FDA Seeks to Regulate a Medical Treatment Using Adult Stem Cells But No Outside Drugs

(Photo: Regenexx SD)

According to the U.S. Food and Drug Administration, adult stem cells — undifferentiated cells found in every human body that can transform into specialized cells with the medial potential to repair certain areas of the body damaged by disease or injury — fall under its jurisdiction for regulation as a drug.

The FDA states on its website:

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.

The Alliance for Natural Health states that the FDA has claimed in a legal conflict with a Colorado medical clinic, Centeno-Schultz, that a treatment it conducts using adult stem cells is under its regulatory jurisdiction. Centeno-Schultz’s Regenexx-SD is a non-surgical procedure to treat joint pain with adult stem cells by removing the stem cells from the patient’s blood and re-inserting them into the area needing treatment. No outside drugs are involved.

Since the stem cells are, as it says in FDA’s statement above, being used as a treatment, they are subject to regulation. ANH states that the FDA claims the authority to regulate because of interstate commerce:

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.”

FDA Seeks to Regulate a Medical Treatment Using Adult Stem Cells But No Outside Drugs

(Photo: Regenexx SD)

In its call for a summary judgement, the FDA expounds upon how under the Federal Food, Drug, and Cosmetic Act (FDCA) and the Commerce Clause it should be able to exert its regulatory authority over Centeno-Schultz’s procedure, which ANH reports it has been battling on this issue for several years. Here are a few snippets of the FDA’s argument from the case documents:

As we show below, the FDCA contains no “practice of medicine” exception that excuses Defendants’ conduct, and FDA’s exercise of jurisdiction over Defendants’ conduct is a permissible exercise of federal power under the Commerce Clause. Defendants’ remaining arguments are likewise without merit.

[...]

The Constitution grants Congress broad power to “regulate Commerce . . . among the several States,” U.S. Const., art. I, § 8, cl. 3. Congress may “regulate the channels of interstate commerce”; it may “regulate and protect the instrumentalities of interstate commerce, and persons or things in interstate commerce”; and it may “regulate activities that substantially affect interstate commerce.”

[...]

In Raich, the Court sustained Congress’s authority to prohibit the possession of home-grown marijuana intended solely for personal use. 545 U.S. at 32-33. It was sufficient that the Controlled Substances Act “regulates the production, distribution, and consumption of commodities for which there is an established, and lucrative, interstate market.”

[...]

United States v. 9/1 Kg. Containers, 854 F.2d 173, 176 (7th Cir. 1988) (“Congress gave the FDA comprehensive powers to license the manufacture of drugs and limit their sales. To regulate drugs is to be ‘involved’ in the ‘practice of the healing arts.’”

SlashGear states that the next step is for the court to decide “whether or not something that resides in every human being can be subject to government intervention.”