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Pharmas Attack on pyridoxamine dihydrochloride or any other compound c


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#1 Anthony_Loera

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Posted 27 January 2009 - 06:56 PM


I just received this from the NPA, although we don't sell any it bothers me because if this goes through it can have a domino effect on many supplements you maybe taking today:

Special Request for Assistance with Response to FDA Regarding Pyridoxamine

Natural Products Association Supply Members:

The Natural Products Association needs your help. Enclosed is the Food and Drug Administration’s (FDA) response to a citizen petition filed on behalf of a pharmaceutical company (http://www.naturalpr....pdf?docID=9001). FDA has determined that products containing pyridoxamine, a form of vitamin B6 (the letter specifically cites "pyridoxamine dihydrochloride or any other compound containing pyridoxamine") are not dietary supplements within the meaning as indicated by DSHEA, specifically Federal Food, Drug, and Cosmetic (FFDC) Act § 201(ff) and "may not be marketed as such."

In a confusing twist, the agency goes on to clarify that although pyridoxamine is a dietary ingredient within the meaning of § 201(ff)(1), FDA has determined by the petition that pyridoxamine is excluded under § 201(ff)(3) because:

1. pyridoxamine is authorized for investigation as a new drug for which substantial clinical investigations have been conducted and their existence made public; and
2. there is no "independent, verifiable evidence" of prior marketing of pyridoxamine as a food or dietary supplement; this includes the Natural Products Association’s (developed as NNFA) list of grandfathered ingredients.

While this development presents a number of problems, including the agency's interpretation of §301 (ll) of the FFDC Act (which prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added), the Natural Products Association has contacted the agency regarding the submission of records and documentation to the agency demonstrating that products containing pyridoxamine were marketed pre-DSHEA. For that, the NPA needs your help. If you have sales records, shipping orders, labels and/or other relevant documentation that clearly demonstrates that pyridoxamine was in commerce prior to DSHEA, please contact Daniel Fabricant, Ph.D., NPA vice president, scientific and regulatory affairs, via e-mail (dfabricant@naturalproductsassoc.org) at your earliest convenience.


Please pass this on to suppliers and folks that are interested in this possibly large can of worms...

A

#2 StrangeAeons

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Posted 27 January 2009 - 07:38 PM

I get the impression this ties in really heavily to the P5P issues. The pharmaceuticals appear to have their sights set on B6.

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#3 rubegoldberg

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Posted 28 January 2009 - 02:40 AM

what date "clearly demonstrates that pyridoxamine was in commerce prior to DSHEA"?

#4 rwac

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Posted 28 January 2009 - 03:06 AM

what date "clearly demonstrates that pyridoxamine was in commerce prior to DSHEA"?


Heres' the relevant section from DSHEA

http://www.fda.gov/o...laws/DSHEA.html

"NEW DIETARY INGREDIENTS

  • "SEC. 413. (a) IN GENERAL.- A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 402(f) unless it meets one of the following requirements:
    • "(1) The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.
    • "(2) There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
    The Secretary shall keep confidential any information provided under paragraph (2) for 90 days following its receipt. After the expiration of such 90 days, the Secretary shall place such information on public display, except matters in the information which are trade secrets or otherwise confidential, commercial information.
  • "(b) PETITION. - Any person may file with the Secretary a petition proposing the issuance of an order prescribing the conditions under which a new dietary ingredient under its intended conditions of use will reasonably be expected to be safe. The Secretary shall make a decision on such petition within 180 days of the date the petition is filed with the Secretary. For purposes of chapter 7 of title 5, United States Code, the decision of the Secretary shall be considered final agency action.
  • "© DEFINITION. - For purposes of this section, the term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.".



I believe that's the date Anthony may be talking about, October 15, 1994.
Anthony should confirm ...

EDIT: Whoops. from the document itself:

The fact that pyridoxamine is authorized for investigation as a new drug does not automatically exclude it from being a dietary supplement. This is because under the prior market clause in 21 U.S.c. 321(ff)(3)(B)(ii), pyridoxamine would still qualify as a dietary supplement if it had been "marketed as a dietary supplement or as a food" before being authorized for investigation as a new drug on September 1, 1999.

