Herbal medicines regulation needs balanced approach

25 February 2010

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The Australian Self-Medication Industry (ASMI), the industry body representing nonprescription consumer healthcare products, today said consumers should treat with caution reports suggesting lethal dangers associated with herbal remedies.

ASMI was responding to a research paper by Professor Roger Byard of the University of
Adelaide published in the US-based Journal of Forensic Sciences and which was featured on the ABC's The 7:30 Report.

ASMI Regulatory and Technical Manager for Complementary Medicines, Ms Ruth Kendon, said the paper was based largely on studies of herbal products in the United States where these products are unregulated. It does not reflect the situation in Australia where herbal and complementary products are subject to quality control.

"Australia has one of the most comprehensive regulatory arrangements in the world for
complementary medicines. The Therapeutic Goods Administration (TGA) is the body
responsible for overseeing this regime and it has an outstanding reputation for ensuring quality and safety including quality materials," she said.

"Some of the adverse reactions cited relate to cases where there have been extremely high doses. Many of the interactions with other medicines that have been cited are theoretical, and many have been disproven," Ms Kendon said.

Regulation ofmedicines in Australia is based on a risk-based management model in which the aimis to ensure that the level of regulation is commensurate with the level of risk posed by the medicines. Herbal medicines are considered relatively low risk products but, as with all medicines, consumers should not assume that they are entirely risk-free.

In the case of Black Cohosh, which featured in the report, the TGA mandated label warnings several years ago to alert consumers to the possibility of a very rare risk of liver damage.

Ms Kendon said complementary medicines including herbal medicines, have formed an
important part of the healthcare practices of many Australians over many decades.Most of these medicines do have scientific data supporting their safety.

As with all health-related products, ASMI encourages consumers to consult the advice of an appropriate healthcare professional when considering using a new treatment.

"In the case of herbal medicines, consumers should first consult their pharmacist or qualified naturopath or herbalist when considering using a product. ASMI also recommends consumers talk to their healthcare professional before combining any forms of medication, whether it be prescription or over-the-counter."
About ASMI: The Australian Self-Medication Industry (ASMI) is the peak industry body for the Australian self care industry representing consumer healthcare products including over-the-counter medicines and complementary medicines. ASMI's
mission is to promote better health through responsible self-care. This means ensuring that safe and effective self-care products are readily available to all Australians at a reasonable cost. ASMI works to encourage responsible use by consumers
and an increasing role for cost-effective self-medication products as part of the broad national health strategy. www.asmi.com.au

Media contact: Bob Bowden, Foresight Communications (02) 9241 2811, 0412 753 298