In a recent article, The Economist discusses How the European Union is becoming the world's chief regulator. The article says the EU regulatory framework is in the process of becoming "world standard". The Economist quotes an unnamed US official:
One American official says flatly that the EU is “winning” the regulatory race, adding: “And there is a sense that that is their precise intent.” He cites a speech by the trade commissioner, Peter Mandelson, claiming that the export of “our rules and standards around the world” was one source of European power. Noting that EU regulations are often written with the help of European incumbents, the official also claims that precaution can cloak “plain old-fashioned protectionism in disguise”.
While the prime example in the Economist's article is a fine imposed on Microsoft for bullying its competitors, the fact that EU regulations are copied in the rest of the world holds true in many sectors of the economy. In the area of nutrition and healthcare, EU legislative activity has led to several new pieces of legislation that are - seen in their context - potentially disastrous for public health. The directives and regulations discussed in the linked document prepared by the Alliance for Natural Health diminish individual choice in health and prevention, while preserving the profitability of big industry and indeed slanting the 'playing field' in favor of the largest competitors.
Codex Alimentarius, the United Nation's international food standard-setting body, has also been discussing food supplements, one of the subjects of the recent EU health legislation.
The Codex guidelines, adopted at the Codex Commission's plenary session in July 2005 here in Rome, are little more than a copy of the European Directive adopted some years before. This seems to confirm the view expressed in the Economist's article, according to which the EU is "winning the regulatory race".
Americans are proud of their freedoms, particularly in the area of health and nutrition. The Dietary Supplement Health and Education Act of 1994 (DSHEA) put food supplements firmly in the food category, preventing the FDA from regulating nutrients as either additives or medicines, a practice which previously had led to much friction between the FDA and the producers and consumers of supplements. To the chagrin of the FDA and the pharmaceutical interests that influence its policies, supplements have enjoyed a period of unprecedented growth since the passage of DSHEA.
Perhaps that is why the FDA is now working to harmonize US law and administrative practice for supplements with Codex guidelines and with other countries' more restrictive regulations. The Life Extension Foundation laments this trend in a recent article:
The anti-American FDA is actively seeking to undermine U.S. laws and harmonize our dietary supplement laws with Mexico and Canada. This is being done through the Trilateral Cooperation Charter – an illegal agreement set up with health regulatory agencies in Mexico and Canada. It is part of the campaign towards a North American Union, one which would be a catastrophe for health freedom in this country as dietary supplement laws in Canada and Mexico are far more restrictive than in the U.S.
The FDA would also like to harmonize our dietary supplement laws with the evolving international standards set by Codex, thus branding therapeutic nutrition as dangerous and risky and needing to be sold by Big Pharma or removed from the market altogether (if it competes with a blockbuster category of drugs). Codex is planning to use the same proteomics and biomarker technology that will be used by the FDA’s Critical Path Initiative to remove therapeutic dietary supplements from the international market and force their policies on America, thereby superseding the sovereignty of American law on threat of trade sanctions. The FDA fully supports draconian Codex guidelines to regulate dietary supplements and is working with the Germans to concoct technology to brand nutrients as drugs.
Will Americans be able to maintain their nutritional freedoms in the face of pressure coming from both, international and domestic agencies?
It appears that the problem may no longer be only American - there is an international trend of using "precaution" to brand nutrients as more dangerous than the pharmaceutical drugs that are killing hundreds of thousands every year.
To counter the trend, we may have to look at its origins: a conservative view of nutrition rooted in certain European nations that never had a culture of nutrient-mediated prevention and healing, coupled with a view that the only remedies for good health are pharmaceutical drugs.
Research and education will be essential to meet the challenge. Research to find and better define the effects of nutrients in prevention and healing, education to bring the conservative Europeans up to speed on how useful nutrients can be in prevention and maintenance of good health.
With food supplements, we have an extremely cost effective and very safe tool to better public health.
Why not use it to its full extent?
