|
   |
|
|
|||||||||||||||||||||||
|
The Food Supplements Directive Vitamin and Minerals
Q: What is the threat to vitamins and minerals in the UK? A. The EU introduced the Food Supplements Directive (FSD) and although couched as a measure to ensure consumer safety, the Directive has been prepared in order to harmonise the vitamins and minerals market across all Member States. Even though the Directive has been accepted by the Government into British law, there is still a great deal to be done to secure higher dose safe levels, plus substantial additions to the Lists. There are two major problems; the first with the Positive Lists, the second with maximum permitted doses. The EU operates using Napoleonic Law, meaning that everything is forbidden unless it is specifically allowed, which explains the Positive Lists showing nutrients and nutrient sources attached to the Directive. These lists were lifted from the PARNUTS Directive, not specifically prepared for FSD and dictate the nutrients and nutrient sources permitted for use in dietary supplements. Because of this, more than 300 nutrients and nutrient sources currently on the British market and accepted as legitimate and safe by the Regulators are not on the Lists. These missing substances span thousands of products that will be made illegal under this Directive and will either have to be reformulated or removed from the market. A temporary period of grace (until 31st December 2009) allows these missing nutrients and sources to be used in the UK PROVIDED that a full safety dossier has been submitted (and not rejected) to the relevant EU scientific advisory body, The European Food Standards Agency (EFSA), by 12th July 2005. There are further problems with the dose levels of each nutrient to be allowed. At the moment, the UK has easy access to a wide range of high dose nutrients that good science supports as being safe, but this will come to an end unless the British Government steps in, which it has already stated it has no intention of doing. Only Holland and Ireland have similar markets. The Expert Group on Vitamins and Minerals (EVM) delivered their draft report into the safety of nutrients at the end of August 2002. Working since 1998, the group regularly posted their papers for discussion on their web site, but it was not until 2002 that their guidance on dosages was made known. Unfortunately, until that moment, nobody had any idea of the Groups thinking and how they might arrive at nutrient levels. The reports coming from Observers at the EVM meetings gave every indication that Manufacturers, Retailers and Consumers would be happy with the levels. The final document, trumpeted by FSA in a most unprofessional, sensationalist and biased way, did little to help encourage EU regulators to examine supplements favourably
Q: Which nutrients are affected? A. The most important of the 300 missing nutrients is the trace mineral BORON (used extensively in supplements, to help the uptake of calcium into the skeletal structure of the body). Boron is invaluable for strong bones and teeth and is often used in formulations for women, together with Magnesium, vitamin D and VANADIUM (also not on the list) for pregnancy, PMS, menopause and the brittle bone disease, Osteoporosis. Another important missing mineral is SULPHUR, used in countless supplements and essential for healthy skin, connective tissue and other body functions. Being able to obtain nutrients in the form most acceptable to the human body is extremely important, so the omission of all ten amino-acid-chelate forms of minerals is of major concern to both consumers and professional nutritional therapists. Selenomethionine, the most bio-available source of Selenium (the same form found in broccoli) has already been rejected by EFSA, so this most favoured nutrient source used in the UK, US and other countries for more that 30 years, will be lost.
Q: What will this mean for UK consumers?
It has often been argued that all consumers need to do is to take multiples of lower dose tablets in order to obtain the levels they need. Of course they could, if they were prepared to swallow ten or more tablets at a time and able to pay many times the price in most cases, the difference in price between a high dose vitamin and a low dose tablet is less than 5%. Such a situation would do nothing to advance the action for consumer safety claimed necessary by the regulators. Bio-availability is a key requirement for supplement users. Low dose, low price mass market vitamins are likely to be produced using chemical forms of the nutrients that the body cannot absorb so the benefits of such supplementation would be negligible. In many cases, consumers will be forced to seek help from their GP, placing an additional and unnecessary burden on our already overloaded health service.
