EU Food Supplements Directive: Scientists Challenge Philosophy of Precaution

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Two Dutch scientists, Aalt Bast of the University of Maastricht and Jaap Hanekamp of the HAN Foundation are challenging the philosophy of caution and control of the European directive that regulates food supplements, healthy products containing vitamins, minerals and other bio-ingredients useful to human health.

Food Supplements and European Regulation within a Precautionary Context: A Critique and Implications for Nutritional, Toxicological and Regulatory Consistency

In their article published in Critical Reviews in Food Science and Nutrition, they charge that the real effect of the directive is not so much protection of consumer health but a kind of "secondary protection", a shield for the good repute and careers of lawmakers, administrators and scientists. What those authors of the directive have really done, according to Bast and Hanekamp, is that they covered themselves. They have 'done something', just in case anything might go wrong with supplements. Meanwhile, the good that abundant nutrient availability from vitamin and mineral supplements could be doing for public health gets all but smothered in bureaucratic red tape - threatening to achieve exactly the opposite of the publicly stated objective, which is a "a high degree of protection of consumer health".

The European Food Supplements Directive has been sharply criticized by practitioners of natural medicine as well as consumers, producers and retailers of health foods. The directive has even been subject to a lawsuit challenging the validity of this legal framework for foods containing concentrated nutrients. The European Court of Justice chose to let it stand, although its own Advocate General had strongly recommended to take remedial action, calling the directive's procedures "as transparent as a black box".

Originally, the intention of this piece of legislation was to facilitate commerce of supplements in the European common market, while protecting the health of consumers. Presumably one of the objectives was to avert supposed dangers of getting "too much of a good thing". What the directive's authors have not considered is that, according to government surveys, most people don't even get the indispensable minimum of nutrients, not to mention optimal amounts for good health.

Although the directive was passed as far back as June 2002, its major issues still remain unresolved today. Limits to nutrient dosages in supplements are still under discussion by the European Commission. A decision is not expected before the end of this year. The restrictive listing of nutrient sources that may be employed as ingredients in supplements is anything but satisfying. The Alliance for Natural Health has recently filed some dossiers to test the procedure for approval of nutrients that the directive hasn't considered in its original lists.

Scientific proof of non-toxicity of ingredients that have been in use for years, some for decades, has been requested from manufacturers, but the data - clinical trials and expensive scientific assays usually made for pharmaceuticals - are hard to come by for simple nutrient substances. A final determination on the continued use of these ingredients in supplements is not expected before 2009. Temporary extensions of the status quo are slated to run out in December of that year.

Like the sword of Damocles, this directive has been threatening the freedom of choice and health of consumers, the profession of nutritional practitioners and the livelihood of health food producers and shops for close to five years now, with no resolution in sight - an unworkable political "solution" to a problem that may never have existed to begin with.

What exactly is the view of the two scientists that have now weighed in on the discussion around the restrictive philosophy of the directive an what do they propose as a way forward from this seemingly hopeless, botched situation. Here is a summary but if you are interested in the fine details, you may have to fork out some money to buy the article...

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Food Supplements and European Regulation within a Precautionary Context: A Critique and Implications for Nutritional, Toxicological and Regulatory Consistency

J. C. HANEKAMP
HAN Research

A. BAST
Mastricht University, Department of Pharmacology and Toxicology

(original available here)

Authors' Abstract: In this paper, we review European legislation in the field of micronutrient food supplements and find it wanting. It is shown that the precautionary principle, embedded in European food legislation, pre-empts innovative developments in this field. In view of the scientific advances in micronutrients research, we subsequently critique the precautionary perspective and propose a novel outlook on micronutrients food supplements regulation. However, this requires a transition from the “survival” approach of the current deficiency-related RDAs to a “health-optimization” approach of a n(ew)-RDA. Genomic integrity is central in this envisioned transition.

Summary of salient points by Sepp Hasslberger:

Food is essential to the maintenance, development, functioning and reproduction of human life. The major risks connected with food are microbacterial contamination (spoiled or otherwise "gone bad" foods) and an imbalance of nutrients, meaning at times we get too little or too much of some nutrient.

The food supplements directive is based on some ground-rules and ordering principles, which include a high level of consumer protection, ubiquitous availability of food; the idea that Safe Upper Limits should be established through conventional risk assessment methodology and that Maximum Permitted Levels should be developed with reference to the average dietary intake. There should be risk assessment prior to market entrance of micronutrients not yet listed on the directive's Positive Lists and rules on presenting micronutrient food supplements to the public, including directions on how to label supplements and what health claims are acceptable.

These ground-rules and principles carry distinct overtones of precaution, focussed on the risk of excess intake of micronutrients from food supplements. Even products that have been marketed for years under national laws now are subject to approval, and they may lose their status as legitimate products as part of this review process mandated by the directive.

A great problem with this approach is that it is practically impossible to demonstrate total safety. Cramer, Ford and Hall described the dilemma in 1978 in their seminal paper on the “assessment paradigm”. Their view highlights some of the values entertained by the Food Supplements Directive:

“Safety evaluation is caught in a frustrating circle. It is neither possible nor sensible to try to obtain the information needed to assess every imaginable toxic risk associated with every substance, and pursuit of greater safety therefore demands the setting of priorities as well as sensible limits for investigation. To do this with confidence requires possessing the very information that is lacking and that can be won only slowly on a few substances at a time, with significant uncertainty and at considerable cost. This requires priorities, and completes the circle of frustration.”

The unremitting assessment, in other words, of increasing numbers of micronutrients or other food substances will prove prohibitive in terms of restricted research and government facilities and resources, both human and financial. More importantly, although questions of safety can be framed in scientific terms, they are not answerable by science because of these constraints.

Management options deriving from a fixation on toxicological concerns however may prove to be extremely conservative and indeed unworkable. As there is a cost to regulation, another type of cost-benefit analysis should include a look at

how much of what type of regulation generates how much health and/or prevents how much risk with the aid of how much scientific research in relation to the consumption of micronutrient food supplements.

Numerous economic analyses show that beyond certain social-economic and governmental expenditures, regulation devised to enhance safety can have the opposite effect from what is intended. There are "cost-induced fatalities", which need to be included in the analysis of expected risks and benefits.

This brings up the question whether regulation and controls should be ex ante (before the fact) or ex post (after the fact). The view of the authors is that regulation that leaves a certain freedom and regulates matters ex post is definitely preferable to the directive's ex ante approach.

Homeostasis

Micronutrients are characterized by a two-sided profile of risks and benefits. There are risks of too little and risks of too much. Generally, with micronutrients, the risks of too little outweigh those of too much. There also is a range benefit, of optimal intake - homeostasis - between the extremes of deficiency and excess.

In this graphic (click to enlarge), the authors have summarized the generalized pharmacological dose-response curve of essential micronutrients such as vitamins, minerals and other compounds. The U-shaped curve is presented in an inverted fashion. The figure does not addres