" Let thy food be thy medicine and thy medicine be thy food."
Hippocrates (460-377 BC)

We might say that the debate of what is food and what is medicine goes back more than two thousand years, to Hippocrates, the Greek physician who is also known as the father of modern scientific medicine.

In the early 1960s, pharmaceutical medicines were in the headlines with a tragic development. Mothers who had taken thalidomide during pregnancy gave birth to children with severe deformities, while contraceptive pills were being sold without any controls. New pharmaceutical legislation was introduced in Europe in 1965 to prevent such disasters in the future. The European directive regulating what became known as 'medicinal specialties' defined these products in a very wide way in order to catch all possible products that should be subject to mandatory registration.

In 2004, a general overhaul of the European Union's pharmaceutical laws further extended the definition of what is to be considered a pharmaceutical medicine. According to a Commission clarification, the extension was necessary to cover new types of drugs being developed. Gene therapy, radiopharmaceutical products and certain medicinal products for topical use are specifically mentioned. The document is at pains to allay fears that the further extension of the definition of a medicine could be used to remove existing health products from the market. It is argued that only in cases of doubt would the provisions of the new pharmaceutical laws be applied to products that might also be fitting in other categories.

While this sounds reasonable, it is fraught with grave uncertainties for both producers and consumers of supplements. The devil is clearly in the details here, because it is that whole category of borderline products which this new definition seeks to eliminate, that's in danger of vanishing. These products are perhaps the most sought-after of the natural remedies but I doubt the Commission officials or the politicians who passed the law have come to realize the extent of the problem yet.

A series of pending legal cases before the European Court of Justice might give us more of an idea of what we are talking about. These cases are against the German health authorities and regard their refusal to acknowledge that certain products are food supplements and should be freely on sale there.

The products subject to these cases are:

- a probiotic product supplying several strains of diverse l

  actobacillus-type cultures

- a 1000 mg vitamin C with bioflavonoids

- a product with oligomeric procyanidins - flavonol extract

- a buffered C product with 1000 mg vitamin C and 110 mg of

  calcium - providing calcium ascorbate

- a 400 IU vitamin E product in tablet form

While most people who consume or otherwise have to do with natural products would agree that these products are indeed supplements, the question seems to be looked at quite differently by national health authorities, at least by the Germans (who stopped importation) and by Spain and Sweden (who filed pleadings arguing in favour of the Germans' viewpoint).

These are the most salient impressions I got when reading the papers.

1) Both the Commission and the member states seem quite serious that there will be no more "grey area" products. After passage of the food supplements directive and the amendments to the pharmaceutical directive, all products on the market will be forced into either one or the other of two categories: a food or a medicine.

2) The Commission is exceedingly cautious in its approach to this question, recommending that the EU court should not decide on the merits of where to collocate individual products, saying this is for the national health authorities and for the national courts to decide. I take this as a sign of acknowledging that supplements are an exceedingly hot potato politically, and that although the Commission did everything in its power to usher the new directives on supplements and pharmaceutical medicines through the parliamentary approval process, it now wants to leave the "dirty work" (of deciding what supplements to take off the market) to the national health authorities and the national courts.

3) The Commission also argues that the European Food Safety Agency should not make such a decision either, nor supply any "expert opinion" to the national (German, in this case) court for guidance. This can only reinforce the impression that the Commission does not want to be caught in the middle of a fight between natural health stakeholders and the more restrictive EU member states.

4) After reading all three opinions, it seems to me that they may have been co-ordinated in some way, (perhaps by the Commission itself or by the Germans asking their colleagues from other countries to "give them a hand"). Although there are some differences of views, there are remarkable similarities in the three sets of arguments, especially in the precedents they all refer to.

5) The Spanish Abogado del Estado states quite clearly that all the products in question, in Spain's view, are certainly medicines, but concedes that such national views are not necessarily binding on other member states, where the same products may be considered foods and be sold as supplements. Spain does seem to see a slight problem in this diverse classification but the only recommendation is to streamline the medicinal registration procedures so as to speed up market access for products that may have been taken off as "unregistered medicines".

6) The Swedish government, through the legal secretariat of its Foreign Ministry, does not pronounce an opinion on the products as such and in this aspect argues in a similar way as the Commission, in the sense that it is up to national authorities and courts to decide. The Swedes however do see a problem with differing national interpretations and would like to see common criteria for decision making to be established at the EU level, for what constitutes a medicine and what instead is a food supplement.

