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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 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.”
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.
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.
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.
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
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.
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.