FDA is On the Attack Again- They just announced new rules on claims...
Ron Birckhead warns us here that this is the same pattern that was used to subjugate Norway...
Here again, we expose the EAPC, which has infiltrated the supplement industry world wide....
In America: Please help us get cosponsors on HR 2868 which will counterattack this. See IAHF website for information.
In Canada: Support the Foods are Not Drugs Amendment by pushing C-307. (Chretien will never accept a private members bill, but if enough pressure is put on him, he won't have any choice but to adopt the Foods are Not Drugs Amendment.)
Other countries: see IAHF website.

At 05:12 AM 4/25/98 -0400, you wrote:
>Restrictions on Supplement claims beginning in USA..following same exact
>process as in Norway
>
>This WILL also effect the products that LEF mag. says can help prevent
>diseases and products cannot legally claim to
>do such things as "prevent cancer" or "lower cholesterol."
>
> "Friday, the FDA proposed clearing the confusion by prohibiting
> supplements from even implying they can diagnose,
>treat, prevent
> or cure a disease or definitive disease symptom. "
>

Ron, I have the article titled "FDA Rules to Restrict Herbal Remedy Claims" from today's Washington Post. The FDA has never allowed therapeutic claims to be made on dietary supplements, and over the past several years since DSHEA passed they have sent warning letters to a number of companies demanding that they stop making therapeutic claims.

This doesn't stop people from making structure-function claims, and it will only assist me in getting more people working on HR 2868, which WILL allow us to make therapeutic claims, IF we can break past the proGerman influence in NNFA, and CFH.

Right now there is a Mexican standoff on both of those boards. NNFA was going to come out with a public statement condemning the bill, but we were able to head that off and neutralize the attack via a conference call. We have 2 key people on our side: Rae Howard, (former President of NNFA, who is still on their board), and Jim Turner, legislative director of CfH).

What happened in the conference call was that the majority of the people on both the NNFA and CfH boards favored making a public statement condemning HR 2868, but NONE of them were willing to go ON RECORD as being against the bill as long as Howard and Turner were FOR it. Did you see the article I just sent out last night in which I identified the members of the European-American Phytomedicines Coalition? I will attach it here in case you didn't. It would be helpful to get any thoughts you might have re its composition.

>The FDA is circumventing DSHEA by trying to use claims (positive and
>truthful informaiton on their benifits) to redefine foods (supplements) as
>drugs.This is EXACTLY what I have been warning about in my messages (and
>articles in LEF and what is beginning now in the USA). Codex used a
>similiar method.

I know, this is why we have introduced HR 2868, which will remove food from the current overly broad statutory definition of "Drug". The problem is the European American Phytomedicines Coalition, which has infiltrated NNFA, and which undoutedly CREATED CfH in the first place as a vehicle to steer things in the direction they want things to go in. (See the article I posted last night which I am attaching here.) It is very clear to me that Schauss is working for the EAPC and always has been. Murdock is alligned directly with Boerhinger Ingleheim, Lichtwer Pharma, etc, Murdock is working INDIRECTLY with the FDA and so is Schauss, and they ALWAYS HAVE BEEN! They have put up a SMOKESCREEN alled DSHEA, which never has been what people think it is! The EAPC is behind the ASTROTURF groups world wide! All the CfH Chapters which Dag oversees in Scandinavia are fronts for the EAPC.

>In the EU the tighting is continuing and going the next step....dual use
>(which is allowed in the above) is no longer tollerated (the process only
>took 2 years from where you are now to the stage we are at)... here today
>IF a supplement CAN be a food and also have the effects discribed in the
>FDAs Friday proposal then it can ONLY be sold as a medicine. That is the
>next step you will also see in the USA after this one.

