Streaming ‘We become Silent’ from ANH siteAbout Codex 4-9 July 2005
so we don’t become silentClick here to read the governmental plans.
World Health Freedom Initative
I will raise a foundation and a company. The foundation is for providing free information about natural health & peace. The company is there to sell products in the rich western world and for every sold product in the western world there is going to be one free product given in Africa and parts of Asia which are not wealthy. In other words: The rich countries will be helping the poor directly by giving them REAL health care. Not the one which is put together by the pharmaceutical industries.
With kind regards,
World Health Freedom Foundation
Translation from German text proves EU is protecting Pharma Industry by all means Ad. 1 to writing of 9.2.2001 quotations from European Union guidelines: (65/65/EWG); (87/19/EWG); 87/22/EWG)
Guideline of the advice of 26.1.1965 for the adjustment of the on the right of and administrative writings of Medicaments (65/65/EWG): “All on the right of and administrative writings in the area of the production and the selling of Medicine must primarily serve the protection of the public health. This target must be achieved however with means, those the development of the pharmaceutical industry and the trade with pharmaceutical products within the community cannot be restrained. The differences between some regulations of the individual nations, in particular between the regulations of medicaments with exception of such materials and material-composition, which are food, feeds or bodycare -, obstruct the trade with Medicaments within the community and affect themselves thus directly the reaching and functioning the Common Market off.
Therefore these obstacles have to be eliminated; for this purpose an adjustment of the relating legislation is necessary. Guideline of the advice of 22.12.1986 on changing the guideline 75/318/EWG for the adjustment of the on the right of and administrative regulations of the member state the analytic, toxicological-pharmakological and medical or clinical regulations and proofs on attempts with medicaments (87/19/EWG). The attempts with medicaments must regularly be adapted to scientific and technical progress, to keep an optimal general health protection in the community. The guideline of the advice of 22.12.1986 for the adjustment concerning of the measures of the individual nations the circulation of technologically high-quality medicaments, in particular from the biotechnology (87/22/EWG). “Technologisch high-quality medicaments, which are the result of a long and expensive research, will be further only developed in Europe, if its favourable legal prerequisites and in particular the same conditions for the bringing the medicaments into circulation in the whole community are equal.”
March on Brussels [for political reasons…] – from 1995 – action for Rwanda in the Netherlands & Belgium – still very actual.
That wat tore the heart of the world,
on which the Netherlands and Vlaanderen (Piece of Belgium, talking Dutch),
is grieving with seven Television nets,
didn’t come out of the dark.
It is there because there has passed something before.
And what happens in Rwanda,
happens on the Balkan,
It happens also in Sudan,
and maybe it happens in Nigeria too.
Although, that last is not likely,
because in that country is much oil,
and it has other materials for sale,
that gives always a positive turn on the march,
of events in history.
Of course, I support
that we must give much money
on accountnumber 5 5 5.
but what I insist on too, is that after paying for the helping here,
another action should not longer be put on the line.
There is much pain and much suffering
in the longer the more places
You won’t loose the evil in the world,
but you don’t have to be a phantast
With the genocide that passed in the near past,
the slaugtering and deportations,
from Mostar until Ghoma
could not escalate so strongly
with less doubtful and amphibious operations,
from Europe and the U.N.
Does these politics without pressure of the public
ever become integer and powerful
If the people,
and the people WE ARE,
fall silent after donating these emergency rotations,
Why should they, who represent our people, use their mouth anyway?
We cannot visit the Anne-Frank house in Amsterdam
On May 4th the flag hanging halfway its flagstaff,
regret the haulocaust
and that what should never happen again,
let exist anyway.
That existing anyway,
that the guilty people at the same murder as then
and from which we told: This must never happen again,
nevertheless with them is an agreement again.
On Sunday, 31th of July I wrote this poem,
The radio told about Rwanda,
that it was sick, hopeless and poor.
After that on Balcan ground,
again a group of around 300 Muslims was deported
and every house of them had been seized.
And the whole of the Netherlands complained that it was terribly warm.
There are still riding trains with Jews to Auschwitz
However Auschwitz is sometimes Mostar or Kichali,
and Jews are sometimes Hutu,sometimes Tutsi
And in our name that train rides again
because those who are in Brussels,
also ruling this world
choosen by us.
Emergency rotations come first,
but if you leave it with that
then it is nothing more than ever allow
that one after the other train is leaving for Auschwitz
to gather money for the surviving people
Last year a march on Brussels was proposed,
That march has been postponed,
and later it didn’t take place,
because so was told us,
A massive protest would not be normal to nineties.
That was then, and now is now
This is the time of the individual
who want to manifest himself personally
and doesn’t seem to bind himself to politics
so the following happend
at a morbide turning point
While people at some places are still killing,
the following genocide is already prepared,
and that etnically cleaning,
can take place without notification,
because protesting is out of fashion.
I think with the eye on the good fashion,
that it becomes the time to do something which is out of fashion.
It is the time for us, a-diplomatic outsiders
that something has to be told to them who talk in the name of Europe
that for us people a nation being into genocide
does not count less heavy
than a war
in which oil is involved
The lingering held by the world’s nations
done with our ratifications,
from that rude working,
there can only be one outcome:
That is such a march on Brussels.
The next genocide doesn’t take long to arrive,
We appoint on a date,
Reserve our seven television nets again
The pain afterwards can be relieved,
But the alread departed deportation train cannot be stopped anymore.
An action like this should consist of 2 steps,
2 steps who belong to each other
The second stap cannot go without the first one
and withoud step two, step one is lost.
Now step one,
But if we then stop
Then the emergency rotations from the first hour,
will linger this politics on the long run
Because when the people, and the people are WE, fall silent,
after the sending of this emergency rotations,
why should they, who represent our people,
ever open their mouths again?
