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The FDA birth tissue company Neobiosis that its products derived from human amniotic fluid and umbilical cord are unapproved drugs.

In its warning letter to CEO Ian White, PhD, the FDA specifically named the Gainesville, Florida-based company's Purified Amniotic Fluid, as well as its human umbilical cord-derived products, Wharton's Jelly Cellular and Wharton's Jelly Acellular.

The agency stated that the products were "not the subject of approved biologics license applications (BLAs) nor are there INDs [investigational new drug applications] in effect for these products," noting that the introduction of unapproved products into interstate commerce violated the Food, Drug, and Cosmetic (FD&C) Act and the Public Health Service (PHS) Act.

Neobiosis told FDA investigators that the company "does not promote or suggest any intended use of their products," according to the letter. "However, based on statements on your Facebook page, YouTube channel, and in public interviews, you intend your amniotic fluid and umbilical cord derived products for uses including wound healing and orthopedic uses," the agency added.

The company's umbilical cord-derived products fail to meet the minimal manipulation and homologous use criteria that would qualify them as human tissue products, the agency said. "Using umbilical cord derived products for the treatment of diseases or conditions, such as orthopedic diseases and healing of damaged tissue is not considered homologous use ... because the treatment of these diseases or conditions is not a basic function of umbilical cord tissue in the donor," the letter stated.

As for the amniotic fluid product, the agency noted it must be regulated as a drug, but didn't mention homologous use or minimal manipulation criteria.

Among the current good manufacturing practice violations cited by FDA were failures "to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile"; "to have an adequate system for monitoring environmental conditions in an aseptic processing area"; "to establish laboratory controls that include scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity"; and "to have an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions."

The FDA did acknowledge receipt of the company's initial response letter dated March 14, 2023, and eight subsequent status reports. The agency also noted that the company's ninth and tenth status reports were under review as of earlier this month, and acknowledged the corrective actions within the company's responses, including that it is working with a consulting firm to assist with remediation efforts, some of which are in progress.

However, the FDA also said that the company's responses do not address plans regarding the products that have already been distributed, nor do they address the company's intentions about obtaining BLAs or INDs for its products.

Neobiosis did not immediately respond to request for comment.

FDA has been trying to crack down on birth tissue companies. Notably, the FDA sent a warning letter last year to Texas-based Stratus Biosystems over its amniotic membrane and fluid products, marketed under the Cell Genuity brand. A physician assistant was convicted of fraud earlier this year for giving patients those unapproved injections, and then illegally billing Medicare for the shots.

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