FDA Using ‘Interstate Commerce’ to Regulate Your Stem Cells As a ‘Drug’
- Posted on February 2, 2012 at 9:44am by
Liz Klimas
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(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.”
(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.”
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Comments (47)
Seagal45
Posted on February 2, 2012 at 4:49pmPass the duct tape…..
Report Post »Meyvn
Posted on February 2, 2012 at 4:14pmand next they will want to regulate each one of us as a drug.
Report Post »cosmic dogma
Posted on February 2, 2012 at 3:56pmOn an airplane a couple of months ago with a gentleman working in a foreign country, with stem cells, using similar technique. America is falling behind the times in scientific advancements. There is a fine line between protection, and smothering restrictions, which we may have crossed. Since these stem cells are harvested from one’s own body, to be used in one’s own body, does that mean one’s own body is owned by the government?
Report Post »ColoradoBoots
Posted on February 2, 2012 at 6:04pmTraveling to Panama for stem cells for my son. They will use his own, and donated umbilical cord cells, no ethical dilemma, and mostly his own cells. $30K we are spending outside the USA, on a treatment that may or may not be FDA approved in years. He shouldn’t have to wait. We are an hour from Regenexx, and their website was very helpful in doing my research. Too bad they only do orthopedics and not neurology. At least they did orthopedics……
Report Post »jb.kibs
Posted on February 2, 2012 at 8:49pmyes, we are slaves. prove me wrong.
Report Post »biblegeek119
Posted on February 2, 2012 at 1:47pmToo much regulation leads to less people obeying regulations and the increase of corruption.
Report Post »amdoktor
Posted on February 2, 2012 at 1:21pmNot only do they want to control everything in our lives, we are now basically owned by the State as commerce. Are you still sleeping or will this wake up the sleeping general public. Were is the outrage
Report Post »on turning us into subjects to serve our precious Government. It will not stop until the American people demand a elimination of the corrupt Government Departments. Ron Paul 2012 and you think.” I’m Crazy !”
God bless us all
roadhog
Posted on February 2, 2012 at 12:28pmCut off the Funding to the FDA Stem Cells Can save lives with out Drugs.
Report Post »Red herring
Posted on February 2, 2012 at 12:20pmSo, taking something from my own body, and injecting it back into my body somewhere else can be controlled by the government? So this opens a pandora’s box, how would they consider these other situations:
- Blood/Plasma donation (The best drug ever for curing blood loss!)
- Organ donation (you don’t really need that kidney!)
- Transplanting your toes to replace lost fingers. (We can’t let you do that over state lines!)
- Sperm donation (Don’t want the government to go there…)
… Is there anything that they WON’Tclaim control over?
Report Post »Melika
Posted on May 24, 2012 at 3:32pmA very apt reply.
Report Post »TH30PH1LUS
Posted on February 2, 2012 at 12:06pmAlso, your DNA is being patented, bought and sold by drug companies. The anti-God mindset is stripping our very humanity from us.
Read the last chapter of The Seven Daughters of Eve and you will hear the utter disgust and bitterness from one of the brilliant minds of genetics Brian Sykes. http://www.amazon.com/Seven-Daughters-Eve-Science-Ancestry/dp/0393323145/ref=tmm_pap_title_0
Report Post »P8riot
Posted on February 2, 2012 at 11:51amThe government ALWAYS uses the commerce clause to liberally. It got a huge boost when the supreme court said that the effect on commerce can be looked at in the aggregate – ruling that a guy on his own farm could be told by the fed how much crop he can and can’t harvest – even for himself.
Report Post »GhostOfJefferson
Posted on February 2, 2012 at 11:42amInterstate commerce clause was clearly and unquivocally intended to prevent states from levying differing trade conditions (and weights and measurements) as if they were sovereign nations. It was not a charter for the government to control private businesses in any manner.
