Comments on the BEUC position on food supplements

December 2000

Introduction

There are many consumers in Europe who take food supplements not as a simple addition to the diet to provide nutrients they did not get in their food, but rather as an active means of prevention, as a means of staying healthy in an environment that assaults us with pollution and stress, in a world where "normal medicine" is reduced to merely treating the symptoms of disease and where approved pharmaceutical medicines are so dangerous as to cause the untimely death of perhaps a million persons worldwide each year. These consumers take supplements as part of an active and healthy way of life, as part of a strategy of staying healthy and of avoiding, where possible, to have to resort to pharmaceutical medicines with their damaging side effects.

Many of us have not seen a doctor in years, and when we do, we prefer to consult a naturopathic practitioner or a doctor using homeopathic methods of treatment, out of a deep distrust for the "official" kind of medicine. These "alternative" practitioners often do recommend, among other things, to take certain products (vitamins, minerals and herbs or other similar substances) which are generally only available in the form of food supplements.

It is easy to say, as we read in the BEUC paper, that "supplements which are not considered foodstuffs should be considered medicines". However the practical consequence of such a statement, if taken to it's extreme conclusion, is that many products which are available as supplements today and are taken with excellent success by many consumers will no longer be available tomorrow.

This is because the companies producing them, being small or medium sized businesses, do not have the resources to go through the expensive authorization process connected with registering a medicine. Many of the products do not have the requisites, especially that of scientific demonstration of efficacy against specific diseases, needed for such a registration, nor will any of the large pharmaceutical companies produce those products. They have no need and no desire to enter into what they consider a mere niche market.

On the balance of statistical evidence. . .

Thus, while we agree with most of the conclusions reached in the BEUC paper, we wish to point out that there is an important issue, that of the need to ensure continued availability of products that are important to the health maintenance of many European consumers, which is not dealt with adequately. That issue, to many consumers of supplements, is at least as important as the issues of labelling and of safety levels, which figure very prominently in BEUC's paper.

From actual statistics, supplements as a category are the safest products available today! There is a much greater danger of death from the from the ingestion of normal food then there is from the use of supplements, and one cannot even begin to compare the danger inherent in the ingestion of pharmaceutical medicines (properly approved, prescribed and taken according to the instructions of the medical doctor) with that inherent in the consumption of supplements. Medicines are something like 26000 (Yes, twenty-six thousand) times more dangerous than supplements. This is from an elaboration of statistics from the USA, (where supplements are consumed by more than half of the population) prepared by Ron Law, who is the executive director of the New Zealand National Nutritional Foods Association and is a member of a New Zealand government panel advising on strategies for the reduction of medical error. For more information, see the following: http://www.laleva.org/petizione/english/ronlaw_eng.html

Judging from the statistical data, and keeping in mind that there are numerous well documented benefits from an increased intake of certain nutrient substances (over and above what is obtainable even from a perfectly balanced and varied diet) it would seem wrong to put too much emphasis on lists of ingredients and on "safety levels", while there is doubt about future availability of these products. Some of them may be "considered medicines" and thus left in a legislative limbo, in a future "grey zone" of half illegality because they can be neither fish nor meat, that is to say, they cannot fit into any one of the existing legislative "containers". Others may be simply swept off the market because an ingredient, even if perfectly safe in actual use, has not been able to take the expensive hurdle of "demonstrating" this safety to a panel of scientific experts.

An example of this is the recent controversy between stevia, a plant based sweetener that has been in use in various countries for decades and even centuries, and aspartame, a chemically manufactured sweetener made by a large pharmaceutical company, known to cause a plethora of damaging effects on consumers. While aspartame has been "approved", despite damaging side effects being reported in large numbers (http://www.laleva.org/food/dorwayasp_eng.html), stevia has recently been refused approval by the European Union's Scientific Committee for Foods, thus eliminating a natural and safe alternative to a damaging pharmaceutical sweetener that is causing untold harm to consumers.

Specific comments on the BEUC position

Apart from the general tendency toward control and the absence of visible concern for the future availability of these important products, we would also like to make some specific comments to the BEUC paper:

Restrictive definition:

We believe that the definition of food supplements proposed in the BEUC position does not do justice to the important role supplements play in maintaining health, beyond a mere supplementation of the intake of particular nutrients in the daily diet. We would be prepared to work with BEUC so as to arrive at a comprehensive definition that does cover the important health roles supplements play in today's world.

It is true that medicines are defined in a very extensive way in directive 65/65 but nothing prevents a revision of this definition, or a different interpretation, or a new comprehensive definition for food supplements, which would leave space for nutritional prevention and nutritional therapies, in addition to the strictly pharmaceutical means regulated in the directive on medicinal products.

Maximum limits:

The health risks connected with supplements are largely theoretical (there are extremely few actual cases reported in the literature) and are in no relation whatsoever to the actual damage done by other comparable products: we are especially thinking about pharmaceutical medicines, but even normal foods are statistically much more dangerous than supplements.