Edited by rwac, 28 January 2009 - 03:46 AM.


#5 ortcloud

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Posted 28 January 2009 - 03:13 AM

You just got this from the NPA ?

Are you sure that this is current and the FDA is pursuing this ?

As they are a little late, this whole situation with biostratum was years ago.

Heck from what I understand they arent even in business anymore !

Maybe this got delayed in the courts or something I would be really shocked if the fda is still
pursuing this. Unless some other company re-licensed the patent and is trying to revive this.

Does anyone know the current status of this ?


(P-5-P is a whole different story)

#6 rubegoldberg

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Posted 28 January 2009 - 03:37 AM

http://triangle.bizj.../17/story2.htmlFriday, October 14, 2005Big problem for BioStratumCompany spends millions on drug, then finds central compound on InternetAfter pumping about $100 million over 11 years into a biotech company developing a promising treatment for diabetic kidney disease, investors in BioStratum discovered the drug's only active ingredient is sold on the Internet to anybody with a credit card. ...undoubtedly, after Biostratum went BK, its officers moved on to WS investment banks.

#7 OneScrewLoose

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Posted 28 January 2009 - 07:02 AM

http://triangle.bizj.../17/story2.html Friday, October 14, 2005 Big problem for BioStratumCompany spends millions on drug, then finds central compound on Internet After pumping about $100 million over 11 years into a biotech company developing a promising treatment for diabetic kidney disease, investors in BioStratum discovered the drug's only active ingredient is sold on the Internet to anybody with a credit card. ... undoubtedly, after Biostratum went BK, its officers moved on to WS investment banks.


...in a word...

BAHAHAHAHAHAHAHAHA

frickin' hilarious

#8 Anthony_Loera

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Posted 28 January 2009 - 04:34 PM

Hi Guys,

yes I just got this from the NPA (see attached it shows the document dates).

I believe the 1999 date is the one to be concerned about in this case because of the "investigation as a new drug" status in 1999, although I am sure the 1994 date still applies if it has been found that someone has sold this before 1999.


Issue one:
The company filed to study this as an "investigation as a new drug" in 1999, which they were granted. The FDA's stance on this is... if this substance has not been sold before as a supplement and anyone files an IND, then it is considered a drug and the company possibly has protection for some years. So the date these guys are talking about is the 1999 date. If however it is found that it was sold prior to 1999, then it can be considered a supplement as well as a "investigation as a new drug" (due to research and claims). If it has not been found to be sold prior to 1999 when the IND was granted, then the FDA says it cannot be sold as a supplement.

Ok, say someone here provides a receipt that they bought this before the 1999 date... say in 1998... then the second challenge that needs to be fought comes into play, and although similar, it is technically a different issue, but for B6... it's really a non-issue because of it's proven safety:

Issue two:
Was this sold prior to 1994 or is it considered a new dietary ingredient?




A

Attached Files



#9 StrangeAeons

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Posted 28 January 2009 - 10:50 PM

(P-5-P is a whole different story)


I find it hard to believe that there are two nearly identical FDA petitions trying to get a supplement taken off the market so that it can be sold as a drug, for two vitamers of B6, and that there's no connection; though I suppose there is some precedent with variants of a vitamin being sold as a drug (see Accutane and Retin-A).

Anyways, regardless of my poor understanding of the topic, here is the thread discussing this issue some years ago, initiated by the nefarious LifeMirage. Pardon me for sounding cynical, Anthony, but I get the impression this topic is coming to light because you're considering pyridoxamine for one of your products.

#10 Anthony_Loera

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Posted 29 January 2009 - 01:15 AM

Actually,

we will stick with Resveratrol, and 2 others for most of this year. The neither of the last 2 is pyridoxamine.

Sure we may actually combine a few ingredients other than those mentioned in a capsule or two along with one of our main ingredients for the first time as well...

