According to an argument put forth recently by President Obama's Food and Drug Administration, a person's body can be classified as a "drug" and regulated under interstate commerce laws, according to a Feb 1 article at slashgear.com.
"That’s the meta-level, theoretical interpretation," Slash Gear notes, before addressing the actual case leading to this interpretation:
At issue is a Colorado clinic which performs a non-surgical treatment called Regenexx-SD. It’s used for patients who have joint or bone pain, and the process involves using adult stem cells. Other than that, no drugs are used so the clinic has been operating without the stringent restrictions in place by the FDA. But now the FDA is arguing that stem cells, which exist in every living human, are drugs and thus subject to government regulation.
An article at the Alliance for Natural Health USA explains further:
- Stem cells are drugs and therefore fall within their jurisdiction. (The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA’s jurisdiction!)
- The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”
The ANH-USA further explains that the FDA says "an 'interstate commerce' test must be applied to all steps in a product’s manufacture, packaging, and distribution."
The group further notes:
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.
But the Centeno-Schultz Clinic, the provider involved in this case, says that it simply takes one's blood and places it in a centrifuge to separate the stem cells so a doctor can put them back in one's own body. There is no manufacturing involved and the clinic argues that one's own stem cells are not drugs.
The FDA, however, argues otherwise: “Stem cells, like other medical products that are intended to treat, cure, or prevent disease, generally require FDA approval before they can be marketed. At this time, there are no licensed stem cell treatments.”
In other words, components of one's own body are drugs to be approved and regulated by the same government that gave us Obamacare.
The group notes that at one time, the FDA allowed the use of stem cells treated with “minimal manipulation,” which, according to federal regulations, are defined as “processing that does not alter the relevant biological characteristics of cells or tissues” - "which is certainly the case with the Regenexx clinic," the group argues.
According to ANH, breakthrough technology now gives doctors "the ability to obtain more stem cells from a patient than previously thought possible, which is why we’re now seeing new treatments."
But if the FDA can classify parts of one's own body as a drug to be regulated by federal law, there are no limits to what the government can - or cannot allow.
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