What does an FDA warning really mean?
Why historically in some years has the FDA issue no warnings related to biologics, while in other years it issues many? Some of it likely reflects the philosophy of the agency leadership. Of course, another factor is how much activity there is that the FDA sees as non-compliant.
Non-compliance seems way up over the past 15 years, particularly using birth-related biologics.
It’s been interesting to see that the biologics branch of the FDA, CBER, has continued to issue quite a few warnings in 2025. Further, as in the past, these warnings most often relate to umbilical cord, placental, and amniotic products.
NuVida FDA warning
With this in mind, check out this new warning letter to NuVida Medical. The letter was addressed to firm leader Park Thomas. I recently wrote about two other new FDA warnings in this space including one to Platinum Biologics. Unlike some past warning letters, this one to NuVide did involve an inspection of the firm.
The NuVida warning notes products that the agency says are unapproved drugs. The letter also explains why including, “For example, your Procenta, XCELLERATE, completeFT, and Coll-e-Derm products fail to meet the criterion that the HCT/Ps be “intended for homologous use only.”
As I’ve written before, it is somewhat encouraging that the FDA seems to be carefully overseeing biologics still in 2025. I hope the trend continues.
Clinic doc in the Netherlands banned
Doctor banned from giving experimental stem cell treatment, Dutch News. This is about unauthorized use of umbilical cord blood in the Netherlands. Reportedly, patients often received the material in hotel rooms including for autism.
There are unproven cell therapy clinics in the US that will come to your house or other locations to inject you. Some spas and resorts now offer unproven “stem cells” too. I also wrote earlier this year about a supposed stem cell cruise. It also claims to offer CRISPR on the high seas.
More upbeat recommended reads
- UC Davis Scientists Pioneer Stem Cell Gene Therapy for Angelman Syndrome, UC Davis. On a more positive note, while I’m not involved with this work, it is exciting to see colleagues doing this kind of research. It is funded by $4.5M from CIRM.
- UCLA scientists advance gene therapy for deadly blood disorder, UCLA. I’m also hearing that UCLA may get a good chunk of its NIH funding back soon, but we’ll see.
- Want better corn? Color its stem cells, Pop Science. I often have to remind people that plants have stem cells too. There’s also a great deal of cool research in this area. Note that cosmetic products claiming that they contain plant stem cells is not based on good research. Often these products just have general plant extracts.
- Parkinson’s is on the rise. Here’s one future treatment giving researchers hope, NPR. This is about one of several teams working on new therapies for Parkinson’s including via stem cells. I recently wrote about promising early data from three teams on using stem cells for Parkinson’s.
Hi Paul,
Long time lurker here. I appreciate the information you aggregate and comment on every week.
This time I wanted to leave a comment, because there is a slight error in the interpretation of the Dutch news article. According to the article, treatments were likely not administered in a hotel (the article only mentions families stayed in a hotel). Instead, it is likely treatments were done in a dentist office where the doctor also worked.
Of course, as a Dutch citizen, I am frustrated that this type of unproven therapy is provided here. Apparently 200 “treatments” were already administered, which is baffling to me. Let’s hope oversight remains vigilant.
Kind regards,
Ruud