Herbal medicines sold legally in Australia assured of high quality

16 October 2013

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16 October 2013 - Consumers can continue to have confidence in the quality and safety of complementary medicines (herbal medicines, nutritional and dietary supplements) that are legally sold in Australia, the Australian Self Medication Industry (ASMI) has today advised.

ASMI's comments follow a study published in BMC Medicine which showed herbal medicines that are available in North America frequently contain unlisted ingredients that could pose health risks.1

"Two-thirds of all Australians use complementary medicines regularly to optimise their health and wellbeing and to address a range of chronic conditions, with popular examples being fish oil, St John's Wort and glucosamine," said ASMI Regulatory and Scientific Affairs Director, Steve Scarff.

"Consumers can be assured that the Australian complementary medicines industry is one of the most tightly regulated in the world, with all products subject to stringent regulations relative to their risk profile. Unlike many other countries in the world, Australia ensures that complementary medicines are manufactured safely and only contain approved, safe ingredients."

Australia has a two-tiered system for the regulation of medicines, including complementary medicines. Prior to sale, supply or use, higher risk medicines must be 'Registered' on the Australian Register of Therapeutic Goods (ARTG), which involves individually evaluating the quality, safety and effectiveness of the product. Lower risk medicines containing pre-approved, low-risk ingredients and that make limited claims can be 'Listed' on the ARTG.2

The majority of complementary medicines are 'Listed' on the ARTG because of their low-risk ingredients. Both Registered and Listed medicines must be manufactured to very high standards of quality.

"When a consumer purchases any approved complementary medicine in Australia, they can have confidence that the ingredients listed on the label are, without doubt, contained in the product. Unfortunately, it's a very different picture in many other countries."

"This is why Australians are advised not to order medicines, including dietary supplements and herbal preparations, over the Internet unless they know exactly what is in the preparation and have checked the legal requirements for importation and use in Australia."

Unlike in Australia, there are currently no legal standards for authentication of herbal products in the United States, which has contributed to an environment of unethical activities within the industry including false advertising, product substitution, contamination and use of undeclared and potentially allergenic fillers.1
While the internet can offer consumers a convenient way to access therapeutic goods, the TGA advises that online purchases of medicines or medical devices should be approached with caution. Products available on international websites are not regulated by the TGA. If care is not taken, consumers may inadvertently break the law, waste their money or risk their health.2

As with all medications, it is important that consumers follow the label instructions and consult with their healthcare practitioner if they have any concerns.
Media contact: Michelle Sollitt-Davis - ASMI PR Manager
Ph: 02 9923 9410 | M: 0422 084 951 | Email: michelle@asmi.com.au

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

1. Steven G Newmaster et al. DNA barcoding detects contamination and substitution in North American herbal products. BMC Medicine 2013, 11:222.
2. Therapeutic Goods Administration (TGA). Buying medicines and medical devices over the