Wake Up Canada! The European Canary Has Landed In North AmericaRobert Verkerk, PhD June 1, 2012
“How on earth have you Europeans allowed a bunch of unelected bureaucrats in Brussels to tell you what you can and can’t put in your mouth?” This is a common sentiment expressed to me by American friends and colleagues. They are rightly horrified when they learn that by November 2012, thousands of foods and natural health products within the European Union (EU) will need to be re-labelled so as to remove any claim alluding to any health benefit they might have. That includes things like glucosamine aiding joint function, and coenzyme Q10 supporting cardiovascular health. EU authorities have seen fit, supposedly, to protect its citizens by introducing the most draconian laws on commercial free speech relating to food and natural health products found anywhere in the world.
The EU’s Health Claims Regulation: building a passport system for big business
Having evaluated thousands of health claims on foods and their constituents in the European marketplace, the European Commission and its sister institution the European Food Safety Authority (EFSA), with the support of Member State governments and a narrowly split European Parliament, have now passed into law the highly controversial Nutrition and Health Claims Regulation (No 1924/2006) (NHCR). It is a draconian regime that bans all health claims on commercial products, whether in written, spoken, pictorial or in video form, other than those considered by EFSA (the ‘highest authority’ on food safety issues in the EU) to be causally proven. Scientifically speaking, proving cause and effect is a very tricky business, as evidenced by the decades it took to prove that smoking has the potential to cause lung cancer.
That’s why just 222 generic health claims have passed the test and emerged successfully from the EU’s health claims sausage machine. And that’s out of nearly 5,000 evaluated! Even more incredibly, nearly 10 times this number were discarded because they weren’t supported by human studies; they were principally underpinned by animal studies or biochemical evidence – all of which is viewed as worthless by EFSA without support from human studies of healthy (as distinct from diseased) populations. Most successful claims were principally for vitamins and minerals (the most extensively studied group of micronutrients that have benefited from over 70 years of intense basic research). These include claims such as “Calcium is needed for the maintenance of normal bones,” or “Iodine contributes to normal energy-yielding metabolism.”
But it is the thousands of claims to be stripped from natural health products that’s the biggest concern. So far, not a single probiotic and almost no botanical substances have been allocated health claim status.
Big Food and Pharma Trade Associations
Are we to believe the justifications given by European authorities that the food and natural products industries are out of control, and are using false or spurious claims which mislead millions of European consumers? And isn’t it ironic to see so many positive attributes stripped from food and nutrient labels just at a time when European society, like so many others, is splitting at the seams with the burden of chronic degenerative diseases like obesity, Type 2 diabetes, heart disease, cancer and osteoporosis? 
Evidence that we’ve amassed over the last few years demonstrates that the real driver of the machine is not a concerned European government protecting its citizens. It is actually a very large food industry that works hand in hand, behind closed doors, with the European unelected bureaucracy, aided and abetted by pharmaceutical interests.
Those looking for evidence of the Big Food and Pharma footprint need look no further than the specific activities of the key associations that support these vested interests. Worldwide, one of the prime movers here is the International Institute of Life Sciences (ILSI), that has, for over 10 years, been building its first blueprint system that works to lock out smaller businesses, or at least make their lives very difficult, jeopardizing their very survival in the process. The undemocratic world of bureaucratic governance that is the EU provides the perfect fertile ground for such an experiment. Once tried and tested in Europe, the system can then be exported around the world. That is, we believe, the plan and it amounts to nothing short of controlling the world’s food supply.
Among ILSI-Europe’s 60 or so members are companies that need no introduction. They include (alphabetically) BASF, Bayer, Cadbury, Coca-Cola, Danisco, Danone, Heinz, Kellogg, Kraft, Mars, McDonald’s, Monsanto, Nestlé, PepsiCo, Procter & Gamble, Tate & Lyle and Unilever. These companies appear to be more than happy with the tortuous regulatory regime designed to be primarily accessible to those with the resources to buy their way in.
ILSI isn’t, of course, the only body driving this. Other co-pilots include the major European Big Food and Pharma associations, such as FoodDrinkEurope that also represents the PepsiCos, Krafts and Unilevers of this world, as well as the Association of the European Self-Medication Industry (AESGP), that represents pharmaceutical interests.
EU Laws Set To Destroy Small Business, Stifle Innovation, and Jeopardize Public Health
While the health claims issue has been top of the agenda for the last few months in Europe, there is a raft of other pieces of European law that are beginning to bite hard. These are causing increasing numbers of European citizens to lose access to highly efficacious products, often on which their health and vitality depends. In some cases it is because products are banned because they’re considered either unauthorized drugs or ‘novel foods’; in other cases, and more often than not, it’s because companies are forced to withdraw products, being incapable of managing the new regulatory regimes. Some companies are even going out of business, while others are choosing not to sell in Europe because the regulatory hurdles are deemed too onerous.
