Frequently Asked Questions
August 2010
CODEX and Dietary Supplements
For years, many Americans, especially those who value their access to dietary supplements have expressed concern that decisions made by the CODEX Alimentarius Commission (and other international rule making bodies) may restrict their access to vitamin and mineral dietary supplements. This fear was exacerbated in 2005 when the CODEX finalized the Guidelines for Vitamin and Mineral Food Supplements, which included a provision to set maximum amounts of vitamins and minerals in food supplements. This provision is in direct conflict with existing U.S. dietary supplement laws (explanation provided below).
What Exactly is CODEX?
You are not alone if you do not understand what CODEX is and why over the last ten years so many people especially those in the health freedom movement have expressed concern.
The CODEX Alimentarius Commission was established by parallel resolutions of two United Nations affiliated organizations - the Food and Agricultural Organization (FAO) in 1961 and the World Health Organization (WHO) in 1963. The purpose of this joint program is to ensure food safety and fair practices in food trade through the coordination of all food standards undertaken by governmental and non-governmental organizations. These purposes are to be achieved through the development of food standards, guidelines and related texts such as codes of practice.
Background: During the second half of the 19th century, laws and standards began to be established that were designed to insure food products were clean and pure and to protect consumers against fraud. (Issues like watering down milk products, selling spoiled meat, rancid oils, or putting fillers into food products without informing the buyer.)
The development of industrial chemicals and their increased use to preserve or color foods created new safety concerns and the concept of adulteration was expanded to include the illegal use of harmful chemicals in foods. (Adulteration is defined as the alteration, especially the debasement, of a substance by deliberately adding something not ordinarily a part of it.)
In 1950, during a joint FAO/WHO meeting, it was noted, "Food regulations in different countries are often conflicting and contradictory. Legislation governing preservation, nomenclature and acceptable food standards often varies widely from country to country." There was an expressed concern that "the conflicting nature of food regulations may be an obstacle to trade and may therefore affect the distribution of nutritionally valuable food..."
Today, CODEX has 27 Committees on topics ranging from meat, poultry, food additives, methods analysis, dairy, and natural mineral waters. The Committee under which the 2005 Guidelines for Vitamin and Minerals Food Supplements was developed is the Codex Committee on Nutrition and Foods for Special Dietary Uses.
What is the role of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU)?
According to the official CODEX Alimentarius Commission website, the CCNFSDU which is hosted by the Federal Republic of Germany was founded:
- to study specific nutritional problems assigned to it by the Commission and advise the Commission on general nutrition issues;
- to draft general provisions, as appropriate, concerning the nutritional aspects of all foods;
- to develop standards, guidelines or related texts for foods for special dietary uses, in cooperation with other committees where necessary; and,
- to consider, amend if necessary, and endorse provisions on nutritional aspects proposed for inclusion Codex standards, guidelines and related texts.
Shortly after the passage of the Dietary Supplement Health and Education Act of 1994 in the United States (DSHEA), which provided clarity to U.S. law regarding dietary supplements, the CCNFSDU initiated a discussion about establishing guidelines for vitamins and mineral food supplements in countries like the United States that regulated these products as foods. In those countries in which food supplements were regulated as drugs, these guidelines would not apply.
Many considered their focus on ingredient potency rather than quality control to be outside of the duties of this Committee, however; the CCNFSDU moved forward, adopted the Guidelines in November 2004, and then sought and obtained final approval of these Guidelines by the Commission in 2005. The Guidelines include a provision to set maximum potency limits.
It is important to note that these guidelines do not affect all of the countries that participate in CODEX, it only affects those that regulate vitamin and mineral supplements as foods. Countries for which these guidelines do not apply were able to participate in the deliberations and the developments of the guidelines. Just like in the United Nations, each country gets one "vote". The only exception to this is the European Union (EU), which is allowed the vote of each member country plus the vote of the EU representative. Consensus is the usual way of obtaining Committee and Commission agreement without voting.
In addition to the discussions on vitamins and minerals, the CCNFSDU has conducted discussions on issues such as promoting breast feeding and at what month of age to support the initiation of supplemental feeding in infants; setting standards on gluten free foods; infant formula ingredients; and the classification of sports drinks.
What Are the Guidelines for Vitamin and Mineral Food Supplements?
The CODEX Guidelines for Vitamin and Mineral Food Supplements of 2005 outline a standard for countries that regulate supplements as foods. It includes a definition, a composition standard on both minimum and maximum potencies, as well as labeling and packaging guidelines. The standards on composition are not specific, but rather set the stage for the development of a list of approved ingredients, and for limit setting on potencies of ingredients. At present, the guidelines are more in the nature of a framework with the working figures to be filled in later.
It is important to note there was no formal request from any member nation to develop this Guideline, but rather a self-initiated project of the CCNFSDU.
Isn't CODEX a Voluntary Standard?
From its inception, the CODEX Alimentarius Committee has promoted that compliance with the standards and guidelines it puts forward is purely voluntary and nonbinding.
According to a 2005 publication of the US FDA, "All Codex standards and related texts are voluntary, and vitamin and mineral food supplement products sold in the U.S. would not be required to comply with provisions that are more restrictive than U.S. law (i.e., DSHEA)."
However, in a 2006 Report to their Secretariat, the WHO raised the alarm that the adoption of CODEX standards may no longer be voluntary. This report stated, "WTO's Agreement on the Application of Sanitary and Phytosanitary Measures and Agreement on Technical Barriers to Trade recognizes Codex standards, guidelines and recommendations as reference points for international trade within the context of WTO, regardless of their formal acceptance by the States Parties to those agreements. This development consequently casts doubts as to the relevance of the Codex acceptance procedure provided for in the Statutes and other procedural documents of the Codex Alimentarius Commission."