FOOD SUPPLEMENTS INDUSTRY FIGHTS OFF EUROPEAN RESTRICTIONS
A European Commission proposal to extend pharmaceutical powers to judge and classify food supplements has been rejected by the European Parliament thanks to the united voices of three leading European trade associations.
Yesterday (Wednesday 23 October) the Parliament voted to reject the Commission’s proposed extension of the scope of the new medicines Directive*. The Parliament’s rejection of the Commission’s plans follows a hard-fought campaign by the European Health Product Manufacturers Association (EHPM) and its members, who joined forces with the European Responsible Nutrition Alliance (ERNA), the European dietetic food association (IDACE) and the European food industry federation (CIAA).
The campaign is part of long struggle to provide a clear legal status for food supplements under food law. The recent EU food supplement Directive appeared to have provided food supplements with a ‘safe haven’, but the Commission’s medicinal proposal has thrown their future into doubt once more.
The Commission had proposed that any product falling under the definition of a medicine should be treated as a medicine regardless of whether it also fell under the scope of other EU food or supplement legislation. Given that the current definition of a medicine includes substances that ‘modify physiological functions’, food supplements, foods and cosmetics could all fall under this definition and therefore be controlled by pharmaceutical authorities under the new rules. “This would give the national medicine agencies unprecedented powers to decide on whether supplements could be sold or not and would negate the benefits of the recent supplement Directive,” argued Anthony Bush, Chairman of the EHPM. “It could lead to the sort of destructive, arbitrary decisions at a national level that necessitated the supplement Directive in the first place.”
The current definition of a medicine has been a further successful target of the campaign. The definition of a medicine was first drafted in 1965 and preceded the current consumer interest in health-oriented food supplements. At that time, the definition of a medicine was extremely broad to include emerging medicines such as the contraceptive pill, and embrace, not only the cure, prevention and treatment of disease, but also those products “modifying physiological functions”. This all-inclusive definition has shaped regulator’s thinking over the subsequent decades and has left the food supplement industry fighting to defend its corner. “The definition of a food supplement is a critical issue that has been a thorn in the side of the food industry for over 30 years”, said Bush.
A qualifying amendment proposed by EHPM, ERNA and CIAA sets out the difference between the physiological functions of foods and those of medicines. With the adoption of the amendment “modifying physiological function by exerting a pharmacological action”, the European Parliament has forced the Commission and Member States to thoroughly rethink the medicines definition. “The food-medicine borderline issue is a notoriously tricky one,” comments ERNA Chairman Luc Claessens, “but yesterday’s result is an important first step to redressing the balance for our industry.”
– end – October 2002
The full title of the medicines Directive is Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
and the supplements Directive is Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements.
For further information on this issue and the two directives, please contact
Pedro Vicente Azua, EHPM, 50 rue de l’Association, B-1000 Brussels, Belgium
tel +32 (0)2 209 1155; fax +32 (0)2 223 30 64; email firstname.lastname@example.org
EUROPEAN DIRECTIVE TO BOOST PUBLIC CONFIDENCE IN HERBAL MEDICINE
Health Minister updates herbal sector on European Directive on Traditional Medicinal Products
Health Minister Lord Philip Hunt today spoke of the boost in public confidence that will result from the regulation of traditional herbal medicines.
Speaking at a meeting between the Medicines Control Agency (MCA) and representatives of the herbal sector Lord Hunt responded to the concerns of potential over-regulation that have been raised in recent months and highlighted the public health issues that have arisen in the past through lack of a systematic approach to the safety and quality of herbal medicines.
He said that any regulation must be proportionate with the ultimate aim of protecting public health.
Lord Hunt said:
“Across the herbal sector there is broad support for a scheme that will systematically prevent poor quality and unsafe medicines reaching the UK market – a scheme to protect public health. A new regulatory scheme recognising the status of traditional herbal remedies really could lead to a boost in public confidence and a boost to the sector. It could cut through much of the hype and exaggeration about products which is still prevalent in some parts of the sector. Herbal remedies have a significant effect on the body. For example, St John’s Wort, is regarded by many as a useful remedy. However, it is also associated with risks resulting from interactions with other medicines which can lead to a range of outcomes from rejection of transplanted organs to unintended pregnancies. It is in everybody’s best interests that remedies that have a significant effect on the body and can interact with other medicines should be regarded as serious medicines and be appropriately regulated.”
Since July, when Lord Hunt asked concerned representatives of the herbal sector to send in to the MCA specific evidence to illustrate their concerns over the proposed Directive, the agency has been looking at a range of around 1,000 products submitted. This request came in response to fears that a large number of currently legal products would fall outside the Directive’s proposed definition of traditional use and so would become illegal.
Following a broad assessment of 270 different herbal ingredients brought to the agency’s attention, the MCA’s initial view is in only two or three cases would there likely to be a problem in demonstrating traditional use. Lord Hunt sought to allay fears that herbal combination products (those containing more than one herbal ingredient) would fall outside the definition of traditional use in the Directive. He said:
“The MCA has shown the information on about 200 herbal combinations to two herbalists and asked them for some general feedback. Their initial view was that in many cases they were either familiar with the combinations themselves or could envisage the possibility, given their stated ingredients, that a herbalist would be able to give a positive opinion on the combination’s traditional use.”
He also added that there might be a limited number where some adjustments in the combination might be necessary.
Lord Hunt stressed at the meeting that as regulatory decisions could only be taken on actual applications, all figures quoted were illustrative and not exhaustive. However, he said that the work agreed with the earlier thinking of the MCA – that the potential for registering single ingredient and herbal combination products under the Directive would be very wide. Questions raised over regulation of herbal nutrient combinations were also addressed by Lord Hunt who said that the proposed Directive could potentially give sufficient flexibility to provide a regulatory home for some of these. The MCA would also be pressing in Europe to give industry greater flexibility to take account of traditional usage from outside the EU and to make early progress on creating a regulatory home for non herbal traditional medicines.
