Caruso’s Natural Health has been fined $12,600 for making false claims about holding evidence to support indications on their Caruso’s Kids Eye Care product.
The product made claims about reducing free radicals formed in the body, reducing damage caused by free radicals, and supporting macula and retinal health. The TGA issued the infringement because it found that Caruso’s made a false or misleading certification that it held evidence to support these indications.
This signals a strengthening of the TGA’s approach to non-complaint listed medicines.
The TGA said:
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.
You can read more on the TGA website.
If you are concerned that your products could be non-compliant, please do not hesitate to contact us to discuss your concerns, or find out more about us.