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.
- The document is titled Codex Draft Guidelines for Vitamin and Mineral Food Supplements.
- The Preamble states that a normal diet provides all the nutrients you need. There is no mention that supplemental nutrition can enhance health and prevent disease--even in the face of a World Health Organization (WHO) publication documenting these facts. And the WHO is a parent organization of the Codex Alimentarius.
- We do not know which vitamins and minerals will be allowed, but numerous restrictive criteria are included.
- We do not know what dosage levels will be allowed, but several layers of options for lowering them are available.
- We do not know exactly how these unknowns will be determined or who will have the power to make these decisions, but sympathetic FAO/WHO bodies have been set up to produce results preferred by the EU.
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.