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Dr. Rath Health Foundation

EU-U.S. Summit Signals New Threats

To Natural Health Therapies
New transatlantic economic integration agreement and secret FDA-EU ‘confidentiality arrangement’ threaten the harmonizing of
U.S. dietary supplement legislation to restrictive European regulations
By Paul Anthony Taylor

June 2006 – The European Union and the United States recently announced the
signing of a Framework for Advancing Transatlantic Economic Integration at a summit
in Washington. Describing the agreement as “a statement of the importance of trade”,
President Bush, speaking at the post-summit press conference, claimed that it was “a
commitment to eliminating barriers to trade” and “a recognition that the closer that
the United States and the EU become, the better off our people become.”
Because the signing of this agreement received only
minimal media coverage, U.S. consumers could perhaps be
forgiven for assuming that its potential to affect the
regulation of dietary supplements was negligible. In
reality, however, not only does the existence of a secret “confidentiality agreement”
signed by the FDA with its European counterparts in 2005 now threaten the
harmonizing of U.S. dietary supplement legislation to restrictive European regulations,
but the European Commission President, José Manuel Barroso, has specifically stated
that the pharmaceutical sector will be one of the areas that would benefit the most
from transatlantic regulatory cooperation.

Economic integration – the new threat to natural health German Chancellor Angela Merkel (Left),
US President George W. Bush (center) and
therapies European Commission President José
Manuel Barroso at EU/US Summit, April
30, 2007, The White House, Washington,
Historically speaking, regulatory threats to natural health therapies DC. The agreement they signed threatens
the harmonizing of U.S. dietary supplement
have almost exclusively been of a national, as opposed to an legislation to restrictive European
international, nature. In the United States (U.S.), for example, the regulations.
pharmaceutical industry-inspired Advance Notice of Proposed
Rulemaking (ANPR) that was published by the Food and Drug Administration (FDA) in June 1993 -
which suggested, among other provisions, that vitamins and minerals contained in dietary
supplements be limited to low multiples of the Recommended Daily Intakes (RDIs) – would not, had
Meeting of the Codex Alimentarius
it been implemented, have directly affected consumers living outside of the U.S.. Similarly, in the
Commission in Rome, July 2005. Following United Kingdom (UK), the unsuccessful attempt by the Blair government to limit the maximum
the Commission’s adoption of its restrictive
‘Guidelines for Vitamin and Mineral Food
permitted level of vitamin B6 in supplements to 10 mg in the late 1990s would not, had the proposal
Supplements’ as the new global regulatory become law, have affected the freedom of choice of consumers living in other countries.
standard for dietary supplements, the
threats to natural health therapies are
Following the creation of the World Trade Organization (WTO) in 1995, however, and the subsequent
becoming increasingly international in
nature. adoption by the Codex Alimentarius Commission, in 2005, of the controversial Guidelines for Vitamin
and Mineral Food Supplements, regulatory threats to natural health therapies are becoming
increasingly international in nature. The WTO uses Codex standards as the benchmark in its adjudication of international trade
disputes involving foods and, as such, Codex standards that had once been entirely voluntary now have the bite of law in the global
trade system - thus giving Codex coercive authority and WTO Members very real incentives to harmonize their regulations by adopting
its standards.
Moreover, the key methodology via which countries are increasingly harmonizing their domestic regulations with those of their
neighbors is by organizing themselves into regional trading blocs. Membership of such blocks - which can take the form of free trade
areas, customs unions, common markets and other forms of economic integration – increases the pressure upon countries to
harmonize their regulations and, in the case of food and dietary supplements legislation, to base them upon Codex standards.

