Dave AspreyEntrepreneur, author and podcast host · founder and CEO of Upgrade Labs · no clinical or scientific credential claimed
No, they are yours
What it rests onAn analogy to surgery: cells taken from your body and returned to it are not a manufactured product, plus an unnamed federal ruling.
Source: daveasprey.com ↗
Paul KnoepflerPhD · Professor of Cell Biology and Human Anatomy, UC Davis School of Medicine · stem cell and cancer biologist
Yes, most of them are
What it rests onThe FDA's HCT/P framework and the narrowness of the 361 exception, argued across a decade of peer-reviewed commentary.
Source: sciencebasedmedicine.org ↗
Asprey is describing your own cells generally, including cells grown for weeks in culture, which is the case least likely to qualify for any exception. Knoepfler is describing what direct-to-consumer clinics actually sell, which is the same group of people seen from the other side.
Both accept that minimally manipulated tissue used in the same surgical procedure is treated differently from an expanded cell product, and both accept the FDA is the body with authority to draw the line. They disagree about where it falls and whether it should exist.
A binding appellate ruling the other way, or a rule change that moves the 361 boundary. One court decision already goes against this position: United States v. US Stem Cell Clinic, LLC, No. 19-13276 (11th Cir. 2 Jun 2021), https://media.ca11.uscourts.gov/opinions/pub/files/201913276.pdf, which upheld an injunction and rejected both claimed exceptions for a fat-derived procedure using a patient's own cells.
You do, and your call is dated, kept, and yours to change. Follow the people you already trust and what they publish turns into a short daily practice.
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