‘Low risk’ product reform under question

“Ear candles (and candling) are ineffective and dangerous,” say Dr Ken Harvey and Dr Prasad Ranaweera.

Not everyone is happy with the options for regulatory reform being proposed by the TGA, with some calling for stricter rules

The TGA is currently looking to reform the regulations surrounding low-risk products, including homeopathic and complementary medicines.

It has recently conducted a consultation into the issue, after an expert panel suggested a further review into low-risk products.

The panel had expressed concern that “there are a range of products listed in the ARTG that are subject to a level of regulation which is not commensurate with the risk posed by these products to Australian consumers”.

Some product types, for example ear candles, were objectively confirmed as low or very low risk by the TGA, and were used as candidates for exploring recommendations in the consultation.

I object!

Associate Professor Dr Ken Harvey from Monash University, and Sri Lankan Department of Health Fellow Dr Prasad Ranaweera, vehemently disagree with the TGA’s conclusion that products such as ear candles are “low risk” products.

“Ear candles (and candling) are ineffective and dangerous,” they write in their combined submission to the TGA, which has been endorsed by the Friends of Science in Medicine.

They add that the TGA should ensure a prominent warning is provided on packaging, labelling and promotional materials regarding ear candles:

Warning: these products do NOT remove wax and other impurities from the ear and have been associated with INJURY including burns, ear drum perforations and ear canal infections.

“Neither the current promotion of these products, nor their ARTG Public Summary documents point out these dangers,” they say.

In addition to ear candles, other products deemed low risk included: nappy rash creams; antiperspirants; hard surface disinfectants; sunscreens; tampons and menstrual cups; and low-risk OTC products such as antiseptics for first aid, lozenges for sore throat relief, antacids etc.

The conclusion that the products identified posed little or no risk to consumers appeared to largely depend on the direct risk or harm these products might produce, say Dr Harvey and Dr Ranaweera.

“Indirect harm caused by misleading, unbalanced or incorrect claims did not appear to be considered,” they say, “the latter more commonly harming consumers through delaying their access to more evidence-based products, sometimes to the detriment of their health, and by imposing unnecessary costs.”

Homeopathic products

As at February 2017, there were 142 homoeopathic preparations entered in the ARTG. The number of exempt homeopathic preparations currently on the market in Australia is unknown.

There are issues of questionable evidence and inconsistency in regulation over claims being made with regards to homeopathic products, admits the TGA.

It has suggested four main decision options regarding regulatory reform for homeopathic products:

  • Maintain the status quo regulation of homoeopathic products;
  • Serious therapeutic claims must be supported by scientific evidence;
  • Exemption from listing in the ARTG and/or GMP; or
  • Declare homeopathic products not to be therapeutic goods.

Dr Harvey and Dr Ranaweera argue that the above options fail to provide a viable solution to the problems outlined.

Firstly, they say that maintaining the status quo fails to address the problems with homeopathic products and implies government endorsement of non-evidence-based products.

Secondly, they argue that the suggestion that serious therapeutic claims must be supported by scientific evidence is “absurd“.

“There is no evidence supporting homeopathic products making serious therapeutic claims,” say Dr Harvey and Dr Ranaweera.

Exemption from listing could result in a greater range of products and also runs a greater risk of sub-standard products.

And if homeopathic products are declared to be non-therapeutic goods, they will come solely under the auspices of the ACCC—”given the workload of the ACCC this would effectively mean no regulation at all”, say Dr Harvey and Dr Ranaweera.

While the TGA should retain responsibility for regulating these products as a specialist regulation, its suggestions are not effective for such products, they say.

“In short, the consultation document fails to document many long-standing concerns about the supply and promotion of homeopathic products and, in our opinion, fails to provide a viable solution to the problems outlined.”

They suggest that homeopathic products should come with mandatory disclaimers/warnings, for example:

Warning: This product’s traditional claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts. There is no scientific evidence that this product works.

Vitamins & minerals

Vitamins and minerals sold in supermarkets, health food stores and some pharmacies demonstrate problems of unsubstantiated claims, and sometimes fail to identify key ingredients such as sugar and salt, say Dr Harvey and Dr Ranaweera.

This lack of correct labelling does not allow consumers to properly limit their consumption as advised by the World Health Organization and other authorities, they say.

Essential vitamins and minerals are also readily available in foods as attained through a balanced diet.

Voicing their concerns over the TGA’s suggestions for regulatory reform, the doctors argue that more needs to be done to protect consumers through:

  • Mandatory product warnings;
  • More stringent post-marketing surveillance;
  • Higher penalties for regulatory non-compliance; and
  • Education of the public and non-registered health practitioners.

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