"They are scientists performing a very difficult task, as instructed by EU law makers."

I observed the EFSA health claims panel in action; conspiracy theorists will be disappointed


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I observed the EFSA health claims panel in action; conspiracy theorists will be disappointed

Related tags Health claims Nutrition Peer review

Last week NutraIngredients was one of 10 organisations invited to observe the European Food Safety Authority (EFSA) health claims panel in action for a day at its Parma, Italy, base.

We weren’t permitted to ask questions or be involved at all but we sat in office chairs against adjacent walls and observed the panel sat facing each other in rectangular formation work through two opinions – not health claims but dietary reference values (DRVs) for vitamin C and fluoride. There was meant to be another – molybdenum – but time ran away.

Other ‘observers’ included Kemin; Merck Consumer Health; Rephine Balticum; Instituto Kurz Italia; Nestlé-L’Oreal joint venture, Inneov; Mead Johnson; Danone Baby Nutrition and European Advisory Services.

The European Commission’s Basil Mathioudakis was also there, to listen and give EC input on certain matters.

While not able to report on the detail of what was being assessed, I was struck by the selection process on display as the 19 panelists took a red pen to the draft docs they were working through – and the awareness the panel has of how its work will be perceived in the wider nutrition community.

Although each panelist did not explicitly know the detail of each study relevant to the opinion – that was the job of the specialist working groups that had compiled the original draft opinions – if a study's inclusion was questioned it was called up on-screen, and a decision taken on its relevance or power.

The panel agreed on occasion to omit studies deemed ‘outlyers’; studies that were usually under-powered and did not fit with the overall body of science, or the conclusions being built toward in the panel’s opinions.

The panelists asked questions about dosage; about potentially confounding dietary factors and inputs; about animal versus human data; biomarker usability; about study populations. They debated wordings and definitions. About how 'science speak' would be interpreted by ‘readers’. What other bodies like the FDA, IOM or WHO had said on particular matters.

What struck me the most was the insane difficulty of the task of constructing a definitive scientific statement about nutrients, dosage and health effects from vast and often contradictory sets of data.

But that is what the panel is tasked with and the task they continue to plough on with.

Good science?

This panel – the Panel on Dietetic Products, Nutrition and Allergies (NDA) – has questioned so much nutrition science it has come in for all manner of criticism from industry and academia and beyond.

Its chair, professor Ambroise Martin, and the other 18 members of the NDA panel and their predecessors have been accused of mistreating peer-reviewed data. They have been accused of bias; of pharma conspiracies. Of misplaced didacticism to a badly written piece of legislation - the EU nutrition and health claims regulation (NHCR). Of blocking commercial freedom of speech.

Even wilful scientific ignorance...there has been no shortage of criticism and some of it from esteemed scientists.

While EFSA was established in 2002 to be the EU’s champion of good science, it has – at least in its health claims work – been frequently cast as a merchant of bad science.

EFSA's Parma HQ where the NDA performs its work
EFSA's Parma HQ where the NDA performs its work

And not just bad science, but innovation-killing bad science at a time when the European food industry needs all the help it can get as the Euro economy struggles and other regions offer alternate regulatory models in markets often flexing economic muscle on a ‘western’ scale for the first time.

In this landscape the NHCR and the NDA’s work within it have come to be widely despised as EU food industry innovation killer numero uno.

But can the panel be blamed for rejecting peer-reviewed science? As one said after the day’s work was complete: “The peer review process is not perfect and our criteria are different.”

Seeing them work I don’t think they can be blamed this way. They are scientists performing a very difficult task, as instructed by EU law makers.

It would seem any problem with the treatment of nutrition science lies there, in the writing of laws.

What do you think? Does EFSA's scientific output stand up?

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Fluoride risk --EFSA's unsafe assessment escapes Commission oversight. .

Posted by Robert Pocock (Ireland against Fluoridation),

Sadly, the diligence and bona fides of the NDA Panel (David Whitney Comment) can not be accepted when it comes to DRVs for fluoride. Its Opinion on the TUIL of fluoride (EFSA-Q-2003-018) shamefully failed to set a UL for infants even though they are most at risk because fluoride retention in bone can be 90% in infants versus <50% in adults. It then DOUBLED ‘the beneficial level in the prevention of dental caries' (not a permitted health claim!) from 0.05mg/kg body weight per day to 0.1mg/kg per day based on the equally irresponsible criterion that one child in twenty will develop ‘moderate’ dental fluorosis, an adverse effect – see www.irelandagainstfluoridation.org for pics).
Perhaps the most breathtaking aspect of this EFSA panel at work on ingested fluoride is that the EU watchdog on medicines and food law Mr Basil Mathioudakis –who is well aware of fluoride’s adverse effects in fluoridated Ireland – does not seem to have contributed any European Commission input.
For example did he mention that fluorosilicic acid, the molecular form of fluoride most widely consumed in the EU (by >10 million in Ireland, UK & Spain) is not an authorized product either as a food additive, food supplement or a medicine under EU legislation? Its not red pens that should be distributed in EFSA but a straight red card for the Commission food law watchdog asleep at the wheel.

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DRVs are not health claims

Posted by Robert Verkerk,

It's all too easy to say that EFSA is just doing its job. First of all, the job that was witnessed involved deliberations over DRVs, not health claims. The science that tries to establish the level of adequacy for an essential nutrient is very different to that which establishes the causal relationship between intake and a given benefit i.e. health claims, EFSA-style. But who's validating EFSA's methodologies in relation to its impact on risk/benefit management, especially when it comes to health claims? Is it appropriate, for example, that a negative finding according to EFSA's criteria effectively leads to consumers being told that the effect doesn't exist? Looking at this bigger picture, did Merck, Inneov, Kemin, Nutraingredients or any of the other observers wonder why fluoride was being treated as a nutrient, when the 'nutritional effects' it is purported to have in relation to reducing tooth decay are actually 'medicinal' (see: http://www.ncbi.nlm.nih.gov/pubmed/20188138)? These bigger questions were probably never considered by the panel, which just gets on with the job it was tasked with, seemingly oblivious of the implications. And that's what's wrong - and none of the big food or pharma companies seem to care much about that. It's not a conspiracy theory, it's just plain old bad science.

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What objective science contributes and what more is needed

Posted by David Whitley,

I think Mr Starling’s report is useful in pointing out the diligence and bona fides of the NDA panel and that the whole NHCR process has been a useful reality check for some health claims that may have been applied over- enthusiastically. However it is necessary to bear constantly in mind that objective science tends to provide precise and reliable data on very narrow questions. At the other end of the knowledge scale is long tradition which tends to provide imprecise data on very broad questions. Since health is a very broad question it seems essential that objective science be guided by tradition and, of course, vice versa.

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