Everyone has been paying such close attention to the EU’s Food Supplements Directive (FSD), which came into force 10 days ago, that few are looking beyond that to the tsunami of legislation from Brussels that is following in its wake.
Each new law represents a threat to alternative and nutritional medicine that is as great as that posed by the FSD, if not more so.
First up is the Traditional Herbal Medicinal Products Directive, which will put herbal remedies into the same regulatory framework as pharmaceutical drugs, is likely to be adopted by the British parliament in October. Only ‘finished products’ – and not the individual herbs that are the ingredients – that have been in use for 30 years, including 15 years in an EU country, will be exempt from the more onerous limitations of the new legislation. Any product that fails the test will effectively be withdrawn because few, if any, herbal manufacturers could afford the massive costs of licensing. It’s feared that the directive will send many small manufacturers to the wall, and dramatically reduce consumer choice.
The Products (Pharmaceutical) Directive is even more damaging. This is mirror legislation to the Traditional Herbal Medicinal Products Directive, and does for many popular products, defined as food supplements, as is being proposed for herbal remedies. So, like herbal supplements, food supplements will be subject to the same controls and regulations as pharmaceuticals. It is perhaps the most sinister assault on alternative medicine, partly because the legislation is incoherent and ill-defined. As it stands in its current draft, any ‘product’ that may make you feel ‘good’ or ‘better’, and so have some health benefit, could be subject to rigorous licensing. Its detractors point out that a cup of tea can have these qualities, and so, as the legislation stands, would be banned until it was proved to be safe.
Then there is the Addition of Nutrients to Foods Directive, which will determine the safe upper limits of nutritionals that have survived the FSD. Currently the UK and the Netherlands enjoy very high limits, whereas in France and Germany those limits are set at around the Recommended Daily Allowance (RDA), an arbitrary level that is supposed to sustain minimal health. As the EU seems unable to agree on a suitable measure, it’s likely it will instead adopt those determined by Codex, an ‘independent’ body that is overseen by the World Health Organization. Its self-appointed duties include offering advice and guidance to the 100 or so countries that make up its membership (see E-news bulletin 170). Key members include Germany, France and delegates from America’s drug regulator, the Food and Drug Administration (FDA), one of whom was recently quoted as saying that nutritional supplements merely ‘enrich the urine’. You can probably guess that the safe upper limit will be set at around the RDA, thus forcing off the market the supplements that offer therapeutic benefits.
The Sports Nutrition Directive will be announced late this year. This legislation seeks to control any supplements and foods that is intended to help anyone involved in ‘intense muscular effort’, and is likely to be as swingeing as anything seen so far.
Finally, the EU Nutrition & Health Claims Regulations will control all claims made about a health product. This will control not just the labeling on the product, and its package inserts, but also any announcements, press releases, marketing and advertising – indeed, it’s legislation that goes much further than that which currently controls announcements about pharmaceuticals.
These directives want to treat harmless and safe nutritional supplements as drugs, which kill hundreds of thousands of people each year. They also fail to understand the infrastructure that supports the pharmaceutical industry, which makes it the most profitable in the world.
As a result, an industry that has harmed few, if any, consumers, and made modest profits, faces extinction. Meanwhile, the various pressure groups representing different factions of alternative medicine will doubtlessly continue sniping at each other.