The influence of the European Union

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The Dr. Rath Health Foundation | Responsibility for a healthy world http://www4.dr-rath-foundation.org/us/summit07/index.html

The European Union (EU) is the world’s largest - and arguably the most powerful - trading block.
Established by the Treaty of Rome in 1957, its number of member countries has grown over the past
fifty years from the original six participants to a current total of twenty-seven. This dramatic growth
has naturally resulted in a parallel increase in the EU’s economic and political power, the most
obvious example of which - from a natural health perspective - being at Codex meetings, where it is
now effectively able to shape the drafting of global food and dietary supplement standards to reflect
European law.
In this respect, it is particularly notable that the Codex Guidelines for Vitamin and Mineral Food Six nations established the European
Supplements (which, unlike the United States’ relatively liberal Dietary Supplement Health and Economic Community by signing the
Treaty of Rome, above, in 1957. Now
Education Act of 1994 (DSHEA), contain a requirement for maximum nutrient levels to be set) utilizes consisting of 27 member countries, the
the EU’s highly restrictive Food Supplements Directive as its blueprint. As such, it is with these facts European Union is the world’s largest
trading block. Its restrictive Food
in mind that the signing of the new transatlantic agreement - and the commercial and political Supplements Directive was used as the
influences that led to it - must be examined. blueprint for the controversial Codex
‘Guidelines for Vitamin and Mineral Food
Supplements’.
Laying the basis for a U.S.-EU single market
The agreement signed by U.S. President George Bush, European Commission President José Manuel
Barroso and German Chancellor Angela Merkel as head of the German term of the rotating EU
Presidency has three main components.
Firstly, it has a regulatory focus on finding ways to converge the different regulatory structures and
regulatory approaches of the United States and the European Union. In this respect, it is significant
that the Senior Administration Officials who conducted the post-summit press briefing specifically
stated that they had “interacted with the business communities on both sides of the Atlantic” and that
The new Transatlantic Economic Council the feedback that they’d received was that the different regulatory frameworks of the United States
will be chaired by U.S. National Economic
Council director Allan Hubbard (left) and and European Union “pose real barriers to economic advancement and growth.” Perhaps not
European Commission Vice President surprisingly, therefore, and as we shall discover, the pressure to deliver this agreement came from
Günter Verheugen (right). Together, they
will oversee the efforts to achieve some of the world’s most powerful multinational corporations, including the pharmaceutical industry.
transatlantic regulatory convergence in
nearly 40 areas. The second key component of the agreement is a set of priority projects focused on intellectual
property rights, trade, financial markets, consolidation, investment promotion and technology.
Finally, the agreement also includes the setting up of a Transatlantic Economic Council, to be chaired by U.S. National Economic
Council director Allan Hubbard and European Commission Vice President Günter Verheugen. The Council will be a permanent body
and will oversee the efforts to meet the agreement’s objectives, with the goal of accelerating progress and achieving regulatory
convergence in nearly 40 areas.
Notably, therefore, within only hours of the pact being signed, the BBC was already describing it as “laying the basis for a US-EU single
market.”

The influence of the TransAtlantic Business Dialogue

Originally the idea of the late U.S. Secretary of Commerce Ron Brown, it has long been the stated goal
of the TransAtlantic Business Dialogue (TABD) to establish a Barrier-Free Transatlantic Market.
Given this objective, it is hardly surprising that TABD’s Executive Board Companies comprise some of
the world’s richest and most powerful corporations and include the pharmaceutical manufacturers
Merck, Pfizer, AstraZeneca and BASF.
In the run-up to the April 30 summit, TABD issued no less than three separate press releases in
which it recommended that a barrier-free transatlantic market should be established, urged that time
was running out for the U.S. and EU to tackle trade barriers and stated that it was time for the
transatlantic political process to catch up with the deep integration already achieved by the business
community. Clearly, given the size and economic power of its Executive Board Companies, these press President Bush has close links to the
releases translated into a great deal of pressure upon President Bush, President Barroso and Executive Board of the Transatlantic
Business Dialogue (TABD), having met
Chancellor Merkel to deliver what TABD required. personally - at an EU-U.S. summit in
Ireland in June 2004 - with TABD EU
That said, however, there can be little doubt that all three of the signatories were fully supportive of chairman Niall FitzGerald (Chairman and
CEO of Unilever) and interim TABD US
the agreement’s aims - particularly so Chancellor Merkel, who had already promoted the idea in a chairman Michael Eskew (Chairman and
previous meeting with President Bush at the White House in January, only four days after Germany CEO of UPS) to discuss TABD’s
recommendations for a barrier free
assumed the rotating presidency of the 27-nation European Union. Moreover, a mere eight days after transatlantic market. The creation of such a
the signing of the agreement, in a further demonstration of TABD’s political influence, Merkel, market – to include the harmonising of
EU-U.S.dietary supplement regulations -
accompanied by European Commission Vice President Günter Verheugen - who along with U.S. has long been TABD’s goal.
National Economic Council director Allan Hubbard will chair the new Transatlantic Economic Council
set up by the agreement – was a guest at TABD’s Innovation Conference Healthcare in Berlin.
The closing speech at the TABD Conference was given by Verheugen, who especially stressed “the crucial role of Chancellor Merkel
and the German Presidency in catalysing the new EU-US Framework” and praised “Its organiser, the Transatlantic Business
Dialogue which has been central in making the case for transatlantic economic integration.” Even more significantly, perhaps, a
large proportion of Verheugen’s speech was given over to a discussion of the benefits of regulatory cooperation in which he specifically
cited pharmaceuticals as an example.
President Bush, meanwhile, is already known to have his own close links to the TABD Executive Board, having previously met with it
to discuss TABD’s recommendations for a barrier free transatlantic market at an EU-U.S. summit in Ireland in June 2004.

