Washington Report:
The CODEX Alimentarius Commission and Dietary Supplements

©Copyright 1998 by Emalee Murphy, Esq., McKenna & Cuneo, LLP, Washington, DC, USA
(Explore Issue: Volume 8, Number 5)

Providing ample evidence of the power of the Internet for spreading misinformation, the CODEX Alimentarius Commission's effort to adopt guidelines for vitamin and mineral supplements has generated conspiracy theories worthy of an Oliver Stone screenplay. These theories, which typically portray the CODEX as a puppet of German pharmaceutical companies that seek to implement a world-wide premarket approval system for dietary supplements, have begun to appear in the mainstream press of the supplement industry, putting in jeopardy the future of the draft guidelines.

Fortunately, the CODEX is far from the sinister international threat to health that some believe it to be. In fact, it could provide an opportunity for the United States to educate regulators in other developed nations about the benefits that an open market for dietary supplements, such as the one in the United States, could offer to their citizens. On the other hand, the consideration of international standards for vitamin and mineral supplements should be viewed with some concern, since it could lead to increased worldwide regulation of supplements and adversely affect consumer choice and the advancement of health and nutrition. Identifying and addressing the issues of legitimate concern, as well as realizing the benefits that could be gained from the process, requires us to separate hysteria from reality and understand the true nature of CODEX activity in this area.

What is CODEX?

The CODEX Alimentarius (Latin for "nutrition code") was created in 1962 as a joint effort of two United Nations' organizations -- the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) -- to encourage international trade in food and protect consumers from contaminants and other food-related health threats. The mechanisms adopted by the CODEX to accomplish this objective include food standards, codes of practice, and other guidelines, which the Commission develops and promotes for adoption by individual national governments. Since the organization was founded. the United States has participated through the U.S. CODEX office at the Department of Agriculture and numerous offices in the Food and Drug Administration's Center for Food Safety and Applied Nutrition.

 

Following the adoption of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT), the CODEX has assumed an increasingly important role in trade affairs. The Uruguay Round was the first multilateral trade agreement aimed at addressing regulatory requirements and other non-tariff laws that adversely affect the ability of foreign companies to compete with domestic industry. Toward that end, the Uruguay Round encouraged the harmonization of regulatory structures, primarily by promoting the use of international standards in the regulation of products. More importantly, the agreement created an international tribunal for the resolution of trade disputes between nations, and provided that failure by a nation to harmonize its regulatory system to the standards of certain international organizations identified in the agreement would provide evidence that a basis for holding that nation's law imposes an impermissible trade barrier. CODEX was among the standards-setting organizations identified.

Most likely, the CODEX conspiracy theories have arisen due to widespread confusion over the effect of GATT and the decisions of the international trade tribunal on the sovereignty of individual countries. In this case, this confusion has led some to believe that dietary supplement standards adopted by the CODEX that are in conflict with U.S. law under DSHEA would automatically override U.S. law, which is not true. Unfortunately, the confusion has been aggravated by overly broad statements by the Clinton Administration and GATT supporters, and language in the U.S. law implementing GATT, asserting that all provisions of GATT that are in conflict with U.S. law are invalid. That is not completely true either.

In simple terms, GATT allows one country to bring charges in the international tribunal against another country when the first country's failure to harmonize regulatory requirements acts as a competitive disadvantage to goods imported from the second country. If the tribunal determines that the country's law does violate the Uruguay Round agreement, it can impose trade sanctions against the country, a mechanism intended to encourage the country to change its law voluntarily. Neither the tribunal nor any other organization created or recognized by GATT has the power to override U.S. law. Furthermore, the Uruguay Round includes an exception for health-related regulations that conflict with harmonized standards if there is "scientific justification" for the more stringent measure or they are necessary to achieve "the level of protection a Member deems to be appropriate." Therefore, the decision of the United States to retain DSHEA in the face of even CODEX guidelines that directly conflict with the law might not even provide a basis for action by the tribunal.