He also called for the dialogue between the MCA and the herbal sector to continue on all the issues that have been raised in response to the directive.
“This is an important regulatory issue on which there are clearly strong feelings and on which I will continue to take a close personal interest. As the Directive continues to make progress, the watchword will be a sensible, flexible interpretation, consistent with protecting public health and meeting necessary legal requirements.”
Lord Hunt’s speech to herbal interest groups at the Medicines Control Agency
on 10 October 2002
- I am very pleased to have this opportunity to take part in this meeting, the latest in the serious of ongoing discussions about the proposed Directive on traditional herbal medicinal products. This is an important regulatory issue on which I continue to take a close interest.
- I would first like to pay tribute to Michael Baker who, as many of you will know, died suddenly over the Summer. I met him most recently when he participated in the last stakeholders meeting on the Directive in July, and he will be much missed.
- In July on two occasions I met a range of representatives from the herbal sector to discuss the Directive. This gave me an opportunity to hear a very wide spectrum of views on the Directive ranging from strong support to opposition. We agreed then that the early autumn would be a suitable point to reassess progress on a number of issues that the MCA was taking forward. As you know I also extended the period of domestic consultation on the Directive in order to allow those with concerns to provide more specific evidence to illustrate their fears about the impact of the Directive. We are now in a position to give an initial response on the concerns that have been raised. I would like very much to emphasise that we are talking about work in progress on a wide range of fronts.
- Let me start by saying something about my approach to herbal medicine. The practice of herbal medicine has very strong historical roots in this country and the sector has grown substantially in recent years. It is clear that very many members of the public greatly value herbal remedies. It is clear that the expansion of the herbal sector has reflected a growing trend for people to take greater responsibility for their own health. This is a development that ministers warmly welcome. So I’m very keen to see astrong confident herbal sector and I believe regulation is an important component in supporting the sector. Certainly, effective regulation is vital if we are to address the critical public health issues and ensure a systematic approach to product information and a high standard in quality of products.
- Many experienced people in the sector have told me that they see improved regulation as essential to the continuing maintenance of public confidence and the future growth of the sector. This is a powerful argument: a new regulatory scheme giving enhanced status and recognition to herbal medicines, requiring consistent standards and proper consumer information, could be a major advance.
- It is also an issue of public confidence. Both ministers and the MCA have been told on various occasions by individual companies – both large and small and in the health food as well as the herbal medicine sector – that while they themselves manufacture herbal remedies to very high standards they believe that some of their competitors may be short changing the public, for example by using inferior ingredients or putting forward products which could not conceivably be efficacious. Under the current regime, frankly, everyone can set their own standards. I share the views of those who argue that this is not a recipe for continued stability and growth in the market.
- I am the Health Minister responsible for Better Regulation, I don’t want regulation for the sake of it, it has to be reasonable and proportionate. Much of our input on the proposed Directive both in Europe has been directed to this end – for example in negotiations we have supported the pragmatic argument for replacement of the normal efficacy requirement for medicines by evidence of traditional use for this category of medicines. We have strongly advocated the proposed creation of a substantial positive list that would remove the need for companies to demonstrate safety and traditional use for many products. Clearly there is always room for discussion about the proportionality of any particular legislation and I expect that much of our dialogue this morning will cover aspects of this theme.
- I would like to turn now to cover briefly the progress of negotiations in Europe. European negotiations on the Directive have now resumed after the Summer break. There was a debate in the environment committee of the European Parliament on 2 October, and our current understanding is that the committee will vote in early November after which the Directive will need to be considered in plenary by the European Parliament. The council working group, where the MCA represents the UK government, is due to have its second discussion of the Directive on 16 October. On several occasions those worried about the Directive have told me of their fears that the Directive is being rushed through European
negotiations. So far at least, the rate of progress on negotiations does not seem unduly hasty. While no one is in a position to say for certain, our best estimate remains that the Directive – which was formally proposed by the commission in early 2002 – is unlikely to be agreed until well into 2003. Indeed, it could be that negotiations are not completed until 2004. With the proposed transitional arrangements, the practical effect is that existing products on the market would not be required to comply with the Directive until around 2008 or 2009. In fact many of you will want to take advantage of implementing it before that date; that will up to your own commercial judgement.
- Strong fears have been expressed, particularly by the health food retail sector, that large number of currently legal section 12 herbal remedies will fall outside the proposed definition of traditional use and will be made illegal as a result. The MCA has been looking at the range of about 1000 products submitted in the form of samples or lists. This follows my invitation, in June, to the sector to send in examples of products that they feared would be made illegal as a result of the Directive. This work is ongoing, bearing in mind that much of the information continued to arrive in August or September. However, it is possible to give a preliminary indication. On the work done so far, a total of over 270 different herbal ingredients have been brought to the agency’s attention by the herbal sector. The MCA’s broad assessment is that in perhaps as few as two or three cases do they think it would be problematic for a company to demonstrate the necessary period of traditional use. There are several other individual herbs where a period of 15 years EU use may perhaps not be currently met but is likely to be completed well within the transitional period envisaged under the Directive.
- In relation to herbal combinations, the MCA has long taken the view that one of the main ways for companies to demonstrate traditional use would be for them to take the opinion of herbal experts, notably herbalists. Accordingly, the MCA has showed to two herbalists, in non company specific form, the information on about two hundred particular herbal combinations which companies particularly feared would not meet traditional use
- Their initial feedback was that in many cases they were either familiar with the combinations themselves or could envisage the possibility, given the stated ingredients, that a herbalist might well be able to express a positive opinion on the traditional use of the combination. There were others, naturally, where the particular herbalists were not familiar with the combination. There were also, they noted, some combinations consisting of herbs from several different herbal traditions. They queried whether in all cases such a combination could be demonstrated to have traditional use. They also queried whether in some cases, where a particular herbal ingredient had only recently completed 15 years in the EU, it might not be feasible to demonstrate its traditional use across a large number of different combinations.