As a friend recently said, Europe has really no need for all these complicated regulations. The Community has a principle - the free movement of goods and services - which would be quite sufficient on its own to ensure a working internal market. That means people could determine whether to use supplements to stock up on nutrients and to what extent they want to do that. The Germans and the French could buy their supplements in England or the Netherlands, if they weren't locally available. But apparently some governments believe they have to control every last aspect of our lives, and the EU bureaucracy seems to agree.
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How the European Union is becoming the world's chief regulator
A VICTORY for consumers and the free market. That was how the European Commission presented this week's ruling by European judges in favour of its multi-million euro fine on Microsoft for bullying competitors. American observers had qualms. Would a French company have been pursued with such vigour? Explain again why a squabble among American high-technology firms ends up being decided in Brussels and Luxembourg (where Euro-judges sit)? One congressman muttered about sneaky protectionism and "zealous European Commission regulators". It certainly seemed zealous of the competition commissioner, Neelie Kroes, to say that a "significant drop" in the software giant's market share was "what we'd like to see".
More broadly, the ruling confirms that Brussels is becoming the world's regulatory capital. The European Union's drive to set standards has many causes-and a protectionist impulse within some governments (eg, France's) may be one. But though the EU is a big market, with almost half a billion consumers, neither size, nor zeal, nor sneaky protectionism explains why it is usurping America's role as a source of global standards. A better answer lies in transatlantic philosophical differences.
The American model turns on cost-benefit analysis, with regulators weighing the effects of new rules on jobs and growth, as well as testing the significance of any risks. Companies enjoy a presumption of innocence for their products: should this prove mistaken, punishment is provided by the market (and a barrage of lawsuits). The European model rests more on the "precautionary principle", which underpins most environmental and health directives. This calls for pre-emptive action if scientists spot a credible hazard, even before the level of risk can be measured. Such a principle sparks many transatlantic disputes: over genetically modified organisms or climate change, for example.
In Europe corporate innocence is not assumed. Indeed, a vast slab of EU laws evaluating the safety of tens of thousands of chemicals, known as REACH, reverses the burden of proof, asking industry to demonstrate that substances are harmless. Some Eurocrats suggest that the philosophical gap reflects the American constitutional tradition that everything is allowed unless it is forbidden, against the Napoleonic tradition codifying what the state allows and banning everything else.
Yet the more proscriptive European vision may better suit consumer and industry demands for certainty. If you manufacture globally, it is simpler to be bound by the toughest regulatory system in your supply chain. Self-regulation is also a harder sell when it comes to global trade, which involves trusting a long line of unknown participants from far-flung places (talk to parents who buy Chinese-made toys).
A gripping new book by an American, Mark Schapiro, captures the change. When he began his research, he found firms resisting the notion that the American market would follow EU standards for items like cosmetics, insisting that their American products were already safe. But as the book neared completion, firm after firm gave in and began applying EU standards worldwide, as third countries copied European rules on things like suspected carcinogens in lipstick. Even China is leaning to the European approach, one Procter & Gamble executive tells Mr Schapiro, adding wistfully: "And that's a pretty big country."
The book records similar American reactions to the spread of EU directives insisting that cars must be recycled, or banning toxins such as lead and mercury from electrical gadgets. Obey EU rules or watch your markets "evaporating", a computer industry lobbyist tells Mr Schapiro. "We've been hit by a tsunami," says a big wheel from General Motors. American multinationals that spend money adjusting to European rules may lose their taste for lighter domestic regulations that may serve only to offer a competitive advantage to rivals that do not export. Mr Schapiro is a campaigner for tougher regulation of American business. Yet you do not have to share his taste for banning chemicals to agree with his prediction that American industry will want stricter standards to create a level playing-field at home.
Winning the regulatory race
One American official says flatly that the EU is "winning" the regulatory race, adding: "And there is a sense that that is their precise intent." He cites a speech by the trade commissioner, Peter Mandelson, claiming that the export of "our rules and standards around the world" was one source of European power. Noting that EU regulations are often written with the help of European incumbents, the official also claims that precaution can cloak "plain old-fashioned protectionism in disguise".