<deleted>

Cheers
A

Edited by Anthony_Loera, 29 January 2009 - 01:16 AM.


#11 jagged

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Posted 29 January 2009 - 04:19 PM

http://triangle.bizj.../17/story2.html Friday, October 14, 2005 Big problem for BioStratumCompany spends millions on drug, then finds central compound on Internet After pumping about $100 million over 11 years into a biotech company developing a promising treatment for diabetic kidney disease, investors in BioStratum discovered the drug's only active ingredient is sold on the Internet to anybody with a credit card. ... undoubtedly, after Biostratum went BK, its officers moved on to WS investment banks.


...in a word...

BAHAHAHAHAHAHAHAHA

frickin' hilarious


They are now Nephrogenex and appear alive and well and in clincals.

http://www.nephrogenex.com/

#12 rubegoldberg

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Posted 29 January 2009 - 11:36 PM

http://www.nephrogen...s... 8 2006.pdf

May 9, 2006 – NephroGenex, Inc, a privately held drug development company focusing on kidney disease, announced today the signing of a licensing agreement with BioStratum Incorporated that acquires commercial rights to Pyridorin™ (pyridoxamine dihydrochloride) for diabetic nephropathy.

#13 ortcloud

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Posted 30 January 2009 - 04:14 AM

http://www.nephrogen...s... 8 2006.pdf

May 9, 2006 – NephroGenex, Inc, a privately held drug development company focusing on kidney disease, announced today the signing of a licensing agreement with BioStratum Incorporated that acquires commercial rights to Pyridorin™ (pyridoxamine dihydrochloride) for diabetic nephropathy.


holy cow they are still going !! what a bummer, I was hoping they crashed and burned.

Thank you for finding this. Well, this makes sense why the fda is still popping off.
I am bummed that Jarrow stopped selling it. I liked the fact that they stood up
to the fda, well now it is up to life extension as I see they are selling it now, and
I know they are always up for a fight with the feds. I am going to keep an
eye on how this plays out. I suspect that lef and fda will fight it out and determine
the availability of this in the end.

#14 neogenic

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Posted 04 February 2009 - 01:42 PM

From Natural Products Insider:

FDA Nixes Pyridoxamine in Supplements
02/02/2009
WASHINGTON—Pyridoxamine, a form of vitamin B6, cannot be used in dietary supplements, according to FDA. The agency responded to a 2005 petition filed by Biostratum Inc. asking for clarification on the regulatory status of the ingredient; the company manufactures Pyridorin (pyridoxamine dihydrochloride) and has been the subject of investigational new drug studies since 1999. While no enforcement action will be taken against companies that have been marketing dietary supplements containing pyridoxamine, those products can no longer be sold as dietary supplements.

FDA’s decision, background information and comments can be seen online.

The Council for Responsible Nutrition (CRN) had filed comments with FDA regarding the Biostratum petition. In a statement from Andrew Shao, Ph.D., CRN’s vice president, scientific and regulatory affairs, the association said it was disappointed with FDA’s decision, and particularly with the extensive evidence the agency is seeking regarding the status of ingredients marketed as supplements prior to passage of the Dietary Supplement Health & Education Act (DSHEA). He noted, “Demanding that industry maintain these records, but failing to work with industry to develop an agreed-upon list of ‘grandfathered ingredients,’ places more burden on dietary supplement companies to be sure that they can substantiate that an ingredient has in fact previously been marketed as a dietary supplement.” Shao added the decision could set a precedent for companies to challenge the status of other dietary ingredients.

#15 Anthony_Loera

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Posted 04 February 2009 - 03:11 PM

“Demanding that industry maintain these records, but failing to work with industry to develop an agreed-upon list of ‘grandfathered ingredients,’ places more burden on dietary supplement companies to be sure that they can substantiate that an ingredient has in fact previously been marketed as a dietary supplement.” Shao added the decision could set a precedent for companies to challenge the status of other dietary ingredients.


I couldn't have said it any better myself...

