Codex dietary supplement standards are expected to mirror those currently being built into European guidelines, where the maximum limit for beta carotene would be the amount found in half a large carrot, while that for selenium would be no more than what is typically available in one third of a Brazil nut! How will Codex affect your vitamins?
As Europe escalates integration of Codex-like guidelines severely restricting access to supplements, it’s appropriate to ask, what will happen here in the United States? Will we continue to enjoy access to high quality, therapeutic doses of nutrients? This article will analyze Codex Alimentarius (Codex) to determine the potential implications, if any, on our domestic supply of higher-dose dietary supplements that contain vitamins and minerals.
Codex, the system used by governments and major corporations to develop global guidelines and standards, deals with virtually all aspects of the food supply. Presently only one guideline relates to vitamins and minerals, and although the guideline was ratified in 2005, full implementation by governments as a template for national laws is expected in 2012-13. The once outstanding elements such as which methods to use to determine risk of high dose supplements have now been agreed.
The present analysis is two pronged:
- is there a relationship between Codex and the U.S. domestic policy on dietary supplements; and
- if yes, then what might the effect on U.S. domestic policy be (i.e., is Codex more restrictive or more liberal than current U.S. domestic policy)?
Codex will very likely not affect U.S. domestic policy today or tomorrow; however, there is legitimate concern for the long-term effects, which could be detrimental to the freedom U.S. citizens currently enjoy in accessing high-quality, higher dose dietary supplements.
The ANH, through its US and European offices, is a proactive organization whose efforts are aimed at ensuring consumers will have continued access to effective and safe dietary supplements. By being proactive and with great foresight, ANH takes every precautionary step to protect the right to access, such as monitoring foreign policy and international bodies that may impact existing domestic policy.
Founded in 1963 by the Food and Agriculture Organization of the United Nations and the World Health Organization, Codex Alimentarius was established to remove trade barriers and develop food standards and guidelines. The primary objectives are given as:
1) to protect the health of the consumers;
2) ensure fair trade practices in the food trade; and
3) promote coordination of all food standards work undertaken by international governmental and non-governmental organizations.
Codex has 180 governments as member organizations, including the U.S. and the European Community, and as a result of Codex’ work, hundreds of standards and guidelines have been created in areas ranging from hygiene, additives, and contaminants, to permissible levels of pesticide residues.
In the early 1990s, Codex broached the subject of creating guidelines for vitamins and mineral supplements and in 2005, the Guidelines for Vitamin and Mineral Food Supplements (Codex Guidelines), CAC/GL 55-2005, were adopted. The adoption of the Codex Guidelines triggered immense concern from the natural health community due to statements made in the preamble that essentially discount the benefits from dietary supplements, and the fact that the scope of the Codex Guidelines includes developing minimum and maximum levels of vitamins and minerals.
This is a direct carbon copy of what is currently happening in Europe [LINK TO ANH-EUROPE] except that Europe is mandating the levels into law. Although the process is still underway, indications are that the maximum levels will be highly restrictive and could effectively eliminate all therapeutic high-dose supplementation. ‘Maximum levels’ are anticipated to be set in Codex around 2012-13.
At issue is how Codex will determine the ‘maximum permitted levels.’ As is true within any governmental body, the key stakeholders at the table will set the tone for any policy issued and in this case, Codex is heavily influenced by the EU due to the large number of developed countries within the EU.
Currently, member countries of the European Union (EU) operate under individual national regulatory frameworks with, for example, Germany and France being on the restrictive end of the spectrum and the United Kingdom, Holland and Sweden being on the more liberal end. In 2002, a Directive (2002/46/EC) was established to harmonize legislation amongst the EU member countries in regards to food supplements.
As a result of this Directive, a narrow ‘positive list’ of allowed vitamins and mineral forms becomes mandatory EU-wide as of December 1, 2010. Any vitamin and mineral not complying with the ‘positive list’ will be banned. The revised ‘positive list’ contains only about 180 discrete forms of vitamins and minerals, compared with the over 500 that have been on sale for many years in liberal countries such as the UK. Omitted from the list are such commonly used food supplement ingredients as silver, sulphur, and vanadium.
In addition to the release of the ‘positive list,’ by early Spring of 2010, the EU will propose minimum and maximum permitted levels for vitamins and minerals following much debate, industry discussion and even strong opposition from some quarters. Central to the approach used will be the view of the controversial European Food Safety Authority, based in Parma, Italy. At issue with the EU setting maximum permitted levels is the risk assessment and management methods being implemented to develop the guidelines.
ANH-USA’s European office, ANH-Europe, has been at the forefront of exposing the flaws in the methodologies under consideration for a number of years. The methods being used originate from methods that were originally intended for use with environmental toxins, which of course have no beneficial role in health. Nutrients are quite distinct, and as such, require a completely different approach. The approaches presently under consideration would compromises consumer choice and unnecessarily restrict approaches aimed at using nutrients for the all-important purpose of disease risk reduction.
