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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.
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.
Larger companies have been seeking approval for their products since 2006. Most complain that EU regulators are applying pharmaceutical science standards to nutritional products.
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.
- European Directive 2001/83/EC, as amended June 12, 2003.
- Photo courtesy of Laura Bernhardt by Flickr : www.flickr.com/photos/lmbernhardt71/7966902528/