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Crucially, therefore, and as we shall discover, although dietary supplements are not specifically mentioned in the agreement itself, the
paper trail that led to its signing strongly suggests that they may already be scheduled for transatlantic regulatory harmonization in
the not-so-distant future.

The “roadmap” to harmonization

Achieving harmonization of the regulatory framework for vitamin and mineral food supplements on both
sides of the Atlantic - including the setting of maximum levels - has been a specific aim of TABD since at least
November 2000.
However, whilst the passing of DSHEA in the U.S. in 1994 created what is still arguably the most liberal
regulatory environment for dietary supplements in the world, the current situation in Europe could hardly be
more different. In the majority of European countries, for example, the availability of dietary supplements is
far more limited and, in those that are available, the doses are frequently limited to amounts that are below
therapeutic levels. Worse still, even those few European countries where supplements have traditionally been
regulated in a relatively liberal fashion – such as the UK, Ireland, Netherlands and Sweden – are now at risk
of losing their access to effective supplements as a result of the passing by the European Parliament of the
highly restrictive Food Supplements Directive in 2002.
However, as well as requiring the setting of maximum permitted levels for vitamins and minerals in supplements – the specific
amounts for which are expected to be announced later this year by the European Union’s executive body, the European Commission -
the Food Supplements Directive also restricts the sources of these nutrients to those (largely synthetic varieties) that are contained on
its so-called “positive list”. Under the Directive’s requirements, any manufacturer wishing to use types of vitamins or minerals other
than those specified on this list is required to submit a safety dossier for evaluation by the European Food Safety Authority.
Moreover, because the Directive was used as the blueprint for what is now effectively the global standard for dietary supplement
regulations – the Codex Guidelines for Vitamin and Mineral Food Supplements – European regulations are, by definition, already
compliant with that standard. As such, it is clear that in order to achieve the goal of transatlantic harmonization, American dietary
supplement legislation will have to be harmonized to the restrictive European model, as opposed to the other way around.
Given this reality, one should perhaps not be surprised to discover that regulatory cooperation between the FDA and DG SANCO (the
European Commission’s Health and Consumer Protection Directorate) is already well advanced.
Close examination of the 2005 Roadmap for EU-U.S. Regulatory Cooperation and Transparency, for example, reveals the following
information:

Objective: Cooperation between FDA and DG SANCO on issues of mutual interest in the field of nutritional labelling.
Progress/Results: Experts from FDA and DG SANCO are engaged in discussions on regulatory issues relating to health
claims, nutrition labeling, fortification, supplements, and infant formula. Specific areas under discussion include: 1) possible
collaboration on the EU’s Estimated Average Requirement (EAR) and the U.S. Recommended Daily Allowances (RDA) for
nutrients; and 2) cooperation on food labels.
Next Steps: Identify specific activities for cooperation on technical issues such as reference values for nutrient labeling,
nutrient definitions, and energy conversion factors. Pursue a confidentiality arrangement to facilitate the sharing of
non-public information in this subject area.

