cell therapy. However, it has used the possibility of such a change to delay 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 stem cell treatment market
• 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

The lawsuit raises a fundamental question: *Can the FDA arbitrarily block an American company from operating overseas because it might change how it regulates that company's products in the future?*

A related question—whether Regenative's products are drugs or HCT/Ps—remains unresolved. Last year, the Supreme Court declined to review a case in which the FDA had determined that stem cell products were drugs.

Political Context

While Regenative Labs seeks a legal remedy, the lawsuit may also be seen as an effort to bring the issue before the Trump administration, which now has a chance to address a regulatory problem that emerged under the Biden administration. The case presents an opportunity for the Trump-era FDA to provide regulatory certainty to a small American business seeking to expand.

Regardless of the outcome, the FDA's handling of Regenative Labs' application has been widely criticized as unacceptable. American businesses should not face indefinite delays while regulators decide what rules they might apply in the future.