FDA, B6, Conspiracies and Culture Wars



The following has been suggested:
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In 2009 the FDA changed the status of readily available supplement, a
form of B6 called Pyridoxamine, to a drug - thus removing free
availably to a substance that's been shown to have unique benefits to
diabetic complications. Pyridoxamine had been available for years
without prescription to all US citizens. And now free access was
denied and exclusive distribution rights were given to a drug company,
Biostratum, that was completing final testing.
Keep in mind that pyridoxamine is one of six substances that qualify
as B6.
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Shockingly (to me) I discovered the above was true. Whoa, Could the
FDA actually be as corrupt as would appear. Could the claims of those
I've accused of paranoia and conspiracy fantasies actually have been
right after all. There seemed to be no way to resolve the
contradiction. I decided to dig deeper and obtained the actual FDA
report on the ruling here: http://tinyurl.com/7m7ag26

After I read the full report I was impressed with FDA's fairness in
dealing with the issue and felt their decision was ethical, consistent
with the law and supported the common good.

Before I summarize the reasoning behind the ruling I'd like to review
current US law regarding supplements as it differs quite a bit from
Europe (and Australia/Canada - I believe).
In 1994 the US Congress passed the "Dietary Supplement Health and
Education Act of 1994" (DSHEA). This legislation was supported and
sponsored by the supplement industry (much to the consternation of the
FDA) and allowed for the very lenient rules regarding supplements as
compared to (most) developed countries.

Under this legislation:
-FDA regulates supplements as foods, not drugs.
-Supplement manufactures do not have to established the safety of the
supplement.
-The FDA must prove a supplement "unsafe" to remove it's status as a
supplement
-All a supplement manufacturer must do is notify the FDA of the
substance they want to distribute and, unless the FDA proves
supplement unsafe it can be marketed 90 days latter. The supplement
will be listed on the FDA's web site.
-Once the substance is marketed, it can not be removed from supplement
status to be marketed exclusively as a drug.
-A substance can be given "investigational new drug" status and not
be available as a supplement only if these 3 conditions are satisfied:
1. The substance had Not been previously marketed as a supplement.
2. Substantial clinical investigations had been instituted for the
substance. Note - This cost money that Biostratum provided
3. These clinical investigations had been made public. Note
Biostratum had to make it's investigations public and that's when the
supplement industry started labeling and producing/marketing
concentrated pyridoxamine supplements.

Here’s the history and reasoning of the ruling:
In 1999 Biostratum applied for "Investigational New Drug (IND)" status
for pyridoxamine. They supplied proof that they had fulfilled FDA
requirements by proving they had done "substantial clinical
investigations" and had made these investigations public. The FDA then
granted IND status to Biostratum for pyridoxamine.

Before 1999 there were no supplements that were labeled pyridoxamine
or that contained concentrated pyridoxamine. Vitamin supplement using
B6 used one of the other forms of B6. The supplement industry was
ignorant of the benefits of pyridoxamine and did not promote/produce a
product as such.

It was only after Biostratum released it's research on pyridoxamine,
as required by the FDA, that the supplement industry Hijacked the
information and started producing and marketing pyridoxamine
supplements.

Initially, Biostratum privately contacted supplement companies and
most agreed not to manufacture pyridoxamine. But they couldn't contain
the situation and in 2005 submitted a petition to the FDA stop
supplement companies from manufacturing pyridoxamine and to clarify
that the status of pyridoxamine as a “investigational new drug” and
not a supplement. In 2009 the FDA refused any enforcement, but did
clarify that pyridoxamine was no longer a supplement, but a
"Investigational New Drug (IND)" .

It's important the note that the FDA made it very clear in their
report that if there were any supplements labeled as pyridoxamine
before 1999 - supplement status would not have been removed and
pyridoxamine would still be available. From the report:

//*******************************************************************
"The prior market clause does, however, permit continued marketing of
a dietary supplement that was first marketed as such or as a food,
even if the article is subsequently shown to have therapeutic benefit
and is studied or approved as a new drug. In such a case, the dietary
supplement was on the market first and should not be penalized simply
because a drug manufacturer later chooses to study or seek approval
for the article as a new drug."
//*******************************************************************

And here:
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The prior market clause does, however, permit continued marketing of a
dietary supplement that was first marketed as such or as a food, even
if the article is subsequently shown to have therapeutic benefit and
is studied or approved as a new drug. In such a case, the dietary
supplement was on the market first and should not be penalized simply
because a drug manufacturer later chooses to study or seek approval
for the article as a new drug.
//*******************************************

Without protecting companies that are researching substances in foods/
herbs/botanicals that have NOT previously been marketed as
supplements, independent research on potential drugs from food and
herbs would stop. In fact the unique properties of pyridoxamine would
likely not have been discovered.

From the report:
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The prior market clause in 21 U.S.C. 321(ff)(3) establishes a system
for determining whether articles will be deemed dietary supplements or
drugs, and regulated accordingly, depending on how such articles were
marketed and categorized when they first entered the marketplace.
Stated simply, the prior market clause prohibits the marketing as
dietary supplements articles that have gained recognition in the
marketplace as new drugs by being approved or studied as new drugs.2
DSHEA reflects Congress's determination that to allow such an article
to be marketed as a dietary supplement would not be fair to the
pharmaceutical company that brought, or intends to bring, the drug to
market, and would serve as a disincentive to the significant
investment needed to gain FDA approval of new drugs.
//****************************************************

In summary:
If the supplement industry had produced one product labeled as
pryidoxamine before 1999 it would still be available as a supplement.

Instead Biostratum had fulfilled FDA requirements (done significant
research and made its finding public) to establish pryidoxamine an
"investigation new drug" removing it from supplements status.

If these rules had not been in place it's doubtful that research would
have been done to show the unique qualities of pryidoxamine.

Here's the summary from the FDA report:

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"Pyridoxamine dihydrochloride is authorized for investigation as a new
drug under the name Pyridorin. The IND for pyridoxamine
dihydrochloride was filed with FDA in July 1999 and went into effect
on August 2, 1999. Substantial clinical investigations have been
conducted and the existence of those studies has been made public.
There is no verifiable, contemporaneous evidence documenting that
pyridoxamine dihydrochloride or any other compound containing
pyridoxamine as its active moiety was marketed as a dietary supplement
or as a food prior to pyridoxamine's authorization for investigation
as a new drug under an IND. Accordingly, a product containing
pyridoxamine is not a dietary supplement as defined in 21 U.S.C.
321(fl) and may not be marketed as such. For the reasons stated above,
FDA has· granted your request to establish a new docket for your
citizen petition and denied your requests that the agency 1) state in
writing that dietary supplements that contain pyridoxamine are
adulterated under the Act and 2) exercise its enforcement authority
under the Act to remove from United States interstate commerce dietary
supplements containing pyridoxamine."
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Regards
Randy
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