What is Codex?
Codex representation is on a country basis. National delegations are led by senior officials appointed by their governments. Delegations may include representatives of industry, consumers’ organizations and academic institutes, as determined by national governments. Numerous NGOs and INGOs attend in an observer capacity. Observers are able to state their points of view, but are not able to vote and do not take part in any final decision-making processes. Observers are also not invited to attend or participate in Codex Executive Committee meetings.
In 1997, the Codex approved a list of 111 observer organizations comprised of 104 industry-funded groups, six health and nutrition foundations and one international consumer group – Consumers International. One difficulty for health freedom and natural health issues is that Consumers International has been anti-supplement both in Codex and outside, arguing, with surprisingly little evidence to justify their stance, that supplements and natural health products present a risk to consumers and need to be regulated stringently. Currently, the National Health Federation is the only health freedom organization to have observer status within Codex and as such has been a lone voice. Consumers International in theory represents U.S. consumers, but given its opposition to supplements, it has not served health conscious vitamin consumers or integrative medicine practitioners.
Will Codex affect us in the United States or would it apply only to other countries?
Codex guidelines and standards are already implemented in the U.S. in many areas of the food trade. For example, the Codex organic standards, which many would view as a watered down version of a proper, sustainable, ecologically-based organic approach to agriculture, have already been accepted in the U.S. and allow some of the biggest food retailers in the U.S. to trade in internationally sourced, low cost, certified organic food which is neither as good for the environment nor as good for health as the real thing. When it comes to supplements, there is a new guideline, the Codex Guideline on Vitamin and Mineral Food Supplements that has been passed and is awaiting fine tuning before coming into effect in around 2012 or 2013.
Codex standards are officially recognized international guidelines for allegedly ensuring food safety and fair trade practices. With the goal of international harmonization of food standards largely for the benefit of transnational corporations, Codex member countries are encouraged to adopt Codex guidelines or standards at the national level.
While only those countries that adopt Codex guidelines are subject to them on the national level, they guide countless countries that do adopt them. In today’s interdependent world of trade, the U.S. is undoubtedly impacted by Codex on many levels.
For example, Codex standards have become reference texts used by the WTO for the settlement of international trade disputes and are increasingly being used as baseline, reference food standards for international trade. National governments are able to set their own food standards at a higher level than Codex. But they cannot demand that food imports meet higher standards than Codex, unless it can be justified to the WTO.
In one of AAHF’s main areas of focus regarding Codex, dietary supplements, the FDA says that they will develop a two-tiered system: 1) Higher dose levels in the United States; and 2) Lower dose levels that the U.S. would comply with for export. Note, however, that U.S. delegations have been instrumental in shaping significant Codex guidelines, including those relating to genetically modified food (GM), food irradiation, and most recently vitamin and mineral dietary supplements. The USFDA has a proven anti-supplement track record. The Agency’s pro drug agenda leads it to ignore first amendment protections and censor the communication of valid scientific information about the health benefits of supplements.
It remains to be seen whether the FDA will pursue adoption of Codex guidelines on dietary supplements. But three things are clear: 1) The U.S. delegation at Codex appears to be enthusiastically supporting highly restrictive approaches to the guidelines which are directly in line with those of draconian regimes such as that represented by the European Commission; 2) FDA actions have eroded consumer access to dietary supplements; and 3) Currently, it appears that Codex dietary supplement guidelines will fall directly in line with FDA’s, Health Canada’s and the European Commission’s anti-supplement stance.
How will Codex attempt to limit our access to higher, therapeutic dosages of nutrients?
Unfortunately Codex is in the process of codifying global supplement potency limits which are far below current standards in the U.S. and are even well beneath those currently allowed in more liberal European countries like the UK, the Netherlands, Sweden and Ireland. Rather cleverly, Codex is at the moment confining itself to the principles to be used to develop these proposed ‘maximum safe levels’, while they are avoiding getting into the generation of actual numbers that would probably cause opposition in some quarters. However, if one looks at Europe, one can see much more clearly what happens if you use the risk assessment and management principles under consideration to generate actual values. Using the methods currently being built into European guidelines, 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! European officials do not, however, follow this to its illogical limit and argue that eating several carrots or Brazil nuts is dangerous.
These ridiculously low levels result from an excessively precautionary model which is based on applying massive ‘uncertainty factors’ to the most ‘toxic’ (usually synthetic) form of a nutrient. Worse still the highest mean dietary intakes (that consumed by the top 2.5% of the population) are subtracted from these already low levels—and are then applied to all nutrients, regardless of form! This system reduces all maximum dosages to levels that are beneath those required for any therapeutic benefit. It effectively provides the basis for what we believe will increasingly be regarded—assuming the process is not altered—as an international borderline between foods and medicines. This means that wherever Codex guidelines are implemented into law, the only way to get a therapeutic dosage to market is to go through a full drugs regime. This would obviously be cost prohibitive for most manufacturers and suppliers and would amount to the ‘knee-capping’ of nutrition-based integrative or functional medicine.
The Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), the key Codex committee concerned with supplements, is also developing Nutrient Reference Values for international application. These are akin to Recommended Daily Allowances (RDAs) for all people in the world, regardless of their nutritional or health status. They are based on a very limited perspective of the benefits of nutrients and do not factor in any of the science on which integrative, functional or ecological medicine principles are based. Put simply, the NRV approach is about averages and not individuals. It is about selective use of science, and apparently arbitrary avoidance of relevant, high quality science. There is no consideration of clinical experience or any of the principles of preventative medicine based on nutrition. The levels being considered for NRVs are even beneath those being considered as ‘maximum safe levels’ so the whole process will serve to dumb down those levels perceived as necessary or beneficial for optimum human health.
Is Codex a real or imagined threat to our ability to access high quality therapeutic dietary supplements in the United States?
The U.S. has enjoyed liberal access to natural health products since the passage of the Dietary Supplements and Health Education Act (DSHEA) in 1994 following mass public opposition to the proposed excessive restriction and 'medicalization' of natural health products.
If Codex standards are adopted by the U.S., the recommended daily allowances will be far below current therapeutic levels. Higher levels would be considered “drugs” and would be available only by prescription. However, before making supplements available to the public, manufacturers would have to invest the money to take nutrients through the drug approval process, which can cost as much as many hundreds of millions of dollars. This is a hard sell to a manufacturer that cannot patent natural ingredients to recoup the enormous expense involved in the drug approval process. As a result, it is possible that some dietary supplements simply won’t be available, and those that are will be increasingly more expensive.
When will Codex be implemented?
Codex guidelines are often confused with various pieces of key European legislation affecting natural health, in part, because so many key areas of Codex mirror what is already found in European legislation. Codex is seen by some as a way to export European regulatory approaches internationally. Codex guidelines on dietary supplements will begin to be implemented in 2012 or 2013, while the first ‘harmonized’ European laws affecting supplements came into law in 2005 and are being phased in over a period of more than 6 years.
What is AAHF doing to protect U.S. citizens and populations worldwide from the threat of Codex?
The American Association for Health Freedom, in partnership with its international affiliate, the Alliance for Natural Health, has provided comments as an “interested party” on behalf of integrative medicine practitioners. These practitioners, as well as their patients and clients, are dependent on nutritional supplements, presently used safely under the Dietary Supplement and Health Education Act of 1994 (DSHEA). AAHF will continue to monitor the Codex process. Should the FDA pursue adoption of unacceptably low international dietary supplement standards in the U.S., AAHF will work to uphold DSHEA and protect practitioners’ and consumers’ access to dietary supplements.
What influence can the consumer have on the Codex process?
Although much of the Codex agenda has already been decided, many items are still in the review process. You can access the official Codex Web site at www.codexalimentarius.net and review forthcoming meetings to get a sense for issues remaining to be discussed. In addition, circular letters (requests for comments on Codex proposals and texts) are available at various points within the Codex process. Any member or observer can send a written response to a circular letter and expect to have those comments noted and considered at the next step or presented to the next committee meeting. Unfortunately participation is not open to the general public. However, the public may weigh in on comments submitted by the U.S. Delegation. For example, the FDA recently circulated U.S. draft positions on agenda items to be discussed in the 30th session. The American Association for Health Freedom, in partnership with its international affiliate, the Alliance for Natural Health, provided comments as an “interested party” on behalf of integrative medicine practitioners and consumers in the U.S.
The schedule of Codex meetings is posted on the Codex web site and updated at regular intervals. Scanning the listing of agenda items provides a good idea of their contents.
Consumers should be aware that there is misinformation about Codex on the World Wide Web. One piece of such misinformation is that the World Trade Organization could order the US to adopt Codex standards. Another is that Codex rules on supplements will come into effect in 2010. Accurate information can be obtained on this website and that of AAHF’s international affiliate and Codex participant The Alliance for Natural Health.
AAHF is particularly concerned that an attempt might be made by the FDA to adopt Codex through the regulatory process. This will be monitored watchfully. Codex may eventually come to the US as a treaty. If so, that would require a two thirds vote in the Senate. On the other hand, treaty law supercedes other legislation, such as DSHEA, so that also will have to be closely monitored and appropriate actions taken at the time.
Premature action against Codex in the US Congress could easily backfire since it might be interpreted by Congress as “crying wolf”, imagining threats that do not exist. The truth is, however, that Codex is a threat to the use of supplements in the US, and strong action may be required by American voters to meet the threat at the appropriate time.
Source: American Association of Health Freedom