Denmark has withdrawn the herbal supplement saw palmetto because it believes it to be in violation of Europe's novel foods and food ingredients laws.
Danish authorities notified the European Union of its action, stating saw palmetto was a novel ingredient and therefore had to gain authorisation under the EU's complex novel foods laws.
Those laws require foods and ingredients that were not on the European market before May 1997 to seek approval via a lengthy process involving European food agencies. Without such approval foods and ingredients cannot legally be sold within the EU.
But Lorene Courrege, director of regulatory affairs at the European Health Product Manufacturers Association, questioned the Danish decision. "Saw palmetto has been reported by EHPM members as being on the market prior to May 1997, and therefore appears not to be a novel food ingredient," she said in an email to industry members.
A call for those with information that may refute the Danish position to come forward was issued by EHPM as well as influential US industry leader Loren Israelson.
"In order to build our case, we urgently need to know whether any national association member has any proof of marketing of food supplements containing saw palmetto prior to May 1997 in any EU member state," Courrege said.