Vast and cumbersome red tape

In the UK, it's common for people to raise their eyes heavenwards in a gesture of exasperation when talking about Brussels-originated 'red tape' that seems to be creeping into every aspect of our lives. The vast and cumbersome European Union (EU) Nutrition and Health Claims Regulation (NHCR) (No. 1924/2006), originally set up to facilitate trade harmonisation within the EU whilst also protecting consumers from misleading advertising by food producers, is no exception. In fact, being the most amended piece of European law ever to emerge from Brussels gives it special status. As it begins to bite and transitional measures, which have delayed some of the pain, get close to expiring, the NHCR is beginning to give the food and natural health industry an almighty headache. Not immune from the headache is of course the scientific body in Europe that is doing all the controversial evaluation, the European Food Safety Authority (EFSA).

Although ANH characterised this Regulation as 'a passport system for Big Business' a few years back, it is becoming clear that the very businesses that pushed it so hard in the early stages, such as the members of the International Life Sciences Institute, have not found it as amenable as they possibly once thought.

UK Sunday Times puts the boot in

Whilst much of the food and natural products industry across Europe has been dutifully negotiating its way to NHCR compliance, trying to jump through the hoops and hurdles offered, and knocking its square pegs through round holes—all within a climate of recession—the UK Sunday Times saw fit to deal a further nasty blow to those natural products suppliers.

The implication given in the article is that companies which have received negative opinions on health claims for which they have applied have been up until now promoting their products using false or misleading claims. The reality is that this is simply not the case for the vast majority of companies. The problem is that the obstacle course set, and the level of proof for claims required, is simply too high for the vast majority of products to successfully have claims approved. Of course, to really put the boot in, the Sunday Times went as far as to 'name and shame' companies who had been given a negative opinion by EFSA.

In our opinion, The Times Newspaper group, who have themselves in the past referred to the EU regulators as "barmy Brussels bureaucrats", have totally misrepresented the situation. With their headline "EU inquiry pours doubt on benefit of health foods", they suggested that the "rejected" products have been "exposed by a Europe-wide investigation for making unproven claims about their health benefits"!!

This misleading supposition seems clearly designed to fuel suspicion and mistrust by consumers of natural health products. Yes, that same old game plan. It’s funny how, when referring to the food industry generally, The Times paints EU rules as "unnecessary and burdensome over-regulation", while for the natural products industry, the Brussels regulators have suddenly been portrayed as a special investigative body, out to expose unscrupulous health food sellers.

An EFSA negative opinion does NOT necessarily imply lack of efficacy!

Whilst there is no doubt that unscrupulous health food sellers exist (the same is true in any industry), the UK mainstream press is wrong to suggest that a negative opinion from EFSA regarding a health claim automatically means that there is a lack of scientific evidence for the efficacy of these products.  When the scientific criteria for evidence of proof of a claim are set so high, the vast majority of health relationships become impossible to verify on the basis of these standards of evidence.

Two good examples are the association between salt and high blood pressure, and the association between a high intakes of fruit and vegetables with reduced risk of cancer and heart disease. Neither of these 'claims' meet the standard of evidence now required by EFSA, yet these claims are made—and held as true—by virtually all health authorities around the world!!

The real problem here is that EFSA has seen fit to only accept evidence from human studies, and, not only that, it primarily requires evidence from randomised controlled trials (RCTs), the sort of trials used to prove the efficacy of drugs. Well, let's recognise they don't show drugs in the brightest of lights, as only 13% of medical treatments as evaluated by the British Journal of Medicine’s Clinical Evidence journal have been shown to be beneficial using these criteria!

Take a look at the pie chart summary for yourself:

Source: http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp

The most appropriate form of evidence for health claims is disallowed!

The problem is that all-important observational and epidemiological evidence—the sort of evidence that is much more appropriate for determining associations between particular foods and health benefits among people over time—are disallowed for the NHCR. They are relegated purely to being allowed as supporting evidence.

So it doesn’t matter how convincing your epidemiological evidence is, you’re locked out if you don’t have a pile of very expensive, very hard to conduct, RCTs that may well contain confounding problems and biases that barely makes them worth the paper they’re written on.

Health claims applications: clarification issues

The food industry is also facing clarification issues over the NHCR data requirements. It seems that negative opinions from EFSA have been based as much on the wording that has been used as they have on the quality of the science used to support claims. EFSA itself has referred over 2000 NHCR dossiers back to the European Commission for clarification on various points. The inability of EFSA to stick to its deadlines, and the resulting staggering of EFSA opinion publications, as well as the manner in which rejected claims are being dealt with, are resulting in further knock-on effects and problems for the beleaguered industry.

EU Health Claims Regulation: a sledgehammer to crack a nut?