The way they are trying to bring this about is via harmonization. Go to http://www.eudra.org/emea.html (There you will find FDA's statement on US-EC Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, which you'll find at http://europa.eu.int/en/comm/dg01/mra03.htm They are trying to force us to full ISO pharmaceutical standards. Murdock and the whole EAPC WANT this so they can knock off their smaller competitors. Alex Schauss is a consultant to Young Living Essential Oils, and he advised them to go to full ISO standards, which they have. He had a reason for advising them to do that. He certainly appears to be working as a double agent and is well aware of all aspects of harmonization and the direction it is going in.

As more proof of what I'm saying, check out this page in S.Africa: www.medicine.co.za where it becomes very clear that they are trying to force us to full ISO pharmaceutical standards. The page is for Shuttle Computer Systems Ltd, a company owned by Rene Doms, who once worked for the South African MCC, and who is responsible for bringing the Australian "listings system" software to S.Africa where he has modified it. (Shuttle Computer Systems licenses vitamin companies to use their software to register products faster and less expensively than the paper route.) Doms is the MD for PharmaNatura, one of the "big 3" which dominates the S.African Health Products Assn. Pharma Natura appears to have been bought out recently by Boerhinger Ingleheim.

We think this because Pharma Natura didn't renew their membership in the HPA, but Boerhinger Ingleheim just became a member. I am really hoping that Saul Kent and Bill Faloon and other vitamin industry CEOs won't ignore what I am trying to point out to them. I am really hoping they will publish the article I just wrote, because the writing is on the wall for this industry, I couldn't agree more with your warnings- its just very hard to alert people with full plates who aren't immersed in this stuff like you and I are.

>>The information of what supplements are used for will in itself make these
>products medicines and illegal to sell as supplements, from April 24th on.
>Enforcement will come on a gradual basis. Where is CfH now? Why the loud
>silence? Alex has told me he was always for the medicine system we have
>here. The same exact situation we had here, when I was writting articles
>for LEF, is what you have there today. I can assure you it will only get
>worse. Saul, I hope you will put priority on a real political effort to
>allow theraputic claims for supplements being defined as foods. This is a
>very critical time in the USA.

Ron- I am going to forward this email out to my whole distribution list and I really do hope people listen. I hope Saul and Bill do at LEF, and I hope EVERYONE out there listens, because you are absolutely correct in your concerns. There is a DIRE need for people to get behind HR 2868, but I have felt like the lone voice crying in the wilderness for far too long. I am very worried about what I see unfolding world wide, because most people are literally asleep at the switch! People should QUIT NNFA and CfH in droves unless their Boards get in sync with Rae Howard, and Jim Turner. If members of NNFA and CfH don't pay attention to what we are saying here, then they will DESERVE their fate.

>This course of events really upsets me an I would like to do something, if
>possible to change this situation. Would it help if I wer

You never completed your sentence, Ron, and I can understand why you stopped writing. You stopped because you feel like no one is listening. Well, I am listening, and so are a lot of people, so please don't give up hope! The IAHF website would not exist if not for your efforts to alert me to what is going on. Every day I check the site log and people from more and more countries are going to our site and our daily hit count has been mounting steadily, averaging now over 3,000 hits per day. I feel terrible bad the whole situation, but haven't given up. You and I clearly see the takeover, but most people don't see it at all. It is very frustrating for me here to try to get cosponsors on HR 2868, which would STOP the takeover here in this country, only to run full tilt into NNFA and CfH at every turn. They certainly show every sign of being manipulated by the EAPC, which I am identifying here:

By doing some digging through the FDA's archives, IAHF has just come up with a list of the names of members of the shadowy trade association known as "The European-American Phytomedicines Coalition." They are represented in Washington DC by the multinational lawfirm Akin,Gump,Strauss, Hauer, and Feld (which has refused to answer any of our questions as to which companies are involved, but now we know because we dug it up.)

We have long suspected Nature's Way of being a part of the EAPC along with their German partners, Madaus and Schwabe.