Instead of a generalised call for maximum limits, we would favour a differentiated approach as adopted in the Netherlands, of establishing upper limits only for those nutrient substances that have presented actual (not just theoretical) problems, such as vitamin A, iron, vitamin B6, etc. and to consider both the importance of the positive effects of supplementation and the entity and severity of the negative (side) effects encountered at higher dosages.

For instance, supplementation with selenium has been shown to actually prevent the development of certain cancers, while the "toxic effect" of selenium overdose generally involves brittle hair and fingernails, symptoms that are reversible and should be of little concern if put in relation to the important health benefit of saving lives though the prevention of cancers.

One might say that the prevention of cancer is a medical effect and therefore is of no concern in food supplements. We would not agree with such an argumentation, because even normal foods can prevent cancer and that fact is recognized by most governments and nutritionists. No one would think of classifying those foods as "medicines", simply because they have a health promoting or preventive effect.

We do agree that the fixing of maximum limits for vitamins and minerals in food supplements should depend on properly conducted evidence based risk assessments by the Scientific Committee for Foods, but with the provision that upper limits of dosages are established only for those substances that have caused actual, (not theoretical) problems, and that in setting such limits, the benefits of intake are weighed against the importance of any "toxic" effects.

Natural Toxins and contaminants:

We agree that natural toxins may be a problem in supplements, especially where herbal ingredients are used. Those toxins should be identified and limits should be set to ensure that the finished product does not have harmful effects because of a too high content of these naturally occurring toxic substances. While in the original form of the herb, toxins may be of no concern because other natural constituents of the plant counteract them, they may be concentrated in a supplement because of the particular form (extract) the ingredient is presented in.

As for contaminants, pesticides are a concern, but it is heavy metal contamination that is most frequently encountered. Limits should be set for both.

Positive list:

We do not believe that lists are a good means of protecting the consumer of food supplements. Nutrient sources are continuously evolving. The establishment of a positive list will inevitably stifle innovation and therefore prevent future beneficial effects of supplements, for example through introduction of more efficient "carriers" of the various nutrients. The only positive effect of a "positive" list of nutrient sources will be in favour of the pharmaceutical companies who are the producers of yesterday's inefficient nutrient sources. Many of the forms of minerals for instance, that are allowed according to the preliminary lists attached to the proposed directive, are the "traditional" but inefficient non organic mineral salts such as phosphates, carbonates, sodium combinations, while the more recently introduced forms such as mineralized yeasts, amino acid chelates, aspartates, orotates and others are conspicuously missing.

Positive lists as conceived today will distort competition in favour of the large pharmaceutical companies, the only "players" who can afford the expense and delays inherent in the approval process. Their introduction in the directive will damage small and medium sized businesses which are the major innovative force in the supplements market, and will reduce consumer choice, as well as the efficacy of supplements on offer. Positive lists will also have no effect for the protection of the consumer. Any "protecting" effect they might have is either not needed (products are already extremely safe today as shown by statistical data) or is offset by the damage done to public health through the limitation of availability of health promoting and disease preventing substances.

For these reasons we are in favour of the principle of ensuring non toxicity of supplements but with specific determination of the actual dangers that are to be eliminated. We do not agree with the necessity to establish a blanket of safety precautions that will end up reducing consumer choice and leave us with what the pharmaceutical multinationals are willing to concede, a bland, grey, equalised and . . . inefficient "choice" of products.

Information and claims:

We do appreciate being informed of health promoting properties of the various substances offered in food supplements. It is not in the interest of the consumer to continue the present ban on any type of "medical" information for supplements and other natural products.

If the product is dangerous, consumers should be informed. If it is a promising healthy addition to the diet that may help prevent a disease, why should we be denied information about this?

It seems highly hypocritical to on the one side make government campaigns about nutrition centered cancer prevention ("Mediterranean diet") and on the other hand to stay silent on the very substances in supplements that have been shown to decrease the incidence of certain illnesses, including cancer.

Conclusion

The position paper of BEUC with regard to food supplements is the result of thorough work, but it seems that the views of actual consumers of supplements were not included. Indeed, the paper shows an imbalance towards severely controlling and limiting both the composition of the products themselves and the information that may be given about them on labels and in other accompanying descriptions. The positive health effects of supplements are either not understood or have not been fully appreciated, resulting in a call for excessive control that will limit the future availability of products on the market and will eventually result in the opposite effect to what is intended: the positive potential for public health of a widespread use of supplements will be wasted if the European food supplements directive follows the philosophy indicated by BEUCs paper.

What will BEUC do?

Our question is, what will BEUC be doing to represent, in the European Community discussions, and in talks with MEPs and other decision makers, the legitimate point of protecting freedom of choice and consumer access to vitamin and mineral supplements, including those "high dosed" products that are being pushed into a future legislative "grey zone"?