The Therapeutic Goods Administration (TGA) has issued twelve infringement notices totalling $151,200 for the alleged unlawful advertising of Miracle Mineral Supplement (also referred to as Miracle Mineral Solution) (MMS) and other medicines by Southern Cross Directories Pty Ltd trading as MMS Australia. The TGA is concerned about the harmful effects that can be caused by the ingestion of MMS, and has published an updated safety alert to warn consumers about claims made online about Miracle Mineral Solution (MMS) for the treatment, cure, prevention or alleviation of disease, including COVID-19.
There is no clinical, scientifically-accepted evidence showing that MMS can cure or alleviate any disease. The use of MMS presents serious health risks, and can result in nausea, vomiting, diarrhoea and severe dehydration, which in some cases can result in hospitalisation.
As MMS Australia has promoted a number of its products as being for therapeutic uses, the products are subject to the regulatory framework established under the Therapeutic Goods Act 1989 (the Act) and administered by the TGA.
Therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied or advertised in Australia unless they are subject to a relevant exemption, approval or authority.
The infringement notices were issued based on alleged contraventions of the Act and the Therapeutic Goods Advertising Code (No. 2) 2018 in relation to advertisements that:
- referred to therapeutic goods not entered in the ARTG
- included prohibited representations (e.g. HIV/AIDS and cancer)
- included restricted representations (e.g. diabetes, Parkinson’s and arthritis)
- implied that a health practitioner had endorsed a product, and/or
- included a testimonial where the person giving the testimonial appears to be directly involved with the production, sale, supply or marketing of the goods.
The TGA takes action concerning unlawful activity
The TGA regulates all medicines, medical devices and biologicals under the Act. The regulatory scheme is important to the safety of Australian consumers, and the TGA investigates suspected illegal activity relating to therapeutic goods.
The TGA is monitoring non-compliance, particularly in relation to the advertising of products that claim to prevent or cure COVID-19 and will continue to take action in relation to any advertisements that do not meet the requirements.