Caruso’s Natural Health Pty Ltd (Caruso’s Natural Health) has paid penalties of $12,600 in response to an infringement notice issued by the Therapeutic Goods Administration (TGA) within the Department of Health. The infringement notice was issued to the company for making a false or misleading certification that it held evidence to support some of the indications for the product Caruso’s Kids Eye Care.
Specifically, it claimed to hold evidence to support claims that the product:
- reduces free radicals formed in the body
- helps reduce/decrease free radical damage to body cells
- helps maintain/support eye macula health
- helps maintain/support eye retinal health
Sponsors of listed medicines must hold relevant evidence
At the time of listing a medicine on the Australian Register of Therapeutic Goods, sponsors are required to certify/confirm that they hold evidence for all the indications and claims made about their medicine. Unlike registered medicines, listed medicines are not subject to full pre-market scrutiny due to typically being low-risk, so the certifications that sponsors make in a listing application are critical to ensuring the safety and efficacy of the medicine.
Providing false or misleading certifications in a listing application, i.e. claiming that the medicine is effective without holding the appropriate evidence to support this claim, undermines the integrity of the listed medicines regulatory framework and exposes consumers to products that may not be safe or efficacious. Sponsors are reminded to undertake proper due diligence to ensure they hold sufficient evidence in support of their products before they are listed.
The TGA undertakes random post-market checks of the evidence
The TGA conducts post-market compliance reviews of listed medicines, with a proportion of these selected randomly using a computer algorithm. These reviews allow the TGA to determine whether listed medicines comply with relevant regulatory requirements, including the truthfulness and accuracy of the certifications a sponsor makes at the time of listing a medicine. Caruso’s Kids Eye Care was randomly selected for a compliance review which involved an assessment of the evidence held by the sponsor to support the efficacy of the medicine.
About infringement notices
The TGA can issue an infringement notice where it has reasonable grounds to believe a person or business has contravened the Therapeutic Goods Act 1989 (the Act). The payment of an infringement notice is not an admission of guilt or liability.