News
Regenative Labs Files Federal Complaint, Seeking Export Certificate
Jul 17, 2026
PENSACOLA, Fla., July 17, 2026 — Regenative Labs (Regenative), an American-owned and operated biotechnology company headquartered in Pensacola, today filed a complaint in federal court asking the U.S. Food and Drug Administration (FDA) to grant the company a Certificate to Foreign Government (CFG), which would enable the company to export its products overseas.
Founded in 2019, Regenative manufactures products from donated human birth tissue that are used in a homologous fashion — serving the same basic function as they did in the donor — to provide cushioning and structural support to patients directly at the site of a defect. The company’s products are ethically sourced from umbilical cord tissue obtained from consenting mothers following planned Cesarean sections. The products are securely processed, rigorously tested, and manufactured in accordance with applicable FDA requirements.
Since 2023, Regenative has applied for CFGs for multiple products on three occasions. Following its latest application in September 2025, the FDA issued a CFG for the company’s AmnioText product, certifying that Regenative’s facilities and operations comply with the agency’s requirements. However, the FDA did not meet the statutory 20-day deadline to issue CFGs for Regenative’s eight other applications, placing them instead on a “Return for Action” status and neither approving nor denying them.
The complaint asks the FDA to act on Regenative’s outstanding applications, ending the regulatory limbo that has caused ongoing commercial harm and prevented the small business from competing globally, expanding its U.S. operations, and delivering cutting-edge American-made biotech products to patients and physicians around the world.
“Small businesses like ours deserve a fair, predictable, and timely regulatory process,” said Tyler Barrett, CEO of Regenative Labs. “Decisive FDA action on our applications will allow us to serve patients around the world and add jobs in the U.S.”
“As we seek relief from the current administration, we’re committed to doing what we’ve always done — manufacturing safe, high-quality products that benefit patients, grow the economy, and help the U.S. remain a worldwide leader in biotech innovation.”
With a sterling product safety record and nearly 20 peer-reviewed publications highlighting patient outcomes, Regenative has established itself as a leader in transparency and cutting-edge science that has delivered for patients throughout the U.S. Obtaining a CFG would enable the company to continue innovating and significantly expand its operations domestically, supporting the creation of hundreds of new jobs.
About Regenative Labs
Regenative Labs is an American-owned and operated biotechnology company headquartered in Pensacola, Florida. Founded in 2019, Regenative Labs is an FDA-registered and inspected HCT/P manufacturer that operates under strict compliance with all federal and state regulations. Regenative Labs products are manufactured in state-of-the-art ISO Class 7 cleanrooms. All equipment is calibrated and validated to ensure valid and consistent results are produced.