Better regulating CMs

New complementary medicine health claims lack evidence, so why are they even on the table? asks Dr Ken Harvey

Dr Ken Harvey  is Associate Professor at the School of Public Health and Preventive Medicine, Monash University

Australia’s drugs regulator seems to be endorsing pseudoscientific claims about homeopathy and traditional Chinese medicine as part of its review of how complementary medicines are regulated.

In the latest proposed changes, the Therapeutic Goods Administration (TGA) is looking at what suppliers (also known as sponsors) can claim their products do, known as “permitted indications”. An example of a “low level” permitted indication might be “may relieve the pain of mild osteoarthritis”.

If approved, the suppliers can use this permitted indication to market its listed product, one of about 11,000 listed complementary medicines on the Australian Register of Therapeutic Goods (indicated by “Aust L” on packaging).

However, the spreadsheet of 1,345 draft permitted indications includes many that seem to lack evidence to back them.

Complementary medicines are the subject of the latest TGA review of permitted health claims. Author provided

For instance, despite the Therapeutic Goods Advertising Complaints Resolution Panel upholding complaints of a lack of evidence that magnesium (and homeopathy) “relieves muscle cramps (and restless legs)”, this permitted indication is on its draft list.

Other examples include “supports transport of oxygen in the body”, “regulates healthy male testosterone levels”.

The list contains around 140 traditional Chinese medicine indications, such as “Harmonise middle burner (Spleen and Stomach)”, “Unblock/open/relax meridians”, “Balance Yin and Yang”.

There are also around 900 additional indications for unspecified “traditions”. These include, “Renal tonic”, “Helps healthy liver regeneration”, “Emmenagogue”, “Vermifuge” and “Vulnerary”.

Endorsing traditional medicines without evidence they work

Australia is a multicultural society, and it’s appropriate we respect and have some knowledge of complementary medical traditions.

Some observations made in these traditions have led to valuable, efficacious medicines, such as Artemisinin derivatives isolated from a herb used in traditional Chinese medicine.

However, scientific investigation has not substantiated many other aspects of such traditions, such as the homeopathic principles of “like cures like” and traditional Chinese medicine concepts of meridians through which the life-energy known as “qi” flows.

We also cannot assume traditional medicines are safe, as emerging data highlights how common adverse reactions and drug interactions really are.

Just because complementary medicines are based on long-held traditions doesn’t mean they work or are safe, as international data show. Author provided

For example, Hyland’s homeopathic baby teething products were recalled by the US Food and Drug Administration and then the TGA. This was because lack of quality control over potentially toxic ingredients – belladonna alkaloids – associated with adverse events in hundreds of babies.

In China, out of the 1.33 million case reports of adverse drug event reports received by the National Adverse Drug Reaction Monitoring Center in 2014, traditional Chinese medicine represented around 17.3% (equivalent to around 230,000 cases).

What we propose

Listed medicines, like those mentioned, are meant to contain pre-approved, relatively low-risk ingredients. They should be produced with good manufacturing practice and only make “low-level” health claims for which evidence is held. However, the TGA does not check these requirements before the product is marketed.

So, to safeguard shoppers, consumer representatives (of which I was one), suggested the proposed list of permitted indications should be short and only contain modest claims such as, “may assist” or “may help”.

We also argued that, for consumers to make an informed purchase, claims based on “traditional use” should always have a disclaimer along the lines of what the US Federal Trade Commission uses for homeopathic products.

For example, “This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no good scientific evidence that this product works”.

However, industry representatives argued they needed a long list of permitted indications to allow consumers to tell the difference between one product and another. They also argued that disclaimers for traditional medicines were unnecessary. Their wishes made it to the draft list, rather than ours.

While we welcome moves to better regulate complementary medicines in Australia, this current list of permitted indications, without disclaimers, represents a government endorsement of pseudoscience.

Worse, it will encourage consumers to purchase often ineffective and sometimes dangerous products.

This article was originally published on The Conversation. Read the original article.

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  1. Ron Batagol

    I agree with the author.
    We shouldn’t be seen to endorsing pseudoscience. Better to have a strictly defined category of allowed phrases all with the caveat with something like” Not supported by validated research”.
    With mumbo-jumbo like homeopathy, a caveat like”Claims not supported by scientific evidence. Should not be used as alternative to medical management”. I would add, as I have (unsuccessfully) suggested to TGA in the past, that homeopathic products should NOT be allowed to be marketed for children or infants, because if the risk severe adverse outcomes in untreated and potentially serious infant or childrens’ illnesses, as has,sadly, occurred in the past.

  2. Jarrod McMaugh

    Creating a long list of permitted indications is stonewalling – the intent would seem to be to ensure that patients are confused, that the list could be expanded, and as stated that legitimacy is lent to the product by the existence of such a list.

    Evidence is available for some indications and some products currently regarded as CAM. Let these products be supported by this evidence. For others, warnings and disclaimers would be a minimum undertaking to ensure patients and consumers can make informed decisions.

  3. Ken Harvey

    The TGA is inviting comments on their draft list, although the main thrust seems to be encouraging industry to add more, see:

    Comments and proposals for new indications and new evidence qualifiers can be emailed to

    Apart from the problems listed in my article some might also to comment on the 15 indications for detox products, no 291-306 on the TGA list!

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