Australia to assess herbal ingredients and claims

Herbal medicines on the Australian market may need to be reformulated after the government's decision this week to back a wave of expert recommendations to tighten scrutiny of the complementary medicines sector.

The Australian government said it has backed most of the 49 recommendations from the Expert Committee on Complementary Medicines in the Health System, which was formed following the April 2003 recall of more than 1,600 products, many of them supplements, manufactured by Pan Pharmaceuticals.

The recommendations, published 18 months ago, include the introduction of quality standards for all ingredients used in herbal and complementary medicines, and new guidelines to verify claims made by companies.

"The complementary medicines industry is estimated to be worth over $800 million per year so it is vital that Australians feel confident in the industry and its products," said Australia's health secretary Christopher Pyne.

The government's response to the report said the toughest option would result in many products being reformulated or relabelled, or even removed from the market.

The report said that complementary medicines "typically contain a larger number of ingredients than prescription or over-the-counter medicines".

"Consequently, the identification of a particular ingredient as a potential cause of an adverse reaction is often far more difficult in a complementary medicine."

Under the recommendations, any ingredients suspected of causing foetal abnormalities will be banned from use other than in complementary products subject to the same scrutiny as that given to prescription drugs.

Among the positive points for industry, the medicines authority the Therapeutic Goods Administration (TGA) has also been asked to draw up a stakeholder group to identify incentives to encourage innovation and research in complementary medicines, including data protection and market exclusivity.

A database will be established to identify researchers and centres of excellence to carry out complementary medicines research in Australia and there will also be action to create greater awareness among all health professionals and consumers of the potential for complementary medicines to interact with other medicines.

The government's response to the recommendations are published on the TGA website.