Briefly, to point out two flaws, the analysis fails to consider diverse population sub-groups. Age, dietary patterns, health status, physiological need, and geographic location are key factors in determining risk benefit analysis. Additionally, the analysis fails to break down a nutrient group and sets a maximum level based on the most hazardous member of a given nutrient group such as Vitamin A (retinol / natural b-carotene), or Iron (iron sulphate / ferrous bisglycinate).
The EU and Codex are so intertwined that an inherent influence over one is inevitable. Due to the heavy influence of the EU over Codex, many believe Codex will utilize EU’s ‘maximum permitted levels’ as a template in setting minimum and maximum levels.
The Dietary Supplement Health & Education Act of 1994 (DSHEA) regulates the dietary supplement industry and is implemented by the Food & Drug Administration (FDA). Government agencies and some individuals argue that Codex has no bearing on DSHEA and Codex will not jeopardize our existing domestic regulatory framework because Codex provides guidelines for international trade.
Current U.S. policy includes three safe guards from international influence over dietary supplements: DSHEA, anti-harmonization legislation under the FDA Modernization Act of 1997 (21 U.S.C. 383), and the Proxmire Amendment of 1976.
The anti-harmonization legislation, specifically exempts dietary supplements from the mandate that the U.S. government must harmonize regulatory requirements. Not exempted are “drugs, biological products, devices, foods, food additives, and color additives … and good manufacturing practices.” This legislation was intended to streamline standards amongst countries and fortunately, dietary supplements were explicitly exempted.
The Proxmire Amendment expressly prohibits FDA from establishing “maximum limits on the potency of any synthetic or natural vitamin or mineral” and from classifying a supplement as a drug “solely because it exceeds the level of potency” the Secretary determines is useful. The amendment was in response to FDA’s overzealous attempts to regulate supplements as drugs if their potency was 150% or more of the recommended daily allowance.
Additionally, before FDA can adopt any Codex standard, technically the FDA must review the standard and issue a ruling of, “accepted without change, accepted with change, or not accepted.” The review process can be instigated by any interested person, on FDA’s own initiative, or by publishing the Codex standards in the Federal Register. Once posted, a public comment period would open to enable consumers and industry to make a statement. (21 CFR 130).
However, even with these safeguards in place, noting what has transpired in Canada over the past several years (a banning of all vitamins and minerals and now bringing back one by one), Germany’s excessively low ‘maximum levels,’ and the troublesome EU Directive, U.S. consumers are justified in being concerned and highly protective of current domestic policy. A few examples of the extreme differences between current U.S. policy on vitamin and mineral levels and Germany’s proposed maximum levels are:
Vitamin B12: Germany = 9 mcg U.S. = 1000 mcg
Vitamin C: Germany = 225 mg U.S. = 2000 mg
Vitamin D:Germany = 5 mg U.S. = 50 mg
Iron: Germany = 0 mg U.S. = 45 mg
Vanadium: Germany = 0 mg U.S. = 1.8 mg
Germany wants these very low limits as the maximum limits for food supplements, so that any supplement selling at higher levels would need to be licensed as a drug. As most people know, this is prohibitively expensive for most supplement companies and this is the final link in analyzing Codex. The never-ending, always present industry influence which is alive and well within U.S. government agencies, exists just as strong, or even more strongly, abroad. The pharmaceutical industry has great hold on food supplement policy—globally. The pharmaceutical industry has great financial gains to reap from implementing restrictive maximum levels—increased synthetic product opportunities and higher volume of sales.
If Codex adopts excessively low maximum levels, this is highly persuasive material for pharma to use in the U.S. to ultimately convince the government to conform, which will open trade opportunities.
The EU, and specifically Germany—the country that hosts the key Codex Committee on Nutrition and Foods for Special Dietary Uses and that is responsible for the vitamin and mineral guideline—have great influence over Codex; therefore, with restrictive levels currently being set in the EU, and the extensive influence the EU has over Codex, coupled with industry’s strong-hold over the FDA in the U.S., current Codex activity and guidelines should be of concern to those Americans who have long enjoyed considerable freedom over the use dietary supplements as part of their personal health care regime and lifestyle.
The threat of Codex adversely impacting U.S. domestic policy regarding food and dietary supplements is real. One has to look beyond the stated purpose of Codex—as being an intergovernmental body to develop standards for international trade purposes—to understand the ripple effects from the Codex ‘Guidelines for Vitamin and Mineral Food Supplements.’ Once an international borderline between vitamins and minerals as foods, and vitamins and minerals as drugs, it is quite possible that the U.S. will ‘cave’ to international pressure because the limits will have been set as a result of international consensus on the grounds of public safety.
One last thought: if the U.S. government delegation is opposed to the European model, why has it not objected strenuously to its incorporation into the Codex guideline? Actually the reverse has been true. The U.S. has been working very closely with the EU, ensuring the highly restrictive European approach is built firmly into the international Codex guideline at every step! Perhaps this makes a statement about the FDA-led, U.S. government delegation’s true colors?