In mid-February four supplement products were withdrawn from the market, and the initial reason given in the rapid alert system (a system used by European countries to advise each other of products they do not accept) was due to non-compliance with novel foods legislation.
However it later emerged that the withdrawal was down to safety concerns.
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.
Dr Kirsten Pilegaard, PhD, senior advisor for the Danish Institute for Food and Veterinary Research told NutraIngredients.com that saw palmetto appears on the 'Drogeliste' of plant substance that have been evaluated for their safe use in foods and supplements.
The evaluation was carried out in 2002, and the Institute examined published literature on saw palmetto. Amongst the studies reviewed were:
Boullata JI, Nace AM - Safety issues with herbal medicine (Pharmacotherapy 2000, 20 3): 257-269);
Cheen P, El-Mefty O, Jazeih AR - Intraoperative haemorrhage associated with the use of extract of Saw Palmetto herb: a case report and review of literature (Journal of Internal Medicine 2001, 250: 167-169);
Klepser TB, Klepser ME - Unsafe and potentially safe herbal therapies (Am J Health-Syst Pharm 1999, 56: 125-138);
Wilt TJ, Ishani A, Rutks I, MacDonald R. Phytotherapy for benign prostatic hyperplasia (Public Health Nutrition 2000, 3 (4A): 459-472).
The evaluation concluded that the there has been concern about effect of saw palmetto on the hormone system in recent years, and there is no information available on the safety of saw palmetto use over a long period of time.
"On the basis of the information available, it concluded that it is not possible to establish a dose that does not give rise to concern," said Pilegaard.
The decision to withdraw saw palmetto products from the market this year was not down to a new review, but to the existence of the products coming to the attention of the Danish Food Agency.
A spokesperson for the Ministry for Family and Consumer Affairs, under which the agency falls, explained that Drogeliste does not constitute a legal enforcement. But when products containing substances about which unsafe conclusions have been drawn are found on the market, the company responsible is asked to show evidence that they is not dangerous.
If it is not able to do that, the products are withdrawn.
Prof Edzard Ernst, professor of complementary medicine at the University of Exeter in the UK, told NutraIngredients.com that he is surprised about the conclusions of the 2002 evaluation.
"In my book saw palmetto is perhaps less effective than we thought in light of the New England Journal of Medicine study [2006 Feb 9;354(6):632-4], but still quite safe."
Saw palmetto is accepted by the Danish medical authorities for use in pharmaceutical products, who carry out their own evaluations.
According to the European Association of Urology, 30 per cent of men older that 65 are affected by BPH.