The Danish ban on saw palmetto, implemented earlier this year over safety concerns, could be overturned if a company or individual was willing to bring the matter before the European Commission (EC), according to Patrick Coppens of the European Responsible Nutrition Alliance (ERNA).
He said it is likely the EC would view the ban as being contrary to its free-trade principles and force Denmark to align its regulations with the rest of the European Union, which permits saw palmetto to be sold as an herbal supplement.
"There is a restriction of trade occurring but no companies have appealed the decision and this may be because they do not wish to upset the Danish government due to trade in other areas. But it does not mean that the ban is sound or beyond challenge," Coppens told FF&N. "Sometimes the EC will act of its own accord but this is rare."
While Denmark is notorious for its conservative regulatory approach to foods and food supplements, as an EU member it has an obligation to abide by EU Directives and statutes. However, exceptions do exist, hence the grey area that allows Denmark to ban saw palmetto despite the fact it is permitted in other EU member states and almost all global jurisdictions.
The Danes banned the herb in February after the Danish Institute for Food and Veterinary Research (DFVF) conducted a safety review of saw palmetto research in 2002 and concluded there were concerns over its effect on the hormonal system, long-term use, and dosage levels in foods or supplements, despite the absence of adverse events.
When four saw palmetto products were subsequently brought to the attention of Danish health authorities, the DFVF asked the manufacturers to submit evidence to substantiate their safety. When this was not forthcoming, the products were withdrawn in lieu of any new safety data.
Despite the ban, saw palmetto remains on the Danish market as a pharmaceutical ingredient, in which form it is deemed safe by Danish medical authorities.
Saw palmetto sales are estimated at $150-200 million in major European markets such as Germany, France and the UK.