This is an article about the recent approval by the European Parliament of the food supplements directive proposed by the European Commission and adapted by the Council of Ministers. The article appeared on www.nutraingredients.com, and is reproduced here as it is of general interest to the current debate over restrictive legislation on the subject of supplements. Added to it are some comments by Ed Fry, a health freedom activist in the USA. Comments are preceded by *** and highlighted in a different color.
Vitamin supplement directive approved by MEPs
14/03/02 - Despite fierce lobbying which at one stage caused the European Parliament's email system to crash, MEPs yesterday voted to approve plans for a tightening of the safety controls for vitamin supplements.
Such was the level of vitriol unleashed against Emilia Mueller, the MEP who proposed the legislation, that Parliament also took the unprecedented step of opening an investigation into the lobbying - not to say bullying - tactics of some of the bill&Mac226;s opponents.
*** Who is bullying whom is open to dispute. A muted, passionless drafting of laws and regulations that does not engage the public in a meaningful conversation about its future access to supplements serves only those in public office and industry who cynically claim that pending (de facto) restrictions in some markets are in the public's best interests.
The new legislation means that manufacturers of food supplements containing vitamins and minerals have three years to provide the European legislators with full details of the ingredients used in the supplements.
Once they have been submitted, they will then be assessed for safety in accordance with existing scientific guidelines and maximum levels will then be set.
Manufacturers will also be obliged to provide detailed labelling on bottles and packaging to give consumers clear daily dosage instructions. They will also have to carry a warning about the dangers of excessive use.
The rules are logical in that they bring dietary supplements under the same kind of safety controls as food and medicines, but they have faced stern opposition from an extremely vocal minority who have claimed that many products currently available for use will now be banned.
The European Commission has strongly refuted these claims, saying that only those products which are not found to be safe will be removed from sale. This, the Commission argued, was clearly in the interest of consumers throughout the Union, and that any product which was natural and safe had nothing to fear.
*** The above passage completely ignores the active steps that must be taken by industry or others to prove (according to criteria yet to be determined) that given products are safe. Many products will be considered only temporarily "innocent". Within an allotted period these products would be removed from the market in the absence of as yet to be defined "adequate proof of safety".
Not everyone agreed, however, and one Dutch vitamin supplement supplier is said to have bombarded the European Parliament with emails claiming that the increased cost of submitting the ingredients for assessment would push many producers and retailers out of business.
Other opponents said that they feared the maximum levels set by the European authorities would err on the low side, forcing manufacturers to reformulate their products and obliging consumers to buy more in order to obtain the same dose.
Reports claim that some 300 nutrients currently used in supplements are not included on the initial list of permitted substances, but these reports have been dismissed by some people in the industry.
"As far as we are aware, there are nowhere near 300 substances on the list" said Simon Pettman of IADSA, an organization which represents national dietary supplement associations across Europe. "There are perhaps 30 or so substances currently on the list for approval by the Commission's Scientific Committee on Food, and there will almost certainly be more, but by no means as many as 300."
*** Is Mr. Pettman referring to 30 classes of products, rather than the many more discrete substances and/ or products that fall within such categories? He appears to be correct rhetorically, but not arithmetically.
The problem is that the most vociferous individuals have been those who are opposed to the regulations, Pettman said, giving the impression that there is widespread discontent with the ruling. "I think it is safe to say that of the 21 or so national associations which we represent in Europe, 17 are delighted with the rules, a couple are neutral and the rest have some slight concerns."
*** Yes, it's generally those who have freedoms snatched away, as will be the case especially in the Netherlands and UK, who are most vociferous in protesting. As for those in other nations who will be "granted" relative freedom by the EU Directive, of course, there would be little complaint. It is the disposition of some to be content with and grateful for "freedoms" bestowed by a patriarchal state, while still others will complain the EU is being too generous in granting even this modest access to nutrients, by which the ignorant masses may still "harm" themselves.
"Even those who are not 100 per cent happy with the rules - for example, we know of some concerns about the way in which the dossiers have to be submitted to the SCF and the costs that might entail - nonetheless realize that they are necessary and inevitable - it is perhaps more in the detail of how they are to be implemented that the concerns arise."
*** These are the undefined dossiers without which given products will not be allowed for continued sale.
Pettman said that the lawmakers could perhaps have decided to set the maximum limits for nutrients from the outset, rather than going through the lengthy procedure of obliging companies to submit details and then assess them. "But if they had done this, I suppose we would simply have been arguing about the limits instead," he added. "The way they have chosen is not perhaps the ideal way, but all things considered it is perhaps the most practical."
*** Leaving the limits open assures that powerful and moneyed interests will influence the limit setting process. As to whether any public input will be regarded remains in question, as to date the EU Parliament's response appears to have be hostile to "non-official" (public) input.
Some of the organizations lobbying against the directive have accused IADSA of not doing enough to stand up for its members, but Pettman explained that they had misunderstood what the organization's role was.
