Health Claims in Europe - New Regulation Coming
The European Union is discussing a Europe-wide regulation for what in legislative parlance is called "health claims", those things that can be said about a food's or a food supplement's relation to health and about its capacity to prevent disease.
The European Union - just as many national governments - is showing a rather schizofrenic attitude here: On the one hand, the conncection between food and health is becoming more and more obvious. Government programs promote prevention of serious illness by healthy eating habits, we're supposed to eat ever more fruits and vegetables to get the nutrients we need to stay healthy - really difficult in the era of fast food and big macs - but on the other hand, instead of promoting and stimulating open discussion about foods and their influence on health, the EU seems intent to clamp down on communication, at least as far as the manufacturers and the sellers of these products are concerned.
Any indication of or hint of a food's relation to health or disease prevention is to be centrally approved, and it can only be given the official stamp "in accordance with the highest scientific standards". Welcome to Big Brother telling you what to eat and what not.
Now who would profit from such a rule? Certainly not consumers who want to find out what's new on the table and what to eat to stay fit. And for sure not those who think that supplements might be part of the answer to stay healthy. As a matter of fact, it looks as if supplements - already under the gun from an earlier EU directive - will be the big losers under this new EU proposal.
Unlike the food multinationals, supplements manufacturers, especially the smaller and medium sized businesses that make up the bulk of the species, will be unable to compete in the "claims" arena. They simply won't be able to tell any more what their products are good for.
Cui bono? Can you say food multinationals?
Nigel Fawkes from the UK explains what the regulation will mean for information available about food supplements, those products that are formulated with the very purpose of helping to stay healthy...
(Thanks to Julia Pendower for sending the article that follows.)
Update 6 April 2004:
It appears that no agreement could be found on the matter of health claims, and the matter is postponed. Since there are European elections coming up in June, discussion of the issue of what can be said about foods will have to wait until after the new EU Parliament is active.
EU Proposal for Nutrition and Health Claims Regulation
…And you don’t believe you’re on the eve of destruction..?
It all sounds so reasonable. No doubt many well-meaning people were in agreement. But, if the EU’s current proposals for the ‘regulation’ of Nutrition and Health Claims is passed into law, it could mean the end of the health supplements market as we know it.This is no idle threat either. The Commission is trying to fast track this legislation so that it is a fait accompli by the time the 10 new countries join the EU on 1 May 2004.
The Proposal
David Byrne, the EU commissioner for Health and Consumer Protection, says the regulation
‘will allow both industry and consumers to benefit from the correct use of claims. Consumers will receive accurate and meaningful information while producers will be able to use serious and scientifically substantiated claims as a marketing tool… furthermore ..it will enable operators to compete on a fair and equal basis in all EU Member States’.This sounds wonderful, and I am sure most people would see no immediate problem with it. BUT, as ever, the devil is lurking in the detail and it is utterly disingenuous. It has clearly been thought up in order to control a perceived problem in the food market, but will also automatically be imposed on the food supplements market (because of course food supplements are governed by food law).
Food supplements are invariably intended for a purpose, and what the new regulation proposes is that it will become illegal to give any clue on the label as to what that purpose is.
Under existing regulations, this has also been a source of frustration and confusion, because of the conflicting pulls of Food and Medicines law, but an acceptable modus vivendi has been established by the use of ‘maintenance’ claims (eg ‘helps maintain joint mobility’). The Food Labelling Regulations 1996 require that “the name used for the food shall be sufficiently precise to inform a purchaser of the true nature of the food and to enable the food to be distinguished from products with which it could be confused” (Regulation 8). Brussels, however, now proposes to remove what little latitude exists to help and inform the customer, on the basis that these statements are ‘vague and meaningless’.We know that such claims are all the law allows – but even this is due to be revoked.
Up until now the law has permitted (and common sense has encouraged) companies to indicate on their packaging and in their literature, what and who the product is for. ‘Pure Marine Collagen for Joints’, ‘Help to Guard Against Winter Ailments’, ‘Helps Reinforce Healthy Eye Function’ etc … as long as they hold evidence for the claims they are making, and the description does not wander over the borderline and make an implied medicinal claim. All these explanations are now about to become illegal. Furthermore, if the product name indicates a purpose – perhaps being prefixed ‘Prosta… ‘ ‘Osteo…’ or ‘Mena…’ such names themselves will also become illegal.
