Comments regarding the proposal of the German Federal Health Office (BGA) for a Codex Alimentarius draft regulation regarding food supplements - Vitamins and Minerals

The proposal of the federal health office (BGA) regarding the area of foods supplements does not propose a specific set of guidelines, referring to a future "discussion of basic principles". But it is obvious from the overall tendency of the draft, that the (European) citizen is not considered mature enough to take care of his own health with a sensible practice of supplementing his diet and in accordance with the latest research results in the area of preventive nutrition. However it is just this attitude, which signifies an obsessive bureaucratic control without sense or reason, that must be held largely responsible for the current disastrous situation in the area of public health.

If on the one hand, we have to say that the citizen has practically no protection against atmospheric, electromagnetic and acoustic pollution of his environment, (it should probably be a duty of the BGA to provide for such protection) then it is obvious on the other hand that an attempt is being made to use legislative authority in order to deprive the citizen of one of the last remaining tools of biological "self-defense".

Our drinking water in many places has become a quite unpalatable liquid. The relevant levels of maximum allowed pollution are changed as and when needed. In any case, most families have taken to filtering the tap water or have started using only mineral water.

Our foods are impoverished by chemical "fertilizers" and the use of hormones and poisons for weed and pest control as well as industrial processing has left them little more than worthless. True, it is possible, with clever combination of foods, to avoid outright deficiency diseases, but an optimal nutrition (for real health and strong immunity) cannot any longer be achieved by just eating normal foods.

Our environment has come to be a general health risk through a technology and industry which are oriented towards fossil fuels and chemical poisons. Medicine based on pharmaceuticals and expensive apparatus has failed miserably in controlling chronic illness and our immune system is under constant attack not only from environmental pollutants but from such "medicogenic" poisons as vaccines and antibiotics applied without limiting criteria.

In view of these facts it must be seen as the maximum of bureaucratic obtuseness if now the people are "to be protected against the undesired effects of food supplements". In many cases it is just those vitamins and minerals and other nutritional substances which allow the individual to "keep afloat" despite continual attacks on his health.

After this admittedly somewhat polemic introduction, which seems necessary to put the discussion in the right perspective, we shall now examine the single parts of the BGA's proposal.

Definitions

It has been correctly pointed out that foods are consumed mainly because of their nutrient content, as well as for purposes of nutrition and taste and that the borderline between foods and medicines is determined by the purpose of the product.

This already shows clearly that a food supplement, regardless of its content of nutrients, has to be considered a food and not a medicine, as long as it is not offered with medical indications. Therefore, discussing a limitation of dosages, as least towards a maximum dosage, seems to be quite superfluous.

The definition of the term "medicine" as a product which serves to diagnose, heal, alleviate, treat and prevent illnesses and disturbances of body and spirit, and/or which serves to change the build and the function of body and spirit and which is sold for this purpose is in accordance with EC regulations (65/65), but we shall examine this is a bit more closely.

First we have to note that this definition has been made very ample with the purpose of including all traditional medicinal remedies. However it was not made in order to work out a distinction between foods and medicines. Thus the attributes of a medicine as listed in the definition must not be seen as exclusive attributes of medicinal products.

In other words, we cannot hold against a food the fact that it may serve to "prevent illnesses or disturbances of body or spirit" or to "change the build or function of body and spirit". For thousands of years, these functions have been fulfilled by both medicines and foods, in many cases mainly by foods. Historically, medicines were used mainly for healing and treatment of illnesses, while prevention was seen as a question of one's lifestyle, and mainly as a question of healthy nutrition.

If we look more closely at the above definition of medicinal product, another important point strikes the eye: In order for a product to be considered medicinal, the mere function of the product is not enough. A second condition must be fulfilled. The product must also be offered as a medicine. We see this clearly expressed in the words "...and which is sold for this purpose".

Of course we cannot presume to put a chemical pharmaceutical substance on free sale, using this argumentation. But when we are dealing with substances that are normally consumed with foods, even if these substances are offered in higher concentration, then these are not to be considered medicines only because that have also been sold as medicines in the past. The food purpose must be seen as prevalent in this case, especially when the producer does not intend the product to be used as a medicine and where this is clearly evident from the packaging.