Europe had no idea the rest of the world was going to copy its standards, retorts a Eurocrat sweetly. "It's a very pleasant side-effect, but we set out to create the legislation we thought that Europe needed." At all events, America's strategy has changed. Frontal attempts to block new EU regulations are giving way to efforts to persuade Brussels to adopt a more American approach to cost-benefit analysis. That would placate students of rigour, who accuse some European governments of ignoring scientific data and pandering to consumer panic (as shown by European campaigns against "Frankenstein foods").
But rigour can quickly look like rigidity when it involves resisting competition. There is a genuine competition to set global regulatory standards, as Europe and America have discovered. There are also rising protectionist pressures. Perhaps zealous EU regulators may be what jumpy consumers need if they are to keep faith with free trade and globalisation. Viewed in such a light, even Microsoft's champions might hope that this week's verdict will help global competition in future.
EU-U.S. Summit Signals New Threats To Natural Health Therapies
(April 2007) - The European Union and the United States recently announced the signing of a Framework for Advancing Transatlantic Economic Integration at a summit in Washington. Describing the agreement as “a statement of the importance of trade”, President Bush, speaking at the post-summit press conference, claimed that it was “a commitment to eliminating barriers to trade” and “a recognition that the closer that the United States and the EU become, the better off our people become.”
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Codex Alimentarius Adopts Vitamin Guidelines
4 July 2005 - The Codex Alimentarius Commission has voted to adopt potentially restrictive guidelines for vitamin and mineral supplements proposed by the Codex Nutrition Committee. In its 28th session here in sun dried, heat plagued Rome, the planet's supreme food regulator has given a nod to industry in approving guidelines for food supplements over the strenuous opposition of consumer representatives. Several associations representing consumers and health practitioners were present... [read more]
July 04, 2005 - Sepp Hasslberger
Codex 2003 - Grossklaus and Mathioudakis: Nutrition not relevant to Health
November 3-7, 2003, the Codex Committee on Nutrition and Foods for special dietary uses met in BONN, Germany, for their once-yearly come-together. On the agenda for discussion were, before baby foods and the description of healthy properties of food on labels, the proposed Codex Giudelines for "Vitamin and Mineral Food Supplements". Such guidelines would be, once passed, the equivalent of international law to be followed in all commerce of vitamin... [read more]
November 25, 2003 - Sepp Hasslberger
Codex and the Titanic's Deck Chairs
Rearranging the Deck Chairs on the Titanic is the title of the report of Scott Tips, correspondent of Whole Foods Magazine and representative of the National Health Federation on this year's meeting in Bonn, Germany where, in the first days of November, the Codex Alimentarius Committee on Nutrition and Special Dietary Foods - CCNFSDU - had its yearly conclave. I have previously reported on this meeting, and have also posted... [read more]
December 04, 2003 - Sepp Hasslberger
European Health Legislation, Codex And The Sustainability Of Health Care
Brussels has been busy "adjusting" EU food and medicine laws for several years now, bringing increasingly onerous controls for natural products - notably herbs and food supplements. Some observers have criticized these moves as designed to give an unfair advantage to "conventional", pharma-based medicine and will cut across preventive health strategies. Prevention is high on the agenda, but official strategies are largely limited to avoiding and killing off germs. Nutritional... [read more]
April 20, 2005 - Sepp Hasslberger
Codex: FDA 'Vetoes' Optimal Nutrition For Health
Just a month ago today, at the Codex Alimentarius Food Labelling Committee meeting in Ottawa, Canada, the US delegate Dr Barbara Schneeman said that no reference should be made to "optimizing nutrition and health" in guidelines that would encourage "adequate information" on food labels. A Codex Committee meeting - Image by Sepp The Committee was discussing how the World Health Organization's Global Strategy on Diet, Physical Activity and Health should... [read more]
June 04, 2006 - Sepp Hasslberger
The Dark Side of Precaution: Preventing Prevention
The precautionary principle mandates intervention to save the environment and - most importantly - our health from degradation in the case of a pressing danger, even if all the scientific data are not yet on hand. It is invoked when we face threats from chemicals, radiation or other causes. The principle seems important, yet it is difficult to find an authoritative definition. The European Union has issued a communication in... [read more]
July 09, 2006 - Sepp Hasslberger