Boiling the frog slowly: Where have all our herbs and supplements gone? (or Don’t get THMPD by the EU!)

This year, two pieces of EU legislation will impact your freedom of choice as a consumer, your local health food store and the arena of natural healthcare.

Although it might not seem so right now, their potential to affect your life, your loved ones and your community is vast, not least because they are part of a much wider raft of legislation on food, herb and supplement issues streaming down from Brussels over the next few years.

Under the Food Supplements Directive (FSD) – which is coming into force in stages – permitted dosages of vitamins and minerals in food supplements will be severely restricted very shortly.

Under the Traditional Herbal Medicinal Products Directive (acronym THMPD!), very few herbal remedies will remain on sale after 30 April 2011.

Three key issues arise directly from these two pieces of legislation:

1. Consumer freedom of choice: Vitamins, minerals and herbal remedies play a valuable role in supporting and maintaining wellness by complementing a healthy diet and lifestyle. Over 50% of people in Ireland use natural health products. Under the proposed regulations, you will be denied access to food supplements strong enough and/or balanced enough to have a positive effect on your health. You will also be denied access to many herbal remedies, including those you might currently take on a daily basis. Only 30 applications for THMP licences have been received by the Irish Medicines Board (IMB).

2. Economics: The degree of over-regulation foreseen for natural products will imperil the existence of roughly 50% of health food shops in Ireland, putting 3,000 jobs at risk.

In addition, smaller manufacturers, many of which are dedicated to quality, innovation and sound ethics, are likely to be forced out of business, either because they are unwilling to compromise on the efficacy of their products or, in the case of herbs, because they are unable to pay the vast sums of money required to license their products in accordance with new EU regulations. This will lead to a decrease in the number, variety and sophistication of supplements and herbal formulae on the market. It will also lead to job losses if their companies take a hit.

3. Health: Health stores fill a valuable primary care role in their local communities by providing free advice and guidance on diet and lifestyle. They reduce the burden on our overwhelmed health system by helping people to stay well. If they have to close, an important service to the common weal will be lost.

The Food Supplements Directive

The Food Supplements Directive (2002/46/EC) was voted through the European Parliament in 2002. It has been keeping a low profile while its proponents pursue its aims behind the scenes. We have written more extensively about the Directive here and here.

Under the Directive, the European Food Safety Authority (EFSA) decides the Maximum Permitted Level (MPL) for each vitamin and mineral per unit dose (per tablet, capsule, etc.). Indications suggest that MPLs for many vitamins and minerals will be reduced to close to the Recommended Daily Allowance (RDA), established in 1941 to prevent deficiency diseases like scurvy and rickets. RDAs were never intended as safe upper limits for vitamins and minerals!

Some EU countries have no tradition of high-level vitamin and mineral supplements. Ireland and the UK do. Brussels wants to harmonise the supplement trade throughout the EU by flattening out the levels of vitamins and minerals allowed in each country. This will make it easier for multinational pharmaceutical companies selling low-dose products to maximise profits from that sector of their business.

The FSD was never intended as a regulatory tool to ensure consumer safety and protection. Its primary purpose was always to regulate commerce. The safety card – which proponents now play – only appeared when regulators realised the extent of opposition to their plans. As opponents became more vocal, advocates started touting safety as the main goal of the FSD. What better way to convince the public of the Directive’s necessity than to scare people into believing that stronger supplements are dangerous or excessive and low-dose supplements are safe because they are ‘regulated’ by the EU?

Based on outdated science, regulators aim to reduce MPLs to the point where they have little or no influence on health and fail to address individual needs, meaning that you, the consumer, will be unable to meet dietary deficiencies with effective supplements and your health may suffer.

For 40 years, high-dose vitamins and minerals have been consumed safely in Ireland and the UK with no record of serious side-effects. In the US, where regulation of supplements has been historically liberal, poisons centres recorded zero deaths from vitamins and almost 800,000 deaths from medical intervention in 2005. ‘Medical intervention’ included prescription drugs.

Traditional Herbal Medicinal Products Directive

After 30 April 2011, when the Traditional Herbal Medicinal Products Directive comes fully into force, many herbal products from all around the world (including Eastern and Western herbal traditions and South America) – and food supplements containing herbs – will be illegal across the EU.

Availability will be restricted to herbal medicinal products registered under the scheme. For a broad range of herbal formulae, the requirements of the scheme are either impossible to meet or impossibly expensive. This applies especially to herbal products from non-European traditions, such as Ayurveda and Traditional Chinese Medicine (TCM). Criteria designed to apply to pharmaceutical drugs cannot be applied in any meaningful way to the complex plants that are herbs, or to the traditions that mix and use them with expertise. Furthermore, each herb has to be registered individually, at great cost. The current estimate is €50,000 to €100,000 per herb.

