In the Vitti Labs FDA lawsuit, a federal judge in Missouri ruled on March 18, 2026, that the FDA’s interpretation of its own “minimal manipulation” standard for human tissue products was “plainly erroneous,” vacated the agency’s classification of Vitti Labs’ umbilical cord product as a biologic, and sent the matter back for reconsideration. Judge Brian C. Wimes of the U.S. District Court for the Western District of Missouri granted summary judgment to Vitti Labs and instructed the FDA that its analysis had improperly ignored how a tissue’s properties can serve the recipient, not just its function in the donor.1PR Newswire. Vitti Labs Prevails in Lawsuit Against FDA Over Minimal Manipulation Criteria for Section 361 HCT/Ps
What the Fight Was Really About
Tissue products in the United States travel one of two regulatory roads. Under Section 361 of the Public Health Service Act and 21 CFR Part 1271, a product that meets four criteria — minimal manipulation, homologous use, no combination with other articles, and limited systemic effect — can reach the market through simple registration, with no premarket approval. Products that miss any of those criteria fall under Section 351 or the Federal Food, Drug, and Cosmetic Act and are regulated as drugs or biologics, which typically means clinical trials and an approved Biologics License Application.2U.S. Food and Drug Administration. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products
The cost and timeline gap between those two roads is enormous. For a small tissue bank, classification often decides whether a product is commercially viable.
The Vitti Labs case centered on Cordgraft, umbilical cord tissue processed into small sheets used to protect nerves and tendons. The narrow legal question: what counts as an “original relevant characteristic” of the tissue? The FDA had looked only at what the umbilical cord does inside the donor, where it serves as a conduit for blood flow between mother and fetus. Vitti Labs argued the agency had to also consider the structural properties that make the tissue useful to a recipient.1PR Newswire. Vitti Labs Prevails in Lawsuit Against FDA Over Minimal Manipulation Criteria for Section 361 HCT/Ps
How the Case Got to Court
Vitti Labs, a Liberty, Missouri tissue bank that began manufacturing in July 2020, had been on the FDA’s radar for years. On July 28, 2022, following a December 2021 inspection, the agency issued a warning letter concluding that several of the company’s umbilical cord and amniotic membrane products were being marketed as unapproved drugs and biologics without a biologics license. The FDA determined the products did not qualify for the Section 361 framework because they were neither minimally manipulated nor intended for homologous use, and it also cited manufacturing deficiencies.3U.S. Food and Drug Administration. Warning Letter: Vitti Labs, LLC 627699-07282022
Vitti Labs filed suit on January 7, 2025, in the U.S. District Court for the Western District of Missouri, case number 4:25-cv-00011. The complaint named the FDA, the U.S. Department of Health and Human Services, then-FDA Commissioner Robert Califf, and then-HHS Secretary Xavier Becerra, and it was brought under the Administrative Procedure Act.4Justia Dockets. Vitti Labs LLC v. US Food and Drug Administration et al.
What Judge Wimes Decided
After oral argument on February 17, 2026, Judge Wimes granted summary judgment for Vitti Labs on March 18, 2026, vacated the FDA’s determination, and remanded the matter to the agency.5PACER Monitor. Vitti Labs, LLC v. US Food and Drug Administration et al.
The opinion called the FDA’s reading “plainly erroneous.” Judge Wimes reasoned that because the regulatory scheme for tissue products “revolves around sending safe products to patients, it would not be logical to cut out consideration of recipients in the minimal manipulation analysis.” The court also found the determination “arbitrary and capricious” under the Administrative Procedure Act.1PR Newswire. Vitti Labs Prevails in Lawsuit Against FDA Over Minimal Manipulation Criteria for Section 361 HCT/Ps6Scribd. FDA vs. Vitti Labs Summary Judgment
The instruction to the agency was direct. When evaluating whether structural tissue has been minimally manipulated, the “original relevant characteristics” must include functions of the tissue in the donor that might aid a recipient. The umbilical cord, under that reading, is more than a blood conduit; its structural properties that could help repair or protect nerves and tendons in a patient count too.1PR Newswire. Vitti Labs Prevails in Lawsuit Against FDA Over Minimal Manipulation Criteria for Section 361 HCT/Ps
Where the Case Stands Now
The FDA is not walking away. On April 15, 2026, the government filed a motion to alter the judgment.7PACER Monitor. Suggestions in Support of Motion to Alter Judgment Vitti Labs opposed on May 8, 2026, and the FDA filed reply papers on May 22, 2026.8PACER Monitor. Suggestions in Opposition to Motion to Alter Judgment As of mid-2026, the court has not ruled on that motion, and the specific arguments in the FDA’s motion are not publicly available.
If the motion is denied, the FDA can still appeal to the U.S. Court of Appeals for the Eighth Circuit. Public filings do not show that a formal notice of appeal has been filed.4Justia Dockets. Vitti Labs LLC v. US Food and Drug Administration et al.
What It Could Mean for the Tissue Industry
The ruling reaches beyond one company and one product. Philipp R. Vitti, the company’s chief science officer, called the decision “an important victory for Vitti Labs and the entire Section 361 HCT/P industry” and said the regulatory classification is “critical for human tissue banking and organ donation to exist in the United States.”1PR Newswire. Vitti Labs Prevails in Lawsuit Against FDA Over Minimal Manipulation Criteria for Section 361 HCT/Ps
The FDA has taken a stricter posture on birth-tissue products in recent years. In January 2025, the agency sent a warning letter to BioStem Life Sciences over injectable umbilical cord and amniotic products, and in August 2025 it cited Platinum Biologics for similar violations.9U.S. Food and Drug Administration. Warning Letter: BioStem Life Sciences 673788-0117202510U.S. Food and Drug Administration. Warning Letter: Platinum Biologics LLC 705090-08152025 The agency has also ended its period of enforcement discretion for certain tissue products.11U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies
If the Wimes ruling holds, the FDA would have to broaden how it evaluates minimal manipulation, giving weight to recipient-side utility rather than donor-side function alone. That change could keep the Section 361 pathway open to products the agency has spent years trying to push into the biologics approval pipeline. Whether the shift becomes durable precedent depends on the pending motion to alter judgment and any appeal that follows.