Ironic, isn’t it, that regulatory bodies supposedly promoting transparency find it necessary to pursue a “confidentiality arrangement”
and the sharing of non-public information when dealing with issues related to nutrition and supplements?
In addition, however, the 2005 Roadmap also reveals extensive cooperation between the FDA, the European Commission’s DG
Enterprise and Industry/Pharmaceuticals Unit and the European Medicines Agency (EMEA) in relation to pharmaceutical products.
It also contains proof that personnel exchanges, joint meetings and the sharing of documents are all now taking place between these
agencies.
Further evidence in respect of these activities was subsequently revealed in the June 2006 Joint Report on the Roadmap for EU-US
Regulatory Cooperation, which discloses that the “confidentially arrangement” for the sharing of non-public information in relation to
nutritional labeling was concluded in 2005.
The April 2007 Joint Report on the Roadmap for US-EU Regulatory Cooperation, meanwhile, released to coincide with this year’s
summit meeting, shows that over the past two years, U.S. and European authorities have expanded their joint activities significantly.
In the area of pharmaceuticals, for example, FDA, EMEA and DG Enterprise staff have engaged in over 800 interactions on almost
200 topics and conducted nearly 20 scientific staff exchanges and visits in the past year alone. In the area of nutritional labeling,
meanwhile, the 2007 Report ominously reveals that an “Implementation Plan” has now been completed under the confidentiality
arrangement.

Is ‘Free Trade’ really ‘free’?

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In the opinion of this writer, the principle of transatlantic harmonization of dietary supplement
regulations is not in itself inherently a bad thing. From the point of view of health freedom
campaigners in Germany, for example, who are currently subject to some of the most restrictive
dietary supplement legislation on the entire planet, the harmonization of their country’s regulations
to those of the United States - DSHEA – would clearly be a cause for major celebration.
The problem, therefore, lays not so much in the actual concept of harmonization, but rather in the
way in which it is applied. In other words, if the transatlantic harmonization of dietary supplement
regulations truly resulted in – to borrow the words of President Bush - “eliminating barriers to trade”, As the politicians and super-wealthy special
then this writer, at least, would be amongst the very first to celebrate. interests behind the proposed Free Trade
Area of the Americas discovered in Miami
The more likely outcome, however, according to many of those in the health freedom community on in 1994, growing numbers of people now
recognize that the real beneficiaries of
both sides of the Atlantic who have been following these issues closely for many years now, appears to so-called ‘Free Trade’ are not consumers,
be that rather than “eliminating barriers to trade”, the harmonization of transatlantic dietary but the world’s richest and most powerful
corporations - including the
supplement regulations will instead – via the banning of the most effective higher-dosed products - pharmaceutical industry.
result in the actual creation of them.
Should this happen - and regardless of whatever ‘consumer protection’ spin the political and regulatory elite may try to put on it –
then only the most extreme advocates of globalization would surely argue that restricting consumers’ freedom of choice by the
illiberalization of a market constitutes the elimination of trade barriers. More to the point, if the transatlantic harmonization of dietary
supplement regulations results in the hard-won health freedoms of Americans being lost, then by no rational means could the trade
that results from such an outcome even remotely be described as “free”.
All of which simply begs the question: “Who benefits?” Clearly, to answer this, one only needs to look as far as those companies who
are the most vocal in support of transatlantic economic integration – especially so given that they include amongst their number some
of the most powerful players in the global pharmaceutical industry.

Seeing things in context

In some senses, the signing of this transatlantic agreement allows us a glimpse of the bigger picture,
thus enabling us to see other current natural health and health freedom-related issues in the United
States in better context.
For example, whilst there can be little doubt that the FDA is now hell-bent upon eliminating the ability
of American consumers to purchase non-patentable natural alternatives to the pharmaceutical
industry’s multi-billion dollar market in patented drugs – in that virtually its every action appears to
be consistent with this assumption – it can be seen that issues such as the Draft Guidance for
Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food
and Drug Administration and Bill S. 1082 (the Food and Drug Administration Revitalization Act) are
Dr. Rolf Grossklaus, Chairman of the each but single steps in a highly coordinated ongoing plan, as opposed to separate ends in
German-based Codex committee that
drafted the controversial Guidelines for
themselves.
Vitamin and Mineral Food Supplements by
This being the case - and bearing in mind the signing of the new transatlantic agreement and the
using the European Union’s restrictive Food
Supplements Directive as its blueprint.
existence of the aforesaid FDA-DG SANCO “confidentiality arrangement” - the ultimate aim behind
Harmonization to these regulatory
the recent increase in domestically-based attacks on supplements in the U.S. can be seen as being to
standards could eliminate health freedom in
America. prepare the ground for the eventual dismantling of DSHEA and the harmonization of the U.S. dietary
supplement market to the more restrictive legislative regimes that exist in Europe and - via the
planned North American Union – Canada and Mexico.
As such, although neither the Codex Guidelines for Vitamin and Mineral Food Supplements – the global standard – or the Food
Supplements Directive – the European standard – have as yet set any maximum permitted doses for nutrients contained in
supplements, it would seem reasonable to conclude that whatever levels are announced later this year by the European Commission
could - as a result of both European political power at Codex meetings and the trans-Atlantic regulatory cooperation outlined above -
eventually be exported to, and implemented in, the United States.