Amongst the most divisive of the EU laws is the Traditional Herbal Medicinal Products Directive (2004/24/EC). This law effectively provide a drug licensing system for herbal products that is regarded as ‘simplified’ because costly efficacy studies required for conventional drugs are not required. Proving a 30-year history of safe use, including 15 years in the EU, is the alternative mechanism offered. But to win a license, pharmaceutical quality standards developed for conventional drugs must be followed. This has meant that most licensed products are single herb, alcoholic extracts, stabilized in a synthetic polymer base, often with added preservatives. Such products are a far cry from the dynamic, multi-ingredient, whole-plant extracts and dried herbs that have been so important in the majority of traditional medicinal cultures, including the two most widespread traditions, Ayurveda and Traditional Chinese Medicine (TCM).
As if this wasn’t enough, the European Commission has in the pipeline a regulation that aims to limit the maximum dosage of any vitamin or mineral food supplement sold anywhere in the EU. Our publication of two scientific papers in a major scientific journal, Toxicology, exposing the scientific irrationality of the approach, [5,6] along with keeping petitions against the proposed law live in the European Parliament, are among the strategies we have been using to prevent passage of this law that was expected to be approved as early as 2007.
There is not sufficient space here to cover the gamut of other EU laws that, in their totality, are set to strangle some of the best products on the European market, while also stifling large amounts of innovation. The principle pay-to-play mechanism that has been built into the EU system is pre-market authorization. This has now been applied to health claims, vitamin and mineral ingredient usage, herbal products, drugs and so-called ‘novel foods’. These are simply foods or food constituents that occur in forms, or have been subject to production processes, that have not been consumed to a significant degree within the EU prior to the passage of the EC’s Novel Food Regulation (No 178/97) on May 15, 1997.
This system is essentially identical to that considered in the revised New Dietary Ingredient (NDI) guidelines of the Food and Drug Administration (FDA) in the USA, that our colleagues at Alliance for Natural Health USA (ANH-USA) are working so hard to defeat. As records of sale and invoices dating back before 1997 become harder and harder to locate, given that they are no longer required for accountancy purposes, proving past usage is becoming ever more problematic. The regulation also locks out any kind of innovation because new manufacturing techniques are immediately deemed “novel”.
The EU and Canadian Mirror Images
With a feel for how the European regulatory system has been put together, it becomes particularly relevant to see what evidence there is for the development of systems that yield similar effects in other parts of the world. The corporations that are driving the process are transnational, so harmonization and globalization is clearly their intended objective. Moreover, the governments of the USA, Canada and Europe, which work so closely on the international stage developing food standards and guidelines at the Codex Alimentarius Commission, have repeatedly stated their intention to converge their regulatory regimes to facilitate global trade.
There are historical, political, legal and cultural reasons why some aspects of the regulatory system look superficially different in one territory compared with another. Canada, for example, has effectively opted for a ‘third category’ for natural health products (NHPs) that could offer a lighter regulatory regime than, say, the drug regulatory regime of Australia, but a tougher one than the food-based regime of the USA. However, it is the prior restraint created by the premarket authorization requirement for NHPs in Canada that provides the biggest stumbling block to manufacturers, suppliers or retailers of NHPs.
When one takes into account the fact that NHPs have been shown to be many times safer than foods, and many thousands of times safer than the average drug, it defies rationality that government regulators should be prepared to spend so much time and effort regulating NHPs. In fact, the risk of dying from a NHP, based on Canadian data, is around 70 times less than dying in a Boeing 747 crash. 
Convergence between EU, Canadian and US regulatory regimes
If 12 key markers of natural health product regulatory systems are compared, you find that the Canadian system already mirrors that of the EU. Even more surprising is the fact that the US has already adopted over 62% of the elements that are strangling the ability of European citizens to manage their health naturally.
The systems are of course different in many important respects, and they are implemented to different degrees in each of the geographic regions. But, in time, the effects will become increasingly similar as the globalization agenda gathers strength. That is, of course, unless citizens decide to take a stand against it.
Table 1 – Evaluating key criteria characterizing the EU’s regulatory regime for natural products and comparing them with those of Canada and the USA
1) Create framework laws that conceal their full potential
2) Impose measures that bypass the democratic process
3) Attempt to cripple small businesses and health food pioneers
4) Develop internationally agreed upon standards, guidelines and recommendations (Codex Alimentarius Commission)
5) Create ‘positive lists’ of allowed ingredients
6) Ban ‘non-positive list’ ingredients
7) Impose a pre-market authorization regime for products, health claims or both
8) Classify some of the most effective supplements as drugs (ingredients, forms, dosages)
9) Force manufacturers to carry out human (clinical) studies on efficacy (using only healthy subjects)
10) Impose unnecessarily high and inappropriate standards for scientific substantiation of health claims
11) Impose a regime for the authorization of health claims
12) Ban all unauthorized health claims
Will the US Be Hit With An EU-style Regulatory Model for Natural Health Products?
