Looks like I've answered my own question:
http://en.wikipedia.org/wiki/Food_and_Drug_Administration#Vaccines.2C_blood_and_tissue_products.2C_and_biotechnology
On Fri, Feb 3, 2012 at 2:31 AM, Patrik <patrikd@gmail.com> wrote:
> Antibodies are a good example. Anyone know whether blood transfusions
> and skin grafts fall under similar regulations?
So it seems the FDA regulates all these things... is this article just
crap then? I'm sure there's a lot of regulations to follow, but the
argument seems a little uninformed about the biologics law of 1902
(110 years ago the citizens cared about companies selling junk
products, so they made regulation into law)
>
> On Feb 2, 10:10 pm, CodonAUG <elsbe...@gmail.com> wrote:
>> Stem cells are biologics and do not fall under the same category as
>> small molecule drugs. Similar issues apply to the way antibodies are
>> produced and used as drugs. If this kind of wording/loophole is not
>> used (and it has to because congress wont change the FDA) then you
>> will have a bunch of clinics popping up that use stem cells that are
>> not tested for safety and efficacy before being sold.
>>
>> On Feb 2, 1:54 pm, Bryan Bishop <kanz...@gmail.com> wrote:
>>
>>
>>
>>
>>
>>
>>
>> > this is a bit editorialized but sad-if-true
>>
>> > From: Anthony Loera <anth...@revgenetics.com>
>> > Date: Thu, Feb 2, 2012 at 2:45 PM
>> > Subject: [GRG] Stem Cells Are Drugs - FDA
>> > To: Gerontology Research Group <g...@lists.ucla.edu>
>>
>> > FDA's New Claim: "Your Body Is a Drug—and We Have the Authority to Regulate
>> > It!"
>>
>> > In another outrageous power-grab, FDA says your own stem cells are
>> > drugs—and stem cell therapy is interstate commerce because it affects the
>> > bottom line of FDA-approved drugs in other states!
>>
>> > 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:
>>
>> > 1. 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!)
>> > 2. 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<http://www.hpm.com/pdf/blog/GovernmentSupportforSummaryJudgmentMotion...>
>> > ."
>>
>> > 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<http://www.anh-usa.org/readers-corner-can-physicians-prescribe-drugs-...>,
>> > 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<http://www.hpm.com/pdf/blog/GovernmentSupportforSummaryJudgmentMotion...>.
>> > 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.
>>
>> > Last year we ran a two-part series on the current status of federal and
>> > state law—and FDA jurisdiction—and how it affects integrative treatments (part
>> > one<http://www.anh-usa.org/readers-corner-can-doctor-get-into-trouble-off...>
>> > and part two<http://www.anh-usa.org/why-selling-natural-products-is-such-a-dangero...>
>> > ).
>>
>> > The Centeno-Schultz Clinic takes your blood, puts it into a centrifuge
>> > machine that separates the stem cells, and a doctor puts them back in your
>> > body where there is damaged tissue. The clinic has argued numerous times
>> > that stem cells aren't drugs because they are components of the patient's
>> > blood from his or her own body.
>>
>> > The FDA says 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." There they go again, saying that components of your body are
>> > drugs and they have the authority to regulate them! It's the only way the
>> > agency can claim that adult stem cell therapy is within FDA's purview.
>>
>> > However, the agency seems to be of two minds. When *ESPN* magazine was
>> > doing a story on stem cell
>> > treatments<http://espn.go.com/espn/story/_/id/7058209/peyton-manning-last-star-l...>,
>> > the FDA stated that US policy is to allow the injection of stem cells that
>> > are treated with "minimal manipulation," which federal regulations define
>> > as "processing that does not alter the relevant biological characteristics
>> > of cells or tissues"—which is certainly the case with the Regenexx clinic.
>>
>> > Despite this policy, FDA has been attacking the clinic for the past four
>> > years. They have tried injunctions and demanded inspections in their
>> > attempts to make the company bend; this court battle is merely the latest
>> > salvo.
>>
>> > The primary role of adult stem cells in a living organism is to maintain
>> > and repair the tissue in which they are found. The hard part has been to
>> > get enough of them. But new technology is giving doctors the ability to
>> > obtain more stem cells from a patient than previously thought possible,
>> > which is why we're now seeing new treatments. Blood, fat, or tissue is
>> > withdrawn from the patient, stem cells are obtained using one of these new
>> > processes, and the cells are injected back into the patient where they can
>> > repair the patient's tissue.
>>
>> > Gov. Rick Perry received this kind of stem cell
>> > therapy<http://www.huffingtonpost.com/2011/08/22/adult-stem-cells-back-pain_n...>.
>> > We and others noted that the governor's defense of freedom of healthcare
>> > choice when it came to his own treatment was starkly at odds with his
>> > directive to administer HPV vaccines to young girls against their own (and
>> > their parents') wishes. It's also at odds with his support for some of the
>> > most egregious witch-hunters on the Texas State Medical Board, which he
>> > appoints.
>>
>> > Behind Perry's blatant inconsistency and the latest FDA attempted power
>> > grab lies the same problem: a medical system run by special interests under
>> > the leadership of the US government, the same government that is supposed
>> > to represent "we the people."
>> > Article is From:http://www.anh-usa.org/fda-new-claim-body-is-a-drug/
>>
>> > If this is true, I have issues with it.
>>
>> > Anthony Loera
>> > President
>> > RevGenetics
>> > (P)888-738-4363
>> > (Pl) 305-938-0889 - Local number
>> > (F) 866-430-3953
>>
>> >www.RevGenetics.com
>> > FDA Registration: 12631095756
>>
>> > _______________________________________________
>> > GRG mailing list
>> > G...@lists.ucla.eduhttp://lists.ucla.edu/cgi-bin/mailman/listinfo/grg
>>
>> > --
>> > - Bryanhttp://heybryan.org/
>> > 1512 203 0507
>
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