Legal Considerations

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California Clinic Chain Wins It’s Case with the FDA: What Implications Will this Have?

A big event happened this week that may shake up what we all thought we knew about the FDA regulation of autologous orthobiologics. Let’s review what happened and how the ruling may change things. Let’s also review the fascinating and long history of the FDA’s regulation over your own tissues. What Just Happened? The court…read more

VittiLabs, the Sopranos, and an FDA Warning Letter

I’ve blogged quite a bit on the crumbling amniotic and umbilical cord fake stem cell market. Despite peer-reviewed research demonstrating that these products clearly have no stem cells, throughout social media, we still see patients who are getting bombarded by influencers who claim they are loaded with young and vital stem cells. One of the…read more

Why Language from a New FDA Amniotic and Umbilical Cord Warning Letter Is a Big Deal

I’ve covered the stem cell wild west for years. One of the crazier things out was amniotic and umbilical cord tissue vendors claiming to sell “stem cell” products that don’t actually contain any live and functional stem cells. In addition, despite an FDA crackdown on these companies, there are still vendors selling this stuff with…read more

What Is Procenta? What Is Human Tissue Therapy (HTT)? Why Is a Former Employee Mixed Up in This?

This week, I had a colleague send me information about yet another birth tissue company selling a product for use in treating orthopedic injuries. The sales rep claimed to my colleague that this product, called Procenta, was “FDA Approved” for that purpose. Let’s dig in. What Is Procenta? Procenta is a placental tissue sold by…read more

Why Did a Major University Sell Amniotic Fluid to a Fraudster?

This week’s blog on the Missouri woman who is being charged for fraud by selling Amniotic fluid brought up an interesting question. She bought this fluid from the University of Utah. Huh? Let’s dig in. The Missouri Case The feds this week brought criminal charges through a grand jury against a Missouri woman who was…read more

He Blinded Me with Science! David Singer Strikes Again

I wrote about David Singer a while back. He’s a chiropractic practice consultant who has now reinvented himself as a stem cell expert. IMHO, he and others like him are helping to perpetuate stem cell fraud in hundreds of chiropractic clinics all over the country. Today we’ll dig into the fraudulent use of research to…read more

From Jail Cell to Stem Cell: The Next Con for the Ex-Con

Way back in February of 2019, a documentary film-maker appeared at the IOF conference wanting to interview people about regenerative medicine. After a year and a half and a worldwide pandemic, his movie is out and it’s a must watch. Let’s dig in. Doug Orchard The film-maker was Doug Orchard, who has an interesting story.…read more

Should Sales Reps Vet the Products They Sell? Apex Biologix

Does a medical distributorship have a responsibility to vet the products they sell to physicians? Or is this an arm’s length relationship and buyer beware? Today, let’s view this controversy through the lens of some of the products pushed by a medical sales company in the regenerative medicine space called Apex Biologix. Let’s get started.…read more
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