Nov 21 2011
Umm….Yes. Yes it does.
This is one of those stories that immediately makes me think that there must be a deeper issue that the press is missing. Recently the European Food Safety Authority was asked to evaluate and approve the following statement:
“Regular consumption of significant amounts of water can reduce the risk of development of dehydration and of concomitant decrease of performance.”
After three years of investigation the EFSA concluded:
The Panel considers that the proposed claim does not comply with the requirements for a disease risk reduction claim pursuant to Article 14 of Regulation (EC) No 1924/2006
This decision has been immediately and widely criticized as absurd – the EFSA is saying that water does not prevent dehydration. It’s surreal. It’s right out of Brazil (the movie), a dark comedic dystopian totalitarian nightmare. Or perhaps it’s just abject stupidity.
I have a hard time accepting that interpretation at face value. I’m not any kind of legal expert, but it is my understanding from my involvement with legal cases that they can be decided on two grounds – the merits of the case, and the technical legal aspects of the case. For example, a court can find a defendant not guilty because the facts imply that they are actually not guilty of the crime committed, or because of some legal technicality.
Scientists sometimes face these considerations when pseudoscience is confronted in the courtroom. For example with the Dover intelligent design trial – that evolution is correct science and ID pure pseudoscience is a slam dunk. But defenders of science were concerned that the Kitzmiller vs Dover case may have been decided on some technical legal grounds (about interpretation of the law, for example) rather than the scientific merits.
So my first reaction to the EFSA ruling is that it must be the result of some technicality – the people filing the request used the magenta form instead of the goldenrod, or there was some problem with the wording. I can see numerous problems with the proposed wording – it does not identify a target population, it does not define what “significant” amounts of water are, and the bit about performance seems deliberately vague, as if they will try to use approval of this wording in order to slip in some dubious claim about athletic performance from drinking a particular brand of bottled water.
Or perhaps it is something even more legally obscure, such as the lack of standing or applicability of the law. There must be something.
I tracked down the actual decision, here is the abstract:
Following an application from Prof. Dr. Moritz Hagenmeyer and Prof. Dr. Andreas Hahn, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to water and reduced risk of development of dehydration and of concomitant decrease of performance. The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The food, water, which is the subject of the health claim, is sufficiently characterised. The claimed effect is “regular consumption of significant amounts of water can reduce the risk of development of dehydration and of concomitant decrease of performance”. The target population is assumed to be the general population. The Regulation (EC) No 1924/2006 defines reduction of disease risk claims as claims which state that the consumption of a food “significantly reduces a risk factor in the development of a human disease”. Thus, for reduction of disease risk claims, the beneficial physiological effect results from the reduction of a risk factor for the development of a human disease. The Panel notes that dehydration was identified as the disease by the applicant. Dehydration is a condition of body water depletion. The Panel notes that the proposed risk factors, “water loss in tissues” or “reduced water content in tissues”, are measures of water depletion and thus are measures of the disease. The Panel considers that the proposed claim does not comply with the requirements for a disease risk reduction claim pursuant to Article 14 of Regulation (EC) No 1924/2006
That didn’t help. They did not identify the reason that the proposed claim does not comply with regulations. That’s what I want to know – what is the reason. I read through the entire decision, and they never go into more detail. The paper simply restates information present in the abstract in different formatting and separated out into different sections, but there is no additional information. No reason is ever given.
A Telegraph article does give the only justification for the decision I can find:
Prof Brian Ratcliffe, spokesman for the Nutrition Society, said dehydration was usually caused by a clinical condition and that one could remain adequately hydrated without drinking water. He said: “The EU is saying that this does not reduce the risk of dehydration and that is correct. “This claim is trying to imply that there is something special about bottled water which is not a reasonable claim.”
If this is the reason then it is not some legal technical ruling. They actually think the claim is misleading. Assuming Professor Ratcliffe’s justification accurately describes the EFSA’s thinking, the decision is absurd, or at least misleading. Dehydration is not usually caused by a clinical condition. It’s usually (in the assumed general population) caused by not drinking enough fluids, most often due to physical activity or hot and/or dry environments. I have become dehydrated many times in my life, always as a consequence of one of the above situations (and one time because I was at high altitude). In every situation drinking water would have done the trick (and eventually treated the dehydration).
It seems what they are saying is that dehydration, when it is a “disease”, is cause by a clinical condition, and drinking water may not work. For example, if someone has terrible diarrhea and is losing significant amounts of water, drinking water will not do the trick. People can die of dysentery even when they drink a lot of water, because they are secreting water through their bowels. You need intravenous hydration to treat severe dysentery, and you need to treat the underlying condition (or at least give IV hydration until it runs its course).
So maybe – maybe – the EFSA decision is the result of the fact that they did not want to allow a blanket statement that could be applied to conditions where the claim is not true, like dysentery. I don’t know, because they did not explain their decision at all in the actual document. They therefore opened themselves up to legitimate ridicule.
My fear is that this sensational event will create a public backlash against regulatory agencies reviewing health claims by product manufacturers. This is a dramatic and emotional case that can have undue influence on what should be a thoughtful and nuanced discussion about the proper role of regulation in health claims. I suspect the anti-regulation crowd will jump all over it.
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