Safe, popular and effective products could therefore be made illegal in their current form by the thousands. The resulting chaos and expense of label changes and new names, which contain no explanation as to purpose, will be a nightmare. Mail order catalogues, brochures and advertising will become impossible. The market will surely crash…
How is Brussels being disingenuous? In this Regulation, Brussels suggests it will allow companies to make more claims and give more details than before. However each claim – and the exact form of words used - must first have received specific approval. These are the ‘serious and scientifically substantiated claims’ referred to by David Byrne above. But the problem is that the burden of proof Brussels will require is being placed so high that very few companies will have the resources or budgets to cope with the system. As the draft Regulation states in para 29 of the recitals ‘Health claims should therefore only be approved …after a scientific evaluation of the highest possible standard’. By this they mean evidence of efficacy of the order of a Drugs licence – and we all know the enormous costs and research time spent by Pharmaceutical companies…
The measure appears even more disproportionate when you consider that under the EU’s own traditional herbal medicines Directive (the THMPD), claims of a much higher order will be permitted on the basis of traditional use and without any new evidence of efficacy. However, Food Supplements, in order to stay as they are, and saying what they currently do on the packaging, are going to be required to submit data virtually equivalent to that required to license a drug.
As a ‘Regulation’ this draconian piece of EU legislation would become law without even needing to be approved by Westminster. ‘Regulations’ (as opposed to ‘Directives’*) are passed by the EU legislature direct into law and our national government has no say. Once published they become law automatically after six months, and all the indications are that – unless we can stop it – this will be passed by May and be law by Christmas.
And in case your flesh is not yet crawling … the draft Regulation ends: ‘An extended assessment on this proposal is not recommended as the proposal has already been subject to extensive consultation with Member States and Stakeholders. Their opinion has been taken into account and is reflected in the proposal. Moreover, the proposed provisions only pertain to voluntary additional information (claims) made by the food producer. Further consultation is not planned’.
This Regulation has crept up without its full implications being widely recognised. This has much to do with the EU legislation overload with which the industry is already battling. Yet, if we do not defeat it, the outlook for the Health Supplements Industry is bleak. Small and innovative companies will go out of business because they are forbidden to suggest the purpose of their products on the shelf. Magazines will fold because advertising will not be able to say anything, and mail order companies will fold because it will be illegal for them to describe the benefits of their products. All that will remain will be a core group of standard vitamins and minerals, each carrying the approved, generic EU wording, and a few supplements for which the larger and better resourced manufacturers have invested heavily in gaining EU claims approval.
What can be Done? This is a purely political matter, so write to the Prime Minister, your MP and especially your MEP and to the Food Standards Agency - and pressure them to stop this Nutrition and Health Claims Regulation.
The government, the NHS and all right minded people want us to take more responsibility for our health. Knowledge of nutrition and of supplements can play a vital role in this. But, just as the message is beginning to get through, it seems as if Brussels were going to stop it in its tracks and return us to a dark age of ignorance, hear-say and deprivation.The Regulation has been conceived in haste, is being rushed through for all the wrong reasons, and no one has properly considered its disproportionate and nonsensical effect on the Food Supplements market.
Go on – complain now – or very soon it will be too late.
*(A ‘Directive’, as per the ‘Food Supplements Directive’ on the other hand, does require UK parliamentary approval).
Nigel Fawkes
26 Feb 04
See also:WHY EU LAW SAYS FOOD CAN'T AFFECT YOUR MIND
EU to extend concept of medicine - eliminate "borderline products"
EU Commissioner Snubs Nutrition
UK Joint Health Claims Initiative - Final Report
HOW TO STOP FDA CENSORSHIP NOW!
By Dr. Carolyn Dean, MD, ND and Elissa Meininger
December 1, 2005 - NewsWithViews.comEuro Parliament votes through health claims compromise
17/05/2006 - European Parliament voted through a compromise to the controversial Health and Nutrition Claims Regulation yesterday, following frantic behind-the-scenes negotiations to reach a compromise and avoid conciliation with the Council.
Update April 2004:
Say no to EU restrictions
by Patrick Holford
Institute for Optimum Nutrition, Putney
Your right for accurate and useful information about foods and food supplements is, I'm afraid to say, once more under attack. A proposed EU regulation, to be voted on in the European Parliament later this month, will mean that virtually nothing can be said about any of the health promoting properties of food. It may also restrict what I or any journalist can say to you, or what a health practitioner can say to you - unless it is an allowed claim.The Food Standards Agency has sponsored the development of a list of allowed claims for the EU to approve. This first list of possible claims, eg for a multivitamin, are unbelievably minimal. For example, neither of these claims would be allowed: vitamin A is necessary for normal growth or folate helps normalise homocysteine levels.
Personally, I am incensed by yet another dictatorial piece of unthought-through regulation and am writing to my MEP. If you would like to write to your MEP, please feel free to copy or amend my letter below. But write soon because this regulation gets voted on at its final committee stage on 5th April, before passing to the European Parliament for a final vote very shortly after.