We were correct in that assumption,(Murdock International is Nature's Way), and we now know that in 1995 the EAPC consisted of Bioforce (Netherlands), Bioforce AG (Switzerland), Bioforce of America (USA), Boerhinger Ingleheim (Germany), Indena (Inverni Della Beffa S.p.A.) (Italy), Instutut Henri Beaufour (France), Lichtwer Pharma GmbH (Germany), Lichtwer US (USA), Madaus AG (Germany), Murdock International (USA), Pharmaton S.A. (Switzerland), R.P. Scherer (U.S.A.), R.P.Scherer (UK), Dr.Wilmar Schwabe GmbH & Co. (Germany), Botanicare Natural Products (Israel), Sunsource Health Products (Hawaii). (More companies may have joined the EAPC in the past 3 years.)

The EAPC submitted an inch thick worth of comments to the FDA in 1995 basically outlining what they would like so that they can dominate the American market. (They've probably taken similar actions in other countries as well.)

They would like for the FDA to establish a botanical review board to review therapeutic claims, allowing them to make claims that go beyond the structure-function claims allowed under DSHEA. The Commission on Dietary Supplement Labels (CDSL) made this recommendation to Congress (on their behalf), when rather than find in favor of the so-called "significant scientific agreement" standard which the FDA uses to arbitrarily block the making of true therapeutic claims, and rather than recommend the creation of an unlevel playing field by advocating the creation of an herbal advisory panel at FDA to rule on OTC drug claims, the Commission on Dietary Supplement Labels SHOULD HAVE defined what kinds and combinations of studies validate claims based on significant scientific evidence.

This is because in the Supreme Court decision of Daubert v. Merrill Dow, (which occurred on June 28, 1993 AFTER passage of NLEA), the "significant scientific agreement standard" was overturned(!) Daubert replaced significant scientific agreement with the Federal Rules of Evidence for admitting scientific testimony at a Federal trial.

So, where does this leave us? The FDA is expected to come out with new regs soon for nutrient content claims, and they will most likely go ahead and CREATE the botanical review board at FDA, but if this happens, it will create an UNLEVEL playing field due to the fact that very few herb companies would be able to AFFORD the move to FULL ISO STANDARDS (Full Pharmaceutical Standards) which Boerhinger Ingleheim, etc, are going to use to drive off their smaller competition.

The US-EC Mutual Recognition Agreement was initialled in June 1997, and is expected to be signed in May 1998. Representatives of the US FDA, the European Commission (DG III) and the European Agency for the Evaluation of Medicinal Products (EMEA) met to exchange initial views on the implementation of the Sectoral Annex for Pharmaceutical Good Manufacturing Practices. In a public statement released on April 2, 1998, the EMEA stated "The scope of the meeting was to develop a better understanding of each others regulatory system and the responsibilities of the organisations to be involved in the implementation of the Sectoral Annex.

The discussions included GMP inspections and mechanisms for the exchange of information. On a basis of the final text of the Sectoral Annex for Pharmaceutical Good Manufacturing Practices, a number of possible agenda items for the first meeting of the Joint Sectoral Committee were identified. This Committee will monitor activities in the transitional and operational periods. The participants agreed to maintain informal contacts until the agreement becomes effective and to exchange information in preparation for the first meeting of the Joint Sectoral Committee which is anticipated to take place in the United States in September 1998.

The text for the MRA Sectoral Annex for Pharmaceutical GMPs can be found at www.fda.gov and at http://europa.eu.int/en/comm/dg01/mra03.htm

This statement, together with other info on the EMEA can be found at www.eudra.org/emea.html"
 

WHAT CAN BE DONE?

In the USA, we need to get cosponsors for HR 2868, which removes FOOD (herbs) from the current overly broad statutory definition of "drug". This will allow anyone to make therapeutic claims on a dietary supplement as long as the claim is true. Why should only the big companies that can meet ISO standards be the only ones allowed to make claims? That would give Boerhinger Ingleheim, Nature's Way, Madaus, Schwabe, Pharmaton, Scherer, Indena, Lichtwer Pharma, Bioforce, Institut Henri Beaufour,Botanicare Natural Products, and Sunsource Health Products a HUGE market advantage.Go to the USA section of this website, download material on HR 2868, call Congress and get others to- we NEED COSPONSORS!

