New Restrictions on Herbal Remedies in the European Union

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.

European Restrictions on Herbal Remedies and Nutritional Supplements Widely Seen as Unfair

Even companies that have the money to register their products, however, do not see the new regulations as fair.

Larger companies have been seeking approval for their products since 2006. Most complain that EU regulators are applying pharmaceutical science standards to nutritional products.

Generally, when a pharmaceutical company wants to show that a new medication is effective, it recruits a large number of terminally ill people who could not benefit from any other medication and then gives some of them the new drug. If fewer people die on the test drug than die on the placebo, then the new medication is proclaimed as effective, with side effects a minor consideration since the alternative is death. The effects of the medication are attributed (in almost all cases) to a single chemical that the drug company has patented before the clinical trial.

When a nutritional product maker wants to show that a long-used herb or nutritional supplement is effective, it generally recruits a small number of healthy people to see if the herb or supplement makes them even healthier. If more people show a predetermined measure of good health after taking the herb or supplement than not, then the product is deemed "not ineffective." The effects of the herb or supplement are attributable to it and other good health and nutrition practices.

Up until now, different European countries have enforced EU legislation with different degrees of enthusiasm.

Denmark has been especially tough on registrations for herbs, vitamins, minerals, and other nutritional supplements. In 2006, the Danish health ministry even "arrested" unregistered products, summarily pulling them off store shelves. The enthusiasm of the Danish Ministry of Health for removing even slightly questionable products from Danish shops, however, has not kept Danes from buying them in Germany and Sweden, which are a short drive from most of Denmark. The Danish action goes beyond the requirements of the European Union directive.

The Irish Medicines Board, on the other hand, has been extremely rational and reasonable with many registrants. When an American maker of herbal doggie shampoo (who retained the author of this article as a consultant) approached Irish regulators for registration of their product, the primary concern was making sure the product caused no harm, and then giving consumers accurate information. There was a tough documentation process, but each step was clearly designed to protect the public, not to protect a big pharmaceutical company. The Irish Medicines Board tends to act in ways that follow both the letter and the spirit of the European Union directive.

And the German manufacturers saw all of this coming long ago.

Even the tiny companies who cannot afford to register their products, however, are not necessary completely banned in Europe. They just are no longer allowed to make any claims for the products they sell. If you were to concoct your own herbal dog shampoo, for example, and you could not go through the registration process, you could label your product "Shampoo for Fido" and list the ingredients (assuming the ingredients themselves are not banned). What you could not do is to claim it "soothes" or "stops allergies."

The downside of the new regulations is that they add a considerable economic burden to small companies in tough times. The upside of the new regulations is that they stop fraudulent claims and establish trust for all herbal products sold in Europe. Manufacturers who have not been able to find the resources to complete registration over the last seven years, however, can no longer make claims for their products.