A controversial set of rules in the EU that changes the way herbal medicinal products are licensed and marketed in Europe came into full force this May, ending a seven-year grace period that had allowed manufacturers to come up to speed on the new measures.

Under the law, any plant product with a new curative claim sold over the counter is subject to an approval process the same as the one that pharmaceutical drugs are required to undergo when seeking marketing authorization. Additionally the new regulations, known as the Traditional Herbal Medicinal Products Directive, will force natural products producers to adhere to the standards of good manufacturing practice, a set of guidelines designed to ensure the quality of a product.

Although the use of herbal medicines in Europe is on the rise, the safety regulations governing these products in the EU have been “a mess,” according to Frederic Vincent, spokesperson for the EU Directorate General for Health and Consumers in Brussels.

There has been a considerable public outcry within the European community. A petition led by the web-based political action group Avaaz aims to amend this legislation in Brussels to remove all barriers to traditional remedies with a long history of use inside and outside of Europe. Opponents fear it will lead to a reduction in the choice of herbal remedies, leaving big pharma with a monopoly on natural medicinal product development and smaller manufacturers traditionally in the business unable to come up with the increased licensing costs.

The petition might be seen by some as futile, however, because the law has already been implemented at national levels. And there has been an ongoing erosion occurring for several decades that has gone largely unnoticed even by many medical practitioners, with traditional herbal products steadily disappearing from shelves.

“On the one hand, this is a good law. We want regulation,” says Michael Hartmann, a hospital pharmacologist in Jena, Germany and an advisor on medicinal products for the European Council. “But this will most certainly restrict thousands of traditional Chinese medicinal products that have not yet been registered in the EU as well as any combinations of vitamins and plant products from entering the market,” he says.

Ayurvedic and traditional Chinese medicinal products are often plant mixtures that until recently have been available as food supplements and must now be registered as medicinal products.