Comments submitted by e-mail June 6, 2005 to the U.S. Codex Office for Dr. Frank Edward Scarbrough
TO: Dr. Frank Edward Scarbrough, U.S. Manager for Codex, U.S. Codex Office
Comments to be considered when drafting the United States' position related to the Draft Guidelines for Vitamin and Mineral Food Supplements document, which is on the agenda at Step 8 for finalization at the Codex Alimentarius Commission session July 4-9, 2005 in Rome.
As a consumer education organization, the American Holistic Health Association (AHHA) has been working to educate the American public about the Codex Alimentarius and the Draft Guidelines for Vitamin and Mineral Food Supplements (Guidelines) being developed by the German-hosted Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU).
AHHA urges that the U.S. delegation NOT support the finalization of the Guidelines that has been submitted to the Codex Alimentarius Commission (CAC) at Step 8 by the CCNFSDU.
The following comments are based on our personal research of Codex and World Trade Organization (WTO) documents and attendance at the 2002, 2003, and 2004 CCNFSDU sessions in Germany.
1) CCNFSDU delegates were not fully informed of how the Guidelines could be used. Therefore, their approval to advance the Guidelines to Step 8 was based on incomplete information that did not allow CCNFSDU delegates to consider all of the ramifications of finalization of this document.
At the November, 2004, CCNFSDU session, delegations twice inquired as to how the Guidelines could be used, and were twice informed that the Guidelines were only optional. While this is true under Codex auspices, there was no mention that the WTO can use any Codex document to settle international trade disputes.
Official reports of Codex and the WTO state that the WTO can use Codex documents to resolve international trade disputes and that the WTO does NOT differentiate between Codex standards, guidelines, and recommendations. Therefore, this would allow the WTO to use the Codex Guidelines as a mandatory trade standard to settle a trade dispute and would not honor the optional status the CCNFSDU delegates intended.
2) CCNFSDU delegates advanced the Guidelines to Step 8 with several important aspects left unspecified. At the time the delegates advanced the Guidelines to Step 8, they did not know exactly what the final regulations would end up being. Until these are known, the CAC and CCNFSDU really have no idea of the ramifications of finalizing the Guidelines.
The Guidelines COMPOSITION 3.2.2 addresses maximum upper limits and references the use of scientific risk assessment. This risk assessment protocol did not exist as of the November, 2004, CCNFSDU session, nor was a specific organization designated to develop this protocol. 3.2.2 goes on to allow whatever upper limits are set by risk assessment to be further reduced by two additional factors. The CCNFSDU delegates had no idea what the specific upper limits for individual vitamin and minerals would end up being when they advanced the Guidelines to Step 8.
The Guidelines COMPOSITION 3.1.1 states that the U.N. Food and Agriculture Organization (FAO) and the World Health Organization (WHO) are the authorities designating which vitamins and minerals will be recognized as valid. Yet neither the FAO nor WHO has provided an official list, nor is one to be found on their websites. Therefore, the CCNFSDU delegates had no idea which individual vitamins and minerals would be allowed when they advanced the Guidelines to Step 8.
The Guidelines SCOPE 1.3 allows countries designating vitamin and mineral supplements as drugs to be exempt. This is not in alignment with the Codex purpose to create trade standards with which all countries are to harmonize their national standards. If the Guidelines were indeed optional guidelines, this would not matter. However, since any Codex document can be used by the WTO as a mandatory trade standard, the CAC needs to request that the WTO review this Guidelines document in its current form and inform the CAC and CCNFSDU how a WTO Dispute Settlement Panel would apply this document. Until that is known, the CAC and CCNFSDU really have no idea of the ramifications of finalizing the Guidelines.
3) The limited role of vitamins and minerals, as presented in the Guidelines PREAMBLE, is inconsistent with the FAO and WHO findings and U.S. and international scientific research. The WHO 2002 publication, "Diet, Nutrition and the Prevention of Chronic Diseases," specifically references the preventive value of vitamins and minerals.
Through the years of the development of the Guidelines by the CCNFSDU, all attempts to expand the Preamble paragraph to at least mention the preventive aspects of vitamins and minerals were disallowed. Each year a different reason was used to put down the attempt to insert a broader view of vitamins and minerals. The negative climate for the value of vitamins and minerals might be better understood if you are aware that at the November, 2003, CCNFSDU the German Chair lectured the delegations that drugs--not vitamins and minerals--were for preventing and treating disease.
If the Guidelines document in its current form were finalized and became the international standard for vitamin and mineral supplements, could this be used to disallow the use of these dietary supplements for legitimate, science-based use to prevent and to support treatment of diseases? Were the CCNFSDU delegates really supporting this? Could the U.S. delegation justify supporting this?
4) The United States was against the development of the Guidelines. The official CCNFSDU session report for 1996 states, "The U.S., United Kingdom and Japan were against developing the guidelines as the provisions therein were inconsistent with their national regulations and would unnecessarily restrict consumer access to dietary supplements." It is unfortunate that the U.S. position did not prevail. However, the U.S. does have a responsibility to protect the U.S. consumer's access to dietary supplements.
Our research into the power of the WTO does reveal potential scenarios where the U.S. could be forced by the WTO to revise DSHEA to harmonize with the Guidelines. We would be happy to share our research with you.
AHHA urgently requests that the U.S. Delegation reviews our concerns and takes the position of NOT supporting finalization of the Guidelines or at least postponing until the decision is based on full disclosure of ALL of these matters.
Thank you for your consideration.
These comments submitted by