Report Post »P8riot
Posted on February 2, 2012 at 11:56amAgreed, thus preventing certain states from -in effect- imposing “sanctions” on other states… the commerce clause is completely being used out of context… especially when they start saying that ‘this action’ will effect ‘that action’ which effects interstate commerce.
Report Post »THX-1138
Posted on February 2, 2012 at 11:35amIf we don’t destroy the Federal government it will destroy us. This government has gone from a useful camp fire to a destructive forrest fire.
History indicates that it will not stop until it has consumed every last aspect of our lives.
Everything born, dies. Everything.
Would you rather go down with this ship or head for the lifeboats and build another?
We won’t be able to put that decision off much longer.
Report Post »US-First
Posted on February 2, 2012 at 11:23amWhat is sad and telling is that not one of the arguments indicates that the FDA is interested in protecting individuals. The FDA is not questioning the safety of the procedure presumably because that has already been established. It is only concerned with controlling the flow of money and collecting fees. That is corrupt government plane and simple.
Report Post »I.Gaspar
Posted on February 2, 2012 at 11:02amSoon obama’s people will require you obtain a license to blow your nose.
Report Post »There is no end to what statists will try to control.
Darla_K
Posted on February 2, 2012 at 10:52amI don’t have any trust in the FDA and if I want to use my stem cells for something it is MY business. Hands off and worry more about the things coming into this country that are harmful to the people.
Report Post »pdw
Posted on February 2, 2012 at 10:50amSounds like our government-business has found another profit making project.
Report Post »mapgirl10
Posted on February 2, 2012 at 10:29amHey big brother hands of my stem cells!
Report Post »TXPilot
Posted on February 2, 2012 at 10:38amUsually, I require someone to buy me dinner first, before I let them touch my stem cell.
Report Post »bospopp
Posted on February 2, 2012 at 10:29amI assist with this type of procedure for a living. The machines are FDA approved to concentrate platelets, white cells and Bone Marow Aspirate (stem cells) but the acctual procedure of injecting/applying the end product is still considered “off label” use. This classification means that insurance companies normally will not cover these procedures, often costing $500-$5,000 each depending on platelet or stem cell therapy. The push, is for these procedudres to become the first line of treatment before surgery. The question now is, would this regulation be to make sure that every procedure is performed to the highest standard, or is it a way of controlling the process?
Report Post »NOBALONEY
Posted on February 2, 2012 at 10:17amControl
Report Post »byehlik
Posted on February 2, 2012 at 10:01amHow much regulation is enough? Our freedoms have been squandered by a bunch of idiots that think they know better. Be ready, it’s coming!
Report Post »Ironeagle
Posted on February 2, 2012 at 10:01amThe only way to bring down the Matrix is to undermine the Supreme Court decision on Wickard v. Filburn, 317 U.S. 111 (1942). This was truly the undoing of the barrier that held the Feds back from undue (unconstitutional) interference in our lives. This U.S. Supreme Court decision recognized the power of the federal government to regulate economic activity. A farmer, Roscoe Filburn, was growing wheat for on-farm consumption. The U.S. government established limits on wheat production based on acreage owned by a farmer, in order to drive up wheat prices during the Great Depression, and Filburn was growing more than the limits permitted. Filburn was ordered to destroy his crops and pay a fine, even though he was producing the excess wheat for his own use and had no intention of selling it.
The Supreme Court, interpreting the United States Constitution’s Commerce Clause under Article 1 Section 8 (which permits the United States Congress “To regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes;”) decided that, because Filburn’s wheat growing activities reduced the amount of wheat he would buy for chicken feed on the open market, and because wheat was traded nationally, Filburn’s production of more wheat than he was allotted was affecting interstate commerce, and so could be regulated by the federal government.
This is what we need to attack or else we will be total slaves of the Federal gov’t one day.
Report Post »Sirfoldallot
Posted on February 2, 2012 at 10:05amYeah ur right , dream on , we gave up our freedom to this group in the WH !