Q: What will this mean for health food retailers? A. Specialist health food retailers are at risk from this Directive. They will lose the very specialist supplements that set them apart from chemists and supermarkets and thereby lose those products that help maintain their trade margin and support their business. Their range would be limited, they would be unable to compete against the low prices of supermarkets and others many small businesses will go under with considerable loss of jobs, and consumers will be unable to obtain the one-to-one advice they currently enjoy from health store supplement experts.
Q: What will this mean for supplement manufacturers? A. Specialist supplement manufacturers are facing major problems. Those who are prepared to abandon their higher dose, specialist products will find they have become very small fish in an ocean of other manufacturers across Europe, all trying to compete with the same limited range at the same low doses. Because the Positive Lists have been lifted from the PARNUTS Directive they are completely inadequate for food supplements and show a substantial number of chemicals that are inappropriate in human nutrition. Those still hoping to continue their existing business are trying to put together the required dossiers for approval in order to get important nutrients and nutrient sources added to the Positive Lists. But in almost all cases, this is proving to be an impossible task. EU is demanding a drugs charter for a food substance, which means that in almost all cases the information required is not available. Manufacturers have actively been seeking this information from their colleagues around the world, yet nobody can provide it. Even if the information could be found or produced, the costs in terms of research studies, clinical trials and administration would run into hundreds of thousands of pounds and therefore, be prohibitive. In addition, if research studies must be commissioned, they are unlikely to be completed by the July 2005 deadline. It could also mean animal testing, something abhorrent to most consumers, a possible requirement currently being investigated by RSPCA. There is no incentive for any manufacturer to produce dossiers, because there is no protection to stop any other manufacturer immediately using that substance once it has been approved having incurred no costs at all! To date, less than a dozen dossiers are being prepared. This means more than 288 nutrients and nutrient sources, affecting thousands of products, could be lost to the industry forever. The final problem for manufacturers is the uncertainty on dose levels. The British supplements industry is self-regulating and routinely takes advice from scientific experts from around the world on the safety of dose levels. The Directive became British law on 31st July 2003, yet nobody knows even now just what daily dose levels of nutrients will be allowed. Because consumers expect a minimum of two-years shelf life on supplements, many nervous and disappointed manufacturers are already reformulating their products in line with the existing, inadequate Positive Lists with dose levels down to low multiples of the RDA, in order to have something to sell in 2005. This is a desperate situation where all sides of industry, manufacturers and retailers and consumers lose out.
Q:Why have a million postcards gone to MPs? A. MPs need to act NOW to secure Upper Safe Levels and an easy way of getting substances added. Many MPs really do not understand how serious this situation is. Serious for their constituents, serious for consumers generally, serious for specialist health food retailers, serious for Practitioners and serious for health supplement manufacturers. They also have not yet realized that this Directive is likely to hit at the time of the next General Election. But its time they did because there is still the opportunity to make a difference. A debate was held in the House of Lords on 30th June and Peers voted by 132 votes to 70 to revoke the proposals. This excellent result should have encouraged those members of the SSCDL to think twice about the effect on all sides before they recommended acceptance of the legislation. CHC has many supportive MPs and Peers across all parties many, from all parties, worked together to block the regulations. The SI was laid before Parliament in Westminster and the new committee of 16 MPs, the Second Standing Committee on Delegated Legislation met on 3rd July to debate the SI. Unfortunately, the appointed members of this Committee were changed three times in seven days and all those sympathetic to the consumers view were removed. Unfortunately, the Liberal Democrat member failed to turn up for the debate and we lost by just one vote. 1.2 million constituents sent the postcards, distributed by health food shops, appealing for their own elected MP to take appropriate action and support those who are attempting to force changes to this ruinous legislation and preserve our freedom of choice.
