FDA: Your Body is a Drug and We want to Regulate It

ERRATUM: Many news sites and blogs have been misreporting that FDA wants to regulate our Regenexx-SD treatment, this is not the case. The issues over stem cells=drugs are with the Regenexx-C Treatment (now in the Cayman Islands)

As many of our followers know, we’ve been engaged in a David and Goliath struggle over a basic civil right-who gets to regulate your body. Most of us, when posed this question, would say that the answer is clear, our body is ours to regulate. However, not according to the FDA, which in court documents has now said that since it regulates chemical drugs, and since all living things produce chemicals, then all living things fall under FDA jurisdiction (there’s an excellent legal review of the background issues leading up to that point by KL Gates). This nutty statement by FDA came in recent court filings in response to a judge’s order slapped on the agency in our landmark case. The judge pointed out that congress only authorized FDA to consider chemicals which had “chemical action” as a drug. The judge also asked the obvious question, how do you get from chemicals=drugs to cells=drugs? She gave the FDA 30 days to respond and denied their motions. Well the response is epic in it’s hubris and concerning for every American who considers their body not to be an FDA regulated drug factory. In FDA’s response back to the judge, their own internal expert responded with, “When living cells interact with their environment to mediate repair of and/or regenerate damaged tissue, they do so by chemical action.” So here’s the agency’s logical fallacy:

-Congress said chemicals=drugs

-All cells produce chemicals

-Hence cells=drugs

??? If you think I’m kidding, check out these recent letters by the agency that fat processed at the bedside to obtain stem cells is a drug (here and here). This “interesting” assertion in our case is now making it’s way around the internet (see Gizmodo, SlashGear, Alliance for Natural Health, The Blaze, The Examiner, OzHouse, Attack Machine). My favorite comment on the topic is by a non-US citizen discussing the SlashGear story:

Hahaha, you Americans always provide us with the best jokes. Pizza is a vegetable and the human body is a drug, well played sir!

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Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

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NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. All content provided in this blog, website, or any linked materials, including text, graphics, images, patient profiles, outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you.