In Canada- please push hard for the Foods are Not Drugs Amendment- do so by pushing C-307, and by getting behind David Rowlands lawsuit, which is the only thing that stopped site licensing. Contact Citizens Voice for Health Rights in BC at 604-793-9087, and Freedom of Choice in Health Care at 416-282-6496. Read Health Naturally Magazine. Go the the Canadian section of this website.

In New Zealand- Get in touch with Healthy Options magazine's editor Janice Priest at 07-578-5120,<options@wave.co.nz> and help derail the Australian listings system. Also get in touch with Ken McIver <healthch@ihug.co.nz>

In South Africa- Get in touch with Stuart Thompson - 04457 7765 or T/Dr. Anthony Rees - 031 231438 of Pharmapact www.angelfire.com/biz/pharmapact/MAIN.html

For other countries, go to the IAHF website. If you have any people or groups to add, please let me know.

For additional info on the agenda of the Pharmaceutical Industry, check out Jorg Grunwald's article

The European Phytomedicines Market
Figures, Trends, Analyses
by Jörg Grünwald, Ph.D.
Director, Medical-Scientific Department
Lichtwer, Pharma GmbH
Berlin, Germany
http://www.healthy.net/Library/journals/HerbalGram/1995/Summer/features/phytomed.htm

Please forward this article widely and send your donation today to IAHF to assist us in our work. No one else is making the effort we are to expose the international pharmaceutical takeover plans! There is still time to monkeywrench the pharmaceutical takeover, but we MUST ACT NOW, or we will LOSE our CHANCE! 

By doing some digging through the FDA's archives, IAHF has just come up with a list of the names of members of the shadowy trade association known as "The European-American Phytomedicines Coalition." They are represented in Washington DC by the multinational lawfirm Akin,Gump,Strauss, Hauer, and Feld (which has refused to answer any of our questions as to which companies are involved, but now we know because we dug it up.)

We have long suspected Nature's Way of being a part of the EAPC along with their German partners, Madaus and Schwabe.

We were correct in that assumption,(Murdock International is Nature's Way), and we now know that in 1995 the EAPC consisted of Bioforce (Netherlands), Bioforce AG (Switzerland), Bioforce of America (USA), Boerhinger Ingleheim (Germany), Indena (Inverni Della Beffa S.p.A.) (Italy), Instutut Henri Beaufour (France), Lichtwer Pharma GmbH (Germany), Lichtwer US (USA), Madaus AG (Germany), Murdock International (USA), Pharmaton S.A. (Switzerland), R.P. Scherer (U.S.A.), R.P.Scherer (UK), Dr.Wilmar Schwabe GmbH & Co. (Germany), Botanicare Natural Products (Israel), Sunsource Health Products (Hawaii). (More companies may have joined the EAPC in the past 3 years.)

The EAPC submitted an inch thick worth of comments to the FDA in 1995 basically outlining what they would like so that they can dominate the American market. (They've probably taken similar actions in other countries as well.)

They would like for the FDA to establish a botanical review board to review therapeutic claims, allowing them to make claims that go beyond the structure-function claims allowed under DSHEA. The Commission on Dietary Supplement Labels (CDSL) made this recommendation to Congress (on their behalf), when rather than find in favor of the so-called "significant scientific agreement" standard which the FDA uses to arbitrarily block the making of true therapeutic claims, and rather than recommend the creation of an unlevel playing field by advocating the creation of an herbal advisory panel at FDA to rule on OTC drug claims, the Commission on Dietary Supplement Labels SHOULD HAVE defined what kinds and combinations of studies validate claims based on significant scientific evidence.

This is because in the Supreme Court decision of Daubert v. Merrill Dow, (which occurred on June 28, 1993 AFTER passage of NLEA), the "significant scientific agreement standard" was overturned(!) Daubert replaced significant scientific agreement with the Federal Rules of Evidence for admitting scientific testimony at a Federal trial.