Q: What can MPs and Peers do to help? A. MPs must write to the Minister (Ms Melanie Johnson MP) expressing the concerns of their constituents and asking for an urgent meeting to discuss the issues. MPs must persuade the Minister that large numbers of consumers are anxious and distressed at the thought of losing their higher dose vitamins and minerals, and the Minister needs to find a way out. The MP can remind the Minister that nobody spoke in favour of the regulations at the SSCDL debate on 3rd July and that the Government blatantly gerrymandered the membership of the committee to force the SI through, against the clear wishes of the majority of the House. Also, that many MPs across all parties are disturbed by the lack of effort the Government has spent on this issue and the very limited resources allowed for it. However, the Minister can still ease the situation through negotiations in Europe. The priority is to work with Europe to find a simplified system to get the 300 missing nutrients and nutrient sources added to the Lists. That would be an excellent start, as would a firm commitment from Government to fight for higher range nutrients with their counterparts across all Member States. Government ministers always argue that they HAD NO CHOICE but to implement the Directive, otherwise they would have been in breach of the Treaty of Rome - and legal action would have taken against the UK by the European Parliament
Q: Is there a way out for the UK? A. Yes ~ there is definitely a way out but it requires political will which has been lacking so far. With a certain amount of effort from the Government, there is still time to resolve the issue successfully for all concerned. We can also simply withdraw from the EU and regain all our freedoms. One option is that, even at this late stage and even though they dont want to, the Government can go back to the negotiating table in Brussels and forcefully argue for an Amending Directive applied to the UK alone. An amending directive would allow those products (of higher dose or containing any of the 300 missing nutrients/sources) already on the UK domestic market and accepted as legitimate and safe by the regulators, to remain. They could not be traded anywhere else in Europe, but would continue to be available to British consumers. Britain could also continue to import specialist supplements from US, Australia and other countries providing they were safe, of good quality and conformed to labeling requirements. There could be a cut-off date ~ the Novel Foods Regulations have a cut-off date of 15th May 1997 and all products on the market at that time were automatically accepted as legitimate. Using the same date would capture most, if not all the missing nutrients and nutrient sources.
Q: How will that affect the Food Supplements Directive? A. An amending directive would not affect the Food Supplements Directive in any way. The vitamins and minerals market would still be harmonized without any changes to FSD the amending directive is an excellent solution and could be the Governments Get out of Jail card!
Q: What is the other option we have? A. Because the Government has already made it clear that they are not prepared to ask for EU negotiations to be reopened, we must assume that no amount of pressure will persuade them to do so. Therefore, we need to be practical and suggest an alternative that might be acceptable. The best option is to create such a fuss that the Government finally understands that this is an important issue that is not going to go away even though the Directive has now passed into British law. In essence, we help create the political will to take the appropriate action that should have been taken months if not years ago! The best option is to tactfully force the Government to allocate sufficient resources, in terms of time, people and money, then instruct the Minister (Ms Melanie Johnson MP) to take action in Brussels to secure a fundamental review of the dossier requirements, to remove some of the more onerous demands to enable the 300 missing nutrients/sources to be added before the Directive comes into force in July 2005. If the Minister fails to win them over in Brussels, the next option for the Government is to provide financial and practical help to enable manufacturers to submit the required dossiers within the now tight 22 months time frame. Next, the Minister MUST fight for Upper Safe Levels for all nutrients. It is essential that she makes the case in Europe for nutrient levels to be set on the basis of safety not on the outmoded concept of nutritional need. This will not be an easy task. The former Minister (Ms Hazel Blears MP), admitted several weeks ago that the UK was losing the argument on USLs in Europe in favour of nutritional need as demanded by Member States such as France and Italy.
Q: Is this not now a done deal? A. Absolutely not! You can see from the above that there is still a great deal to play for. We need to keep focused, keep lobbying (both in the UK and Europe) but most of all, we must use every opportunity to keep the Government on its toes and make sure they fight for the rights of the British people.
Q: So are our Vitamin and Mineral supplements safe until 2005? A. Probably not. Remember the EVM report and its recommendation of disappointingly low levels of nutrients? The British FSA are not going to just sit on it and wait a possible further 3-4 years for the EU to set nutrient levels. The most likely outcome will probably be action from FSA within the next few months the best we can hope for is a change to the labeling requirements for existing products. If they feel vindictive, the EVM gives them a perfect opportunity to remove some higher dose nutrients immediately, on the grounds of consumer protection.
 |