- One of the herbalists commented that, from his preliminary perusal, in perhaps three-quarters of the particular herb-herb combinations submitted it might be likely that evidence of traditional use of the combination could be found. This is just one source and clearly a company seeking registration potentially could draw from a range of different sources. Indeed, the relatively small number of herbal/herbal combinations sent in by
the herbal sector represents only a minute fraction of the possible number of herbal/herbal combinations which will be possible under the directive – and indeed large numbers of traditional combinations are currently legally on the market in UK and many other member states and no doubt this position will continue.
- It is important to stress that at this point it would be wholly wrong for the MCA to give anything that could be construed as a regulatory decision as to whether a particular herb or a particular combination can or cannot show traditional use. Decisions on products could only be taken in relation to individual applications for registration of a product. It will be open to company to provide evidence of traditional use in relation to any particular product.
- Overall, this suggests that the potential for registering products under the Directive both single ingredient and herbal combination – will be very wide indeed; and second that there could be a number of herbal combinations where it might be necessary for the company to make an adjustment to a product, for example by removing a particular ingredient, in order to come within the requirements of traditional use as currently drafted.
- We know that the case for greater flexibility for non-European traditions is supported not only in the ethnic medicines sector but also much more widely across UK herbal interest groups. We will continue to argue the case in Europe for greater flexibility. The case, put simply, is that we believe the strength and relevance of evidence relating to traditional use is more important than its geographical origin. This is a point the MCA has argued vigorously right from the outset and it is encouraging to note that a number of MEPs from various parties have put down amendments on the subject.
- As regards non-herbal traditional medicines, there is of course currently no simplified registration arrangement available under the present regime. The question therefore is whether the Directive will provide a way forward. In negotiations we will press for an early date to be built in for the proposed review of the scope of the Directive. We will also explore the scope for national derogations for member states to put in place or maintain national schemes for at least some kinds of non-herbal traditional medicines pending that review. I cannot obviously guarantee success but this is the way we are seeking to go.
- The regulatory position of herbal nutrient combinations is perhaps the issue on which the strongest feeling have been expressed. Our assessment is that there is the possibility of early progress. It is important once again to emphasise that it would be misleading if anyone is giving the impression that the directive is somehow responsible for the current position whereby some herbal/nutrient combinations lack a clear regulatory home. The real issue is a different one, namely is the directive a possible vehicle for creating a regulatory home for some of these products.
- The key point we have been addressing is that the Directive as drafted is actually more flexible on this issue than the current UK legislation on unlicensed herbal medicines. In terms of non-herbal ingredients, UK section 12 herbal remedies are only permitted to contain water or other inert substance. The proposed Directive, however, is less restrictive and envisages the possible inclusion of ingredients that are non active in the context of the traditional herbal remedy. I have discussed this matter closely with the MCA and our view is that it would be a reasonable interpretation of the proposed Directive to permit the principle of including nutrients as non active ingredients where the added ingredients are clearly non medicinal. An important advantage for industry would be that where ingredients are reasonably regarded as non actives they do not need to have been traditionally used as part of that combination. There would be some important caveats: clearly it would not be possible to make claims for any non active ingredient. The product itself would of course also need fully to meet the terms of the Directive as to the traditional use of the herbal remedy, safety, quality and product information.
- Our current assessment is that this may be the best way forward to give industry some of the flexibility it seeks. Indeed, this approach could be beneficial for example to a range of ethnic medicines.
- A number of people told me that they believe it would be helpful if MCA could publish a full list of herbs that it would regard as medicinal. I therefore asked the Agency to review the position on whether it would be possible to achieve greater transparency in this area. The MCA report that this issue has been discussed on a number of occasions with trade associations representing manufacturers that place products on the market.
- So far there has not been a clear consensus in favour of such an approach and this lack of a common view remained evident as recently as a meeting in September when MCA raised the issue again. The latest situation is that the MCA has asked the various trade associations to review their position and submit their considered position in writing during October. This should indicate the scope for reaching a common industry position through further dialogue.
- The MCA is looking at an issue that has been raised about the regulatory requirements for a qualified person who, as in other areas of medicines manufacture, would be required to take personal responsibility for the release of batches onto the market. This is an issue that has been specifically raised by some very small businesses. The Agency is also looking at the wider question of the nature of documentation likely to be required for applications under the Directive. I will ask the MCA to outline progress in these technical areas. Overall, the MCA point out that there are very considerable similarities between the proposed manufacturing requirements for traditional herbal medicines and those set out in the codes of practice operated by the Health Food Manufacturers Association and the Council for Responsible Nutrition.
- Finally, the question of fee levels is naturally of great interest to many in the herbal sector. While we can give a number of pointers, it is not possible at this early stage to give a specific indication of the likely fee levels. There are obvious uncertainties in the negotiations – for example, if we achieve greater freedom in relation to non EU usage this could lead to products coming forward with active ingredients largely unstudied by western science – which may require quite a detailed safety assessment. If we are able to have flexibility with the inclusion of nutrient ingredients, including synthetic substances such as vitamins, some of these products can be relatively sophisticated and complex to assess – for example in terms of their stability. Also as I have already indicated, the agency will need detailed dialogue with industry about the documentation required for registration and to discuss ideas for streamlining both the submission and assessment of dossiers. These are all factors affecting the likely level of registration fees.