Thus, in view of the above, the desired distinction between foods and medicines must be shifted in favour of foods, i.e. we have to admit that also foods may have at least a preventive function, as in fact they do have and as has been affirmed historically.

It is true that a food supplement can be sold both as a dietetic food as well as in the form of a food of general consumption. The difference is mainly due to the definition of purpose.

Dietetic foods are foods that are directed towards a specific nutritional purpose, which has to be clearly put in evidence on the label.

Foods of general consumption including food supplements are not specific. They are offered without a special dietetic objective. However we must, as already said above, be aware of the fact that even general consumption foods may have at least a preventive function against illnesses and disorders, as well as the capacity to cause changes in the build and the function of the body.

In connection with the definition of food supplements, the BGA's proposal mentions (under point 4.4) the term "nutritional need".

This term is considered equivalent with the daily recommended dose (RDA), without however saying one word about the difficulties that are connected with determining these daily doses. These difficulties arise from the fact that all individuals are different and from the lack of sufficiently accurate studies for many nutrients to allow a somewhat certain determination of the actual daily need.

This lack of reliable research is clearly evidenced in the report of the Scientific Committee for food (EU): "Nutrient and energy intakes for the European Community, 31st Series (1992)" which is referred to by the BGA's draft.

The SCF committee in the report refers many times to insufficient data for single nutrients. The reports says about the RDAs for children, that the recommendations are "best estimates" and that they should "perhaps be regarded as serviceable values for food labelling and planning purposes rather than definite statements of need".

The committee furthermore refers to the general lack of research in the EC and in the world at large and states that "the nutritional needs of the normal healthy individual are commonly classified as a low priority for medical research".

If now the BGA tries to make the availability of food supplements depend on such incomplete research, if one proposes to make "lists of allowed substances" and if the dosage of various substances is proposed to be limited to a largely unresearched "nutritional need" then this goes really too far. Obviously the objective here is not the protection of public health but the satisfaction of an exaggerated bureaucratic desire to control.

The discussion about positive and negative lists

Basically, the establishment of lists of nutrient substances, be they positive or negative, must be seen as an excessive bureaucratic effort to control. Food law is already sufficiently clear in not allowing toxic substances as part of foods. If there is a fear of undesirable side effects of some nutrient substances in higher dosages, then one should also think about the free availability of substances such as alcohol and tobacco, the harmfulness of which is hardly a point of discussion, or of simple sodium chloride, which is harmful in high dosages, without anyone thinking about limiting the availability of these substances.

Apart from the fact that it is impossible to produce a really exhaustive positive list, it is the very existence of such a list which would be a serious barrier to necessary further research. As pointed out very well by the SCF committee, medical research is not interested in researching nutrient substances. Furthermore, even food oriented research would lack incentive for further research into a known substance if it was already included in a positive list, and on the other hand it would be discouraged from investing in research on a substance that is not included in the list.

Also a negative list seems to make no sense, as can be seen reading the reasons given by the BGA in favour of making one. Reference is made to nutrients, for which there are insufficient data about normal or harmless levels of intake, to nutrients for which exist national or regional programs to increase intake in the population and to nutrients for which there is no need for supplementation in the population.

These arguments show even more clearly the general insecurity and the lack of data about single nutrients. It does not seems correct to take such a lack of data as a justification for the general prohibition of a nutrient substance. Furthermore, considerations about the nutritional status of population groups must not have an influence on the availability of food supplements used by individuals.

Even nutrients, for which "by reason of intoxications there is general agreement" and for the supplementation of which "there are no scientifically recognized reasons" do not, in our opinion, have to be completely prohibited. It would be sufficient to put an obligatory warning on the packaging or to limit such substances to a dosage that is recognized as having no side effects. This would satisfy both a desire to protect public health, as well as the freedom of citizens to determine their nutrition in accordance with their individual desires and their persuasions.

A positive or negative determination of the various forms of nutrient substances is not practicable because, even though the criteria for such a determination come necessarily from medical research, the use of these substances is not medical but nutritional. So we have to rely on medical research which, as already stated above, is available in sufficient quantity and quality only for few nutrients or forms of nutrient substances and if at all, it is available only because, at one point or another, a pharmaceutical company intended to market the nutrient or the specific form of nutrient substance as part of a medicinal product.