Report Post »zman173rd
Posted on February 2, 2012 at 10:17amIRON EAGLE IS RIGHT. You need to read The Forgotten Man by Amity Shlaes to understand what happened. Personally, I think it’s too late for this country to get back on her feet again. Laws to fix laws to fix laws to fix laws that were made to benefit a few that should never have been written in the first place. It will impossible to unravel all that.
Report Post »SgtB
Posted on February 2, 2012 at 10:44amGlad to see another person who realizes the dangers of the Wickard v. Filburn decision. Thanks to the Supreme Court, the gov’t can come into your backyard and do whatever it wants. That is not freedom or liberty in my book.
Report Post »DD313
Posted on February 2, 2012 at 11:20amMore like Wicked v. FullBarn to further governmental regulation of everything.
Report Post »booger71
Posted on February 2, 2012 at 11:31amWhat irks me is that subsequent Supreme Courts have always been reluctant to re-visit past Court decisions. It is like they just protecting their brotherhood instead of doing their job in protecting the Constitution.
Report Post »Walkabout
Posted on February 2, 2012 at 5:15pmbooger71
What irks me is that subsequent Supreme Courts have always been reluctant to re-visit past Court decisions.
It is like they just protecting their brotherhood instead of doing their job in protecting the Constitution.
___
You are so correct. Precedent is so sacred to the zombies. You could tell them that slavery would still be legal if precedent was never reversed barring the 14th Amendment.
Precedent is always sacred unless they want something, then it is “What? Precedent? What is that?”
Report Post »thegreatcarnac
Posted on February 2, 2012 at 9:58amThe Congress and other government agencies use the ‘interstate commerce clauses’ to try to control every aspect of America. The original intent meant that the congress would not regulate the whole nation through that clause but to ‘make regular’ the trade between each state. In other words…they would make sure railroad tracks between state would match up at borders and other trade/travel rules would be common. It did not mean what the liberals have turned it into. They try to gather tons of power through the interstate commerce clause. It was not meant to be a route to dictatorship.
Report Post »ozchambers
Posted on February 2, 2012 at 9:55amWhaaa?
Report Post »lukerw
Posted on February 2, 2012 at 9:54amThe Gov’t can regulate any thing… using FDR’s interpretation of the Commerce Clause!
Report Post »TomFerrari
Posted on February 2, 2012 at 10:49amDo I now need a license because I now manufacture “drugs” aka “stem cells?”???
Since we all are drug manufacturers now, can we start manufacturing other drugs too?
What forms do I have to file now???
Report Post »Sirfoldallot
Posted on February 2, 2012 at 9:49amCamel nose under the tent, now he is getting a foot in.
Report Post »TomFerrari
Posted on February 2, 2012 at 10:01amAbsolutely something more going on here!!
Otherwise, blood is or will be a drug, as will sperm and eggs.
Where are the baby killers now? Shouldn’t they be screaming, “hands off my body?”
How long until they start a DNA database and force test us? After all, those stem cells are regulated by the FDA, and they may contain the cure for cancer or some other disease.
Report Post »Note: I suspect they already put all samples, regardless of source or reason, into just such a database. It is just a matter of time til they justify mandatory testing.
oldguy49
Posted on February 2, 2012 at 10:32amtomferrari…………….have you not known that when a child is born in the hospital that the gov take test……….this is so when the healthcare bill is in place they may decide to withhold medical care if that persons test show they are prone to certain disease …….for years the progressives have wanted to purify society
Report Post »Dismayed Veteran
Posted on February 2, 2012 at 10:51amFoot in. The camel has already eaten and is now taking a dump.
Report Post »Inkbottle
Posted on February 2, 2012 at 9:48amCompletely and totally out of control, these federal agencies should be shut down. Next thing you know they will consider white blood cells and red blood cells a drug too!
Report Post »islamhater
Posted on February 2, 2012 at 10:01amYou want these agency’s gone? Vote for Ron Paul.
Report Post »chips1
Posted on February 2, 2012 at 10:03amThat’s a racist comment!!!! Wait till Sharpton hears about you.
Report Post »