So, where does this leave us? The FDA is expected to come out with new regs soon for nutrient content claims, and they will most likely go ahead and CREATE the botanical review board at FDA, but if this happens, it will create an UNLEVEL playing field due to the fact that very few herb companies would be able to AFFORD the move to FULL ISO STANDARDS (Full Pharmaceutical Standards) which Boerhinger Ingleheim, etc, are going to use to drive off their smaller competition.

The US-EC Mutual Recognition Agreement was initialled in June 1997, and is expected to be signed in May 1998. Representatives of the US FDA, the European Commission (DG III) and the European Agency for the Evaluation of Medicinal Products (EMEA) met to exchange initial views on the implementation of the Sectoral Annex for Pharmaceutical Good Manufacturing Practices. In a public statement released on April 2, 1998, the EMEA stated "The scope of the meeting was to develop a better understanding of each others regulatory system and the responsibilities of the organisations to be involved in the implementation of the Sectoral Annex.

The discussions included GMP inspections and mechanisms for the exchange of information. On a basis of the final text of the Sectoral Annex for Pharmaceutical Good Manufacturing Practices, a number of possible agenda items for the first meeting of the Joint Sectoral Committee were identified. This Committee will monitor activities in the transitional and operational periods. The participants agreed to maintain informal contacts until the agreement becomes effective and to exchange information in preparation for the first meeting of the Joint Sectoral Committee which is anticipated to take place in the United States in September 1998.

The text for the MRA Sectoral Annex for Pharmaceutical GMPs can be found at www.fda.gov and at http://europa.eu.int/en/comm/dg01/mra03.htm

This statement, together with other info on the EMEA can be found at www.eudra.org/emea.html"
 

WHAT CAN BE DONE?

In the USA, we need to get cosponsors for HR 2868, which removes FOOD (herbs) from the current overly broad statutory definition of "drug". This will allow anyone to make therapeutic claims on a dietary supplement as long as the claim is true. Why should only the big companies that can meet ISO standards be the only ones allowed to make claims? That would give Boerhinger Ingleheim, Nature's Way, Madaus, Schwabe, Pharmaton, Scherer, Indena, Lichtwer Pharma, Bioforce, Institut Henri Beaufour,Botanicare Natural Products, and Sunsource Health Products a HUGE market advantage.Go to the USA section of this website, download material on HR 2868, call Congress and get others to- we NEED COSPONSORS!

In Canada- please push hard for the Foods are Not Drugs Amendment- do so by pushing C-307, and by getting behind David Rowlands lawsuit, which is the only thing that stopped site licensing. Contact Citizens Voice for Health Rights in BC at 604-793-9087, and Freedom of Choice in Health Care at 416-282-6496. Read Health Naturally Magazine. Go the the Canadian section of this website.

In New Zealand- Get in touch with Healthy Options magazine's editor Janice Priest at 07-578-5120,<options@wave.co.nz> and help derail the Australian listings system. Also get in touch with Ken McIver <healthch@ihug.co.nz>

In South Africa- Get in touch with Stuart Thompson - 04457 7765 or T/Dr. Anthony Rees - 031 231438 of Pharmapact www.angelfire.com/biz/pharmapact/MAIN.html

For other countries, go to the IAHF website. If you have any people or groups to add, please let me know.

For additional info on the agenda of the Pharmaceutical Industry, check out Jorg Grunwald's article

The European Phytomedicines Market Figures
Trends, Analyses
by Jörg Grünwald, Ph.D.
Director, Medical-Scientific Department
Lichtwer Pharma GmbH
Berlin, Germany
http://www.healthy.net/Library/journals/HerbalGram/1995/Summer/features/phytomed.htm

Please forward this article widely and send your donation today to IAHF to assist us in our work. No one else is making the effort we are to expose the international pharmaceutical takeover plans! There is still time to monkeywrench the pharmaceutical takeover, but we MUST ACT NOW, or we will LOSE our CHANCE!