The following are the AHHA comments submitted to the FDA representative, Dr. Barbara Schneeman, to be considered when drafting the United States' position related to the Proposed Draft Guidelines for Vitamin and Mineral Food Supplements that will be discussed at the 26th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) to be held in Bonn, Germany, November 1-5, 2004.
September 9, 2004
Comments for U.S. Head Delegate, Dr. Barbara Schneeman, to be considered when finalizing the United States' position related to the Proposed Draft Guidelines for Vitamin and Mineral Food Supplements that will be discussed at the 26th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) to be held in Bonn, Germany, November 1-5, 2004.
As a consumer education organization, the American Holistic Health Association (AHHA) has been working to increase the American public's awareness of the Codex Alimentarius. The highest consumer interest has been in the Guidelines for Vitamin and Mineral Food Supplements being developed by the CCNFSDU.
It is our understanding that the WTO expects the Codex Alimentarius to draft food standards for international trade regulations and for food safety. In order to resolve international trade disputes these standards need to be applicable in all situations and for all countries.
In the case of vitamin and mineral supplements there are so many variables and exceptions that it is not possible to present the WTO with one trade standard that could be applied to every nation.
The key concern expressed by the American public is that there are conflicting indications for how the Guidelines for Vitamin and Mineral Food Supplements document will be used after it has been finalized. AHHA urges the U.S. Delegation to spearhead an effort to verify how the WTO will use these Guidelines. Currently, it appears that those drafting this important document are misinformed as to how it will actually be used.
Firsthand experience talking with delegates at CCNFSDU sessions in Germany and members of the German Codex staff indicates strong convictions that the Guidelines is a document with optional suggestions to be used by those countries needing this type of data. Delegates seem to believe that because the document is entitled "Guidelines" it is only guidelines, or suggestions. However, in 1998 the WTO informed Codex that it does not differentiate between standards and guidelines. Both will be used as mandatory standards.
The content of the Codex Guidelines for Vitamin and Mineral Food Supplement specifically excludes the roles of prevention and treatment. It also limits application to only countries designating vitamin and mineral supplements as food. The wording of the Guidelines has been changed to have should, not shall. References have been made in 25th CCNFSDU session report to CAC that "as the text was not a standard". However, under SCOPE 1.2 the text states "These Guidelines do apply..." To clear up any future confusion, if the CCNFSDU does intend for the Guidelines to not be a mandatory standard, this needs to be stated within the document, most appropriately under the SCOPE section. This would be in keeping with the WTO clarifications to Codex "...how a Codex text was applied depended on its substantive content rather than the category of that text."
Otherwise, once the Guidelines are finalized, the WTO might decide that, since there is no international standard, it will use the Guidelines for Vitamin and Mineral Food Supplements as a mandatory standard and apply to all countries, perhaps even those designating these supplements as drugs. The WTO might even decide to use the Guidelines to apply to all uses of vitamins and minerals, even those used for therapeutic purposes.
Increasing numbers of American consumers are becoming aware of what a valuable privilege they have to be able to purchase the vitamin and mineral supplements of their choice. They see the looming restrictions going into effect in the European Union countries and are genuinely concerned that this might happen in the U.S.
While most industry sources are confident there is no reason to be concerned, there are a number of individuals with legal training who are concerned after studying how the WTO handles international trade disputes.
AHHA urges the U.S. Delegation to
AHHA urges the U.S. Delegation to make certain that the CCNFSDU delegates are accurately informed as to the answers to these two questions. How the Guidelines document will be used by the WTO needs to be on record in the CCNFSDU session report - from the WTO, not from a Codex source.
AHHA also urges the U.S. Delegation to take the leadership role supporting the addition of appropriate wording to the Guidelines document, stating that this document is not to be a mandatory standard, but only optional suggestions. AHHA will be present to support you in this. Our president, Suzan Walter, will be attending the CCNFSDU session as an observer.
Please make sure the Guidelines for Vitamin and Mineral Food Supplements document is not finalized until these matters have been resolved.
In reviewing the preliminary U.S. Positions on the Guidelines for Vitamin and Mineral Food Supplements we offer the following comments:
1) 3.1.2 Synthetic sources not food
2) Work on your rationale for 3.2.2 section deletion
3) Concern about wording of 3.2.2
4) 5.5 should be in square brackets
These comments submitted by