Sponsored by John R. Moolenaar (R)
Shandra Eisenga Human Cell and Tissue Product Safety Act
Establishes civil penalties for violations of human cell and tissue product regulations and requires FDA education and transparency efforts.
Tradeoff
Creates enforcement penalties up to $10 million per proceeding for violations of tissue product rules. Requires FDA to spend resources on workshops, public reporting, and educational materials about tissue regulation.
What's in it
Increases spending by $2 million over 2026-2030 and collects less than $500,000 in civil penalties over 2026-2035.
The $2 million federal cost is just administrative overhead for to conduct an awareness campaign, develop educational materials, and direct FDA activities—the actual regulatory burden falls on human cell and tissue product manufacturers and handlers who must comply with expanded oversight requirements.
Passed the House by on June 23, 2025 — sitting in the Senate.
House
Introduced
(Feb 6, 2025)
House
Committee on Energy and Commerce(Feb 6, 2025)
House
The Committee on Energy and Commerce voted to send it to the floor
Reported by (Apr 29, 2025)
Committee report H. Rept. 119-160.
House
Passage of the bill
Passed by (Jun 23, 2025)
No individual votes were recorded.
Senate
Received from the House
on Health, Education, Labor, and Pensions(Jun 24, 2025)
- Debbie Dingell (D-MI)