International trade regulations for vitamin and mineral supplements are scheduled for finalization in July 2005. These could have been modeled after the lenient United States’ approach. However, retracing events of the last fifteen years reveals how the EU tenaciously fought the U.S. every step of the way to emerge victorious in getting their restrictive rules as the international standard.
For three years I have been compiling information in an attempt to understand the controversy over the Codex Draft Guidelines for Vitamin and Mineral Food Supplements (the Guidelines). Gaining insight into the different perspectives wasn’t enough to explain why this international document related to dietary supplements was so important and the motivation behind the tenacity of some parties to get their way.
Then I learned a key fact that made so many other facts fall into place. The European Union (EU) is close to implementing an EU Pharmaceuticals Directive, which takes the position that anything that changes or enhances human physiology needs to be controlled as a medicinal product. This includes items that might prevent disease. Stop and consider the vast range of what this covers. The EU has a powerful agenda at stake with this Directive.
I had been comparing the Codex Guidelines and the EU Food Supplements Directive and trying to understand why it was so important to the EU that these be similar. Only when I stepped back and placed these documents within a larger context that included the EU Pharmaceuticals Directive did I grasp the significance.
Only then did the very short “positive list” of vitamins and minerals allowed by the EU Food Supplements Directive make sense. In EU countries, with so many dietary supplements regulated as medicinal products under the strict definition in the EU Pharmaceuticals Directive, there would be very few nutrients left over to be regulated by the EU Food Supplements Directive, and these would need to be at very low, ineffective dosage levels. Any supplement dosage high enough to benefit a human being would shift that product into the drug category.
Place this information in the context of the Codex Alimentarius, which provides food-related international trade standards that all countries can be forced to adopt through the enforcement powers of the World Trade Organization (WTO). You can see why it was vital to the EU that the Codex Guidelines be in alignment with the EU Food Supplements Directive. You can understand why the EU representative was motivated to fight so vigorously to add “Food” to the Guidelines‘ title and keep out any mention that vitamins and minerals might have any health benefits. And why he was particularly fervent to block any mention that vitamins and minerals could prevent disease.
If the Codex Guidelines had ended up lenient, there would be the potential that international harmonization could force the EU to give up its strict regional control of maintaining low levels of vitamin and mineral supplements as food and higher levels as drugs. To protect its interests the EU must keep the Guidelines and other Codex standards restrictive and in alignment with its Directives.
With this new understanding in mind, I retraced the history of the development of the Codex Guidelines looking for signs of a EU’s strategy. I found that the idea to control dietary supplements had been first openly discussed at the 1988 session of an EU country-based Codex committee, the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). Through the years, the EU representative to this committee kept successfully positioning the developing EU Food Supplements Directive ideas as core elements of the Codex Guidelines. The EU representative made a big issue of the fact that he was speaking for fifteen countries. This large EU block of “votes” in the CCNFSDU and other Codex sessions worked.
Where was the U.S. as this unfolded? CCNFSDU reports show that initially the U.S. protested the regulation of dietary supplements as inconsistent with U.S. national regulations. The U.S. said that regulation would unnecessarily restrict consumer access to dietary supplements. When this did not work, the U.S. did not, however, propose an alternative agenda. Rather, the FDA-led U.S. delegation constantly compromised its views and ended up accepting what the EU wanted. In fairness, it should be pointed out that the EU had the benefit of a block of “votes” and the sympathetic CCNFSDU Chair from Germany (an EU country) declaring group consensus (approval) for whatever the EU supported.
What could the U.S. have proposed? Like the EU, the U.S. has a definition for health-enhancing products that can designate them as drugs. However, in the early 1990s the U.S. Dietary Supplement Health and Education Act (DSHEA) was passed. It designated vitamins, minerals, herbs, and many other dietary supplements as food, rather than drugs. There is no indication that any individual, group, or U.S. government entity felt motivated to encourage the rest of the world to follow suit. Therefore, without significant opposition, a commitment to prevail and effective use of the Codex system were powerful keys to success for the EU agenda.
With all of this in mind, take a fresh look at the various sections of the Codex Guidelines to see just how successful the EU has been.
In short, while we know the Codex Guidelines will be restrictive, we do not actually know what this document will specifically allow. And yet the Guidelines document is on the agenda for finalization by the Codex Alimentarius Commission at the July 4-9, 2005, session in Rome.
Once the Guidelines are finalized–whether in July 2005 or at some future date–will the EU be satisfied to let the U.S. be an isolated haven that allows unrestricted consumer access to high potency dietary supplements? Probably not. Understandably, the EU will want to secure its powerful regional position and will most likely look to removing any influence from the lenient U.S. DSHEA law. This could be done very readily by having an EU country file a trade dispute with the WTO against the U.S., naming something related to the differences between Codex and U.S. supplement regulations. The WTO Dispute Settlement Panel would compare the restrictive Codex Guidelines and the lenient U.S. DSHEA regulations looking for an unfair trade advantage and/or non-harmonization with international trade standards. Since the WTO historically makes decisions that will level the trade playing field, there would be a high probability that the WTO would rule against the U.S. and direct the U.S. to revise DSHEA to match the Codex Guidelines. And the U.S. would have to pay an expensive trade sanction every year until it knuckled under and changed DSHEA. Could the U.S. just refuse to pay? It may take years, but the WTO keeps after a losing country until it does what the WTO demands. Historically, the U.S. has changed its laws.
Should this happen, and DSHEA regulations were modified to be as restrictive as the Codex Guidelines are ultimately expected to be, would you be able to continue to freely purchase the wide range of dietary supplements at your local health food store? Based on what is already happening in several European countries, probably not. Could the WTO really use economics to pressure the U.S. to its will? A review of trade agreements signed by the U.S. shows that it definitely could.
What can be done to protect your interests? Is it too late? There aren’t any easy answers. Advocacy groups in the U.S have tried for years, but they have consistently found it difficult to generate concern. Americans have confidence in their government’s ability to protect their rights and freedoms. They cannot believe that there are outside organizations (like the WTO) with more power than the U.S. government. Yet, my research has verified that the WTO has forced our country to change U.S. laws in the past.
I am sharing the facts I have uncovered in hopes that you will be better informed and more vigilant for positive actions to protect health freedoms in the U.S., particularly from the power of outside trade regulations. Remember the strong motivation of many other countries to restrict access to health-enhancing options, such as dietary supplements. These countries have become skilled in using international organizations to support their preferences. You can increase awareness of this serious matter by talking about this with your friends and colleagues. If you hear about advocacy campaigns for protecting health freedoms, listen. If you agree with their ideas, support what they are suggesting. Complacency supports and encourages those working to undermine the current heath freedoms in the U.S.
Related Documents for your reference:
· WTO explanation about Standards and Safety Agreements — SPS and TBT — and identification of Codex Alimentarius as source for food standards
Suzan Walter, president of the American Holistic Health Association, researched how the Codex Alimentarius and the World Trade Organization function and applied this information to track the potential impact of the document Codex Guidelines for Vitamin and Mineral Food Supplements. She attended the Codex Committee on Nutrition and Foods for Special Dietary Uses