California broke new ground with our stem cell law that went into effect on January 1. It requires stem cell clinic firms to post notices informing patients of important information such as the fact that their offerings are non-FDA approved. At this point, 4+ months into the enforcement period, I’m not sure if anyone has […]
Update on state laws on stem cell clinics: California, Washington, & Florida Read More »
At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network). What does this big development mean in practical terms and how might it
Helpful Zettler insights from Q&A on FDA suits against stem cell clinics Read More »
If the FDA can “go big” to issue 40 warning letters to the e-cig industry as it just yesterday, why has it recently only issued 1 or fewer warning letters per year to the unproven, for-profit stem cell clinic industry in the U.S., which includes hundreds of businesses blatantly operating in what seems to be a
40 FDA warnings to e-cig biz, but stem cell clinics allowed to keep blowing smoke Read More »
Is “snake oil” too harsh a term for some of what is sold at some of the worst stem cell clinics? Is the phrase “stem cell clinics” itself accurate and useful in a broad sense? When we read or write the phrase “stem cell clinics”, most people generally know what we’re talking about, but it
What should we call “stem cell clinics” & is “snake oil” too harsh for some? Read More »
We have a big problem with clinics in the U.S. selling unproven and non-FDA approved stem cell “treatments” to patients and part of the reason in my view why we have this mess today with upwards of 700 such businesses from coast to coast is that regulators including both the FDA and state medical boards
Pending State Medical Boards Group Report on Stem Cell Clinics Could be Game Changer Read More »
There’s some also encouraging action at the state level on direct-to-consumer stem cell clinics operating without FDA approval including most recently in Washington State. Last year here in California we passed a bill into law that (1) requires stem cell clinics selling non-FDA approved therapies to post notices for patients and (2) instructs the state medical
Washington State Bill to Require Unproven Stem Cell Clinics to Post Notices Read More »
There are now so many clinics selling non-FDA approved stem cell offerings across the U.S. that tens or hundreds of thousands of patients are at risk. How did we get here? What if we had a way of understanding how stem cell clinics spread across the U.S. in the first place? For example, an animated
Animated map video shows wildfire spread of US stem cell clinics lacking FDA approval Read More »
Florida is a hot mess on the for-profit stem cell clinic front. My own state of California isn’t much better and actually has a great number of clinics, but more problems are coming to light in Florida, at least at this point. Now WLRN reports that a legislator in Florida has proposed a new bill to try to
Florida bill aims to “crack down” on state’s for-profit stem cell clinics Read More »
Now that in the past few months the FDA has issued stern statements (one this summer and more recently), both final and draft guidances, and at least one warning letter, what comes next? What will the clinics do if anything moving forward? What if anything will the FDA do in terms of actual concrete actions?
Polls: What will stem cell clinics & FDA do now? Read More »
In a nutshell, what does all of this week’s big FDA developments on stem cells and regenerative medicine mean for stem cell clinics? There’s much to be upbeat about so overall I’d say it’s good news, but I see three significant potential problems too. Dang. The good news is that the FDA seems determined to
Deconstructing FDA Mixed Bag Approach to Stem Cell Clinics Read More »