After the great news earlier this month that three MEPs had lodged an objection to the health claims list, it’s time to move on to Stage Two of campaigning for a veto of the list.
Plenty of you have already received responses from your MEPs to your own letters asking them to support a veto. Many of these responses have been forwarded on to us.
You will have noticed that many MEPs respond to our concerns as if we are fully naïve of the situation. We have felt it necessary, therefore, to look at some of the MEPs’ key justifications in support of the Nutrition and Health Claims Regulation (NHCR) – and explain why their reasoning, much of which simply toes the ‘pro-NHCR party line’, is simply nonsensical.
Spinning the 'party line'
Many of the MEPs appear not to realise that the EU’s health claims agenda in the form of the NHCR, while dressed up to look like it’s protecting consumers, actually does the complete opposite. It wrestles further control of our food supply into the hands of the corporatocracy. It creates a playing field in which smaller operators, the very small businesses that pioneered health foods, are left on the sidelines, peering in at the corporate giants – the only parties with the financial resources to buy their ‘authorised health claims’.
This system can only operate if one buys into the fundamental premise being used to sell the legislation to the half a billion people living within the European Union. The story goes that consumers are being misled by companies selling foods and natural health products, because these products’ labels and advertising contain information about non-existent health benefits. While anyone of sane mind would have to agree that this has happened on occasions, the first thing to recognise is that every national government currently already has legal mechanisms to deal with charlatans.
The vast majority of products that will have their health claims stripped if the legislation progresses unchanged make perfectly plausible claims. The EU’s purpose-built ‘highest authority’ on food safety, the European Food Safety Authority (EFSA), requires an extremely high level of causal proof of health benefit. Its scientific substantiation process is akin to a binary system that only allows claims that are supported by very specific forms of human studies, carried out exclusively on healthy people! In the EU’s binary system, everything else gets a zero. That means no health claim allowed – no signal to the consumer that the given food or natural product is good for you. We’ve written about this before, but it’s incredibly important to be clear on this issue.
Let's evaluate the responses we're getting
That’s why we felt compelled to collate some of the key arguments being used by MEPs to rebut your and our arguments. Hopefully, this will also provide fodder for you to continue to engage with your MEPs. We say they are being hoodwinked. It’s worth appreciating they are dealing with hundreds of issues simultaneously and rather than researching the full implications of the EU’s planned health claims regime, it’s easier for them to simply follow the ‘party line’.
Below are some of the stand-out arguments being used by MEPs in support of the NHCR, as well as our rebuttals to those arguments.
MEP response: Your email refers to the list of 220 permitted 'general function' Article 13.1 health claims. This list concerns the health claims which may be printed on branded products, but does not restrict their sale.
ANH-Intl rebuttal: It is true that the no products will be removed from the market following adoption of the Community list – only disallowed claims will be removed from the market. It is crucial to realise, however, that it is not only health claims that EFSA has assessed and rejected which will be removed from the marketplace. Under the terms of the NHCR, only those health claims that appear on the Community list will be allowed to be used by manufacturers: all non-approved claims will become illegal.
It is impossible to know the effects of a marketplace devoid of most of the currently available health-related information related to foods and food ingredients, because no impact assessment has been performed. We simply have no idea of the effects of a restricted environment for health claims in terms of product availability, consumer behaviour, manufacturer innovation and other important considerations. Many people only buy products when they are guided by health claims describing specific benefits, for example.
Performing an impact assessment after the health claims list becomes law is a case of bolting the stable door long after the horse has escaped, since the effects of the list will begin to be felt while the impact assessment is taking place. Should the impact assessment reveal serious problems with implementation of a restricted health claims list, it will be too late to change the relevant legislation. The only way to gain the knowledge necessary to decide whether a highly restricted health claims environment is a good idea at this stage is to veto the health claims list, and perform an impact assessment at a later stage but before a new list is proposed.
There is another reason why a restrictive health claims environment may reduce product availability. Very few companies will want to risk investing in new research into innovative food products, when it is overwhelmingly likely that EFSA will prevent those companies from making any health claims about their new products. Only the largest, most well-resourced companies will be able to afford the clinical trials, in healthy human subjects, necessary for EFSA to approve a health claim. Therefore, the availability of products could be expected to decrease overall, with small- and medium-sized enterprises the hardest hit.
MEP response: The EFSA received 44,000 applications and so it is unsurprising that a lot of these were unsuccessful. It is our understanding that many of these were rejected because they had been wrongly submitted, or because the evidence was not able to prove cause and effect.
ANH-Intl rebuttal: When EFSA received over 44,000 applications at the start of the process, it had not provided clear guidelines for applicants. It was not until after the applications had been received that EFSA announced it would only consider human clinical trials on their own merits, thereby greatly reducing the number of assessments it had to perform. Even later in the process, it became clear that EFSA was only going to approve applications that included clinical trials in healthy human subjects.
MEP response: With regard to this scientific threshold for these claims, many of the cases that you have referred to or mentioned where "known" claim has been rejected concern claims that were not fully/if at all scientifically backed-up, so although they may be a known remedy, EFSA could not prove their relevance due to lack of evidence.
