Foods Are Medicines: The Elusive Borderline

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September 28, 2004

 

Foods Are Medicines: The Elusive Borderline

 

 

 

" Let food be your medicine and medicine be your food. "

Hippocrates (c.460-400 BC)

 

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

lactobacillus-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

fulfull 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 institutionalises 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

macchinations 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!

 

 

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!

 

You can read the proposal made in the Codex Labelling Committee,

as well as the very informative exchange that followed it, in this

earlier article.

 

 

See also related:

 

Codex Committee To Meet In Germany To Finalize Supplements Guidelines

 

EU Health Products Directives To Have 'Serious International Impact'

 

Denmark To Eliminate Concept Of Supplements: 'They're All Medicines'

 

Risk Analysis - A Study Of Canadian Health Products Legislation

 

European Directive on Medicinal Herbs Discriminates Against China,

India, Other Cultures

 

Posted at September 28, 2004 07:47 PM | TrackBack