For details on the proposed EU regulations
For details of the current allowed health claims
MEP LETTER
31 March 2004
Dear MEP
I have recently discovered that there is a proposed EU Regulation On Nutrition and Health Claims that will have dire consequences not only on my ability to have accurate information about foods and food supplements but, on the commercial viability of the smaller health food companies from which I buy products. While I support the intention of preventing unhealthy foods from being promoted as healthy, and having a means to allow disease risk reduction claims‚ there are numerous problems with the details. I understand that you will be discussing and voting on this EU Regulation in April and I am writing to encourage you to vote against it going through, and, at the very least, to insist on major amendments and delay so that this legislation can be properly thought through. At the moment it is a shot in the foot of any plans to incentivise the public to choose healthy food and food supplements.
The reasons are as follows:
The current situation is that any claim can be made provided it is true. The new situation would be that only approved health claims could be made. The UK's proposed approved list of generic statements is draconian to say the least. For example, a vitamin pill couldn't state that Vitamin A is necessary for normal growth even though it is. Why?
The regulation also wants to avoid hard-to-understand claims. One example they give is 'folate helps normalise homocysteine levels'. They say it is true but too complicated. (In case you are not aware homocysteine is a very important independent risk factor for cardiovascular disease and Alzheimer's disease.) I supplement folate every day for precisely this reason. I'd like to see this kind of truthful information on a label. Why can't companies decide what messages their consumers will understand, not EU bureaucrats?
There is a mechanism for adding new claims to the list, but it is so laborious and expensive that it would be cheaper to apply for a medicinal claim. Also, no research in which the end point is the prevention, treatment or cure of a disease is allowed in providing substantiation for a claim. This is a real catch 22.
Let me explain. You, Hippocrates and I know that food is medicinal. The UK Government spends £17 billion on diet-related diseases. The drug bill has doubled to £7 billion in three years. Somehow, good food has to be made more attractive. This requires pro-active encouragement of health claims - eg antioxidants reduce risk of cancer or folate lowers homocysteine, which lowers your risk of cardiovascular disease - and pro-active prevention of false statements about sugar, hydrogenated fat etc. However, by law, if a food claims to treat, prevent or cure any condition or modify physiology or behaviour it's a medicine. Medicines can only be sold with a medicinal licence. A licence costs around £1 million, and then is a specific claim for a specific disease. Foods and nutrients can't be patented, hence not profitable enough to make it worthwhile to get a medicinal licence.
If there were 100 studies showing that people with raised homocysteine lowered their risk of heart attack with folate, this research would not be allowed to substantiate a folate helps maintain a healthy heart claim because the endpoint is prevention of a disease. It might be possible to gain a disease risk reduction claim as long as the dossier could be funded by a company, and if enough of the studies were to meet all the restrictive criteria being proposed. If there were 100 studies showing that folic acid reduced high blood pressure this research wouldn't be allowed because it would be curing a disease. So, the only research that could be used would be on normal people showing no medicinal benefit. NO ONE in scientific circles gets funding for this so no research exists and no company selling a food product would be able to afford doing it, and cannot make a claim, despite hundreds of studies that clearly show the benefit of consuming folic acid to reduce heart disease risk! Catch 22. In fact, it would probably cost more to do this research than to apply for a medicinal claim! If we are to cut diet related disease there needs to be a softening of the basis for substantiating claims and a broadening of allowed claims.
This manipulative restriction of information to the public also applies to information that, for example, a vitamin company could give to a nutritional therapist, or a nutritional therapist could give to a patient, or a journalist could write in a paper. This is because the subject matter and scope of this proposed Regulation is far too broad. I would like to encourage you to, at least, vote for a derogation excluding practitioners (including complementary health practitioners, journalists/media and company-to-retailer communication). I have been told verbally that this legislation is not intended to apply to the above, but I'd like this in writing. If this regulation is intended to control communication direct to the consumer from the supplier then this should be stated and the appropriate derogation inserted, including for business-to-business communication.
I am deeply fearful that EU regulators are trying to control food and food supplements using the same kind of standards as for medicines. As the table below shows, foods and dietary supplements are not drugs and the same proportion of legal control is not appropriate. The counter argument is that this legislation is designed to protect the public. The table below shows that the public don't need protection from food supplements. Whatever controls exist now seem more than adequate. So who is driving this legislation?
As a member of your constituency please do what you can to vote against, delay or at least substantially amend this unnecessary EU Regulation.
Yours sincerely,
Patrick Holford
Founder of the Institute for Optimum Nutrition, Putney
posted by Sepp Hasslberger on Tuesday March 16 2004
updated on Wednesday December 8 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2004/03/16/health_claims_in_europe_new_regulation_coming.htm
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