Are Stem Cell Products Regulated?
Stem cell products are regulated in the United States, but the rules depend on the type of product and how it is sold. The Food and Drug Administration, or FDA, oversees most stem cell therapies and related items to make sure they are safe and effective for people.
The FDA treats stem cells as human cells and tissues. It regulates them under laws like the Public Health Service Act. This means the agency reviews how these products are made, tests them in clinical trials, and approves them before they can be sold as treatments. For example, some stem cell therapies have full FDA approval, such as Omisirge for severe aplastic anemia and Waskyra for Wiskott-Aldrich syndrome. These approvals come after studies show they help patients with serious conditions.
Not all stem cell products face the same strict checks. Many clinics offer treatments without FDA approval. These may lack strong scientific proof of safety or benefit. The FDA has cracked down on such clinics that sell unapproved products or skip proper manufacturing steps. Laws like the 21st Century Cures Act from 2016 help speed up safe new treatments while blocking risky ones.
Stem cell supplements are different. These are sold over the counter as pills or powders claiming to boost stem cells. They fall under dietary supplement rules, which are much looser. The FDA does not check their purity, consistency, or effectiveness before they hit store shelves. Makers can sell them without proof they work, and the agency steps in only after problems appear. This leads to risks, as marketing often sounds scientific but lacks real evidence.
New laws and guidelines are in the works to clarify rules. They focus on FDA powers over stem cells, faster approvals for new therapies, and limits on ads for unproven treatments. Groups like the International Society for Stem Cell Research support flexible trial designs for rare diseases to help more patients.
Patients should check if a stem cell product or treatment has FDA approval. Approved ones go through tough testing. Unapproved options might promise big results but carry unknown dangers.
Sources
https://int.livhospital.com/are-stem-cells-legal-in-us-important-facts-you-need/
https://www.signalsblog.ca/right-turn-stem-cell-supplements-a-growing-market-with-growing-risks/
https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treatment-wiskott-aldrich-syndrome
https://www.isscr.org/isscr-news/the-isscr-responds-to-fdas-draft-guidance-on-innovative-designs-for-clinical-trials-of-cellular-and-gene-therapy-products-in-small-populations
https://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-severe-aplastic-anemia
https://www.fiercepharma.com/pharma/italian-non-profit-fondazione-telethon-lands-fda-approval-first-gene-therapy-treat-rare
https://www.fdamap.com/blog/the-fda-just-rewrote-the-car-t-rulebook-quietly/
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products