A

#16 ortcloud

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Posted 05 February 2009 - 05:13 AM

From Natural Products Insider:

FDA Nixes Pyridoxamine in Supplements
02/02/2009
WASHINGTON—Pyridoxamine, a form of vitamin B6, cannot be used in dietary supplements, according to FDA. The agency responded to a 2005 petition filed by Biostratum Inc. asking for clarification on the regulatory status of the ingredient; the company manufactures Pyridorin (pyridoxamine dihydrochloride) and has been the subject of investigational new drug studies since 1999. While no enforcement action will be taken against companies that have been marketing dietary supplements containing pyridoxamine, those products can no longer be sold as dietary supplements.

FDA’s decision, background information and comments can be seen online.

The Council for Responsible Nutrition (CRN) had filed comments with FDA regarding the Biostratum petition. In a statement from Andrew Shao, Ph.D., CRN’s vice president, scientific and regulatory affairs, the association said it was disappointed with FDA’s decision, and particularly with the extensive evidence the agency is seeking regarding the status of ingredients marketed as supplements prior to passage of the Dietary Supplement Health & Education Act (DSHEA). He noted, “Demanding that industry maintain these records, but failing to work with industry to develop an agreed-upon list of ‘grandfathered ingredients,’ places more burden on dietary supplement companies to be sure that they can substantiate that an ingredient has in fact previously been marketed as a dietary supplement.” Shao added the decision could set a precedent for companies to challenge the status of other dietary ingredients.



So the official salvo has been launched. Lets see what lef's move is in response.

http://www.lef.org/V...amine-Caps.html

#17 pycnogenol

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Posted 05 February 2009 - 04:47 PM

Now LEF "Pyridoxamine Caps" on iHerb is out-of-stock. It wasn't yesterday or the day before or. . . Hmm. . .

http://www.iherb.com...p...711494&at=0

Edited by pycnogenol, 05 February 2009 - 04:48 PM.


#18 pycnogenol

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Posted 06 February 2009 - 01:14 AM

Hey everyone...OK, I just got back a response from LEF about Pyridoxamine:

From: advisory@lifeextension.com
Subject: Pyridoxamine
Date: February 5, 2009 6:30:30 PM CST
To: [redacted] @ [redacted].net

"Thank you for contacting Life Extension. At this time we are planning to continue our pyridoxamine products. This nutrient is,
after all, a vitamin, and it requires convoluted logic to turn a vitamin into a drug. The Council for Responsible Nutrition is working to override
this absurd FDA ruling, which of course was taken at the behest of a drug company."


Dave Tuttle
Dept. of Correspondence
Life Extension Scientific Information, Inc.


FDA finds vitamin B6 form not legal in supplements:

http://www.nutraingr...-in-supplements

Edited by pycnogenol, 06 February 2009 - 01:21 AM.


#19 youandme

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Posted 06 February 2009 - 09:34 AM

Does this ruling apply to the world... ? How long would it take to ripple across the planet..

This is a really worrying development.

#20 neogenic

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Posted 06 February 2009 - 01:48 PM

They have active D, the active folate now (metafolin/5-methyltetrahydrofolate), and now pyridoxamine. You know methylcobalamin has plenty of pharmaceutical potential...that's got to be next.

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#21 ortcloud

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Posted 07 February 2009 - 12:57 AM

Thank you for posting this, I was confident that they were up for a fight, but it is always re-assuring to hear it from them.

Hey everyone...OK, I just got back a response from LEF about Pyridoxamine:

From: advisory@lifeextension.com
Subject: Pyridoxamine
Date: February 5, 2009 6:30:30 PM CST
To: [redacted] @ [redacted].net

"Thank you for contacting Life Extension. At this time we are planning to continue our pyridoxamine products. This nutrient is,
after all, a vitamin, and it requires convoluted logic to turn a vitamin into a drug. The Council for Responsible Nutrition is working to override
this absurd FDA ruling, which of course was taken at the behest of a drug company."


Dave Tuttle
Dept. of Correspondence
Life Extension Scientific Information, Inc.


FDA finds vitamin B6 form not legal in supplements:

http://www.nutraingr...-in-supplements






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