American Holistic Health Association (AHHA) -Suzan Walter Summer of '05
Summer of '05
Critical Time for Dietary Supplements
by Suzan Walter

The future of dietary supplements may be determined by what happens this summer. Not just one, but many different yet related matters are all coming to a head during the spring and summer months of 2005. Since everything is interrelated, you will want to track national, regional, and international events.

When you review articles and e-mails dealing with supplements (and there are a number making the rounds), it is important that you understand the impact of each of these events individually, as well as collectively. The following review is presented to assist you in understanding the nuances of each issue and in recognizing when some sources blur and confuse the distinctions.

Codex Guidelines for Vitamin and Mineral Food Supplements
The Codex Guidelines for Vitamin and Mineral Food Supplements is an international document drafted to be guidelines for vitamin and mineral supplement products. It states that it is only for countries that designate these supplements as food, exempting countries that designate supplements as drugs. Last November, after over a decade of wrangling over numerous supplement regulation issues, a Codex committee completed an eight-step process that created the official Guidelines document. Finalization of the Guidelines document is on the agenda for the Rome July 4-9, 2005 session of the top Codex body, the Codex Alimentarius Commission. At this time, there does not appear to be anything that can be done to stop this final action. Under Codex authority, these Guidelines are optional suggestions, not a mandatory trade standard that must be followed in trade between countries.

However, there are agreements between Codex Alimentarius and the World Trade Organization that allow the WTO to use Codex documents (such as the Guidelines) as mandatory international trade standards to settle trade disputes. The WTO can enforce dispute decisions by pressuring the losing country through trade sanctions if they do not change their national laws or other regulations to conform to international trade standards. Therefore, the regulations in the Guidelines must be taken seriously.

The section of the Guidelines expected to have the most significant impact is the criteria by which the maximum amounts of vitamins and minerals that will be allowed in a supplement product are determined. The Guidelines state that "... upper safe levels of vitamins and mineral established by scientific risk assessment based on generally accepted scientific data...." As there is currently no generally accepted scientific risk assessment protocol available, what these limits will be is unknown. Some individuals are very concerned that the upper limits will be set too low. This could mean that instead of one convenient high-dosage capsule, the consumer might need to take a handful of low-dosage capsules.

FAO Risk Assessment Protocol
The Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO) announced in December, 2004, that they were accepting applications from individuals who wish to serve as the experts on a joint nutrient risk assessment project to define a scientifically-based nutrient risk assessment. Work is scheduled to begin in May, 2005. The balance of perspectives of the experts selected will be the first sign of how this project will progress. It is anticipated, but not guaranteed, that this nutrient risk assessment protocol will be used to define the upper safe limits of the Codex Guidelines.

European Union Food Supplements Directive
The collection of countries making up the European Union (EU) will be severely impacted by the activation of the EU Food Supplements Directive on August 1, 2005. The Directive is purported to provide reassurance for EU consumers that the ingredients used in food supplements have been thoroughly assessed for safety. There is a "positive list" that includes 28 vitamins and minerals that are deemed safe. After August 1, EU stores can legally only sell supplement products containing these ingredients. What is causing grave concerns, however, is the long list of 200 vitamins and minerals that did not make the "positive list." While a supplement would normally need to be proved dangerous to be removed from public consumption, the Directive works in just the opposite way. The supplement must be proved safe to get onto the "positive list" and be available to the EU consumer. The process of proving that a vitamin or mineral is safe is very costly.

A number of groups are so concerned about the negative impact of the Directive that this matter has been taken to the regional courts in Europe. At a January 25, 2005, hearing the Alliance for Natural Health and Nutri-Link Ltd presented their arguments that the EU is exceeding its powers. An opinion will be released April 5, 2005, with the final decision expected in June, 2005. The decision will set a major precedent for the world, particularly if the EU Directive side loses.

DSHEA & Legislation in U.S.
The key legislative protection that gives consumers in the United States access to dietary supplements is the Dietary Supplement Health and Education Act of 1994 (DSHEA). A number of senators and and members of congress in Washington are working to reverse some or all of these protections. Last year, in the 108th session of Congress, a number of bills were introduced that caused concern among those who use supplements. It is expected that these bills will be reintroduced in the current (109th) session in April-May time frame, with serious committee hearings in the following months. While the bill numbers will be different, the content is expected to be very similar. A few of the bills to watch for are:

  • Dietary Supplement Safety Act (was S. 722)
    This bill would amend the Federal Food, Drug, and Cosmetic Act to require that manufacturers of dietary supplements submit to the FDA reports on adverse experiences with dietary supplements. Opponents question whether dietary supplements need to be held to a higher standard than drugs. Would it be fair to have a supplement taken off the market based on one negative reaction while a drug can remain available even as it harms many?
  • Dietary Supplement Access and Awareness Act (was H.R. 3377)
    This bill would grant the FDA authority to regulate supplements in the same way that it regulates over-the-counter drugs. Opponents are concerned that this is working toward the day when you would need a doctor's prescription to get vitamin and mineral supplements.
  • Safe Food Act of 2004 (was S. 2910)
    This bill would create a new federal food safety agency. Ten separate federal agencies handling various food matters would be combined into one. This sounds like an efficient administrative approach. However, the bill stated that the term "food" would not include dietary supplements. If not food, what's left? Drugs?

How these events are connected
Some of the connections between the events described above are obvious. However, there are some subtle relationships that are not as well known. Here are a few examples:

The EU has a very strong influence on decisions made in Codex committee sessions. In fact, the Guidelines document does not include a number of items because the EU delegate was vehemently against them. In one prominent example the delegate from South Africa tried on a number of occasions to get wording into the Preamble of the Guidelines to acknowledge that vitamins and minerals had preventive benefits. The EU delegate successfully objected every time. At this same Codex session the FAO/WHO publication, "Diet, Nutrition and the Prevention of Chronic Diseases" was being promoted on the literature table. Based on this demonstration of EU influence, many people believe that the EU Food Supplements Directive indicates what Codex documents might end up including in the future.

The United States Federal Register, October 11, 1995, FDA Policy on Standards, states that "where a relevant international standard exists, or completion is imminent, it will generally be used in preference to a domestic standard...." If this is still the FDA policy, once the Codex Guidelines are finalized this summer, will we find the FDA working to use this against the DSHEA?

Have you noticed the growing number of situations where dietary supplement companies are being required to submit costly documentation to prove that a vitamin or mineral is safe, even when there is extensive research already demonstrating its safety and effectiveness? This is what is currently happening in Europe and Canada. The negative economic impact is changing the landscape of the entire industry. Are we seeing a scenario where small companies will either have to sell out to larger supplement companies or fold? Where many of the larger companies are being bought out by pharmaceutical companies? Do current events support the strength of the supplement companies or the pharmaceutical companies?

As you consider the difference between what is on the six o'clock news and what the health freedom advocacy web sites proclaim, evaluate for yourself what this difference might mean for you and those you love. Get involved with groups that support what you believe will be most beneficial.

Suzan Walter, president of the American Holistic Health Association, researched how the Codex Alimentarius and the World Trade Organization function and applied this information to track the potential impact of the document Codex Guidelines for Vitamin and Mineral Food Supplements. She attended the Codex Committee on Nutrition and Foods for Special Dietary Uses sessions as an observer in 2002, 2003, and 2004 and continues working to try to validate true facts in the face of conflicting information being presented by opposing groups. Suzan created an educational website codexinfo.org to explain these matters to the U.S. public and offer a variety of points of view. If you would like to be alerted when new information is posted at codexinfo.org, e-mail your name and e-mail address to codex@ahha.org.