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Denmark's saw palmetto ban based on safety concerns

Denmark has withdrawn saw palmetto products because of concerns over their safety, not because the herb is in violation of European Union novel foods legislation as its health authorities originally indicated.

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 herbs' international usage and 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 When this was not forthcoming, the products were withdrawn and will remain that way in lieu of any new safety data.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 is widely known for its safety and efficacy in treating mild to moderate symptoms of benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate gland that causes symptoms in about 30 per cent of men over 70 years of age, according to

However a recent US study questioned its efficacy in treating BPH, finding no difference between saw palmetto users and a control group in a year-long, double-blind study among men with enlarged prostates.

"The results of this trial need to be seen in the perspective of the preponderance of the existing evidence, including at least 21 controlled trials showing positive outcomes with saw palmetto preparations," responded Mark Blumenthal, founder and executive director of the American Botanical Council.

Saw palmetto has been listed in the US Pharmacopoeia for the best part of a century.

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