Ep. 13: The Good, The Bad, and The Truth About The FDA and Regenerative Medicine

Hey everyone, welcome back to our series, “The Good, The Bad, and The TRUTH About Regenerative Medicine”.

I’m Dr. Jay Bowen, and today we’re diving into a topic that affects the future of regenerative medicine—how the FDA fits into all of this. You may have heard me mention things like “The Right to Try Act” in other videos in this series. If you’ve wondered what this is, this video is for you! We’ll cover the FDA’s role, some of the controversies, and how state laws and federal regulations collide in this space. If you’ve been enjoying this series, be sure to subscribe to our channel and hit the Bell notification so you don’t miss anything. 

Also, please give this video a like and leave a comment letting us know you’re here! Okay,  ready to go? Let’s dive in.

What is the FDA?

First things first, what exactly is the FDA? The U.S. Food and Drug Administration is the agency responsible for regulating everything from food and cosmetics to drugs and biologics. When it comes to regenerative medicine—particularly therapies like stem cells, PRP, and other cell-based treatments—the FDA plays a crucial role in ensuring safety and efficacy. In regenerative medicine, any therapy that involves manipulating cells or tissues, like stem cell treatments, potentially falls under FDA scrutiny. They want to make sure that the treatments are safe for patients and that they work as intended. However, not all regenerative therapies are treated the same.

FDA’s Two Key Pathways: 361 vs. 351

The FDA categorizes regenerative treatments under two pathways: 361 and 351. 

This is where things can get a bit technical, but it’s super important and I’ll try to simplify it. A product classified as a 361 product is considered a ‘minimally manipulated’ biologic. These treatments are derived from the patient’s own cells or tissues, and as long as they meet certain criteria, they don’t need extensive FDA approval. An example would be PRP, or Platelet-Rich Plasma, which is simply blood that’s been processed to concentrate platelets. It’s minimally manipulated and typically falls under this 361 pathway. If you want more information on what PRP is and how we use it at NJRI, check out our video on it.

On the other hand, 351 products are considered more than ‘minimally manipulated.’ These require more rigorous FDA oversight and go through clinical trials, like new drugs. This includes some types of stem cell treatments where the cells are significantly modified or cultured before being reintroduced into the patient. They can even be cells from another person.  Treatments in this category are considered high risk, which leads to tighter control.

Controversies in Regenerative Medicine – Regenerative Sciences or Regenexx Lawsuits & Cell Surgical Network. Now, let’s get to the real controversy or  “the bad”—the lawsuits and legal challenges involving regenerative medicine clinics. Some clinics, like “Regenenexx” and the “Cell Surgical Network”, have faced lawsuits for marketing therapies that haven’t gone through FDA approval under the 351 pathway. These lawsuits highlight the ongoing tension between innovation and regulation in the field. What makes this even more complicated is the interaction between federal FDA regulations and individual*state laws. While the FDA controls the overall regulatory framework, some states have passed their own laws that allow patients to access experimental treatments, often without FDA approval. This is where we start seeing potential conflicts.

The Right to Try Act & Cures Act  

This leads us to two important pieces of legislation: the Right to Try Act and the 21st Century Cures Act. The Right to Try Act, signed into law in 2018, allows patients with life-threatening conditions to try experimental treatments that haven’t yet received full FDA approval – not just cellular treatments. This law gives patients more access to therapies that would otherwise be restricted, but it also opens the door to potential risks, especially in unproven treatments. Meanwhile, the 21st Century Cures Act was designed to accelerate the development of new therapies, including regenerative medicine. While it streamlines some of the approval processes, it also sets the stage for faster but still rigorous pathways for FDA approval.

PRP vs. Blood Products – Where Does PRP Fit.

You might be wondering—what about PRP? As I mentioned earlier, Platelet-Rich Plasma typically falls under the FDA’s 361 pathway because it’s a minimally manipulated blood product. Unlike more complex biologics, PRP is derived from your own blood and is processed without significant modification. If you want to learn more about PRP, you can watch my recent video on it. If you’re struggling with knee pain, check out my knee series to see how PRP can fix your knee (point towards hip). If you’re ready for a PRP consolation. Give our office a call so we can get you the relief you’re looking for!

But here’s where it gets tricky: While PRP is often used for joint pain, tendon injuries, and even cosmetic purposes, its regulation is far looser than some other regenerative therapies, especially since it’s not classified as a drug under the FDA’s HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Products) regulations. All this complexity with FDA regulations, lawsuits, and state vs. federal laws brings us to what I like to call the “Goldilocks Principle”. We need a balance. Too much regulation can stifle innovation and delay access to life-saving treatments. Too little, and we risk patients being exposed to therapies that could be dangerous or ineffective. The goal should be finding that ‘just right’ point, where we’re protecting patients while also encouraging innovation. But in regenerative medicine, this balance is still a work in progress and this is where we need data to guide us.

The TRUTH About The FDA & Regenerative Medicine 

So, what’s the TRUTH about the FDA’s role in regenerative medicine? Well, it’s complicated. The FDA exists to protect patients, but their strict regulations can sometimes delay innovative treatments. On the other hand, we’ve seen cases where clinics take advantage of lax oversight, and that’s why a balanced approach is crucial.[3]   Chiropractors have directed or employ nurse practitioners or others to perform the procedure with a substance that does not contain cells and mislead the patient as to what is injected either knowingly or out of ignorance.  This is the importance of getting a clear diagnosis and trying simple and inexpensive treatments. If they fail and the problem has been correctly identified by someone who treats your condition, then progression to other treatments is reasonable. Here at NJRI, I will give you a clear evaluation and give you options from the most conservative treatment which in some cases may just be a simple MEAT protocol and PT. All the way to extremes like PRPs, MFATs, and in the worst cases surgical intervention.

With all of medicine, there are good and bad people with various intentions and training. As always, be an informed patient. Do your homework on treatments, check if they’re FDA-approved (if applicable), get the details on the proposed treatment, see if they collect data on the novel treatments they render, and talk to your healthcare provider about ALL your options. 

That’s it for today’s epi sode of  The Good, The Bad, and The TRUTH About Regenerative Medicine. Thanks for watching! If you found this video helpful, don’t forget to like, subscribe, and hit that notification bell for more deep dives into the world of regenerative medicine. Also, be sure you follow us on socials! We are active on TikTok, X, Instagram, and Facebook!

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