7) All the intervening parties, including the Commission, agree that any product that is intended or may be used to "make a medical diagnosis or to correct, improve or influence human physiological functions", (re-translated from German, English wording not perfectly identical to the pharmaceutical directive) are to be seen as medicines and thus must be registered as such. They also agree, that in case of doubt, the pharmaceutical interpretation must have precedence.

What does all this mean for us?

First, it brings us to the realization that indeed the food supplements directive, but even more so the pharmaceutical directive will potentially lead to the medicalization of a large number of useful supplements - all those that do more than merely "correct deficiencies in the normal food intake".

It also shows that the directives on health products do not fulfill their primary purpose, that of harmonizing the laws of the member countries, with regard to health products. In fact, the situation seems to be quite the same as before the directives: National authorities and courts can and, according to the EU Commission, are actually expected to autonomously decide what is and what isn't a medicine. It is freely acknowledged that there will be differences in interpretation. Barriers to trade inside the EU will likely persist.

No one addresses another question that is prominent, at least in the back of my mind: In case a product gets declared a medicine by national authorities and someone does make an application to register it as a medicine, what happens if that medicine registration is turned down because the applicant could not show efficacy in treating or preventing a disease. Does the product then revert to being considered a supplement, or is it irretrievably lost in the maze of regulatory red tape? I rather suspect the latter.

The Alliance for Natural Health is arguing in their present case before the European Court that there should be no prohibition of sale for products that do not adhere to the narrow prescriptions of the food supplements directive. But the question of medicinal interpretation taking precedence in cases of doubt per the EU's new medicines definition seems to be even more important and potentially more disastrous for the future of food supplements in Europe.

Searching for a solution to the problem, Julia in the UK comments:

... if only supplements that 'correct deficiencies' might be permitted we need to develop stronger arguments along the line that if a supplement can be shown to have a benefit, it must by definition be evidence of a deficiency. i.e if a food can produce a benefit, it is evidence of a deficiency, rather than if a food can produce a benefit it must be a medicine.

To this, Tamara in Denmark replies:

Interesting argumentation! However, with the new definition of medicinal products according to the EU Directive 2004/27/EC, which (as you well know) states that any substance "... correcting ... physiological functions ..." will be defined as a medicinal product, I am not so sure this can be used either.

Examining the problem

My own thoughts trying to focalize the problem so a solution can be found, were sent to both, but I think some readers of this site might also be interested. We should of course realize that the new definition of a medicine was masterfully crafted, but I believe it just goes one step too far. Here is how my argument would go:

The definitions of a food and that of a medicine are clearly overlapping. Foods do much the same things as medicine, they prevent diseases, they correct our physiological functions, and they have even been known to cure illness. Plenty of examples exist, if we want to get into that. Whatever arguments we want to make, we have two important product categories, whose functions overlap to a great extent.

It would be insane to reason that one of these categories - medicine - should determine what is, or is not, a food, by using the functions of a medicine as a yardstick, which as we all know are also the functions of foods.

To do so would certainly be unworkable. The result of applying the definition of a medicine as an overriding yardstick would be the same as if there were no definition: Because basically every decision will have to be made in an arbitrary way - the definition simply does not distinguish the two areas adequately. The dilemma is normally circumvented because in a tacit way, no decision is made (neither is it asked for) about a lot of products which technically fall under the medicine definition. The arbitrary is deciding what products to subject to the test.

We see immediately that by closing an eye on certain products and by raising doubts on others, the authorities have a "free for all" way to "pick out" those products they would like to control and raise doubts about their status as foods. The result is guaranteed. Since technically almost all foods fall within the definition of a medicine as written, whatever the authorities decide to call a medicine will be a medicine. It's as simple as that.

The new EU definition of a medicine even explicitly acknowledges and institutionalizes this arbitrary mechanism by stating that in case of doubt, the medicinal interpretation will always prevail over the food one.

Of course that leads to a great deal of legal uncertainty. One day your product may be fine, while the next day (usually when a pharmaceutical company has spotted your product as "competition") you will lose that product. It will be declared a medicine and will consequently be lost to the "free" market. What could be more arbitrary? And what could be more subject to behind-the-scenes machinations by pharmaceutical influence peddlers?

So we see that we have an unworkable definition, a mere cover for arbitrary action by administrative agencies, and by extension, pharmaceutical interests. The courts in this case are "window dressing", they are obliged to declare any product with a pronounced health effect to be a medicine, applying the legal definition.

