Pharmacare Laboratories is facing a new complaint about its Kids Smart homeopathic medicines amid concerns parents who use the products may delay seeking medical treatment.
The complaint – lodged by a group of oranisations including CHOICE to the Australian Competition and Consumer Commission (ACCC) – alleges promotion of the Kids Smart products implies they are effective in ways that have not been established.
Complainants also claim that the promotion of homeopathic “Kids Smart Calm” for “restlessness, anxiety, irritability and agitation” is inappropriate and dangerous as these symptoms can signify potentially serious childhood infectious diseases such as bacterial meningitis that require medical attention.
Promoting homeopathic “Kids Cold and Flu” and “Kid Pain & Fever” remedies as “effective” against “fever, sore throat and body aches and pain” is also likely to deny children genuinely effective medication such as paracetamol, which can relieve these symptoms. The same holds for the homeopathic “Hayfever” remedy.
Over the past three years, Pharmacare Laboratories have had a least 16 complaints upheld by the Therapeutic Good Administration’s Complaints Resolution Panel (CRP), including a number of recommendations to the delegate of the secretary for non-compliance with CRP requests. Indeed, this company appears to treat the regulatory system with contempt.
The complaint notes that in determination 2011/10/027, the CRP requested Pharmacare Laboratories to publish a retraction and withdraw representations made about claims for its Kids Smart range of homeopathic medicines because it breached a number of provisions of the Therapeutic Goods Advertising Code.
Other upheld complaints about the Kids Smart product range include 2011/10/011, 2011/10/011, 2011/09/043 and 2011/09/044. Pharmacare Laboratories has declined to comply with any of these determinations. And it continues to make the same claims on its website promoting these products.
Pharmacare Laboratories’ behaviour shows the impotence of the CRP (which has no power to enforce their determinations) and also the TGA (which has never taken a company to court for non-compliance with its Regulation 9 advertising orders).
It also highlights the importance of the TGA addressing recommendation 2c of the recent advertising consultation, “Develop a more effective approach to sanctions and penalties (including use of the infringement notice provisions)”, which currently appears to have no timeline.
The case illustrates long-standing and fundamental flaws in the regulation of homeopathic medicines in Australia. Homeopathic preparations more dilute than a one thousandfold dilution of a mother tincture are currently exempt from the Australian Register of Therapeutic Goods (ARTG).
This means that the TGA has no power to de-list or otherwise remove the above products from the market despite their gross advertising violations.
In April 2003, the Australian Expert Committee on Complementary Medicines in the Health System recommended that, “Homeopathic medicines and related medicines making therapeutic claims be regulated to ensure they meet appropriate standards of safety, quality and efficacy.”
In 2008, the TGA conducted a consultation on the “Regulation of homeopathic and anthroposophic medicines in Australia”. It was proposed that, “all homoeopathic and anthroposophic medicines must be included in the ARTG, regardless of the final concentration of the ingredients (subject to separate exemptions which will apply to homeopathic and anthroposophic preparations supplied directly to a practitioner for extemporaneous dispensing or compounding)”.
But the issue appears to have dropped off the TGA’s agenda. Despite the concern expressed by many submissions to the TGA transparency and advertising reviews, there’s no mention of homeopathic or anthroposophic medicines in the 2011 TGA Reform document.
The listing of these medicines needs to be pursued because the TGA’s failure to act on these matters has resulted in increasing proliferation of homeopathic products being promoted to the public with claims of efficacy that aren’t substantiated by scientific research.
This problem isn’t limited to Australia – see “Homeopathic Insect Repellent: Is there anything the Canadian Natural Health Products Directorate won’t approve?”
Submissions by many consumers and health professionals to recent TGA consultations noted that the continued inaction on such matters meant the community has lost trust in the TGA. The TGA was asked to address these important regulatory matters without further delay.
Given the ongoing impotence of the CRP and TGA, the ACCC has now been asked to take action against Pharmacare Laboratories on the grounds that the ongoing promotion of their Kids Smart range of homeopathic medicines involves misleading and deceptive conduct and is in breach of Australian Consumer Law (Competition and Consumer Act, 2010).