By Rob Verkerk PhD

Executive and scientific director, ANH-Intl

As northern Europe is plunged deep into autumn, anticipation mounts among many manufacturers of functional foods and food supplements.  It’s now less than 3 months before an important date — 14th December 2012 — rolls around.  That's when thousands of health claims used by these manufacturers to inform consumers of their products' beneficial properties will become illegal, courtesy of the European Union's (EU’s) controversial Nutrition and Health Claims Regulation (NHCR).  Born out of an EU strategy aimed in part at curbing the obesity epidemic, it is a bald irony that barely a single functional ingredient has yet to be authorised specifically for weight loss purposes.  Many sense the NHCR has badly lost its way, the result of years of tussling between different political factions and governments, and between different stakeholders within the food industry — and of course, the all-powerful European institutions in the form of the European Commission and European Food Safety Authority (EFSA).

But yesterday, in the far north of Germany — in Hamburg — a group of leading academics, lawyers, food businesses, consultants and a few others, including this author, gathered to ponder an important issue.  Namely, the role of clinical trials as one of the few remaining means allowing manufacturers to make claims to consumers about the health benefits of food and supplement products.  The conference, organised by Functional Ingredients (Fi) Conferences, attracted a small collection of less than 50 delegates, one in four of which were also speakers.  The lion’s share of delegates were scientists working with contract research organisations (CROs) and Big Food corporations, who together have the highest possibility of negotiating the obstacle course of successful health claims applications.

The Marriott, Hamburg, location of the Fi conference on the use of clinical trials for health claim approvals

The majority of speakers voiced their frustration with the EU-inspired claims approval process, much of which has had a sense of ‘let's make it up as we go along’.  Some acknowledged that they understood EFSA's scientific substantiation process for health claims a lot better now than they did 5 years ago.  There were even a few who seemed quite satisfied with it all, largely the result of recent successes and — no doubt — lucrative revenues from services rendered.

Roberta Re PhD of Leatherhead Food Research chaired the day session and left no one in any doubt about her sentiments.

She told the conference in her opening address: “People say the process [for gaining an authorised health claim] is as complex as that for pharmaceuticals.  No it’s not, I tell them,” she urged.  “It’s much more complex.  You’re not dealing with a single chemical taken in a standard dose.  With food, you’re dealing with a complex chemical matrix, consumed in different amounts by different people.”

EFSA no-show

We had expected to hear direct from EFSA next.  But when the assembled delegates heard from the organisers that Professor Hildegard Przyrembel was unable to attend owing to poor health, glances and even the odd smile were briefly exchanged.  Nothing had to be said, although I was unsure if the knowing looks reflected an acknowledgement of some sense of karmic punishment for one who’d been so centrally involved in creating the tortuous health claims approval process.  Or could we be so crass as to think that inadequate nutrient or phytochemical intakes may have been to blame for Prof Przyrembel’s absence?

Lawyer sets the scene

The slot was amply filled by Hamburg-based food lawyer Professor Dr Moritz Hagenmeyer.

Professor Dr Moritz Hagenmeyer

He reminded the audience that Recital 17 of the Nutrition and Health Claims Regulation required that a, “Claim should be scientifically substantiated by taking into account the totality of the available scientific data, and by weighing the evidence.”  The lawyer emphasised over and over again that this meant all of the evidence, as confirmed by amending Regulation (EC) No 353/2008 that clarifies aspects of Article 15 of the NHCR.

But Prof Hagenmeyer alleged that, “EFSA only evaluate what they’re given, or what they know about.”  That generally leaves a lot of data out in the cold, data that aren't seen as pertinent or relevant to the claimed effect.

Humour is sometimes the best way of handling disasters — and the good professor used it masterfully to keep his audience engaged.  He couldn’t resist reading out the authorised general function claim for activated charcoal, claiming it would be unfair not to do so for those few who might not be familiar with it.  He grabbed a lever-arch file and with an oratory style only lawyers can manage, he cited: “Activated charcoal contributes to reducing excessive flatulence after eating.”  Emphasising the incongruous nature of the claim further, he added, “And only excessive flatulence, and only after eating.”  To close he said, “I can summarise my talk very easily: you don’t need clinical trials.  They’re for drugs.”

Transitional measures continue for botanicals

You could feel a sense of relief running through the conference room at the Marriott Hotel in Hamburg when the audience heard from the principal lawyer at the meeting that health claims for botanicals and probiotics would continue to be allowed under national rules after 14th December 2012.  They would thus not be subject to the ban affecting all claims that have already been fully scrutinised by EFSA.  The Regulation that authorises the community list, Regulation (EC) No 432/2012, makes no doubt about this in its Recital 10.  But many of us like to hear such things from lawyers.  This is, of course, assuming the claims haven’t already been subject to negative opinions by EFSA, in which case Member States can decide their fate.  But, realistically, this would give some reprieve for the majority of the 1600 or so claims for which the evaluation by EFSA has yet to be completed. 

Legally authorised deception of consumers

I asked Prof Hagenmeyer what he felt about the fact that claims for all vitamins and minerals for which Recommended Daily Allowances (RDAs) have been set can be made if a food or supplement contains at least 15% of the RDA.  This would amount to 12 mg of vitamin C, or just 0.17 mg of thiamine.  I emphasised how much effort was needed to try to substantiate claims in an effort to supposedly stop consumers from being misled, while this seems to do the exact opposite.  A 15% threshold for all vitamins and minerals is arbitrary, not scientific!  The operative part of his answer was straight to the point: Prof Hagenmeyer retorted, “It’s legally authorised deception”.