ANH-Intl rebuttal: In looking at many of the rejections, there is actually ample evidence, just not the type of evidence that EFSA is looking for, namely a causal relationship established unequivocally by means of human trials on healthy subjects. In many cases, there are decades worth of clinical evidence that can be shown via case reports or observational studies, but such retrospective findings are not deemed acceptable by EFSA if they are not also supported by human trials on healthy subjects. A very large number of studies on specific nutrients have been rejected because they have been carried out on unhealthy subjects, where the food or food ingredient has been shown to facilitate a return to normal function. All such studies are immediately rejected by EFSA and we think this is inappropriate. Ironically, in some cases the effect is so well known (e.g. prunes and their effect on the bowel) that clinical studies have not been prioritised.
You can also see a more complete list of MEP arguments, followed by ANH rebuttals.
Call to action
- If you’ve already written to your MEPs, many thanks and please ask all your friends to do the same.
- If you have received a negative reply from any of your MEPs, please check our list of arguments and use it to assist you in writing back to them
- If you haven’t yet written – please do so as soon as you can!
Comments
your voice counts
25 February 2012 at 1:16 am
How can I put this?
It is of no import to many MEPs what people like us want; people must be kept safe, for their own good, by banning things & stopping them doing things that might harm them. We cannot possibly allow free choice, because ordinary people are not properly informed by experts, and that might be dangerous.
MEPs have their own experts, very good experts, and advisors briefed by experts, and a whole raft of Scientific experts, all telling them what is correct. They also have experts from the Industry (Medicine, Pharmacy), who expertly inform them that all these alternatives are dangerous rubbish. And who make such nice contributions in the interests of peoples' health, as well.
MEPs want this legislation because it introduces proper orderly Rules, and Rules are for ordinary people to live by. That is of prime importance.
MEPs have heard that this is a list of safe claims, so it is good.
Also, this is mainly about stopping supermarkets making nonsensical claims like "reduced fat", or "reduced salt", and does not add much more to legislation they have already passed.
So, how do we approach an MEP in such an information bubble? Present as much evidence as we like, they have experts who will tell them that it is not 'good' evidence.
Why, why on Earth, should such an authoritarianly-minded and well-informed MEP listen to the likes of us?
How could these health freedom people possibly be worth listening to when the real experts say they are wrong, not to take any notice of them, they are nutcases?
People like me may well feel that there is a loose conspiracy to control human heath for profit, but I'm afraid that sort of thing puts us even further beyond the pale of conventionally conditioned thinking.
The first step would be to acknowledge the problem; to vary the knocking-head-against-brick-wall approach with some more subtle penetration, arguing policy rather than facts.
William LaChenal (London)
27 February 2012 at 5:59 pm
I offer two quotes that display the FACT that the drug companies corruptly put their own financial interests before those of the public. Those "medicines" that have been "proven" to be safe, efficacious and cost effective are in fact none of those things. The quality of evidence used for their own products is directly opposed to the empirical evidence of natural health strategist that actually work, but are not "proven".
Of around 2500 [commonly used NHS] treatments covered 13% are rated as beneficial, 23% likely to be
beneficial, 8% as trade off between benefits and harms, 6% unlikely to be beneficial, 4% likely to be
ineffective or harmful, and 46%, the largest proportion, as unknown effectiveness.
(BMJ Evidence Centre)
http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp
The MHRA and the Pharmaceutical Industry
The THMPD gives control of licensed and unlicensed herbal medicines to the MHRA, a medicines regulator that is entirely funded by fees from the pharmaceutical industry. When funding is provided by those who are regulated, questions arise about the independence of the regulator. A House of Commons Health Committee Report from 2005, entitled ‘The Influence of the Pharmaceutical Industry’ is highly critical of the MHRA and its close relationship with the pharmaceutical industry. It states, ‘(t)here are regular interchanges of staff, common policy objectives, agreed processes, shared perspectives and routine contact and consultation. Many of the senior staff of the MHRA have previously worked with the industry …’1 It is therefore doubtful whether the MHRA can be trusted to serve the best interests of herbal medicines, herbalists and their patients.
The consequences of lax oversight is that the industry’s influence has expanded and a number of practices have developed which act against the public interest. The industry affects every level of healthcare provision, from the drugs that are initially discovered and developed through clinical trials, to the promotion of drugs to the prescriber and the patient groups, to the prescription of medicines and the compilation of clinical guidelines. We heard allegations that clinical trials were not adequately designed – that they could be designed to show the new drug in the best light – and sometimes fail to indicate the true effects of a medicine on health outcomes relevant to the patient. We were informed of several high-profile cases of suppression of trial results. We also heard of selective publication strategies and ghost-writing. The suppression of negative clinical trial findings leads to a body of evidence that does not reflect the true risk : benefit profile of the medicine.
Extract from The House of Commons Select Committee Report on the Influence of the Pharmaceutical Industry
Your voice counts
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