- The key point is that MCA operates as a trading fund and its fee levels should reflect the amount of work the Agency has to carry out. In line with its normal practice the MCA will look to have differentiated fees within the registration scheme where this is feasible. For example, where a product complies with the European positive list, there will be no need for a company to demonstrate safety or traditional use and patient information will be standard. With such a product only quality aspects will require any significant consideration. It may well also be possible to have a lower fee, reflecting lower assessment costs, where for example a product is made to a very simple process, for example a single herb tincture as compared with a standardised extract. There is also a helpful precedent within the homeopathic scheme for some form of discount arrangement where there are multiple products all made to an identical simple process.
- Overall, looking at the MCA’s current wide range of registration fees, I would expect the herbal registration scheme by comparison to feature very much towards the lower end. There is much further work to be done to develop proposals both on a fee structure and fee levels, but the MCA will keep the sector in particular, in touch and have further dialogue as our thinking develops. In this context the key next step will be dialogue with manufacturing interests in particular about the handling of the dossier requirements. Ultimately, proposed fee levels would need to be subject to public consultation, agreed by ministers and put before parliament. It will be part of a vigorous process taking into account the industry’s comments.
- In conclusion, in the light of the continuing work the MCA will be able progressively to update the initial partial regulatory impact assessment. I envisage that dialogue between the MCA and the herbal sector will continue on a wide range of issues, including some that I have not been able to cover in the time available. If as seems likely the Directive continues to make progress, the watchword will be sensible, flexible, interpretation, consistent with protecting public health and meeting necessary legal requirements. I hope the overview I have given today is helpful and I look forward to comments and questions that you may wish to raise. I would like to meet manufacturing interests in particular, via the trade associations, after the vote in the European Parliament. I also propose that, as a wider group representative of the herbal sector, we meet again in the New Year for further discussions when we should have a better idea of progress in Europe.
Below an email-exchange I had with someone on the WHO Food Standards Programme. His name: Jeronimas Maskeliunas, sending me to hell…
This all started with this mail. I sent this with the intention to tell Codex what it is throwing away on behalf of the people who are suffering from common diseases.
The returning mail:
Who is this Holtjer? Activist? In addition to 10 EURO which I put for Santa
Madona I will put 10 more to send him to hell
Dr Jeronimas Maskeliunas
Food Standards Officer
Joint FAO/WHO Food Standards Programme
Fax: +39 (06) 570 54593
Message from FAO
Mr T.J. Holtjer
Dear Mr Holtjer,
I am writing to you concerning an exchange of emails between yourself and Mr Jeronimas Maskeliunas, a member of the Secretariat of the Codex Alimentarius Commission with responsibility for the Codex Committee on Nutrition and Foods for Special Dietary Uses. I wish to assure you that the views expressed by Mr Maskeliunas in these emails are not the views of the Secretariat of the Codex Alimentarius Commission, especially in regard to the Proposed Draft Guidelines for Vitamin and Mineral Supplements currently under negotiation within the Committee. The Secretariat maintains a neutral opinion on texts under discussion at Committee level and an equally neutral opinion of the positions taken by Member governments and other interested parties in relation to these texts.
On behalf of the Secretariat, I wish to apologise for any hurt done to you as a result of this exchange of emails.
I have relieved Mr Maskeliunas of his responsibilities in regard to the above-mentioned Committee.
Secretary, Codex Alimentarius Commission
Joint FAO/WHO Food Standards Programme
c/- FAO, Rome, Italy Email: email@example.com <mailto:firstname.lastname@example.org>
Phone: +39(06)5705.4390 Fax: +39(06)5705.4593
Dear Mr Holtjer,
It seems that my apology that I sent immediately after my erroneous message did not reach you. Please accept my sincere apology and any inconvenience it cost to you in regard to my message. I am currently out of my office and experiencing a lot of problems in accessing my email account, therefore I was able to see your email only today. Dear Mr Holtjer, I kindly ask you to give me your telephone number as I am willing to call you and talk to you personally. Once more, please accept my sincere apology.
I hope that have understood that only today I have accessed my email and it was the only reason why you did not receive an apology earlier. In addition to my sincere apology I would like to see you and talk to you on my way back to Rome. I would like to make stopover in your city on the 7th or 8th of September at any time which is convenient to you. I would appreciate your reply to this mail account as it is the only computer from which I was able to send message to you.
Very best regards.
Dr Jeronimas Maskeliunas
Hello mr. Mieliauskas,
On that weekend I have an appointment, so it is not possible to meet me by then.
I am not the person to decline apologies. As I try to live as long as possible, because I love life, it is very hard to see somebody ‘wishing you to hell.’ Although I think the message was not for me at all (you sent it to Selma) it is good to see how we are thought about.
If I was not to tell the truth on health issues (as I do on my website and to all who want to hear it) – I would already have died because of too little vitamins in my body, due to swallowing medicine. The man who is known from his emails from http://www.petition450.org/ actually SAVED MY LIFE 2 years ago.
Whenever somebody or people at governmental level is making a decision against the foodsubstances which made me healthy, I will ‘fight’ by informing as many people as I can by supporting my website and anybody who wants to know.
Please read my website story and know what health vitamins can give to you. In times of a lot of stress we use up all the vitamin C in our bodies by creating adrenalin from that molecules. Just the use of extra vitamin C (in my case 2 grams a day) gave me back 70% of my health. It works, even if you don’t believe it.
But people making decisions must, in my opinion, be aware of what they are wanting to throw away. I want my two children to have THE SAME TREATMENT (of vitamins) as I taught myself to take, whenever they seem to suffer from that same bipolar disorder. In a way it is not a disorder at all. People suffering from it tend to be very creative, intelligent and more. Only their brains are not supported with the right fuel.
Last year I was demonstrating at the gates of the BGVV in November 2001, Berlin, I stood there in the pooring rain and it was cold but we knew why we were there… The evening before dr. Rath presented to us a man who had cured his lung cancer with the foodsupplements from him. It was quite impressive to see the man alive after 2 years. Early 2000 conventional medicine had given him up. This man would have gone through a real hell of pain when the foodsupplements had not been saving his body.