Let's say that for now we have established that the current definition of a medicine is perfectly useless for distinguishing between what is a food and what is a medicine. It will result in close to a hundred percent of foods to be declared a medicine, if and when anyone cares to apply the test.

Everything is potentially a medicine, and only if the authorities close their eyes, can any healthy food products be sold at all. That is the situation if we examine it without allowing "reasonable" explanations such as "officials only act in defense of public health", or "who in their right mind would say that an apple or a lemon is a medicine". These may sound reasonable, but they are no guarantee of certainty. The disputes are in contested areas, over borderline products, and borderline products happen to be foods or food supplements that are very effective in what medicines are designed to do!

That does not mean however, that by whim it should be possible to remove them from the market!

What would be the a workable solution?

I admit I do not know, but I do know that a proper legal distinction between foods and medicines must be found, one that will not leave us open to arbitrary administrative action, if we are to attain even a semblance of legal certainty.

Perception has a lot to do with this. In fact the German courts explicitly cite "the perception of the average, well informed consumer" as an important criterium for what to designate a medicine rather than a food. Ginseng, for instance, has long been a medicine in Germany, available from your friendly pharmacist, and per the definition of a medicine that is perfectly legal. However that same product is eaten by Koreans as a healthy side-dish to their meals, and is available in a large number of countries as a food supplement - no questions asked.

Perception may also be the key to the solution for our dilemma.

Perhaps we should accept the widely given advice (by government health agencies) that healthy eating is vital for our good health and that thus prevention of illness is primarily the province of food, not medicine. Certainly the correction of physiological functions depends primarily on what we eat, again making proper physiological functions a prime result of our choice of food.

You might ask what that has to do with the definition of a medicine. Nothing and everything.

If we accept that food does indeed have preventive and physiological properties, which I believe is not an absurd concept but on the contrary quite reasonable, then we should enshrine in our (food) laws some reference to these properties.

We would then have a clearer concept of the possible divide between food and medicine. Both are things we ingest, imbibe, or otherwise "import" into our body. Both have definitely something to do with our health. Both are equally important for our health.

When we have bad health, we turn to medicine for help.

When we have good health, we turn to food in order to prevent bad health.

In other words, medicine deals primarily with sickness, while food, apart from the pleasure we get when eating, has as one of its more important functions our good health, or rather the prevention of sickness.

There are of course exceptions, a medicine may be preventive of illness (rarely, but there might be some) or a food or a supplement may be actually curative (examples abound).

Even with the present definition of a medicine intact, the courts could certainly find the right balance between both fields, if it was understood that foods are a primary tool of prevention and that both food and medicine have an equal part in bringing about good health.

There should even be a healthy competition between foods and medicines - each one providing its best contribution to our health.

So why not let them compete - on equal footing - in the task of bringing about good health!


Lobbying for Change

The Alliance for Natural Health (ANH) pointed out the grave shortcomings of the - then - proposed new European definition of a medicine in December 1993. In a Download file" target="_blank">briefing note to press and politicians it is argued that with the proposed wording of the pharmaceutical directive, no clear distinction will be possible between medicines and other products in adjacent categories such as foods, food supplements, medical devices, biocides or cosmetics, and that therefore an alternative wording must be found.

Avril Doyle, MEP from Ireland, raised the question with (industry) Commissioner Liikanen, in the following terms:

There is a lot of good in the package before us but, if we are honest, there are a lot of problems as well. We have tried to do too much, too fast, with the threat of conciliation and enlargement used as the big stick to knock us into line. I object. In the months and years ahead we will pay the price, not least to the lawyers who unfortunately will have a field day.

Commissioner Liikanen, you mentioned that one of the objectives included the need to prepare for enlargement. I say to you that a race to conclude this package before enlargement is not the same thing.

On the Human Medicines Directive, concerns have been raised that, with the wide definition of medicinal products and the supremacy clause, it is possible that food and food supplements, cosmetics and medical devices could all be classified as drugs. The Commission's and the Council's solution to this problem is to insert wording in Recital 7 - Amendment 60 - to the effect that: 'Where a product comes clearly under the definition of other product categories ... this directive should not apply', thereby distinguishing between medicinal products and other products.

The problem with this solution is that recital 7 will not have any legally binding effect. Indeed this recital will not actually go into the Pharmaceuticals Directive itself. I have seen an expert legal opinion which advises that, unless modified, the Pharmaceuticals Directive will completely subsume the Food Supplements Directive. I have two specific questions on this, which I would like you to answer, Commissioner.

