EU researchers revolted as EFSA clears health claims vault

By Shane Starling

- Last updated on GMT

Desperate times: With EFSA rejecting clinical data en masse, Dr Glenn Gibson dons his magic, technicolour health claim dream labcoat in the hope of winning a claim. The NDA concludes causality has not been demonstrated between magic and dreamcoats
Desperate times: With EFSA rejecting clinical data en masse, Dr Glenn Gibson dons his magic, technicolour health claim dream labcoat in the hope of winning a claim. The NDA concludes causality has not been demonstrated between magic and dreamcoats
The European Food Safety Authority last week delivered the fifth batch of article 13, general function health claim opinions bringing the total issued to 2723. There are just 35 to go – to be published next month in a final mini-batch that will conclude the task begun in August 2008.

The Parma-based agency is no doubt slapping itself on the back for completing an exhaustive and gargantuan task, but industry and academia would prefer slapping the face of EFSA’s health claim panelists who have for the best part of three years relentlessly rejected so much nutrition science.

As the negative opinions piled up, along with the more specific claims in article 13.5 (emerging and proprietary science) and article 14 (children’s development and disease risk factor reduction) these same academics, NGOs and industry stakeholders politely disagreed with EFSA’s conclusions among each other, at conferences, in the press and via official channels established by the nutrition and health claims regulation (NHCR).

When these disagreements gained no traction with EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), the tone became more antagonistic, letters were fired off to MEPs and European Commission figures, the annoyance and frustration palpable when the NDA hosted rare public meetings.

Academics formed groups like the one born late last year when gut health scientists banded together (www.gut-health.eu​) to protest the treatment of pre- and probiotic submissions, and whose members are learning that lobbying is not something scientists can afford to ignore in the new European nutrition science environment.

A first class organisation (not)

But in the face of a scientific agency that has made it made blatantly clear that its pharma-style approach to nutrition science is not going to change one iota, battered academics and business folk are throwing their hands in the air and the gallows-humour is emerging.

Take this highly ironic missive from prominent probiotic researcher, Glenn Gibson, PhD, from Reading University in the UK.

I am sure that EFSA are a first class organisation who know exactly what they are doing by putting the science first. I have to admire their stance in protecting consumers by trying to ensure that all valid pro- and prebiotic products will disappear from Europe within a few years.”

Or this from Gregor Reid, PhD, the Canada-based researcher who has spent more than 20 years researching the ability of probiotics to benefit vaginal health, and who was stunned last week when EFSA concluded vaginal health via nutritional supplements not ingested orally, was not a matter for the regulation.

“I have sent the EFSA committee a picture of the female anatomy. It seems they are unaware of the vagina's location. Next, they will receive a large sack of mail, actually close to one billion letters. They will believe it's fan mail and get excited for the first time in five years, but it will be from women who suffer from vaginal and bladder infections, letting them appreciate the failings of drugs, diagnostics and management practices approved by EFSA's drug colleagues.”

Ouch.

Professor Reid, like a lot of researchers in the area has reached the end of his tether, and no amount of consoling from the NDA about how the experts on the panel are bound by the regulation, and that research is one thing but panel opinions are another, is going to change that.

In the meantime, as the conspiracy theories grow about hidden agendas fueled by the absence of a single minority opinion among all those 1000s of opinions, the NHCR’s effect on Europe's healthy foods, ingredients and supplements purveyors comes into view.

“We’re off to Asia,”​ the owner of a promising French fruit extract firm told NutraIngredients at a recent conference, as he left the hall where an NDA panellist was telling attendees about its approach to guarantee only strong claims made it to market.

“We give up on Europe.”

Shane Starling is the editor of NutraIngredients.com. He dreams in health claims. If you would like to comment on this article email shane.starling'at'wrbm.com.

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5 comments

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EFSA needs education and a lot of pressure

Posted by Robert Verkerk,

Shane - thank you for so clearly setting the tone of what has been going on. Yes, more researchers and companies might be despairing and moving to greener pastures, but people need to be offered hope. The most frightening aspect is that EFSA has managed to keep itself well regarded in many other parts of the world, and many governments are looking to learn from EFSA (they must have good PR agents). Many have signed up for the scientific substantiation principles that EFSA is following, and that the European Commission and Member States are implementing, through Codex. The work has been ongoing since 1997, in the Codex Committee on Nutrition and Foods for Special Dietary Uses. So rather than walking away from it, we need to confront it - head on. I vote that we band together and build a war chest with the aim of sending each member of the NDA panel on a crash course in Functional Medicine. The Institute for Functional Medicine runs some great courses. Seriously, let's keep the pressure on them until they wake up and learn that the kind of proof they're looking for rarely exists anywhere in science. We need to see a shift from conclusive evidence to plausible evidence, and we could ensure that consumers were not misled by being clear on the extent of the evidence. EFSA and the Commission have always wanted to run away from graded evidence approaches, but it is not a choice - that is the way of science. Biological sciences are not binary, or black or white. They are one of a multitude of shades of grey. Wake up, EFSA, and smell that pharmacological coffee!

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EFSA is not the solution

Posted by Fernando,

Completely agree with this article.
EFSA has a noble objective: protect consumer from ineffective supplements or greedy businessman. But EFSA is definetly NOT the solution to that problem. It is well proven that the penalties imposed by the marketplace on sellers of ineffective drugs is sufficient to leave little room for improvement by any regulatory agency (see Sam Peltzman, Regulation of Pharmaceutical Innovation, p 45 or Milton Friedman's Free To Choose chapter on consumer protection).

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And who could disagree?

Posted by Mickael Dominguez,

Unfortunately, I could only agree with Mr Starling's comment piece. While trying to "protect" the European consumers from what seems like evil substances, such as pre and probiotics, the only thing EFSA has managed to do is to reduce the innovation level in the European food industry close to the lowest point one can remember.

I wrote an article a few months ago saying that because of the pressure applied by EFSA on food manufacturers, they would end up giving up on the European market and rather focus on developing regions where a more lenient regulation would ACTUALLY benefit the end consumer by allowing the commercialisation and promotion of nutraceuticals which, let's be honest, we know really work. And from what I can read in this comment piece, I was right.

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