As we indicated above, every industry has its unscrupulous operators, and these certainly won’t be slipping through. The real question is: is the existing form of the EU NHCR really necessary to protect consumers from unscrupulous operators making false and misleading claims?

The bottom line is that there are already national provisions in place dealing with such deception by companies. In the UK, false and misleading claims are policed—surprisingly aggressively—by the Adverting Standards Authority (ASA). This central body has a track record of effectively penalising and prosecuting those who have dared to make misleading, false or unsubstantiated claims about their products. Did we really need to be provided with a sledgehammer to crack the nuts when we had a perfectly good nutcracker?

The ASA's remit is clearly set out through the Committee of Adverting Practice (CAP) Code.

Here are some important excerpts:

Clause 3.1 on Substantiation

"Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove all claims, whether direct or implied, that are capable of objective substantiation".

Clause 7 on Truthfulness

7.1 "No marketing communication should mislead, or be likely to mislead, by inaccuracy, ambiguity, exaggeration, omission or otherwise".

7.2 "Marketing communications must not omit, hide or provide in an unclear, unintelligible, ambiguous or untimely manner material information if that omission or presentation is likely to affect consumers’ decisions about whether and how to buy the advertised product, unless the information is obvious from the context. If the advertisement is limited by time or space, the ASA will take into account steps that the advertiser has taken to make that information available to consumers by other means".

Other European Member States have similar provisions. So why the need to harmonise and at the same time sabotage so much of the ability of companies to communicate with health-conscious consumers, especially when dietary needs and cultures vary so greatly from one part of Europe to another?

Health claims regulation in the United States

An equivalent system operates in the United States through the coordinated interplay between the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). Although, as we reported recently in our article "US agencies challenge natural products in advance of vaccination program", they too are disallowing many claims despite a wealth of evidence supporting the efficacy of a product.

Health claims regulation in Canada

In Canada, where only 5 health claims are permitted by the Canadian Food Inspection Agency, a report has just been published by the Fraser Institute. In this report, Mark Brosens concludes that "Canadian policy makers should study the merits of adopting a less rigid standard for health claims associated with food products. It can be difficult to definitively prove that a particular food element reduces the risk of developing a disease, but the bulk of the research reviewed for this paper seems to suggest that a number of food elements are associated with health benefits".

Will consumers really be better informed under the new EU Regulation?

Infringement of freedom of speech

In our view—and that of may other stakeholders and commentators—the EU's NHCR has now gone well beyond its intended purpose, and is now controlling much more than labelling and marketing claims. It actually controls the spoken word, education, the use of images and, in fact, any type of presentation about the health benefits of foods, in any medium. Given the extent of the restrictions that are moving into place, it is clear that the Regulation amounts to one of the most severe restrictions on our freedom of speech yet seen anywhere in the post-WWII 'western' world. The recent case of the Danish journalist Frede Damgaard serves as a reminder of where all of this is going.

There is a natural, inborn instinct within humans to communicate to others that which they've found helpful for their wellbeing. Never before in the history of humankind has there been such a concerted effort to interfere with this inherent survival instinct. 

Ever since the time we as humans lived as hunter-gatherers, we have instinctively communicated with each other about the health giving properties of food. We communicated which leaves or berries were good to eat, and which ones could harm or even kill us. That way we learned about the medicinal properties of plants, and how particular plant parts could be prepared to deal with diseases and disorders, providing the basis for what we now think of as traditional medicinal cultures. These cultures have developed over millenia from trial and error—they are certainly not the result of a 6-month randomised clinical trial!

Never before in the history of our species has this process been so interfered with—at such a scale at least! With the arrival of the NHCR, Europeans are no longer able to to properly inform each other about the knowledge they have gained which may be helpful to the wellbeing of others around them! In front of our very eyes, we see one of the greatest interferences with our fundamental rights and freedoms.

It is a sad irony that the prevention of our ability to communicate properly with each other comes at precisely the time when nutrition and lifestyle are known to be the primary contributors to degenerative, chronic diseases, the primary burden on healthcare around the world. The World Health Organization’s "Global Strategy on Diet, Physical Activity and Health" makes this emphatically clear, indicating "unhealthy diets and physical activity are the two main modifiable risk factors for most of the main chronic diseases".

Do you want to do something to help (future generations)?

If you feel as concerned as we do about the impact of such State interference with our basic human instincts and rights, then we need to tell our elected representatives exactly how we feel about regulations over health claims. 

To find more information about this process, and for guidance about who to write to, please click here to see our "Get Involved" page, and scroll down to the second section entitled: "Use your democratic right".

We probably don’t need to add that you may want to pass on this information to others you care about, and who may need to know about this for the sake of their own wellbeing and that of those they care about. Let's use our natural instincts to communicate as vigorously as we can—while we still can! 

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