Government goes against ACCC and expert advice in exempting nappy rash products and tampons from strict regulations, and excluding ear candling from the ARTG

Following a TGA consultation into options for future regulation of “low risk” products, the government has decided to exclude antiperspirants and ear candles from the therapeutic goods framework.

Prior to these changes, ear candles were regulated by the TGA as listed other therapeutic goods and required entry in the ARTG.

These products will now be primarily governed by Australia Consumer Law (ACL), administered by the Australian Competition and Consumer Commission (ACCC).

In its submission to the consultation, the ACCC warned that while its role is to identify and prevent supply of unsafe consumer goods, it would not be able to provide the same level of regulatory oversight of therapeutic products if they were excluded from the TGA’s regulatory framework.

“The ACCC is concerned that a regulatory gap may emerge for the following ‘low risk’ products if they are excluded from the TGA – ear candles, nappy rash cream, antiperspirants, hard surface disinfectants, sunscreens, tampons and menstrual cups, vitamins and minerals, aromatherapy and homeopathic products,” it says in its own submission to the consultation.

“While the ACCC is an effective regulator with a broad remit … the ACCC cannot replicate the focus and expertise that a specialist regulator like the TGA delivers.”

Public health professor and consumer advocate Dr Ken Harvey Dr Harvey aligned with the ACCC position, calling for the TGA to maintain regulatory responsibility over all products considered in the consultation.

He said the TGA should retain responsibility for products such as ear candles but ensure that prominent warnings of potential injury are provided on ARTG documents, product packaging, labelling and promotion.

“We advocate that the TGA, as a specialist regulator, retains responsibility for regulating the products we have identified,” he wrote in a submission with co-author and Monash University colleague Dr Prasad Ranaweera.

“However more needs to be done to protect consumers by the application of mandatory product warnings, more stringent post-marketing surveillance, higher penalties for regulatory non-compliance, and the education of the public and non-registered health practitioners who often inappropriately promote and use these products.”

Meanwhile tampons and menstrual products, nappy rash treatments and hard surface disinfectants will become exempt from specified regulatory requirements.

This means they are still therapeutic goods and fall under the TGA’s oversight, but with exemptions from meeting certain legal requirements, which represents a considerably lower regulatory burden.

In its submission to the consultation, the PSA said it “understands the concerns that low-risk nappy rash and skin care products may be seen to be over-regulated”.

However it adds that: “The products themselves may be classified as low risk but they are intended for use in a young and vulnerable patient group.

“In addition, treatment options are wide-ranging and an optimal therapeutic regimen may involve a combination of a low risk product and a registered (higher risk) product and hence, require careful consideration regarding suitability for each individual.”

Under the changes, products that will retain the same level of regulation include water soluble vitamins and minerals.

Vitamin and mineral products currently covered by the regulatory scheme will continue to be treated as complementary medicines and regulated as either listed or registered medicines under Therapeutic Goods Act 1989.

The PSA stated in its submission that while some vitamin and mineral products may pose relatively little safety risk and could be considered as food supplements, the effects of some may be significant depending on factors such as dosage, patient medical history or contraindications.

For these reasons, PSA indicated that regulatory consideration of vitamins and minerals “would need to be determined on a case-by-case basis”.

PSA also recommended removal of homeopathic products from the ARTG and to allow for their regulation as consumer goods, consistent with its position that homeopathic products have no evidence base for efficacy.

“PSA has stated that it does not support the sale of homeopathy products in pharmacy,” it added in its submission.

The Government is yet to determine what would be an appropriate level of regulation for aromatherapy and homeopathic products. Further consultation with affected stakeholders may be required, it says.

See more about the changes here