Important messages from the speakers

It wouldn’t be appropriate to include lots of the detail about the lessons learned by those who had both succeeded and failed to get the science behind health claims approved by EFSA.  The information is rather technical and would not be of interest to the vast majority of our readers.  So I’ll leave you with what I feel to be some of the most important take-home messages from various speakers:

"It’s very difficult getting ethical clearance for children’s health claims. The system is flawed. In some areas, there’s good justification for not having clinical trials.

"In simplifying the procedure for health claims [comparing EFSA’s 2007 and 2011 guidance], seven appendices have been lost and there’s been a move away from pooled studies and more emphasis on randomised controlled trials.  This means less opportunities for small- to medium-sized enterprises reliant on the scientific literature, and I don’t believe it’s what the Commission intended.  It puts it out of the reach of small companies, which is very unfair.”

—   Janice Harland PhD, Harland Hall Associates

Janice Harland PhD

"We have created these two categories of food and medicine and all the problems of demarcation that go with them.  These are man-made problems."

—   Prof Dr Moritz Hagenmeyer, KROHN

"EFSA are looking for the best evidence from the best clinical trials.  There is no consensus on what should be the right control product."

—   Sebastien Marque PhD, Danone Research

Sebastien Marque PhD

"I prefer to think of them as randomised controlled nutritional intervention trials rather than clinical trials [which are for drug evaluation].

Health claims tailored studies are now the most important type of data and you also need to understand the EFSA mindset."

—   Stoffe Loman PhD, NutriClaim

Stoffe Loman PhD

"You need to learn from Pharma.

100,000 might be the minimum amount for an FMD [flow-mediated dilation] study."

 — Prof Dr Med Frank Wagner, Charité Research Organisation

Prof Dr Med Frank Wagner

"There’s now consensus that the response to a stressor is a good measure of health.  So you can look at if the coping ability of people improve following the consumption of a particular food or ingredient.

Two types of stressor are vaccines and intense sporting activity." 

—   Rianne Ruijschop, Nizo Food Research

Rianne Ruijschop

"A new paradigm in nutritional and health research is needed.

We should use resilience as a measure of health.  Exert short-term pressure on the system, see how it responds and how fast it will recover.

The role of nutrition is to maintain optimum health and to be optimally resilient.

You need multivariate statistics and to analyse dynamically — as well as a systems biology approach."

Wim van Hartingsveld PhD, TNO Healthy Living                             

Wim van Hartingsveld PhD

"The fast-track approach to Article 13.1 community list is now closed.  Article 13.5 and 14 health claims use the same procedure for claims applications as shown in Article 15.

Realistically, the EFSA evaluation and authorisation procedure takes 10 to 12 months."

Christiane Alexander, Analyze & Realize

Christiane Alexander

"You’ve got to decide whether you want to go for a health claim on an ingredient or a finished product.

Cross-over designs are cheaper than parallel studies, but each participant is involved for longer."

—   Dr Kirsten Brandt, Newcastle University

Dr Kirsten Brandt

In conclusion

We wouldn’t have pushed so hard for a veto of the health claims positive list at the beginning of this year if we hadn’t felt the public would benefit from a complete fresh start with this Regulation.  It was an effort to disarm the EU’s health claims monster that now not only has a life of its own, but is running amok — and is destined to fail in its most important, over-arching objective: to prevent consumers being misled.  With the health claims regime as it stands, there is a built-in bias toward claims for vitamins and minerals, and those claims may be allowed on products with very low inclusion levels.  How will consumers respond to a plethora of products which receive ‘me-too’ claims, simply because of small amounts of a particular vitamin or mineral that was only put in the product to give it some ability to carry a claim?

We understand why big business likes the NHCR.  Just as we predicted many years ago, it’s a passport system for big business that locks out the majority of small players.  It was lobbying by the Big Food trade associations that narrowly prevented the veto being carried by the European Parliament.  But that doesn’t make it fair or proportionate.  And it certainly doesn’t do much to ensure that consumers are given only truthful information about functional foods and food supplements.

My biggest concern is that, without a gargantuan change in direction, we’ll end up with a disaster for European consumers.  Fortunately, there is some evidence that such a shift may be within the realms of possibility.  Right up there is the kind of paradigm shift that the Dutch lifestyle research organisation TNO is talking about.  Two of its key initiatives in the area, NutriTech and PhenFlex, now have a rather staggering €10 million of research funds behind them, including €6 million from the EU’s own 7th Framework Programme.

Unless the results of this kind of work are incorporated into the operation of the NHCR, a distortion or bias toward claims for chemically purified substances added to processed foods and supplements is inevitable.  The most important components of our diet — namely unprocessed vegetables and fruit, along with uncontaminated, unadulterated and unprocessed meat and fish (for those who are not vegetarian) — will be left out of the equation, being relegated to a category for which health claims are neither proven nor communicated to the public.

We’ve already been squeezed into an impossibly unreal situation, because no disease claims can be made for foods.  This happened well before the EU’s NHCR was even considered.  To anyone other than the EU authorities, the science appears to say that there is no clear distinction between foods and drugs.  The health claims regulation is soon to deliver another major twist to good science — and to logic.

One can only hope that homeostatic processes will help get things back on track in the coming months and years.  And that’s something in which all of us with deep concerns will play a part.


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