Why did the Commission and the Council not propose that the recital 7 wording should go into the operative article of the directive to ensure that it has legal effect? What assurance can the Commission give that even if recital 7 wording is not put into an operative part of the directive, it will still be effective in addressing the problem of borderline or frontier products?

But these concerns were brushed aside in the Commissioner's answer. All the Commission would reply is that "stakeholders will be given the possibility to have input" regarding the implementation of Article 2(2), the provision according to which, in case of doubt, a product will be considered a medicine. Although promised, such a meeting has not yet taken place. Even if a meeting is held, it is hard to see how a "stakeholders meeting", held after the fact, that is, after the law has been put into effect, can do anything to ensure proper interpretation of a provision fixed in community law.

Canadian Government Sued

In Canada, where under the guise of a "third category" for natural health products, medicine law has been applied, and natural products are targeted for removal from the marketplace, the government is being sued over the question of how to define foods and medicines. The action, brought by the Alliance of Natural Health Suppliers and by Freedom of Choice in Health Care, asks that the government declare that

a) the definition of "drug" found in the Food and Drug Act is overly broad so as to take the application of the Act beyond the jurisdiction of Parliament as set out in the Constitution Act.

b) the definition of "drug" found in the Food and Drug Act does not include substances such as food and dietary supplements/natural health products that do not pose a health risk.

...

d) the Natural Health Products Regulations enacted pursuant to the Food and Drugs Act are ultra vires the Parliament of Canada and as such are contrary to the Constitution Act.

It is clear that the same issues come to the fore in various countries across the world. For more full information on the Canadian action, you can contact Trueman Tuck in Canada.

Codex Alimentarius

The problem has also recently been discussed in an international forum, the Food Labelling Committee of Codex Alimentarius, although from a slightly different angle. What Codex was examining was a proposal from South Africa to let science, not politics, be the basis of what can or cannot be said about the health effects of food products.

South Africa argued, much like we have done here, that foods do have health effects, that they prevent illness and indeed cure disease, so why not say it!

March 23, 2005 Update

In the case described in this article, Advocate General Geelhoed of the
European Court of Justice has recently filed his opinion, or concluding
remarks on the case in what is the last formal step before the court's
decision.

The German court of appeals asked the EU court for its view on several
questions. The original problem that led to the cases and their
referral to the EU court was the classification by German health
authorities, upheld by a previous court decision, of several products
as medicines, effectively banning them from being imported into
Germany:

• a lactobacillus product composed of six forms of friendly bacteria

• a vitamin C product of 1000 mg

• OPC 85, oligomeric procyanidins, a bioflavanol extract

• Acid free C - 1000 mg of vitamin C buffered by 110 mg of calcium

• E 400, capsules with 268 mg of vitamin E

The opinion goes into the legal question of how to separate food
products from medicines and shows clearly the great difficulty that an
extremely wide and ambiguous EU medicine definition brings in
determining coherently what is a food and what instead should be
registered as a medicine.

You can find the salient points of the Advocate General's opinion in a
comment below:

New statement by the General Advocate about the limits between medicines and dietary supplements

The General advocate by the ECJ has come with a statement in a number of German cases concerning dietary supplements. The producers had been able to market their products legally in the Netherlands, but received a refusal from the German authorities about marketing their products in Germany, because the products were referred to as medicines.

The General Advocate in his statement thoroughly went through the definitions of supplements and medicines in the Unity Court (Fællesskabsretten), which is why it is very interesting from a Danish perspective.

About the definition of medicine the General Advocate states, that it is up to the national authorities to estimate whether a product is a medicine, but that the definition of medicines in the Pharmaceutical directive (2001/83) can be seen as authoritative, which is why the national authorities in the qualification of products as medicines are bound by this definition. This means that the member states therefore cannot qualify products as medicines from other criteria than the one given by the definition of medicines by the directive.

Concerning the limits of supplements versus medicines the General Advocate among other things states that even though it is up to the national authorities to estimate whether a product should fall under the definition of medicine, it is not allowed to let this definition include products which, according to objective criteria are [not] medicines, and that the member states by their qualification of the product must also show consideration to the evaluation of other member states considering the rules of the free movement of goods.

The General Advocate's statement is also underlining that there are limits to how far the Danish authorities may stretch the medicine's definition to limit the access of the producers of supplements to the Danish market.