Don’t forget to read my story at:
Please email me what you would like me to say when you would have
stopped over in my city. I can only hope you are not going to send me to
hell. Nobody has been given the right to shoot one another, but even the
biggest presidents sometimes take those rights.
Hello mr. Mieliauskas
I have read your message over and over again. I think you have
apologized enough. But remember: when we want to keep our community sane
it is required to keep our freedom of THOUGHT, VITAMINS and PRESS.
Dear Mr Holtjer,
Thank you very much for accepting my apology. Believe me – it was an error I sincerely feel very sorry about that. I was very willing to see you because I would like to invite you for a private meeting-dinner and discuss with you about the life and errors that sometimes we not intentionally make, about supplements because for more than twenty years I was teaching nutrition and food safety at the University and I never ever expressed an opinion that vitamins or other supplements are not important for our health or that I am against a freedom to choose them and about a lot of other things that are very important in our life. If you are busy that weekend I hope that one day we will have a chance to meet each other and to discuss it. It is my understanding that it would also help you to understand that my apology was very sincere therefore I am looking forward for such a meeting-dinner. By the way, I also take some vitamin supplements.
I am going to leave to duty travel next week and I am not sure that I will be able to access my email until 11 of September. Mr Mieliauskas, who kindly assisted to access my email account, has nothing to do with my business. He is a computer expert and assisted in restoring a network connections which were constantly broken. Since he works only half a day today, I will have no chance to send any other reply.
Very best regards.
Dr Jeronimas Maskeliunas
Dear Mr Holtjer,
As you are already aware I have been away from the office for very long time and upon return I have found more than 800 emails queuing on my computer. Additionally, the Joint Meeting on Pesticide Residues started in Rome this week and I have to participate in its work for the two forthcoming weeks. So you can imagine an amount of the work falling on me these days.
In your email you raised a few questions therefore I will try to reply to them one by one. Regarding RDA. As far as I am aware, the concept of RDAs had been used in different countries of the world to define “the levels of intake of essential nutrients that, on scientific knowledge, are judged by the specialised bodies inside countries (like FDA in the US), to be adequate to meet known nutrient needs of practically all health people”. Why there are some differences between nutrient RDAs in various countries I hope that you can find reading scientific articles and comments published in these countries. It is my understanding that bodies responsible for the updating RDAs take into account all scientific information that is relevant and available in their countries. I am not in a position to provide comments on the RDAs developed and used by these countries.
I apologise you even much more because I was not aware of your health before and I sincerely wish all the best for your health. Personally, I use supplements when I am doing additional physical exercises, especially during winter-spring season and usually I take 1-2 capsules per day. For me it works well.
Very best regards.
Don’t you think it would be better to leave the amount of vitamin intake FREE? Our bodies have learned to deal with vitamins during evolution. There is ABSOLUTELY NO NEED FOR AN RDA. Remember that I managed to fight my disease (bipolar disorder) successfully with highly dosed vitamins. If they are going to be forbidden I will go to court to demand for my health. I will be doing this with the whole of my heart and I will fight for my health, because IT IS ABSOLUTELY NOT NEEDED TO BE SICK LIKE THIS. My body is only demanding more Omega-3 fatty acids (maybe genetical) as prescribed by evolution. We as humans came out of the water (not from the savannah) eating much fish and other seafruit. You should read ‘The aquatic Ape Hypothesis’ by Elaine Morgan.
There are no reasons to ‘protect’ us from ‘too many’ vitamins. To many water solvable vitamins are removed by the kidneys. To much fat solvable vitamins are burned as fat. It is completely regulated by the controls of nature: our body.
By using the vitamins of dr. Rath, who saved my life two years ago, my health came back and I am fully functional and thinking fast as I used to before I started my lithium intake. Being without lithium is a great pleasure for my environment. I am glad I found out anything about how to do it safely.
See the book “RDA: Rats, Drugs, and Assumptions” by Majid Ali, MD This link
RDA Rats, Drugs and Assumptions
$21.00 670 pages Trade paperback
“A courageous and brutally honest statement on the sad state of affairs of drug medicine in America.” Walter Ward, M.D., Past President,
The American Academy of Otolaryngic Allergic
A book that challenges most of the cherished assumptions of drug medicine. It lays bare many of the deceptions in medical statistics – most of them intended, it seems. It shows how results of valid medical research are deliberately distorted to promote long-term use of drugs of dubious value. It exposes the deep prejudice of practitioners of drug medicine against natural, non-toxic drug therapies.
This book clearly delineates the scientific basis of energetic-molecular events that cause disease, and shows how accelerated oxidative injury to human enzyme systems – comprised of energy, detoxification and digestive enzymes – is the cause of all disease processes. Furthermore, it describes how oxidative enzyme injury leads to disruptions of the bowel, blood and other body organ ecosystems.
It remained a while silent, but the FAO replied with dr. Alan Randall:
Dear Mr Holtjer;
As I informed you in a previous email, the Secretariat of the Codex
Alimentarius Commission plays a neutral role in discussions between the
Commission’s Member countries on the broad range of issues under discussion
within the various Codex Committees. This includes the on-going discussion
on the “proposed Draft Guidelines for Vitamin and Mineral Supplements”.
Nevertheless, in consultation with our colleagues in the Food and Nutrition
Division of FAO, we have examined the question of upper limits of vitamins
and minerals and have prepared a background paper for the consideration of
the Committee. A copy of the paper is attached.
As you will see, the paper proposes that further consideration be given to
this question and suggests that upper limits should be established on the
basis of the toxicity of these substances, in much the same way that upper
limits are established for other chemicals added to food. Moreover, it
recommends that this should be done on a case-by-case basis so that
potentially toxic substances can be regulated more effectively, while
substances showing no or very little toxicity can be marketed more freely.
