Adam Smith and Robert Verkerk
As reported recently on Nutraingredients, claims made in an email campaign by a UK company called Nature’s Naturals for their products Immuno-AID and Better You Magnesium Oil spray were ruled misleading by the UK’s independent advertising standards watchdog, the Advertising Standards Authority (ASA). Remarkably, this ruling followed approval by the UK’s medicines regulatory, the Medicines and Healthcare products Regulatory Agency (MHRA), the Intellectual Property Office (IPO) and the main UK health trade association, the Health Food Manufacturers Association (HFMA).
The ASA “noted that the [IPO] had approved the Immuno-AID trademark, but did not consider the trademark to be evidence for the product’s efficacy” – itself a fair enough comment – and it did not consider that a link was proven between magnesium oil and the benefits described in the ad, including relief of insomnia and restless legs syndrome, night cramps, stress and travel fatigue.
This case suggests that the ASA has now adopted the kind of evidence assessment system being operated at European Union (EU) level through a piece of legislation known as the Nutrition and Health Claims Regulation (NHCR; No. 1924/2006). Section 15 of the ASA’s Code of Advertising Practice (CAP) that relates to foods and food supplements now specifically refers to the NHCR, which supposedly seeks to “protect consumers” from misleading claims about products’ health benefits.
What the NHCR does, in fact, is enact a Napoleonic regime whereby the only health claims that will be allowed – in any form, whether written or spoken – are those specifically approved by the European Food Safety Authority (EFSA), based in Parma, Italy. And EFSA has refused the vast majority of claims to date; even more revealing, it has rejected 100% of claims linked to botanical or probiotic ingredients. EFSA’s negative opinions are often because companies have not been able to supply data that establish a causative link between the specific health claim and the food or food constituent in question. On other occasions, it is because the food has not been sufficiently characterised, the effect is not proven using human studies, or the human studies – even randomised controlled trials (RCTs) – involve diseased subjects rather than healthy ones.
The latter situation is illustrated by the recent case of the marine polysaccharide glucosamine, widely used for its known benefits on joint health. EFSA rejected claims supported by RCTs because the trials were not performed using healthy subjects, but rather ones who had osteoarthritis!
The NHCR goalposts have been moved so far and so often by EFSA that they must have severe motion sickness.
But those are by no means the only problems with the NHCR.
Take magnesium, for example. This vital mineral, called the ‘master mineral’ in some quarters because of its importance in the human diet, has been dealt with in some detail by EFSA. The Agency has been good enough to pull together its many opinions on different formulations and uses of magnesium into two publications, here and here. A close look at these papers shows just what a mess the whole NHCR regime has become.
Although the Nutraingredients article does not mention it, the ASA will have referred to EFSA’s opinions on magnesium in order to come to a decision on the Nature’s Naturals products. Section 15.1.1 of the new CAP Code states: “Only Nutrition Claims listed in the Annex of EC Regulation 1924/2006 on Nutrition and Health Claims Made on Foods or claims that would have the same meaning may be used in marketing communications.” – meaning EFSA’s opinions. Neither paper addresses the action of magnesium on insomnia, restless legs syndrome or night cramps, which explains why the ASA decided that no link had been established between Better You Magnesium Oil and these health benefits.
At the end of each EFSA opinion is an annex with examples of how the approved claims may be used. At times, these annexes appear to offer an open portal into some strange parallel dimension, a place where no coherent thought exists and everything is upside-down and topsy-turvy — as well as multilingual and devoid of any kind of spell checker! An acute example of this is the detail given for use of a claim around magnesium’s benefits for the circulation, through regulation of blood pressure. The original text is in French and translates to “Essential for regulation of arterial pressure”; true enough. Beneath this is a section for ‘Conditions of use’, which specifies that magnesium must be present in the product at a level of 12 mg/day in order for that claim to apply.
The EU Recommended Daily Allowance (RDA) for magnesium is currently 375 mg/day.
So a claim that magnesium is essential for blood pressure regulation is allowed if a product contains a whopping 3.2% of the (already low) RDA! Strangely enough, no references are provided to back up this sage advice, possibly because no decent science would ever support something so ludicrous.
Remember: this is precisely the same regime that disallows claims for the benefits of high-quality probiotics on gastrointestinal health, claims which are backed with plenty of human evidence! The same regime also would have us believe that there is no evidence that redcurrants have antioxidant effects, or that those effects are even beneficial to humans. What the NHCR regime overseen by EFSA appears to be saying, in many cases, is that there is no point eating healthily, because there is no evidence that doing so – by eating antioxidant-rich berries, for example – is of any physiological benefit. We may as well eat Big Macs instead of organic blueberries: what do you say?
It’s decisions like this that make us think that somewhere beneath the streets of Parma, there must be a giant hangar containing huge vats that churn out soulless automatons with no humanity and no grasp of basic science or common sense, ready to start work at EFSA. At this point, in case you think we’ve gone too far, we would like to remind you of this.
What all this nonsense from EFSA and the NHCR means for the EU population at large is stark and sinister. Very soon, the vast majority of natural healthcare products, if they are available at all, will be available without any meaningful claims on their packaging at all. While this may not seem like such a big deal to you and I, people well used to choosing products with known health benefits in order to maintain and improve our health, it will be an entirely different matter for the incoming generation. Without any form of health claims information to guide them, they will be lost without help from their elders, who will of course not be around forever. Within three generations, say, all knowledge of how these products can benefit health may be lost. We cannot sit still and let this happen.
Updated: 1 Apr 2011
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