American Holistic Health Association (AHHA) - Codex Guidelines Concerns
Guidelines Concerns

Why are so many people upset about the Codex Guidelines? Should you be concerned?

Important background data: There are two opposing factions in the world for defining the role of dietary supplements.

Some countries that believe dietary supplements:

  • are beneficial, effective and safe
  • can be used to supplement the daily diet, plus to prevent and treat diseases
  • should be freely available to the public.
Other countries believe dietary supplements:
  • are potentially dangerous, so should be limited to very low dosages
  • are only needed to prevent deficiency diseases
  • should be used under medical supervision.
This latter faction appears to have initiated drafting the Guidelines, and has been successful in including restrictive elements into this regulation to be imposed on the pro-supplement faction.

An increasing number of individuals are very concerned that the terms in the Codex Draft Guidelines for Vitamin and Mineral Food Supplements are a serious threat to continued free access to dietary supplements of choice. They believe
  • the regulations in the Guidelines are unreasonably restrictive
  • important aspects of the Guidelines are not well defined
  • the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) delegates that drafted the Guidelines did not fully understand exactly what they were approving.

1) Guidelines PREAMBLE
The Guidelines Preamble defines a very limiting role for vitamins and minerals as only for supplementation of the daily diet. This is not consistent, however, with the World Health Organization (one of the parent organizations of Codex) 2002 publication, "Diet, Nutrition and the Prevention of Chronic Diseases," that specifically references the preventive value of vitamins and minerals. The influential European Union delegate to CCNFSDU blocked attempts to correct this inconsistency. more...

2) Guidelines SCOPE 1.3
Codex is supposed to promote "harmonization" of trade standards among all countries. The Guidelines Scope states that this document applies only to countries designating vitamins and minerals as food. Countries designating vitamins and minerals as drugs are thus exempted from having to abide by the regulations in the Guidelines. This is inconsistent with the Codex goal for drafting trade standards to be used by all countries. more...

3) Guidelines COMPOSITION 3.1.1
The Guidelines state that vitamin and mineral food supplements can include only vitamins and minerals whose status is recognized by United Nations' Food and Agriculture Organization (FAO) and World Health Organization (WHO). However, this list of vitamins and minerals is not defined. What is the list the CCNFSDU delegates were approving? A search of FAO and WHO websites uncovers mention of most commonly used vitamins and minerals if you consult a variety of different documents. However, no one document mentions all vitamins and minerals. If only one document ends up as the official "list," this could eliminate a number of vitamin and mineral products currently available by removing them from what is allowed for trade between countries and, in many cases, inside a country's own borders. more...

4) Guidelines COMPOSITION 3.2.2 (a)
The section of the Guidelines expected to have the most significant impact on the future of dietary supplements is that which determines what levels of potency are allowed in dietary supplement products. You might expect that the maximum amounts allowed would be set just below a point that would cause harm. Not so. The Guidelines state "Maximum amounts of vitamins and minerals in vitamin and mineral food supplements per daily portion of consumption as recommended by the manufacturer shall be set, taking the following criteria into account:"

(1) "upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data" However, there is no designation as to what risk assessment protocol is to be used. There is a high probability that it will be what is developed by a FAO/WHO expert panel which met in May 2005 with the assignment to define a scientifically-based nutrient risk assessment. Since this panel was convened under the auspices of The International Programme on Chemical Safety, many anticipate that when the report is issued we will find that dietary supplements were inappropriately handled as toxic substances. more...

(2) "the daily intake of vitamins and minerals from other dietary sources" This means that whatever upper limits are set for each vitamin and mineral by the risk assessment process, these limits will be further lowered to make allowances for amounts estimated to be found in the food consumed each day.

(3) "taking into consideration, as appropriate, the varying degrees of sensitivity of different consumer groups" This criterium means that the upper limits can be still further lowered.

Some individuals are very concerned that the manipulation and/or selective use of scientific "facts" and/or the cumulative reductions could result in the upper limits allowed in a supplement product being set very low. more...

5) CCNFSDU not informed of WTO use of Guidelines
During the November, 2004, CCNFSDU session that moved the Guidelines to Step 8 of the document approval process, the delegates were specifically told that the Guidelines were optional. Under Codex procedures, this is true. However, the delegates were not informed that the WTO can use any Codex document, including the Guidelines document when it is finalized, as a mandatory trade standard.

Many foresee that finalized Guidelines could be used by a future WTO Dispute Settlement Panel to find a country whose dietary supplement regulations are not the same as the Guidelines guilty of not being in harmony with international trade standards. If the United States were found guilty in such a case, then the Dietary Supplement Health and Education Act (DSHEA) laws would have to be changed to be more restrictive (eliminating availability of a number of dietary supplement products) or the U.S. would have to pay huge trade sanctions each year. Historically, the U.S. has changed its laws when required by the WTO. As WTO Dispute Settlement panels tends to level the trade playing field, this scenario looms as a possibility. more...

To provide you a variety of perspectives on the Guidelines issue, AHHA has compiled a list of organizations active in Codex and Guidelines-related matters. They are highlighted in the Guidelines Pro and Con section of this site.