This would take into account the substantial differences between substances
of known toxicity at high levels, such as the fat-soluble vitamins and
selenium, and those where the accumulated evidence suggests that there is
very little toxicity at high doses, such as vitamin C.
We are hoping to approach this matter on a scientific basis.
I also regret that I will be unable to be in Berlin. As you are aware, Mr
Maskeliunas is no longer associated with this Committee.
Secretary, Codex Alimentarius Commission
Joint FAO/WHO Food Standards Programme
c/- FAO, Rome, Italy
Email: email@example.com <mailto:firstname.lastname@example.org>
Phone: +39(06)5705.4390 Fax: +39(06)5705.4593
Replies to mr. Randall:
Onderwerp: UL is not needed for safe vitamins
Dear Mr. Randell,
I cannot guess why mr. Maskeliunas has been fired from the committee but if it has something to do with him wanting me sent to hell, I wonder why he has not been fired from the Fao / UN?
You are seeking to place “UL”s on already safe substances while totally ignoring the REAL danger of toxic pharmaceutical drugs. All this is is a witch hunt. A perfect example is the supposed “UL” of just 35 mg on niacin. When I called NAS to inquire about this nonsense, I was told that they consider the niacin flush to be a “drug side effect”. I told them that all it is is a sign that the niacin is working, that all it is is a sign that capillaries are dilating on the surface of the skin allowing improved and increased blood flow which is a GOOD thing. I told him that the minor annoyance caused by the itching sensation was a minor thing compared to the benefit, and that it was obvious to me that pharmaceutical interests want to suppress consumer access to niacin, but not for safety reasons- they don’t like the fact that niacin is our best, most effective broad based vasodilator because it is unpatented, is inexpensive, and it cuts into the sale of patented prescription drugs.
Remember that the UL or the RDA are all unneeded for the SAFE vitamins. Even the fat-solvable vitamins cannot be overdosed. When they are too much they are simply burned as fat. The vitamins who saved my life 2 years ago are highly-dosed and I know they are working. When they had not come into my life the lithium medication would have caused a heart-attack on me. Please can you tell me why nobody is asking about the dangers of the poisonous medicine produced by the same companies who murdered millions during W.W.II?
They are all safe? No, they are the FIRST-DEATH-CAUSE in America by now, but the statistics are fully manipulated by the pharmaceutical companies in order to wipe out their traces. For your information: Every poisonous molecule taken into our bodies has to be removed from the body by the liver. How is our body arranging that? Every poisonous molecule is enhanced with an OH-group in order to make it able to be removed from the body. The only molecule being able to spend that OH-group is… Vitamin C. When using a lot of medicine it is obvious that the bodies’ amount of vitamin C is decreasing and therefore not anymore able to protect the bloodvessels as it should be. The same reason is true for people with a lot of stress – for every molecule adrenalin they are producing they use a molecule of vitamin C, causing the stop of the protection of the bloodvessels. Therefore it is absolutely not surprising that people who take medicine daily are put in constant danger because they are using their vitamin C to prevent their livers from getting poisoned.
Those bloodvessels are being repaired with lipo-protein-A (ten times more sticky than cholesterol) – the only means our liver can still produce and with which our species survived the last ice-age. Cholesterol is not the CAUSE of heart attacks -the lack of vitamin C is the real cause as heart attacks are an early form of scurvy. Remember that bear who is in winter’s sleep – he has cholesterol levels that are about 20 times the amount we have in the blood. Why doesn’t that bear suffer from a heart attack? His liver is producing about 10-15 grams of vitamin C a day so his bloodvessels are well-protected and the bear awakens at the end of his winter sleep. Ever thought of the fact that people suffer from heart attack or a stroke of apoplexy and why this is not happening in their elbows or their nose? They happen to take place at that place in the body where most of the biological energy is being used for motion (heart) or processing in the brain. There our bloodvessels are most under attack and the risk of getting them broken is highest at that place.
ANY substance can be unsafe at SOME level, even WATER. People have died from ingesting enough water to burst their stomach wall, but I don’t see you clamoring to create “UL”s for water, or for any FOOD. This is crazy. Foods in common form are demonstrably far more dangerous than dietary supplements, but we don’t see any comparable regulatory effort going on, because pharmaceutical interests don’t feel threatened by the sale of food the way they do by the sale of dietary supplements. Of course, they don’t have to because in food is so many less vitamins than 30 years ago… Not surprising when you look at the amount of patatoes coming from that very same soil compared with 30 years ago….
Please be informed that I can reproduce any of the functions of the vitamins, minerals and aminoacids in our bodies. If the Codex commision would take a wise decision they must retreat their measures and take over the Dutch, English or Swedish law for vitamin, herbal and homeopatic substances.
NOBODY was killed by taking supplements, MANY were killed by using medicine which are only ‘treating’ the symptoms.
Arnhem, The Netherlands
IAHF Webmaster: Breaking News, Codex Oversight
IAHF List: No Justice- NO PEACE!!! They want another Seattle in Berlin!!! October 14, 2002
Alan Randell, Secretary
Codex Alimentarius Commission
I read my colleague Tjarko Holtjer’s response to this email of yours (below) before sending you this response.
As demanded in previous emails, IAHF continues to demand that Maskeliunas be immediately fired from FAO/WHO/UN. It is not nearly enough that you have merely removed him from the Committee on Nutrition. His comment in writing to Selma Doyran that he wanted to “send Tjarko Holtjer to hell” because he is an anti Codex protestor should be grounds for his total dismissal from any employment under FAO/WHO/UN auspices.
His so called “apology” to Tjarko Holtjer was not an apology at all, all it was was an insulting, and arrogant statement issued by a former professor of mainstream dogma nutrition who believes that anyone taking more than the RDA of any given nutrient is merely “enriching the urine.” Beyond that however, his arrogant statement was symbolic of the UN’s dictatorial intent on a whole. Now I see that you are attempting to finesse Tjarko Holtjer, and this conduct of yours and of Maskeliunas is patently offensive to vitamin consumers world wide, millions of whom will be reading this.
