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The FDA has sent a to a birth tissue company based in Texas, stating that its injectable umbilical cord product is considered a drug, not the less-regulated cell and tissue product.

The letter focuses on Signature Biologics' human umbilical cord injectable called Signature Cord, which the company describes as a "cushioning agent derived from Wharton's jelly tissue for homologous supplementation," in for healthcare professionals. Wharton's jelly is a gelatinous substance that reportedly insulates the umbilical cord in the womb and gives it structure.

In its letter, FDA states that Signature Cord failed to meet criteria for "minimal manipulation," thus exempting it from solely being regulated under the agency's less-restrictive human cell, tissue, or cellular tissue-based product (HCT/P) pathway.

FDA said the company's processing "alters the original relevant characteristics of the umbilical cord related to its utility for reconstruction, repair, or replacement," but it didn't offer additional details on that processing or how the original characteristics were altered.

The agency also noted that the drug "appears to be intended to treat orthopedic disease and conditions" which would not be considered homologous use -- another aspect that disqualifies the product from the HCT/P category.

In addition, the FDA flagged numerous problems with the company's manufacturing procedures, including failing to implement "an adequate system for environmental monitoring in the aseptic processing areas," which could lead to microbial contamination; a lack of standard quality specifications; no lab testing for pyrogens; and inadequate cleaning and disinfection.

The letter is addressed to Neil Riordan, PhD, the . Riordan is also the , a clinic in Panama that purports to be able to treat autism, autoimmune diseases, cerebral palsy, and other conditions with what the company call "Golden Cells," also derived from umbilical cord tissue.

Paul Knoepfler, PhD, of the University of California Davis, who blogs about stem cells and birth tissue products, in the past. He noted that "it does not seem like this clinic clearly has the needed expertise to treat so many medical conditions and patients ranging from pediatric to geriatric. In my view, this increases risks for patients."

Knoepfler also raised concerns about a lack of research to support the treatments, the riskiness of treating children, and the high , which ranges from $16,000 to $30,000.

Riordan said in an email to MedPage Today that the company "immediately halted" manufacturing of its products after FDA said it wasn't regulated under the HCT/P pathway. "Signature is now focused on researching, developing, and securing regulatory approval of these products," Riordan said.

"Signature has not received any information that there were any defects in the products distributed before the FDA inspection, or since then, and has not received reports of any adverse events related to these products," he added. The company also submitted a response to the warning letter on October 9, he said.

According to the FDA warning letter, Signature Biologics had been distributing and selling Signature Cord to healthcare professionals and facilities, but has recently suspended these operations. The Signature Biologics brochure, which gives instructions on how to order the products, stated, "all products undergo independent sterility testing and are manufactured in a GTP [good tissue practice] facility."

It also states that the product "is (HCT/P) compliant under section 361 of the Public Health Service Act according to 21 CFR Part 1271.10," the section of the rules that FDA's letter said it violates.

Signature Biologics responded to the FDA's inspection results seven times in 2022, according to the letter. However, the FDA wrote that "corrective actions described in your responses are not adequate to address the above-referenced deficiencies" because they "lack supporting documentation."

The letter appears to be part of a larger push by the agency -- and in at least one case, the Department of Justice -- against companies making birth tissue products. Over the summer, FDA sent a warning letter to Stratus Biosystems over its amniotic membrane and fluid products, also claiming these were drugs and not HCT/P products. It also warned Regenative Labs that its Wharton's Jelly product was considered a drug, not a tissue product.

The FDA has long been trying to put a lid on unapproved birth tissue and purported stem cell therapies. In 2017, the agency issued guidance on regenerative medicine products, with a November 2020 deadline for full compliance. That deadline was extended due to the COVID-19 pandemic and . Now, manufacturers must meet the FDA investigational new drug (IND) and premarket approval requirements for certain products before promoting them to physicians and patients.

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