We wish this were a joke, but it’s the US Food and Drug Administration’s latest claim in its battle with a Colorado clinic over its Regenexx-SD™ procedure, a non-surgical treatment for people suffering from moderate to severe joint or bone pain using adult stem cells.
The FDA asserts in a court document that it has the right to regulate the Centeno-Schultz Clinic for two reasons:
We discussed the very ambiguous issue of interstate commerce last September—it’s an argument the FDA frequently uses when the basis for their claim is otherwise lacking. As we noted then, the FDA holds that an “interstate commerce” test must be applied to all steps in a product’s manufacture, packaging, and distribution. This means that if any ingredient or tool used in the procedure in question was purchased out of state, the FDA would in its view have jurisdiction, just as they would if the final product had traveled across state lines.
This time the FDA just nakedly says in court documents that the agency wants to protect the market for FDA-approved drugs. No more beating around the bush—their agenda is right out in the open! This appears to be a novel interpretation of the Food Drug and Cosmetic Act (FD&C), as evidenced by the government’s failure to cite any judicial precedent for their argument.
The implication of the FDA’s interpretation of the law, if upheld by the court, would mean that all food, drugs, devices, and biologic or cosmetic products would be subject to FDA jurisdiction. The FDA is expanding its reach even to commerce within the state, which we argue is far beyond its jurisdiction, in order to protect drug company profits…
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