Postcard From Europe

FOOD SUPPLEMENTS ARE 875 TIMES SAFER THAN MOST FOODS, AND 62,000 TIMES SAFER THAN PRESCRIBED DRUGS

Could the EU’s Draconian Natural Product Regulations Extinguish Natural Healthcare?

In a democratic society, every regulation needs some kind of justification. It doesn’t matter which facet of life you care to look at. Take motor vehicles, children’s toys, or food safety as three diverse examples – if you’re a regulator, it’s not difficult to find some reason why you need more laws. With natural health products, it’s no different.

What the European Union (EU) has done when it comes to natural products over the last 10 years is unique. It has managed to maintain food (dietary) supplements as a category of food, seemingly like the U.S. system managed by the Food & Drug Administration (FDA). The EU has used neither a ‘third category’ for natural products, like Canada, nor has it medicalized supplements, like Australia. It has, however, created an optional simplified drug licensing system for industrially manufactured herbal products, but as you’ll see below, the regulatory ‘ring fence’ for these products is so tightly constrained it only suits a narrow range of herbal products, many of these being far from the most efficacious or even the safest ones available.

While this might look well and good on the surface, there are a few elements of the EU scheme that are causing mayhem to both informed choice and freedom of choice. As you read on, you’ll discover how informed choice is impacted hugely by the EU regulation that controls what you can and can’t say about commercial products, courtesy of the EU Nutrition and Health Claims Regulation (1924/2006). Freedom of choice, on the other hand, is limited by the rapidly declining diversity of products available in the EU. In short, while the food supplements category exists technically as a ‘safe harbour’, the quayside is being diminished rapidly, allowing fewer and fewer ships to dock. The threats to this safe harbour come as much from regulations affecting food supplements as they do from regulations that control the definition and scope of drugs and ‘novel foods’, both these regimes having superiority over the regulations of foods or food supplements.

The EU drug definition is so broad it effectively makes anything we might consume a drug, requiring simply that the substance is used on humans “with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.” [1] Yes, a bottle of water is technically a drug under this definition! It’s akin to giving a regulator a loaded gun that can be used arbitrarily. And increasingly this gun is being fired.

The ‘novel food’ category in the EU was first introduced to safeguard the public from genetically modified (GM) foods by introducing a pre-market authorization system that required some kind of a safety evaluation. As of 2001, when GM foods were gifted their own regulatory regime, the system now acts as a trap for botanicals and other ingredients that exist in forms which cannot be proven to have been sold significantly within the EU prior to May 15, 1997, the key cut-off date. Those also familiar with the U.S. regime will note similarities between the FDA’s ‘new dietary ingredient’ (NDI) notification procedure and the EU’s ‘novel food’ regime. For naturally occurring substances, especially ones that are not standardized, passing the necessary tests is very challenging.

Contaminated Products In Clinics and on the Internet

Coming back to justifications, there have of course been occasional and highly publicized instances of adulteration or contamination in Europe, especially of imported herbal products. The worse case led to the death, following kidney disease or cancer, of over 100 people in Belgium after a drug-herb cocktail was dispensed by medical doctors in a Brussels slimming clinic between 1990-92.[3]  The shocking case reminds us that it is one-to-one prescription by doctors of unlicensed medicines – a provision that is legalized by an exemption for “authorized health-care professionals” under EU medicines law – that represents one of the greatest risks to the public. The products sitting innocently on health store shelves, or those prescribed by qualified naturopaths, herbalists or functional medicine practitioners, may be the target of regulation – yet they pose no significant risk. Instead, they confer numerous benefits, but ones that increasingly can’t be communicated to the public (see Health Claims section below).

Despite the increasing pressure of regulation, some dubious, so-called ‘natural’ products sold by unreputable suppliers continue to be available on the Internet. Some of these may be contaminated, others are spiked with pharmaceuticals, whilst some make outlandish claims or don’t meet their claimed specifications. The sale of these kinds of products, albeit representing a tiny minority of the total, are completely unperturbed by the new EU laws. The fact is, their purveyors by and large have no respect for any law, regardless of where it might originate from. They were generally already in breach of previously existing national laws, such as those governing food safety or the accuracy of labelling, compliance with these all being responsibilities of any legitimate food business operator. Even more disturbing, when European parliamentarians have raised concerns about these kinds of rogue products, they are generally told by the European Commission, the unelected officials who run the EU, that there is nothing they can do about them; they are outside their control. In the same breath, they will voice their commitment to consumer protection! And, as if you hadn’t guessed already, medical doctors without any training in herbalism or naturopathy continue to be able to prescribe ‘unlicensed medicines’ to their patients, in effect allowing for a potential repeat of the Belgian clinic disaster of 1990-92.

