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Numerous news stories have announced the end of herbal medicines in Europe, but the announcements of their demise have been premature.

Not a "Ban" on Herbs as Widely Reported

Back in 2004, the European Parliament adopted a Traditional Herbal Medicinal Products Derivative. This law established an April 30, 2011 deadline for herbal products makers in the European Union to register their products to be allowed to continue making marketing claims for them in Europe.

At first, makers of herbal products in Europe thought this was a great idea. Instead of having to deal with more than two dozen individual national regulatory agencies, they could save time and money by getting product approval with just one agency to allow them to sell in all 27 countries in the European Union. Smiles quickly turned to frowns, however, when makers of herbal medicines learned that EU standards would be much tougher, and the approval process  could be even more arbitrary, than getting national approvals had been before the directive.

Products made in certain countries, however, were allowed a streamlined approval process

The German Commission E, for example, created standards for herbal medicines in the 1980's and 1990's. (The author of this article was one of the editors and translators of those standards for use in the United States.) The European Directive stated that if an herbal product had been used for 30 years in Europe, or for at least 15 years in both Europe and other countries, then it was automatically approved for continuing use in the EU.

This provision in the directive grandfathered all the German herbal formulas, which make up 45% of all herbs sold in Europe. These herb products are included in German health insurance coverage.

The provision also covered traditional Japanese or Kampo medicine. Japanese herbal products have been available in Austria, largely through the efforts of Drs. Helmut and Michiko Bacowsky and their colleagues at EuroKampo, since the 1980's. The exact same products have been registered in Japan since the 1950's. Japanese herbal medicines pass the traditional use test. Ayurvedic and Chinese herbal formulas that are basically "foods" can continue to be marketed even without registration.

The paperwork for registering these "fast-tracked" products, however, is not cheap. A simple product application costs about €20,000/US $30,000, and additional proof that the product is shelf-stable can cost about €50,000/US $75,000—for each and every product the company wishes to sell.

Two of the most popular herbs in Europe, moreover, have been on the market less than 15 years. These are hoodia and acai.

For herbs and nutritional supplements that have been available for less than 15 years, the European Union requires a great deal more documentation. Assuming the company has a scientific study that proves that these herbs actually work, then just the additional paperwork will cost about €100,000/US $150,000. These standards would apply to most South American rain forest herbs as well, and the African herbs that have been so popular for men's sexual health (except yohimbe, which qualifies under a "grandfather" clause in the directive).

Mom-and-pop tincture makers for the most part are being put out of business by the newly enforced European trade rules. People who grow herbs in their backyard gardens, however, are not yet affected by the rules, although most no longer advertise that they have them.

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