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Federal Update Fall 2005

By Bill Sanda

CODEX Guidelines on Dietary Supplements

The international CODEX delegates adopted restrictive global guidelines for vitamin and mineral food supplements on July 4, 2005 in Rome, Italy. The vitamin and mineral guidelines, while not overriding national legislation, provide national governments with a blueprint for domestic vitamin and mineral regulation, which is much more restrictive than the American dietary supplement law, the Dietary Supplement Health Education Act (DSHEA).

CODEX is a broad, rambling, quilt-like enterprise managed by the CODEX Alimentarius Commission officially created in 1963 jointly through the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) under the United Nations, but existing in practice for more than a decade preceding its official creation. The CODEX Commission manages the CODEX Alimentarius or international code of food trade guidelines consisting of about 2000 guidelines on pesticide, food additive and other toxic residues in food and about 500 food guidelines or standards. CODEX had relatively little formal impact until the activation of the World Trade Organization on January 1, 1995. The WTO is empowered to determine whether a nation’s import prohibitions are improper trade barriers or are properly designed, based on sound science, to protect consumers. WTO identified CODEX as one science-based, standards-setting body on which it would rely. More information on the CODEX Commission can be found at www.CODEXalimentarius.net/web/index_en.jsp.

In our opinion, restrictions in the guidelines create a risk for supplement consumers worldwide. As nations begin adopting laws consistent with the guidelines in order to avoid losing international trade disputes with the WTO, there is a risk that the world market in supplements will sink to a lowest common denominator of a relatively few low-potency products. As the market contracts around such limitations, pressure will mount on the US to adjust its law to the international standard. The American supplement industry advocates of the international CODEX guidelines say they will resist such pressures but, critics fear, they have little commercial incentive to do so.

Under the CODEX guidelines, vitamins and minerals will be evaluated for safety as if they were toxic chemicals. Nothing prevents the unbridled use of this approach from discovering very low safe upper limits (it is technically possible, though unlikely, that they could even, in some instances, be lower than the Recommended Daily Allowance or RDA). Fifty years of US legislative and judicial determinations, culminating in the passage of DSHEA, oppose this concept. It appears to critics of the CODEX guidelines that, having failed domestically, the US Food and Drug Administration (FDA) now hopes to get the international community to treat nutrients as poisons. The critics point out that a senior FDA official supportive of treating nutrients as toxins has taken FDA leave in order to run the CODEX-supported toxicological review of vitamins and minerals. The critics find this fact troubling. Industry supporters of the guidelines say they will stand firm against unfair treatment of nutrients as toxins.

In addition to the battle over safety standards, supplement guidelines critics support the FAO/WHO observation that CODEX must do more to include nutrition standards in its commercial trade guidelines. In this context, supplement advocates, while opposing the use of improper standards for the safety evaluation of supplements, support the role of dietary supplements in the campaign to end world hunger and promote world health. They point out that researchers have shown that $1 of vitamin A supplementation equals $30 of development aid. They argue that similar results are likely for all essential vitamin and mineral supplements but that the CODEX guideline could make it more difficult to achieve these benefits. This position is one they believe is not antithetical to supplement industry interests. The dietary supplement community of consumers, producers, researchers, sellers and others could play a leading role in the FAO/WHO contribution to the global effort to end world hunger. This appears to be a position that the manufacturers who support the current guidelines could embrace.

Further information on CODEX dietary supplement guidelines can be found at www.citizens.org/priorities/CODEX/romeupdate.cfm. This report was prepared by Jim Turner, general counsel to the Weston A. Price Foundation, who attended
the Rome meeting.

Organic Standards

A split has occurred in the organics industry, pitting the Organic Trade Association (OTA) against a number of organically
oriented consumer groups led by the Organic Consumers Association (OCA). The issue at hand is publicly centered on an amendment proposed by the OTA to the Senate’s version of the FY2006 Agriculture Appropriations bill now being debated before the US Congress. According to the various consumer groups, OTA’s amendment could: (1) permanently allow synthetic processing aids, including over 500 food contact substances, to be used in organic foods without any type of public review for their safety and compatibility with organic production and processing; (2) leave unresolved whether young dairy cows could be treated with antibiotics and then converted to organic after twelve months; and (3) create a serious new loophole in which organic ingredients could be substituted with non-organic ingredients without any consumer notice based upon "emergency decrees." OCA believes that this amendment could significantly compromise the organic label. OTA contends that it is merely maintaining the status quo. So, where does the "truth" lie? Apparently, right now it is in the eyes of the beholder.

According to the OTA, the existing organic standards allow specific materials essential to making numerous organic processed products. These are non-agricultural materials that are necessary in certain production and processing practices
that have been used in producing foods for decades, such as baking powder, a type of pectin and carbon dioxide. OTA is advocating that products currently labeled as certified organic remain the same products that consumers have been purchasing for the past three years. Because of a recent court ruling (Harvey case), OTA contends that without its amendment, there will be fewer organic products available to consumers in the marketplace, organic products will be more expensive, and there will less incentive for manufacturing companies to buy organic ingredients, thus reducing markets for organic farmers.

The various consumer groups do not agree with OTA’s assessment of the future of organics without its amendment. They say that OTA’s amendment would effectively negate the ruling on the Harvey case that determined synthetics should not be permitted in the processing of certified-organic foods. If adopted, the OTA amendment would officially green-light the use of synthetic substances that are already being used in the production of organic products, and in some cases would enable the USDA to continue adding others to the list without getting feedback from the public or the National Organic Standards Board, the independent advisory group that crafted the first federal organic standards.

The Congress has not settled this issue. A House-Senate Conference Committee is to meet soon to resolve differences between the House and Senate versions of the 2006 Agriculture Appropriations bill. The Senate version did not adopt the OTA amendment but would permit a study of the issue, while the House bill contains no such provision. Stay tuned for more fireworks.

The Organic Trade Association (www.ota.com) is a membership-based business association that focuses on the organic business community in North America. OTA’s 1600 members include farmers, processors, importers, exporters, distributors,
retails and certifiers, including many of the very large food manufacturers such as Kraft and Dole foods. OCA (www.organicconsumers.org) is a 600,000-member grassroots non-profit public interest organization campaigning for health, justice and sustainability. The organization deals with issues of food safety, industrial agriculture, genetic engineering, corporate accountability, and environmental sustainability.

What really needs to happen is for these organizations to heal their disputes so that consumers and producers of organic products do not suffer because of their differences.

About the Author

Bill Sanda, BS, MBA, served as Executive Director and Director of Public Affairs for the Weston A. Price Foundation. Bill was a partner and co-owner of The McAdam Group, a lobbying company specializing in elements of education policy, and was a consultant to Primezyme, Inc., a nutrition and healing clinic. He has extensive experience in Washington D.C. politics and government, having served as a professional staff member in the US Senate.

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