"About 98 per cent of our European members are in favour of the rules. Of course, this means that 2 per cent are opposed, but we cannot take sides with either party. In the UK, for example, there has been a lot of press coverage condemning the regulations, but most of our members there are in favour of the rules. The coverage in Britain is simply another example of Euro-bashing that the UK press enjoys so much."
***Mr. Pettman claims to have taken sides with neither party, yet his other words belie him. He appears, most assuredly, to have taken sides with the nominal majority. By stating that most of IADSA's members are in favour of the Directive, in the interests of full disclosure and transparency, he might acknowledge that the most powerful and influential constituents among IADSA's member organizations are pharmaceutical conglomerates. Taking the politically safe tack of attributing outcries over the Directive in the UK to the press, while nowhere acknowledging that flesh and blood citizens have a legitimate concern or stake in this matter, he only implies his allegiances .
He added that it was hard to understand why opponents were so active now, right at the end of the decision-making procedure, when the proposal had first been put forward in May 2000. "That was the time to scream and shout, not now! In any case, it is hard to understand why there is so much opposition to regulations which will bring greater safety and clarity to the industry.
*** Perhaps a few salient questions would assist Mr. Pettman in understanding the delayed public protest to the Directive. Since when did the EU Parliament invite public participation into this "decision-making procedure"? When was public comment solicited? How could the public respond to pending regulations, when so much is still undecided? When and where were disclosures published by the EU?
"It is true that some of the concerns raised by lobbyists are genuine and need to be addressed. But the way they have gone about putting their case makes them look like extremists and does little or nothing to promote their cause."
*** Only citizens in a minority of EU countries who presently enjoy open access to supplements are likely to be negatively impacted by the Directive's outcome. However, in light of the looming restrictions of regulations about to be imposed, isn't their level of agitation understandable? It is too convenient and facile, and not at all instructive or inclusive, to attribute the public's outrage at its disenfranchisement to an unnamed public figure (Dr. Rath), who has been made a scapegoat by official scorn and derision.
He concluded: "One argument I have seen is that the whole directive is a plot by the major pharmaceutical companies to price the smaller players out of the market. That is tosh - the vast majority of the vitamins produced are made by these same major players who will themselves be subject to the same regulations. They may well be able to shoulder the additional costs more easily than smaller players, but to accuse them of conspiring is frankly ludicrous."
*** Given the EU and U.S. criminal sanctions and significant fines (now pending in Australia, as well) against major pharmaceutical manufacturers of vitamin products for conspiring to "fix" and inflate prices, why is it ludicrous to deduce the pharmaceutical industry (cartel) would seek to extend its monopolistic hold on medicinals to include natural substances? The pharmaceutical industry is the most profitable industry in history precisely because it knows how to exploit laws and regulations in its own favour, particularly those involving proprietary control and pricing of products.
The European Commission also welcomed the decision to approve the legislation. "The aim of this legislation is to put consumer safety and informed consumer choice first, and to solve the problems manufacturers currently face in marketing their products due to diverging national rules," said David Byrne, Commissioner for Health and Consumer Protection.
"Consumers across Europe will have a wide range of safe products available from which to choose, which is not the case in quite a few member states today. The aim of the directive is not to ban food supplements as some lobbies have misled consumers to believe. Some people find they need food supplements to compensate for their inadequate intake of essential vitamins and minerals. Labels must give them clear information about how to use and how not to use them. We also must make sure that the chemical substances used to produce vitamins and mineral supplements are safe and subject to independent scientific assessment."
"These principles of food safety and transparent information as outlined in the White Paper on Food Safety apply here as they do to all other food products. It must however be clear that a varied diet remains the best approach to achieving good health."
*** Commissioner Byrne makes statements about the necessity for proven "safe" supplements for consumers who find the "need ... to compensate for ... inadequate intake of essential vitamins and minerals". Given that parameters of safety and intake levels are yet be defined, and that by scientific analysis there is little "scientific assessment" that is independent of economic influence, why should those in countries facing future restrictions be buoyed by bureaucratic assurances that say, in effect, "We're the government, and we're here to help you". Really.
The scientific truth is that nutritional science has a better understanding of what constitutes optimal nutrient intake for laboratory animals than for humans. For an array of reasons, mostly ones involving maximization of profits and minimization of liability, most human nutritional indices are stated in terms of "adequacy," not promotion of vigorous health.
Specification of levels of an optimal range for human nutrient intake is not a part of the everyday medical or scientific lexicon, nor does it enter into the EU's "discussion" of what or how nutrients will be allowed to be sold. Is it any wonder that those who aspire to a better or more complete dietary regimen, for themselves and their families, would be angered by largely arbitrary dictates of rule and order -- cloaked as science?
As one "cowboy" American who appreciates the liberty of being able to take what in MY judgement constitutes health enhancing supplements, perhaps I might be forgiven for siding with a scientist and clinician who worked closely with a peace loving, biochemical genius and two time Nobel laureate, rather than a brace of attorneys and bureaucrats.