EU food-supplement clampdown overrides consumer choice
August 19, 2010
WASHINGTON, D.C., Aug. 19, 2010/ Troy Media/ –
In 2011, hundreds of food supplements and thousands of health-benefit claims concerning food supplements will be banished from the European market as each European Union member state enforces the EU Supplements Directive of 2002.
That administrative rule is one of the Western world’s most extensive experiments in centralized government planning. By order of the European Food Safety Authority, as confirmed by the European Commission, the nations of Europe will dutifully dispatch their health investigators and police to remove from the market hundreds of food supplements consumed for decades without serious complaint.
Companies forced to downsize or close
Those agents will force the downsizing or closure of a number of companies that have manufactured and distributed the banned products, particularly small to medium-size businesses. The agents will also censor health information in ways more sweeping (reaching health claims made in all 27 member states) than the dreaded English Licensing of the Press Act of 1662.
The food supplement market in Western Europe is estimated to have an annual value of approximately US$80 billion. About 40 per cent of the adult population of Europe use dietary supplements daily, varying in kind preferred and in level of interest by country. Increasingly, Europeans have come to associate above-recommended daily intake of certain vitamins and minerals with beneficial health effects, causing them to depend on access to those products as part of a personal health regimen.
Countries seriously affected
Certain countries in Europe already suffering from high unemployment rates, such as Spain (near 20 per cent), Ireland (13 per cent), Portugal (10 per cent) and Greece (9.2 per cent), stand to suffer the most from unemployment resulting from the EU crackdown on supplements and supplement claims.
The directive has empowered that bureaucratic scientific body - the Safety Authority - to stand between those who make and distribute food supplements and European consumers, and to dictate which products previously lawfully available may henceforth be allowed to reach consumers and what may henceforth be said about them. Its aim is to render uniform the entire European market, despite the great diversity in food-supplement preferences that exist among the peoples of Europe.
The system discriminates against small companies and new market entrants in favor of large companies and incumbent sellers because it presumes all products sold without incident to be unlawful unless proven – based on clinical trial evidence – to be safe and bioavailable. Proof, in the form of scientific dossiers, must establish to EFSA’s satisfaction that products intended for sale are safe and bioavailable. No claims may henceforth be made unless scientific dossiers establish to EFSA’s satisfaction that the claims are proven to a near conclusive degree. The dossiers are expensive, roughly[B1] US$500,000 or more per submission. At least 90 per cent of the companies in this market cannot afford to submit a dossier and so must either cease sales altogether or reduce product offerings to those that others succeed in getting approved.
EFSA, a draconian taskmaster
To date, EFSA has proven itself a draconian taskmaster. Of some 800 dossiers for food-supplement approval that have been submitted, almost 80 per cent haven’t been approved by the agency. Unless a food supplement is placed on EFSA’s list of approved supplement ingredients, it is unlawful to sell. That method reversed the prior burden of proof. Before the EU Supplements Directive, if a product was derived from food, it was presumed safe unless a government in Europe established the product to be adulterated (i.e., to be unsafe for human consumption). Since the EU Supplements Directive, every food supplement is presumed unsafe, regardless of its prior history of safe use, unless scientifically established to EFSA’s satisfaction to be safe and bioavailable.
Proof of safety and bioavailability has proven to be a catch-22 in EFSA’s Kafkaesque system of risk reviews. If a food supplement could be unsafe at some dose level (a truism for everything in nature, including water), then it is presumed unsafe at every dose level unless a dossier proves safety at a particular dose level. In addition, if a food supplement has an effect on the body (true for almost every food supplement and dependent on dose), then if that biological effect can be linked to some potential adverse event it becomes an impermissible dose. In the end, this system reduces dosages for food supplements to levels of inactivity, making them largely useless as aids to health, undermining entirely the market for these products by eliminating them except at dose levels that have no beneficial health benefits.
To date, EFSA has also been an effective censor. Of some 9,000 health-claim dossiers filed, EFSA has acted on only 1,080. EFSA says it will act in September on the remainder still on file. Its rulings have generally been negative, condemning nearly every claim for probiotic products, antioxidants, even omega-3 fatty acids. Claims not supported by proof to a near-conclusive degree are rejected.
Although almost no science, including nutrition science, is ever provable conclusively, EFSA condemns all nutrition science that accurately reflects the extent to which a nutrient may affect health on the illogical presumption that science is false unless conclusively proven true.
In the real world of science, information exists on a continuum between a bare hypothesis and a proposition that is proven, with most existing in the realm between the two, backed by credible evidence that links the nutrient to an effect on health and disease, albeit inconclusively.
EU fails to disclose information
Consumers depend on credible science that is inconclusive in making daily purchasing decisions. Indeed, they depend on inconclusive science to make critical, life-affecting decisions in the market – everything from which car to buy to what drug to take. Uniquely, the EU has chosen to keep from consumers all less-than-conclusive information about nutrients potential to cause illness or disease. In this way, the EU is dumbing down the European marketplace for food supplements, robbing Europeans of essential information on emerging science and the potential of certain nutrients to reduce disease and improve health.
Ironically, while EU officials contend that this experiment in centralized planning protects the health of Europeans, it may well harm their health. Science linking certain nutrients to disease risk reducing effects (such as omega-3 fatty acids and heart and brain health; antioxidants and reduction in the risk of certain kinds of cancer; selenium and reduction in certain kinds of cancer, among many others) may well prove true, yet in Europe, consumers will be denied that information in the market into the foreseeable future.
Consequently, those Europeans who would wish to bet on the provability of emerging science by exercising choice in the market will be denied the opportunity to make that bet by a paternalistic EU, an EU that thinks it knows better than the typical European what is in that European’s own self-interest. The result may well be a higher level of heart disease, senescence, Alzheimer’s, and cancer than would otherwise be the case. At a minimum, this new system reduces the sovereignty of EU member states and, most importantly, citizens of each EU member country, proving once again that a common market can also mean common enslavement.