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.