FDA says cord-blood-derived cell product is an unapproved new drug and unlicensed biological product

The warning letter provides a practical example of how product claims, biological function and manufacturing can change the regulatory pathway for a cellular product in the United States.

In a warning letter dated September 11, 2026, FDA’s Center for Biologics Evaluation and Research told NexCell Scientific that its allogeneic umbilical-cord-blood-derived total nucleated cell product was an unapproved new drug and an unlicensed biological product.

FDA noted that the product was also an HCT/P, but did not meet all criteria under 21 CFR 1271.10(a) to be regulated solely under section 361 of the Public Health Service Act. One cited issue was non-homologous use: promotional materials described applications involving inflammation, injury and neurological conditions, whereas a basic function of cord blood in the donor is formation and replenishment of the lymphohematopoietic system.

The agency also cited dependence on the metabolic activity of living cells in an allogeneic product and described significant current good manufacturing practice deficiencies, including process validation, aseptic processing, laboratory controls and investigation of lots that failed sterility testing.

The letter requires a response from the company and notes that the observations are not necessarily an exhaustive list of potential deficiencies.