Summer of '05 
Critical Time for Dietary Supplements

by Suzan Walter 
President of American Holistic Health Association
April 27, 2005
  
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 within the next eight months. 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. See

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 the mid-March to April 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 acknowledging 
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
American Holistic Health Association
America's foremost non-profit source for holistic resources
PO Box 17400
Anaheim, CA 92817-7400 USA
Phone (714) 779-6152
E-mail  mail@ahha.org
Web site  http://ahha.org

American Holistic Health Association http://ahha.org

Codex information http://codexinfo.org

National Health Federation (NHF) http://thenhf.com

5/6/05 NHF CODEX Press Release:  Click Here