As a result of the concerns raised, rather than challenge or request modification of the WTO policies, the World Health Administration and the FAO considered and adopted an amendment to delete any reference to the procedures of acceptance of standards from the CODEX Procedural Manual.
The United States is party to the World Trade Organization (WTO) which includes a number of major agreements as well as the General Agreement on Tariffs and Trade (GATT) Uruguay Round of Multilateral Trade Negotiations which is the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS). The SPS agreement requires that members of the WTO when establishing their own SPS measures, consider international standards, guidelines, or recommendations. While a country is not required to use an international standard, according to this agreement it must have a scientific justification to establish or maintain a more stringent measure to meet the country's chosen level of protection if that measure will impact on trade. Standards established by Codex regarding food and substances in food have a particularly favorable status under the SPS agreement.
In the U.S. Code of Federal Regulations, the FDA has declared that "All food standards adopted by the Codex Alimentarius Commission will be reviewed by the Food and Drug Administration and will be accepted without change, accepted with change, or not accepted." To date the 2005 Guidelines for Vitamin and Mineral Food Supplements has not been officially rejected by the United States.
Moreover, in the CODEX Alimentarius Commission's publication, "Strategic Framework 2003-2007", the Commission itself mentions and refers to its "clear and strategic interest in promoting the maximum use of its standards both for domestic regulation and for international trade."
Further evidence pointing to a push to mandate CODEX standards are correspondence between the U.S Department of State and the Ukraine regarding reforms necessary for the Ukraine to become a member of the WTO. Among these reforms was adoption of the CODEX standards.
Didn't Congress Already Fix This Problem?
In response to concerns of their constituents about CODEX and the publication of statements by the FDA in 1995 that it was the goal of the agency whenever possible to harmonize with international standards and regulations, including for dietary supplements, the Congress included Section 410 in the Food, Drug, and Modernization Act. of 1997. This section expressly forbids the FDA from harmonizing any international regulation relative to dietary supplements. (In this case, "harmonize" means to bring into legal alignment the laws, rules, regulations, and guidelines of another country or set of countries with those of the United States.)
In the 12 years since the passage of this legislation, the FDA has not updated the Code of Federal Regulations to reflect this change in the law. Furthermore, the United States has not complied with our obligations to make an official notification the CODEX Alimentarius Commission formally rejecting the 2005 Guidelines on Vitamin and Mineral Food Supplements.
The 2005 Guidelines are in Direct Conflict with Existing US Law - the Proxmire Amendment of 1976.
In 1976, Congress passed the Proxmire Amendments to stop FDA from establishing standards limiting potency of vitamins and minerals in food supplements or regulating them as drugs based solely on potency. (PL-94-278 Section 501 (a)).
Throughout the 1960s and early 1970s, the FDA initiated measures to reclassify vitamins and minerals with a potency of 150% or more of their recommended daily allowance (RDA) be classified as drugs. (Vitamins A and D were to be classified as drugs at 100% of their RDA.) Congress considered these actions as infringements on consumer's freedom of choice and amended the law to forbid the FDA from setting such limits. The law, which became known as the Proxmire Amendment barred the FDA from setting the composition or maximum potency of vitamins, minerals, or combinations thereof, unless they were of a specified type (e.g., toxic, habit-forming, administered by a doctor) or unless they were intended for use by a specified clientele (e.g., by individuals in the treatment of specific diseases or disorders, by children, by pregnant women).
Congress Continued to Support Consumer's Freedom of Choice in 1994
In 1994, the Dietary Supplement Health and Education Act (DSHEA) established specific labeling requirements, provided a regulatory framework, and authorized FDA to promulgate good manufacturing practice regulations for dietary supplements. This act defined "dietary supplements" and "dietary ingredients" and classifies them as food. The act also established a commission to recommend how to regulate claims. (PL 103-417)
DSHEA should be preserved and protected. The adoption of an international guideline such as CODEX Guideline on Vitamin and Mineral Food Supplements is contradictory to the will of the American people and should be rejected.
Congress Finally Provide Clarity
In 2009, CodexFund.com drafted potential legislation and began discussions on Capitol Hill. With the health care reform legislation consuming the entire focus on legislators and their staff, we sought another vehicle to provide clarity on the issues. Our goal was achieved when during the Senate Health, Education, Labor and Pensions Committee mark up of S. 510, the Food Safety Bill, Senator Harkin verbally and Senator Hatch in written provided comments to the record a declaration that Congress would continue to determine the laws that regulate dietary supplements in the United States and that CODEX would not undermine DSHEA.
Senator Orrin Hatch addressing Chairman Tom Harkin in his written comments which he was unable to deliver personally but submitted to the record, "Mr. Chairman, I too have recently heard from some of my constituents that they are concerned that standards adopted by the United Nation's Codex Alimentarius Commission will restrict their ability to purchase dietary supplement products in this country, so I echo your statements and look forward to working with you and the other sponsors of the bill to make it absolutely clear that access to dietary supplements is governed by laws established by Congress, including DSHEA, and not by Codex standards."
This is a major victory. We will continue to keep you apprised of the activities of CODEX and other international and domestic regulatory bodies as they related to dietary supplement regulations and your health freedom.
Glossary of Abbreviations:
CCNFSDU - Codex Committee on Nutrition and Foods for Special Dietary Uses
CFR - Code of Federal Regulations
CODEX - CODEX Alimentarius Commission
DSHEA - The Dietary Supplement Health and Education Act of 1994 (PL 103-417)
FDA - U.S. Food and Drug Administration
Proxmire - The Proxmire Amendment (PL-94-278 Section 501 (a))
If you have further questions, please email them to info@codexfund.com.
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