It is not correct however, to make the acceptance of a food or nutrient substance dependent on the more or less accidental availability of medical research. At least one would have to work out criteria for the safety of nutrients and of forms of nutrient substances that are acceptable to the food industry and the food supplements industry, but such criteria would by necessity be different from the standards set for medicinal products.

Limitations of dosage

A limitation of quantity or dosage for single nutrients seems useful only where there is reasonable concern, i.e. where a serious danger to the consumer has to be avoided. This is the case for very few nutrient substances and is at present well taken care of by voluntary limitation of dosages by producers. In any case, there are exceedingly few cases of intoxication by nutrient substances even in the USA and in the Anglo-saxon countries, even though for decades food supplements with dosages many times the RDA have been freely sold there. This cannot be said however of other substances that are freely available such as strong alcoholic beverages and tobacco. For these freely available substances there are thousands of documented cases of intoxication, without anyone seriously thinking about limiting their dosages.

Even though protection of the consumer is an important objective, one should on the other hand avoid "protecting the consumer to death" i.e. we have to weigh the onerosity of the intended protection against the right of the individual to decide for himself, in order to avoid an excessive bureaucratic control of the citizen. These considerations must also include an analysis of the (possible) benefits of a free availability of adequate nutrient concentrations which allow the individual to arrange his/her own preventive measures by a sensible choice of nutrition. It must be left to the individual to decide what he regards as sensible. In any case, the "experts" of conventional medicine are not competent to decide, because their training does not include a knowledge of the latest research in this area.

We see that the usefulness of a limitation of dosages towards a maximum seems extremely doubtful. Also a limitation towards the minimum is completely unjustified by considerations of consumer protection, unless the objective is to control the life of all citizens down to the smallest detail. It would be quite sufficient to demand complete labelling with clear indication of contents in units per doses or per tablet/capsule. All consumers would then be able to determine for themselves, what exactly they are consuming.

Labelling:

It seems useless to want to establish a special name for foods supplements. We are dealing with normal foods that consist mainly of one or more nutrients and other natural substances of high nutritional value. The nature of the product is quite clearly distinguishable from the packaging, without there being a necessity to create a new "product category".

As for dietetic food supplements, these are subject to existing regulations for dietetic foods.

We have nothing to add to the demand for complete labeling, although the usefulness of a listing of the recommended daily doses and of a percentage of these seems doubtful, especially in view of the uncertain and scarse research data and the orientation of daily dosages as population reference values, not as individual needs.

Nothing to be said about point 6 (products for adults). However it seems to be unnecessarily restrictive to a priori exclude health-related claims because foods and especially foods with a higher concentration of nutrients can very well have a preventive function and it seems unreasonable to not inform the consumer about this function.

The BGA's draft regulation

Considering what is said above, the project for a codex regulation on food supplements would at best have to be seen as superfluous, in any case however it would be an unjustified limitation of the right of free development of the personality, which must include the right to freely choose one's own nutrition.

If on the one hand we cannot deny the necessity of consumer protection, on the other hand there is an important right that is just as worthy of protection, the right to free development of the personality and the right to self-determination. Furthermore, an analysis of damage vs. usefulness is necessary. The extremely small damage, which unregulated food supplements can effectively cause and the usefulness (especially in view of the continually rising costs for the single states for medical care and for the treatment of chronic illness), of the free availability of these substances for public health, must be thoroughly analyzed before getting into a hasty overregulation of this product category.

Therefore it seems basically doubtful whether a regulation for food supplements as proposed by the BGA is at all justified. However in the case of a decision to proceed, it would be necessary to proceed with great caution, because the catastrophic situation of medicine today, especially with regard to prevention, has become an extremely critical factor for the single states and an overregulation of alternative ways to maintain health, including that of nutrition, could lead to a rapid and possibly irreversible worsening of public health.

We recommend therefore, to drop the idea of a regulation of food supplements in the area of Codex Alimentarius and in the contrary case, to proceed with the greatest caution and only in agreement with the industry concerned.