Focus your attention on your elected officials, not unelected bureaucrats

There is a growing realization in the U.S. health freedom community that future access to effective
dietary supplements and other natural health therapies is increasingly under threat. However, the
question as to how best to deal with this threat is currently the subject of significant disagreement.
Some health freedom organizations, for example, urge people to voice their objections directly to the
FDA and/or USDA. On occasion, such as where these agencies have specifically asked for public
comment on a document, it is true that such responses are sometimes warranted. In reality, however,
the FDA and USDA are simply not accountable to ordinary citizens in the way that elected
congressional officials are. As such, even when these agencies ask for public comments, the fact is that Direct the majority of your energies into
industry – specifically the large multinational food, drug and agricultural corporations – and the writing and lobbying your Senators,
Congressmen and elected State officials.
government are far more influential with them than is the voting public. Unlike unelected bureaucrats from the FDA
and USDA, elected officials know that if
By way of contrast, elected State and Congressional officials are directly and democratically their actions and voting records are not in
accordance with the wishes of the majority
accountable. Unlike unelected bureaucrats from the FDA and USDA, elected officials know that if of their constituents, they risk losing their
their actions and voting records are not in accordance with the wishes of the majority of their jobs at the next election.

constituents, they risk losing their jobs - and hence, their livelihoods – at the next election.
As such, in this writer’s opinion, American citizens would be best advised to direct the majority of their energies into writing and

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lobbying their Senators, Congressmen and elected State officials. Remember that the FDA consensually agreed – in 2004 and again in
2005 - to the adoption by Codex of its EU-inspired global Guidelines for Vitamin and Mineral Food Supplements. As such, elected
government officials – not unelected FDA bureaucrats – are now the last line of defense against the harmonization of U.S. dietary
supplement legislation to restrictive European standards.

WHAT TO DO IF YOU LIVE IN THE UNITED STATES:

Ring, write and visit your elected officials and express your concern at President Bush’s signing of the
Framework for Advancing Transatlantic Economic Integration. Impress on them that you do not want U.S.
dietary supplement legislation to be harmonized to restrictive European standards. Explain that unless they
defend your access to supplements they will not be receiving your vote at the next election. Tell them that, if
anything, global health would be far better served by harmonizing the rest of the world to DSHEA, rather
than the other way round.
By signing the Framework for Advancing Transatlantic Economic Integration, President Bush has shown
that he is prepared to bring about the destruction of DSHEA.
Whether or not he succeeds is up to you!

WHAT TO DO IF YOU LIVE IN THE EUROPEAN UNION:

Support the Dr. Rath Health Foundation’s European Citizens Initiative.
We want to guarantee free access to scientifically based natural health remedies for everybody in Europe by
working together with you to demand the holding of a European ‘Referendum for Natural Remedies.’
We want to obtain no less than one million signatures!
Support us by signing the petition and collecting more signatures.
Click here to go to the European Citizen’s Initiative website.

Image sources/credits: Delegation of the European Commission to the United States; Codex Alimentarius Commission; Central Audiovisual Library of the European Commission; U.S. Department
of State's Bureau of International Information Programs; European Parliament; TransAtlantic Business Dialogue; Dr. Rath's Health Alliance USA, BV; Agrarsoziale Gesellschaft e.V.; istanbul
indymedia; Encyclopædia Britannica Online.

© 2008 by Dr. Rath Health Foundation | www.Dr-Rath-Foundation.org

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