Are these products FDA approved?
Our products are not FDA-approved drugs or FDA-approved treatments for any disease or medical condition. Human cell and tissue products may be subject to different FDA regulatory pathways depending on the specific product, its processing, and its intended use.
Certain HCT/Ps may qualify for regulation solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271 when all applicable criteria are met. Section 361 regulation is not the same as FDA approval, and regulatory status must be evaluated on a product-specific basis.
Our products may be considered for research, investigational, or other legally permissible uses, depending on the specific product and circumstances. We do not represent our products as FDA-approved therapies or guarantee clinical outcomes.
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.
