Dietary Supplements & EU | Natural Health Blog

EU Regulations and Alternative Health

EU Regulations, Herbal Products

A growing number of health-conscious individuals, practitioners, and businesses worldwide have been watching with alarm as the 27-nation European Union has enacted laws aimed to progressively curtail the availability of herbal and traditional medicinal products. Starting in 2002, when the EU first passed the “Food Supplements Directive,” European consumers have seen fewer and fewer of their favorite health products on the shelves. That measure was followed in 2005 with the “Traditional Herbal Medicinal Products Directive (THMPD)” which demanded that all ‘medicinal herb’ products new to the market undergo a registration process akin to the process imposed on pharmaceuticals. But those restrictions weren’t the end of it, as the Directive calls for gradual phasing in of restrictions on existing products, so that by 2011, even products that have been on the market for years will need to undergo the stringent approval process or else be pulled.

The upshot of the new code is that small companies producing herbals have had to drop out of the market because they couldn’t pay the tab for testing and proving that their products meet specs. Apparently, the cost of the registration process can be upwards of €100,000 per product. The Food Supplements Directive demands that all approved herbal products have a 30-year track record of safety, including at least 15 years of being sold in their current formulation in the European market. Many herbal, homeopathic, and ayurvedic products based on Chinese or Ayruvedic medicine or rainforest herbs simply haven’t been in circulation in the West that long, although they may have thousands of years of successful and safe use behind them.

The regulations also impose requirements that make no sense given the way herbals get produced as opposed to pharmaceuticals. The required documentation and testing procedures are far more suited to large drug companies. Because most producers of supplements, herbals, and alternative medicines have neither the facilities nor budgets to comply, the Directive leaves the door open for those with big budgets to dominate the market — in other words, big pharmaceutical companies. Once the laws take full effect, the drug companies will have unencumbered incentive to develop botanical sidelines as the competition drops away, and you can imagine what the integrity and cost of their products might be. At best, only the largest herbal and alternative medicine manufacturers will survive, most likely by “dumbing down” their products to conform to the regulations and in the process, wiping out both efficacy and small-scale new product development.

If you live outside of the EU, don’t feel too smug. The regulations will most likely still affect you, as the European model is being taken as a blueprint for similar actions worldwide. The United States already has an agreement with the EU to exchange methods for establishing food standards and classification with each other; regulation of herbals seems only a breath away. In addition, EU regulations can be viewed as a stalking horse for Codex regulations now under consideration.

In spite of all this gloom and doom, those in the European alternative health community enjoyed a few moments of gratification recently after meeting with government bigwigs about the Traditional Herbal Medicinal Products Directive. The meeting took place between the European Commission and The Alliance for Natural Health (ANH), a UK-based advocacy group. The ANH representatives came away from that meeting with the belief that the European Commission agreed with them that the Directive was in need of immediate and significant revision. An ANH press release following that meeting stated that the EC recognized that the Directive fell short of its intended purpose of providing an effective simplified registration system for traditional herbal medicines…[and the ANH was] glad to see that the European Commission is prepared to rethink its current approach, which is otherwise scheduled for full implementation in 2011.”

Ah, if wishes were fishes…

Not so, say European Commission spokespeople, ‘that’s not what we said and not what we meant.’ Although the tone of the meeting reportedly was friendly and considerate, the EC says it never admitted that the Directive was flawed, and certainly made no promises about amending the Directive before implementation in 2011.

Alternative health product advocates do have a few friends on the Commission. Marian Harkan, a Parliament member from Ireland, has been seeking support for a separate legislation to cover botanical medicines — legislation far more suited to those products. The problem is that even if Harkan and advocacy groups make themselves heard and even if public pressure makes the EC more willing to amend the Directive, according to EC member Van Lierop, “any possible amendments in the legislation would take several years,” meaning that the amendments would come too late to save companies being driven out of business by the Directive.

But perhaps if the outcry becomes loud enough, it won’t take “several years” for those EC members to come to a simple consensus. The ANH has a track record of swaying policy makers. In 2005, it pressured the EC to exempt natural vitamins and minerals from the oppressive EU Food Supplements Directive, and so there is, perhaps, hope for bucking the proposed regulations governing botanicals. If you want to add to that wave of hope and not necessarily just kiss your favorite products goodbye, you might want to help the ANH in its mission.