Unfortunately, it can not be said for certain that the failure on the part of the United States to adopt any particular CODEX standard covering dietary supplements would be found to fall within this exception. Although the Administration has argued that the determination of what level of protection is appropriate is left to the discretion of the individual country, other member countries argue that appropriateness is at least partially within the jurisdiction of the international tribunal. In any event, the safeguards for health-related statutes and regulations contained in the agreement certainly suggests that CODEX is not the death knell for DSHEA that some people are portraying it to be. Furthermore, the FDA has actively worked to keep the CODEX from adopting any measures that would even arguably conflict with U.S. dietary supplement law.

CODEX Standards for Vitamins and Minerals

Two committees of CODEX have specific jurisdiction over dietary supplements. The first is the Committee on Food Labeling, which promulgates standards relating to the use of nutrition claims and health claims. The second is the Committee on Nutritional Foods and Special Dietary Uses ("CNFSDU"). By far, the CNFSDU has ignited the greatest controversy related to dietary supplements.

Action by the CNFSDU to address dietary supplements was first proposed at the committee's annual meeting in October 1995, by the German delegation, which chairs the CNFSDU. The committee agreed to proceed with the development of guidelines, overriding the objection of the United States. The draft guidelines were discussed at the committee's 1996 meeting, and the United States again registered its dissent, arguing that the proposed provisions were inconsistent with U.S. law and would unnecessarily restrict consumer access to dietary supplements. The U.S. position was supported by the delegations from the United Kingdom and Japan. Despite that opposition, and the fact that the CNFSDU could not reach consensus on key portions of the proposal -- including minimum and maximum dosage levels, risk assessment methodology, and required warning statements -- the committee sent the proposal to the full Commission for review during its 1997 session.

Among other provisions, the guidelines forwarded to the full Commission contained the following proposals:

• Scope -- The guidelines proposed to cover only vitamin and minerals, not supplements containing only botanicals or herbs.
• Permissible Vitamins and Minerals -- The guidelines proposed that supplements should contain only minerals and vitamins "whose indispensability for human beings has been proven by scientific data," although consensus could not be reached as to whether coverage by recommendations for daily intake by established scientific authorities should also be required.
• Composition -- The guidelines propose to establish minimum and maximum levels of each nutrient, although no consensus could be reached as to where and how those levels should be established.
• Labeling -- The guidelines propose to that labeling include recommendations for use of the product (frequency, quantity, etc.) and warning statements related to toxicity level, although there was no agreement as to how the need for a warning statement was to be determined.
• Additional Limitations -- The guidelines provided that they would not apply to countries that define and regulate dietary supplements as drugs, and that the use of individual vitamins and minerals could be limited by an individual nations for reasons of health protection and consumer safety.

At the 1997 session, Canada and Australia joined with the United States in attempts to kill the proposal. While those efforts were unsuccessful, the Commission did vote to return the proposal to the CNFSDU for further consideration. Most significantly, the Commission instructed the committee to specifically consider whether there was a true need for the guidelines. In addition, although the committee had already rejected efforts to extend the guidelines to include botanicals and herbs, including a proposal to develop a list of unsafe botanicals and herbs whose use in food would have been prohibited under CODEX guidelines, the full Commission explicitly removed further action concerning these products from the Commission's Work Program during its June 1997 meeting.

The Real Concerns

Reviewing the proposed guidelines, one can see that even though they would not automatically lead to changes in DSHEA, they are certainly contrary to the direction of U.S. regulation in this area. Dietary supplement manufacturers, consumers, the alternative and complementary health communities, and their supporters in Congress worked diligently to enact DSHEA because they perceived it as the appropriate means for protecting public health without denying consumers the ability to make their own decisions regarding health and nutrition. Assuming that justification is one that should translate across national borders, there should be serious concern that the CODEX standards will emerge as the regulatory model for many other countries, especially those developing nations that have yet to establish their own regulatory systems. This could adversely effect both the health of the citizens of those nations, as well as the competitiveness of the U.S. dietary supplement industry in those markets.