NHPs Proven Safer Than Medication

Most of us will agree that some regulation is not necessarily a bad thing. But when you look at the risks posed by natural health products in the EU, there is no evidence that either food supplements or herbal remedies constitute a significant risk to health, especially when compared to other products we consume like food or prescription drugs. In fact, when it comes to risk of death, UK data shows that food supplements are 875 times safer than conventional foods, and 62,000 times safer than properly prescribed drugs.[4]

Some of these regulations also exist, ostensibly, to ensure fair business practice. Others exist to prevent consumers being misled. In both cases, we see very clear trends. So-called fair business practice is achieved by putting a huge amount of red tape in front of small businesses to the extent that some simply are unable to meet the costs or allocate the necessary resources to jump the regulatory obstacles. This is a familiar story for Canadians who have witnessed the licensing of natural health products by Health Canada’s Natural Health Products Directorate. In addition, product ingredients, or products, from outside the EU face even bigger hurdles; European protectionism is, I’m afraid, alive and well.

Preventing misleading claims is one thing, but the EU has gone to extreme lengths, fuelled by a guideline that has been in development at Codex Alimentarius – the UN entity that develops international food codes – since 1997.[5]

While there are over 10 different EU laws that impact natural health products in the EU, with different national laws applying in addition to those in the 28 EU member states in some cases as well, there are three that really deliver the biggest blows. We think of them as the ‘Big 3’ and they apply, respectively, to food supplements, herbal medicines, and health claims. It is, of course, the combined impact of all these (and the other) laws that hurts most. In contrast with previous accounts I have given of the EU situation in back issues of Vitality magazine, we can no longer think of these laws as threats. That is because their impact is already upon us. It is no longer probable or even possible, it is definite and proven.

Draconian Regulations

At the start of 2010, the list of legally allowed forms of vitamins and minerals became mandatory EU-wide. Simply put, if a form is not on the list, it cannot be used. After we took a case to the European court between 2003-5,[6] we managed to secure an exemption for naturally-occurring forms of vitamins and minerals, which has gone some way to keeping the door open. But minerals like vanadium, as well as many amino acid chelates and mineral salts, along with useful forms of particular vitamins such as folinic acid, have been locked out. Their use continues to be illegal EU-wide.

In terms of ingredients within natural health products, while so far only vitamins and minerals, and their respective forms, have been harmonized EU-wide, botanicals, amino acids, essential fatty acids, and other micronutrients are still regulated according to national rules. Many countries like to follow the German, Danish, Swedish and Finish models, which are strict to say the least. They use the loaded gun of the exceptionally broad definition of a drug under EU medicines law [1] – to force natural products off the market by classifying them as illegal drugs.

Still on vitamins and minerals, we presently await the planned harmonization of maximum and minimum permitted levels (MPLs), ordered under Article 5 of the FSD. Delays in the issue of a proposal have largely been caused by disagreement over what methodology to use, another issue in which we have been right in the forefront.[7]

Variations in the ways different EU member states have gone about the regulation of botanicals has created a highly distorted ‘single market’.  This has inspired the PlantLIBRA project,[8] funded through the EU framework. This project aims to establish a scientifically rational, proportionate, EU-wide approach to the regulation of botanical food supplements. One of its outputs has been the development of a harmonized list of botanical food supplements currently sold in Belgium, France and Italy, known as the ‘BELFRIT’ list. This list is gaining increasing recognition by other EU Member States and may have important ramifications for mutual recognition, which under EC Regulation 764/2008 prevents one EU member state disallowing sale of a product if it is on sale in one or more other member states, on the proviso that is does not represent a public health risk. Currently, it is, in my view, one of the few positive regulatory developments in Europe in the natural health area.

Herbal Medicine Regulations

The Traditional Herbal Medicinal Products Directive (THMPD) (2004/27/EC) was passed in 2004 and different provisions were applied sequentially up until its full implementation on May 1st, 2011. It is essentially a fast-track drug licensing system for herbal products that comply with its specific requirements for quality control and traditional use. This includes the controversial ‘30-year rule’, which requires a total of 30 years continuous safe use, of which 15 must have been in the EU. The UK has regulated more products through this route than any other EU Member State, amounting now to over 400.[9] Many of these products include a similar and rather narrow range of European herbs, such as

Valerian, Echinacea and St. John’s Wort. Many are alcohol or acetone extracts stabilized in a synthetic polymer base, and can be thought of as phytopharmaceuticals rather than full spectrum botanicals. The European Commission admitted back in 2008 that the THMPD, contrary to its original intention, was not suitable for products from non-European traditional systems of medicine, such as Ayurveda or traditional Chinese medicine (TCM). So far, there is only one product from these non-European traditions that has been registered successfully – Padma Circosan, based on a Tibetan medicine. Even then, it had to be tweaked from its traditional form to get in the door, so bending the rules in the process.