The Vitamin Standard under debate at Codex will be profoundly influenced by the mindless standard that has been finalized by the European Union. This mind numbing, pharmaceutically instigated insanity poses a threat to the public health of people all over the world. Nothing at Codex is fair. If it were fair, NGOs would have a vote- instead all they do is serve as window dressing to give an APPEARANCE of fairness. If it were fair, countries represented at Codex would have a voting capacity proportionate to population size, and on this vitamin issue, to whether or not they even MANUFACTURE vitamins. If it were fair, national governments would pay the way of private citizens to be on national delegations, but this isn’t happening. When I was on the US Codex Delegation, I had to crawl over broken glass to raise grass roots donations over the internet in order to be able to get to Germany- and then when I got there, I had no vote. “My” vote was cast by Dr.Elizabeth Yetley, an unelected bureaucrat from the FDA with whom I generally disagree on almost everything and who I observed violate US law at codex meetings on two occassions.
Yetley had me kicked off the US Delegation for attempting to have her investigated by a Congressional Oversight Committee due to her violations of US law at the CCNFSDU meetings in Bonn in ’96 and in Berlin in ’98 when I was on the delegation. Her excuse for having me banned was that in ’98 I shot some video footage of the meeting (until Herr Grossklaus, running the meeting forced me to stop filming, clearly illustrating the gross NON TRANSPARENCY of these bogus proceedings.) Yetley didn’t like me doing this, didn’t like me taking “unauthorized” still photos either, and didn’t like it when I put the videotaped footage of Grossklaus forcing me to stop filming on the IAHF website in the media section in order to call attention to the gross non transparency of these bogus meetings which constitute nothing more than a form of “high drama” put on for public consumption, to give an APPERANCE of “fairness” and “scientific honesty” when in FACT, there is NONE.
In ’98 Bgvv Press Officer Jurgen Kundke denied my entrance to the CCNFSDU meeting despite my holding valid press credentials, so I was left with no choice but to join Dr.Matthias Rath’s street demonstration. Its important that you realize that the Codex Commission has zero credability in the eyes of thousands of vitamin consumers world wide due to all of this.
You feel that the “UL” concept of creating supposed “Safe Upper Levels” is somehow “scientific”. I don’t agree, and neither does Richard Malter, PhD who generated a scholarly rebuttal to the mine of misinformation which the FDA illegally put on the table at the CCNFSDU meeting in Berlin in ’98 in violation of US law. This mine of misinformation was titled “A Risk Assessment Model for Establishing Upper Levels for Vitamins”. Malter’s rebuttal to the pharmaceutically dominated National Academy of Sciences was published in the Journal of Orthomolecular Medicine and can be found on the IAHF website http://www.iahf.com under NAS Paper and Rebuttal. Joining Malter in opposition to the “UL” as a “valid scientific concept” was the late Brian Leibovitz, PhD, former editor of the Journal of Applied Nutrition whose paper “The ABC’s of Confusion as a Weapon” vis a vis Hathcock’s mindless and supposedly “scientific” acronyms of “UL”, “LOAEL” etc can also be found at http://www.iahf.com
The FDA never held a public comments period on the NAS supposed “Risk Assessment” paper because it is being used off US soil at a meeting in Germany in what we know to be a back door effort on their part to set the USA up for harmonization of our vitamin laws to a mindlessly restrictive international standard. FDA is setting us up to lose in a future WTO Trade Dispute by falsely defining vitamin safety with help from the pharmaceutically dominated National Academy of Sciences. They’re setting us up to lose on a basis of the SPS Agreement and the vast screwing is threatened to come via the WTO’s Dispute Settlement Body, an international mickey mouse court designed to rubber stamp the greed driven agenda of multinational corporate interests and which isn’t run in accordance with US rules of evidence. The DSB won’t allow private citizens to present testimony before them, no matter how well qualified. They only allow unelected bureaucrats such as Yetley to appear before them- that is government reps from WTO member nations, so the whole process is rigged.
ANY substance, even WATER can be dangerous at SOME level, but we don’t see the Codex Commission developing a “UL” for water, even though there have actually been cases where people have consumed enough water to burst the stomach wall and they’ve died from overconsumption. We don’t see the Codex Commission debating the creation of a UL for water because aside from the obvious absurdity of doing such an unecessary thing, water is not perceived by the pharmaceutical industry as a threat to their profits- so it is not under attack although there are several contemptable efforts on the part of multinational corporate interests to dominate and control vast supplies of fresh water right now in North America and around the world because there is no limit to their greed.
I told you in my previous communication that unless Maskeliunas is completely fired from FAO/WHO/UN no justice will have been served. No one tells a colleague of mine that they want to “send him to hell” and gets off the hook merely by shifting him away from this Codex Committee on Nutrition. The fact that he wasn’t FIRED gives ample cause for ongoing anger, which could easily lead to civil disobediance in Berlin and around the world on a scale matching or even surpassing that experienced by the WTO scoundrels in Seattle. NO JUSTICE- NO PEACE!!!
In Total Disgust,
John Hardliner Hammell, President
International Advocates for Health Freedom
Onderwerp: EU Protectionism
Attachments: 1 bijlage
Dear mr. Randell,
I found the proof of the bad basis that the EU is acting upon when it comes to protecting the German Pharmaceutical Industries from the nutrients we are using.
I translated the piece from German (as I can read and write German, Dutch and English and a little bit of French) but will also attach the original German document. If you are aware of what you are doing like a pupet on a string in order to stop our mouths from taking the nutrients we need so badly, then you would immediately resign from your function at the FAO / Codex commission because we are talking about the future, not only from us, but also from our children.