FDA Warns on Unapproved Cell and Tissue Products After Death Reports
FDA says unapproved human cell and tissue products marketed online may pose serious risks, including reports of patient deaths after use.
Why now
The gray-market regenerative medicine boom needs a clean evidence boundary alongside real cell and gene therapy breakthroughs.
- Overclaim risk
- medium-high
- Primary source
- Official
- Published
- Jun 30, 2026
