March 2005

Australia raises regulatory bar on herbal products

The Therapeutic Goods Administration (TGA) of the Australian government is planning to demand a “much more rigorous assessment” of all herbal and homeopathic ingredients used in complementary medicines.

The announcement was part of the government’s response to recommendations from an Expert Committee on Complementary Medicines in the Health System. That committee was formed in the aftermath of an April 2003 recall of more than 1,600 medicines (including products regulated as dietary supplements in the United States) manufactured by Pan Pharmaceuticals, a Sydney manufacturer.

The committee assessed the regulatory, health system, and industry structures for complementary medicines in Australia, and published its report 18 months ago (see http://www.tga.gov.au/docs/pdf/cmreport.pdf).

The government accepted nearly all of the committee’s 49 recommendations, expanding upon each in its response document. They include reviewing homeopathic and herbal medicines, raw herbs and other ingredients, and implementing new guidelines to verify claims. Further, quality standards for all ingredients used in complementary medicines will be enforced, and any ingredients suspected of causing fetal abnormalities will be banned from use other than in complementary products subject to the same scrutiny as that given to prescription drugs.

The government is to establish a database to identify researchers and centers of excellence on complementary medicines, and take more action to ensure consumers get reliable product information.

The TGA posted the full response document on its website at http://www.tga.gov.au/cm/cmresponse.pdf.

Source: American Herbal Products Association, www.ahpa.org

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