But now that the THMPD is live, it allows regulators to wield a huge sledge hammer, aimed fairly and squarely at botanical food supplements that might share one or more of the ingredients in a registered product. Since the UK has seen the largest share of registrations under the THMPD, pressure on botanical food supplements is also the greatest. Many with very long histories of safe usage as food supplements containing herbs like echinacea, valerian, black cohosh, white willow bark and even milk thistle, have been challenged as medicinal by the UK’s drug regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA). Some of these cases are presently being appealed.

Health Claims Banned

A health claim, under the terms of the EU Nutrition and Health Claims Regulation (NHCR) (1924/2006), is any claim that attributes, in a commercial communication, benefit to the consumer. The claim can be in any form, be it written on labels, websites, marketing materials, or verbal, pictorial, video. It affects any communication medium! As a product of the Napoleonic law roots of the EU, the Regulation seeks to ban all commercial communications, unless they are specifically allowed, following evaluation of health claims by the European Food Safety Authority (EFSA).

The controversy over the methods used to assess these claims is well known and means that, presently, just 250 health claims are authorized on the EU Register of nutrition and health claims, [10] and these can be made in any commercial communication as long as the stated conditions are met. By contrast, some 1,995 are non-authorized, and hence are banned anywhere in the EU. The fact that not a single authorized health claim has been given to any of the nine essential amino acids suggests there is a problem with the authorization procedure, regarding which a number of legal challenges are pending. In the process, commonplace terms like ‘superfood’, ‘probiotic’ and ‘prebiotic’ have been banned as the terms are considered misleading, given complications proving causal benefit. The 1,500 or so botanicals, and related products that have yet to be fully evaluated by EFSA, continue to be subject to transitional measures under the terms of the Regulation’s Article 28. This means they can continue to be used in individual EU member states on the basis that they were used, and legitimate, prior to the passage of the Regulation on July 1st, 2007. While the breathing space is currently a life-saver, the writing is on the wall unless the whole regime is ditched. That will take some doing given the enthusiasm over the Regulation from Big Food and Big Pharma.

Any strict interpretation of the draconian NHCR would suggest it doesn’t only apply to commercial products sold in supermarkets, health stores, and online. It also applies, technically, to nutritional therapists and other clinicians using food ingredients or botanicals when making communications to the end consumer – i.e. patients or clients.

What’s Next?

There is no doubt that the screws on natural health in the EU are being tightened. It’s something you now really notice when you travel to other parts of the world, especially the U.S. The diversity of products on the U.S. market is now in a different league and many of us – just to maintain our health – have no option but to bring back U.S. products in our suitcases after visits.

I have a strong sense that things will need to get even worse before they get better. The worse things get, the greater the chances of success in court on grounds of proportionality and limitations on fundamental rights and freedoms. In the meantime, regulators, stakeholders and interested parties continue to look very closely at what is going in the EU. Some are taking on-board some of the regulatory approaches, justifying it on public safety grounds.

As has always been the case, it is only the public that can resist. First, awareness is needed, and it is essential that freedom of speech, of the press, and of the Internet, is preserved so that people can be exposed to all sides of these debates. Secondly, people must be allowed to exert informed choice. Failing these things, the people must revolt. It was done in the U.S. in 1994 in the lead-up to the passage of the DSHEA, and there will come a time, hopefully soon, that the EU and its crazed law-makers will go one step too far. That will be the day when the healthcare of human beings, at least in Europe, begins to come back to some form of natural balance.


References

[1] EU Human Medicinal Products Directive, 2001/83/EC, as amended; Article 1.2(b).
[2] Nortier JL, Vanherweghem JL. Renal interstitial fibrosis and urothelial carcinoma associated with the use of a Chinese herb (Aristolochia fangchi). Toxicology. 2002; 181-182: 577-80.
[3] Krell D, Stebbing J. Aristolochia: the malignant truth. Lancet Oncol. 2013; 14(1): 25-6.
[4] ANH Europe website: Natural health products ultra-safe and drugs as dangerous as war, 11 July 2012. http://tinyurl.com/758scod
[5] Grossklaus R. Codex recommendations on the scientific basis of health claims. Eur J Nutr. 2009; 48 Suppl 1: S15-22.
[6] Alliance for Natural Health and others v UK (European Court of Justice Case 154/04): http://tinyurl.com/qyaj7z9
[7] 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.
[8] PlantLIBRA website: www.plantlibra.eu
[9] List of UK products granted a Traditional Herbal Registration (THR): http://tinyurl.com/88nhscq
[10] EU Register of nutrition and health claims: http://ec.europa.eu/nuhclaims

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