Danish saw palmetto withdrawal due to safety
products from the market pending an assessment of their safety.
Supplements containing saw palmetto were removed from the market in Denmark in mid-February, and the initial reason given through the rapid alert system was that they were non-compliant with novel foods legislation, which requires ingredients not marketed in the EU before 1997 to go through a registration process.
However it has since emerged that this report was erroneous and in fact the withdrawal was down to safety concerns.
The Danish authorities are currently conducting a safety assessment, and products remain off the market in the meantime.
Lorene Courrege, director of regulatory affairs at the European Health Products Manufacturers Association told NutraIngredients.com: "We are waiting to see what the risk assessment is. From what we know, saw palmetto has been marketed for a long time in the EU and no member states have reported safety issues."
She added that the safety concerns might not be intrinsic to the herb but could be down to product formulations.
The Danish Ministry of Family and Consumer Affairs had not responded to NutraIngredients.com's enquiry prior to publication.
Saw palmetto, extracted from the berries of a dwarf palm tree, has a long history of use as a remedy for benign prostatic hyperplasia (BPH), a non-cancerous swelling in the prostate gland of older men, early in the 20th century. It was listed in the US Pharmacopoeia in the early 20th century.
According to the European Association of Urology, 30 per cent of men older that 65 are affected by BPH.
However a double-blind randomised trial published in the New England Journal of Medicine in February (Vol. 354, pp. 557-566), found saw palmetto to be no better than a placebo in improving urinary symptoms and objective measures of BHP - results which have been described as puzzling by industry experts since they contradict the conclusions of previous studies.
In Germany, where over half the nation's urologists prescribe plant-based products, saw palmetto sales are believed to be between €100 and 150m per year. The market size in other European countries, including France, is broadly similar.