I fully understand just how hard it is for many Americans, convinced that they are still living in the freest society in the world, to appreciate how quickly their fundamental rights and freedoms are being eroded. Jonathan Emord, a good friend and highly respected Washington-based constitutional lawyer and civil liberties defendant, makes crystal clear in his 2008 book, The Rise of Tyranny, just how far America has strayed from the principles on which it was founded over 200 years ago. Around 75% of US laws, says Emord, now bypass Congress and the democratic process, having been delegated to a swathe of Federal Agencies, among them the Food and Drug Administration (FDA), the Federal Trade Commission (FTC) and the Environmental Protection Agency (EPA).
The Survival of Natural Health Products Depends Upon A United Front By All Of Us
This article aims to signal a wake-up call to Canadians. It is clear that Health Canada has recently turned down the heat on its enforcement process, as well as lengthening the time given to companies to comply with the Natural Health Products Regulations. As indicated to me recently by Shawn Buckley, who heads up the Natural Health Products Protection Association (http://www.nhppa.org), one of the main organizations striving to reduce the loss of NHPs from the Canadian marketplace, “It’s as if the water was getting too hot for the frog, and Health Canada has needed to back off the heat to make sure the frog is boiled more slowly so it doesn’t jump from the saucepan.”
The NHPPA is working closely with ourselves in Europe, our colleagues at ANH-USA in the US (http://www.anh-usa.org), Jonathan Emord and others, in an attempt to deliver strategies that have the greatest likelihood of maintaining citizens’ access to natural health products of their choice. While this is not the place to divulge the detail of such strategies, we urge you to keep a close eye on all of the websites of these organizations (listed below) to find out what is being done, and how you can get involved and help. Some of the work involves taking specific, targeted legal actions, whilst other elements are based on science, advocacy or public awareness.
But perhaps even more important than our actions, are your actions. Ultimately, it is how you choose to live and how, and on what, you spend your money that determines which products and companies will survive. To use an analogy, it is our continued desire to put fuel in our vehicles, along with our reliance on ground transportation based on the internal combustion engine, that maintains fossil fuels as the primary energy source for transportation on our planet. Shall we all get on our bicycles and see what happens?
Accordingly, we must think very carefully about what foods and natural health products we choose to buy, and whether or not the advice or drug prescription from the local medical doctor is the most appropriate and effective health care we can get. We must consider carefully, also, how we are to spend our time, and how physically active we are to be. You are unlikely to hear from your doctor that Type-2 diabetes may be readily cured through appropriate diet and lifestyle, yet it is an established fact, and one experienced by many thousands around the world.
Quite simply, there’s never been a more important time in human history to really understand what living naturally is all about. There has also never been a more important time to defend our fundamental rights and freedoms. Working together, we can at least offer some kind of a future for the coming generations.
 EFSA evaluation of Article 13 ‘general function’ health claims under the Nutrition and Health Claims Regulation (1924/2006): http://www.efsa.europa.eu/en/topics/topic/article13.htm
 EU Strategy on Nutrition, Overweight and Obesity-related Issues: http://ec.europa.eu/health/nutrition_physical_activity/policy/strategy_en.htm
 ILSI membership: http://www.foodprotection.org/events/european-symposia/09Berlin/van%20Belzen.pdf
 FAQ on EFSA’s 2010 budget discharge: http://www.efsa.europa.eu/en/faqs/faq2010budgetarycontrol.htm
 Verkerk RH, Hickey S. A critique of prevailing approaches to nutrient risk analysis pertaining to food supplements with specific reference to the European Union. Toxicology. 2010; 278(1): 17-26.
 Verkerk RH. The paradox of overlapping micronutrient risks and benefits obligates risk/benefit analysis. Toxicology.2010; 278(1): 27-38.
 Risk of Dying in Canada Compared to Being Killed on a Boeing 747 Flight: http://www.laleva.cc/petizione/ronlaw/relative_risk_boeing72.pdf
Robert Verkerk is founder and executive director of Alliance for Natural Health International (www.anhinternational.org), one of the leading campaign organizations worldwide working to protect access to natural healthcare. For further information, contact ANH Europe: www.anh-europe.org; ANH USA: www.anh-usa.org; or Natural Health Products Protection Association (Canada): www.nhppa.org