Are these products FDA approved?
Short answer: No, most umbilical cord–derived biologics are not FDA-approved drugs. And that’s not necessarily a red flag—it’s a matter of how they’re regulated.
These products typically fall under regulation by the U.S. Food and Drug Administration as 361 HCT/Ps (Human Cells, Tissues, and Cellular and Tissue-Based Products).
That means they are regulated as tissue products—not drugs. They are not required to go through the FDA drug approval process.
They are expected to meet specific criteria, including: Minimal manipulation, homologous use, donor screening and testing, sterility and safety standards.
These products can be legally marketed and used when they meet 361 criteria. They are not “unregulated”—they are regulated differently. Safety testing (sterility, endotoxin, infectious disease screening) is still required.
Where the confusion—and concern—comes in:
Some companies market these products like FDA-approved treatments or make drug-level claims.
A responsible, compliant approach looks like:
Being clear that the product is not FDA-approved as a drug, positioning it as a biologic support tool—not a cure, and using data-backed language (cell markers, viability, growth factors)
Avoiding claims such as guaranteed outcomes and tissue regeneration, or disease treatment.
There is real biologic potential in this space with strong scientific evidence supporting the biological mechanisms of these products (anti-inflammatory effects, cell signaling, growth factors). Early clinical data is promising.
There is also real variability—and real marketing noise. The difference comes down to transparency and positioning.
