If you’ve ever heard a stem cell clinic say their treatment is “FDA compliant,” they’re often referring to being regulated under Section 361 of the Public Health Service (PHS) Act. But there’s a big difference between 361 and 351, and it could mean the difference between a legal therapy and an unapproved drug.
Here’s the breakdown:
- 361 Products are typically “minimally manipulated” and used in a homologous way (meaning they perform the same function in the recipient as they did in the donor). These don’t require FDA premarket approval but must still follow good manufacturing and infection control practices.
- 351 Products are considered biologic drugs and require extensive clinical trials, premarket approval, and full regulatory oversight before being offered to patients.
So what happens when a clinic markets something that should be a 351 product but claims 361 status? That’s the core of many legal battles. The FDA has increasingly cracked down on clinics making these claims, issuing warning letters, and even filing lawsuits (as we’ll cover in future posts).
The Regen Report points out that many providers try to get on the line—especially with adipose (fat-derived) stem cells or birth tissue products like umbilical cord blood—hoping to fall under 361 but often running against the 351 criteria.
Why it matters to you:
If a therapy isn’t FDA-approved and doesn’t clearly qualify as a 361 product, there may be legal and medical risks involved. Patients need to ask which classification their treatment falls under—and how the clinic justifies it.
Are you considering stem cell treatment or regenerative therapy? Don’t make a decision without being fully informed. Download our free expert-curated list of 20 critical questions will empower you to evaluate potential providers with confidence and help you decide on the best outcome for your health.
