Danish saw palmetto withdrawal due to safety

By Jess Halliday

- Last updated on GMT

Related tags: Saw palmetto, European union, Eu

The Danish food safety authorities have withdrawn saw palmetto
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.

Related topics: Regulation & Policy, Suppliers, Botanicals

Related news

Show more

Related products

show more

Reach Consumers with Fruit & Vegetable Powders

Reach Consumers with Fruit & Vegetable Powders

vaneeghen | 08-Sep-2021 | Technical / White Paper

Are you looking to create products that appeal to today’s plant-forward consumers? The plant-based revolution continues to captivate the market as consumers...

Turmacin®: Clean Label & Clinically Tested Turmeric

Turmacin®: Clean Label & Clinically Tested Turmeric

Natural Remedies Private Limited | 01-Sep-2021 | Product Presentation

Turmacin® is a clean label project-certified, clinically tested, and clinically safe turmeric extract. Turmacin® is rich in Turmerosaccharides® and doesn't...

How to Enter UK’s £690M CBD Market

How to Enter UK’s £690M CBD Market

The Association for the Cannabinoid Industry | 18-Jun-2021 | Technical / White Paper

The UK has the world’s most developed regulatory framework for legal cannabinoids, such as CBD and CBG. With a 2021 market estimated to be worth £690 million...

Your bioavailable and soluble anti-aging curcumin

Your bioavailable and soluble anti-aging curcumin

Lipofoods, a Lubrizol Company | 11-Jun-2021 | Technical / White Paper

Curcumin´s antioxidant and anti-inflammatory potential is limited by its poor solubility and its low bioavailability. In this respect, Lubrizol microencapsulated...

Related suppliers

Follow us


View more