Human Tissue Safety Act Imposes $10M Fine Cap, Mandates FDA Transparency on Cell Product Oversight

The “Shandra Eisenga Human Cell and Tissue Product Safety Act” is the friend who shows up when you’re getting serious work done, demanding better safety standards and shining a bright light on the process. This legislation is all about tightening up the rules and increasing transparency for human cell and tissue products—the stuff used in transplants, regenerative medicine, and other critical therapies. It does this by hitting violators where it hurts (the wallet) and forcing the Food and Drug Administration (FDA) to open its books on how it manages this sensitive industry.

The New Bottom Line: Safety Violations Get Expensive

If you deal with human cells and tissues, this bill introduces some serious financial deterrents for cutting corners. Section 4 establishes hefty civil penalties for violating safety regulations (specifically Subparts C or D of 21 CFR Section 1271). The fine structure is designed to be comprehensive: you start with a base fine of up to $20,000 per violation. If you get a written warning and still don’t fix the problem, you face an additional fine of up to $20,000 for every day the violation continues. Ouch.

But here’s the kicker: you also have to pay an amount equal to the retail value of the specific cell or tissue products involved in the violation. This means the fine scales up based on the severity and commercial scope of the breach. The good news? The total penalty for any single legal proceeding is capped at $10 million. For regular folks, this means the financial risk for non-compliance is now high enough that businesses will likely invest more heavily in safety protocols, which is a big win for anyone needing a transplant or cell therapy.

Opening the FDA’s Books

Section 5 is where the transparency push comes in, directly affecting how the FDA operates. The law mandates that the FDA Commissioner must start publishing annual data on its oversight of the cell and tissue industry. This isn't just bureaucratic paperwork; it’s accountability. Starting one year after enactment, the FDA has to report on things like how many businesses have registered since 2019, how many inspections they’ve performed (and how that compares to blood establishments), and, critically, the performance metrics of the Tissue Reference Group (TRG).

If you’re a researcher or a developer trying to bring a new therapy to market, you’ll now be able to see the average time it takes the TRG to respond to submissions. This kind of data makes the regulatory process more predictable, helping scientists plan their timelines better. For patients, knowing the FDA is actively tracking and reporting its inspection rates offers peace of mind that someone is watching the store.

Modernizing the Rules and Seeking Public Input

The bill understands that science moves faster than bureaucracy. It requires the Secretary of Health and Human Services (HHS) to set up a public online forum within 60 days to gather feedback on modernizing the rules for these products. They are specifically looking for input on two highly technical, but crucial, definitions: “minimal manipulation” and “homologous use.” These definitions determine how certain cell therapies are regulated. If the rules are clearer and updated, it can speed up the development of safe, effective treatments.

Finally, the Secretary must deliver a report to Congress by September 30, 2026, summarizing all this public feedback and proposing recommendations for regulatory changes. This is a direct attempt to balance public safety with reducing the regulatory burden, ensuring that the rules are smart, not just strict. Meanwhile, Section 3 ensures health professionals get the necessary educational materials covering donation, screening tests, and how to communicate with patients about donation—a small but necessary step to improve the entire process from donor to recipient.