In many cases, both constraints apply. Consequently, very few herbal medicines from Ayurveda or TCM have been registered. Many Western herbal blends are also on the blacklist. If you take any of the above, your choices will be severely curtailed from May onwards.

For a brief overview on the impact of THMPD on traditional Eastern medical systems, please watch this video. Also check out the Alliance for Natural Health website.

It won’t stop here: the big picture and the future

In an interview with Sarah Best, editor of Get Fresh! magazine, Dr Robert Verkerk, Executive and Scientific Director of the Alliance for Natural Health Europe, warned:

‘Unfortunately, it’s not scaremongering to say that our ability to care for our own health as we see fit is under the greatest threat in our history. The screws are being tightened in every direction. We hear all the time from regulators – whether trading blocs like the EU or supranational organisations like Codex Alimentarius – that “the public must be protected” through comprehensive new legislation. However, when you actually look at the proposed or existing laws, it’s frighteningly obvious that the only people being protected are those in big corporations. Their power and ability to reap enormous profits from our healthcare will be very safe indeed if they achieve their aims!’

The Food Supplements Directive and the Traditional Herbal Medicinal Products Directive form part of a wider tranche of legislation already extant in a ‘sleeping’ state in Europe. The lull is to give manufacturers and suppliers time to adjust to profound changes but it also feeds a complacent attitude to the coming danger. Each Directive will come into force after a pre-set time period.

Nutrition and Health Claims Regulation (NHCR)

Next after the FSD and THMPD comes the Nutrition and Health Claims Regulation (NHCR). It is set to ban any claims regarding the benefits of foods and food ingredients unless pre-approved by EU authorities in line with very narrow criteria that are almost impossible to achieve.

Shockingly, the NCHR covers not just the written word but the spoken word, images, diagrams, videos, and any other form of communication. It aims to ban all health claims, except those specifically permitted by the EFSA. This will make it much harder for consumers to determine whether a product is healthy or tailored to their needs. According to Dr Verkerk:

‘It uses Napoleonic law to ban all health claims except those that are specifically allowed by EFSA. The NHCR, in our view, amounts to the greatest restriction on free speech related to natural healthcare ever seen, both because it enshrines Napoleonic law in the realm of health claims about products and because it imposes standards for scientific substantiation that are simply unachievable for most foods and ingredients – especially important therapeutic agents like botanicals, amino acids, probiotics and enzymes.’

Imagine visiting your local health food shop under those conditions! Does the Directive include communication by ESP, or quantum entanglement with your favourite Hopsacker?

All three pieces of legislation are due to be activated between May 2011 and December 2012. Health freedom campaigners refer to the gradual introduction of legislation as “boiling the frog slowly”. The changes are made incrementally, so that people don’t notice until it’s too late.

Although it’s hard to credit, the individual has almost no rights when it comes to health protection. Even though you might think you live in a free country, health protection (like national security) is an issue on which governments have enormous powers to dictate. It is vital, therefore, to mount legal challenges at this stage and to lobby local politicians and MEPs to safeguard our freedoms.

Action this day!

During World War II, Winston Churchill would attach to the top of any urgent order a bright red label stating ACTION THIS DAY.

Who are we to argue? 😉

So what can you do to safeguard your health and freedom?

First: Inform yourself on the issues. Much disinformation is being disseminated about EU regulations, including wild exaggerations online and in the media designed to cause fear and confusion. Feeding our Inner Ostrich = bad. Clarity = good.

Reliable sources of information include:

Second: Spread accurate information as far and wide as you can.

Third … the 25th Day of February. Ask your local candidates the question: “If you are elected, would you be willing to work actively in the political arena to help reverse the drive to over-regulate the natural products sector, so that health stores can remain open, jobs protected and consumer freedom of choice assured?” Or try to suss them out first so they don’t just say “Yes!” to net your vote.

Fourth: Where and how you spend your money is paramount. You can vote with your Euro by supporting ethical manufacturers, retail outlets and local producers and withdrawing your support from companies that espouse contrary values.

See The Fresh Network Blog: 1.1.2011 for lots more ideas! 🙂

Know, too, that you are not alone. In 2007 – and in the space of only two months – 60,000 Irish citizens petitioned the government and the EU, voicing concerns that harmonising levels of vitamins and minerals as proposed by the FSD would impact negatively on public health, health stores and practitioners in Ireland. Citizens of other countries have signed similar petitions. As a result, important clarifications have already been made to legislation. Solidarity works!

We’re going to give the (near…) final word to Rob Verkerk:

‘Everything about our physical being and how it has come to be over millennia is related to our interaction with the natural world around us. To give this up for the sake of a few transnational corporations, their patented drugs, and their simplified, synthetic, chemical-laden, genetically modified, irradiated and heavily processed food, makes no sense. To me at least.’

It makes no sense to us, either.

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