Second, it is conceivable that some CODEX action could be used by the FDA as justification for imposing additional regulatory requirements under DSHEA that it may not have imposed otherwise. DSHEA provided that the FDA may take regulatory action against a dietary supplement if the supplement or one of its ingredients "presents a significant or unreasonable risk of illness or injury . . . ." Although DSHEA placed the burden of proof on the agency to establish the existence of such a risk, adoption of CODEX guidelines that, for instance, establish a maximum level for a particular mineral could be presented by the FDA as a basis for restricting the marketing of products with higher levels. Therefore, the CODEX activities could affect U.S. regulation of supplements without the FDA even explicitly adopting the guidelines.

What Can Be Done?

Given the concerns noted above, it is imperative that supporters of DSHEA get involved in the CODEX process. At a minimum, that means doing the following:

1. Become Educated -- The first step must be to educate yourself about CODEX activities. This means not only learning about the proposal and its possible effects, but about the process by which the guidelines are advancing. Each year, the U.S. CODEX Office publishes in the Federal Register a notice outlining the activities of CODEX during that year. This is an invaluable resource, for it provides not only updates on past and future actions, but also includes explanations of the decision-making process, listings of current committee membership and agendas, and information on the format of CODEX standards.
   
   
2. Dispel the Myths -- Misinformation and ignorance in the United States pose the greatest threat to the ability of the U.S. CODEX delegation to steer the process toward a resolution that will protect the interests of U.S. industry and consumers. Unfortunately, the network of conspiracy theorists is organized and well-ahead of the legitimate alternative medicine community in addressing the possible affect of CODEX.

Stemming that tide and retaking control of the debate could be a difficult fight., but on that is critical all the same.

3. Become Involved -- The U.S. dietary supplement industry and the alternative medicine community must provide support for the FDA's efforts to defeat or modify the proposal to reflect the public policy underlying DSHEA. The CNFSDU will meet again in October 1998 to reconsider the proposed guidelines, including the fundamental question of whether there is a true need for their adoption. FDA is represented on the committee by Dr. Elizabeth Yetley, the Director of the CFSAN Office of Special Nutritionals (202-205-4168). All interested persons should contact Dr. Yetley with concrete examples of how the proposal could affect the consumer choice regarding nutrition and health, as well as the international competitiveness of the U.S. dietary supplement industry.

No less importantly, the dietary supplement community must be prepared to become involved with the FDA's consideration of whether any CODEX standards that are ultimately approved should be adopted by the agency. In July 1997, the FDA published an advance notice of propose rulemaking concerning possible revisions of the process by which the agency undertakes consideration of CODEX standards for adoption. The current procedure was promulgated in 1973, prior to the creation of CODEX's special role under GATT. The notice asked for input into a number of areas, including the appropriate priority of the FDA's participation in CODEX, how the acceptance of CODEX standards may contribute to the agency's mission, reasons why the FDA should not expend resources on reviewing and considering CODEX standards, the most efficient method for undertaking such a review, and the possible impact on consumer protection. The FDA has not proceeded further with the promulgation of a new regulation.

Conclusion

The ongoing debate over the need for, and possible impact of, international standards for dietary supplements has been derailed by accusations that fundamentally misrepresent the nature of the process. Those accusations must be discredited, so that discussion can return to the real issues and opportunities presented by CODEX. Fortunately, the FDA has demonstrated a strong willingness to work with the dietary supplement community to protect DSHEA and to promote its principles in international harmonization efforts, and it is not too late for the U.S. dietary supplement community to educate itself about CODEX and become involved.

To review the CODEX Alimentarius Commission's Proposed Draft Guidelines for Vitamin and Mineral Supplements, visit the Internet site of McKenna & Cuneo, L.L.P., at http://www.mckennacuneo.com/ . . . Additional information about the CNFSDU can be obtained from the FDA website, located at http://www.fda.gov.

About the Author

Emalee Murphy, whose experience in FDA-regulated industries spans over 20 years, provides regulatory and enforcement counseling for clients in the drug (prescription and OTC), medical device, dietary supplement, cosmetic, food, and food additive industries, with particular emphasis on market entry issues and strategies for new products and new companies. She is experienced in FDA import and export issues and provides assistance to companies involved in FDA compliance, import detention, and enforcement matters.

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