Articles

We have issued 2 infringement notices totalling $37,560 to Booty N Buff Nutrition Caringbah Pty Ltd (Booty N Buff Nutrition) for the alleged unlawful advertising of therapeutic goods in contravention of the Therapeutic Goods Act 1989 (the Act).

We have issued 2 infringement notices totalling $7,716 to a Queensland-based individual for the alleged unlawful importation of counterfeit botulinum toxin type A and the unlawful advertising of cosmetic injectables.

We have issued 5 infringement notices, totalling $19,800, to a NSW-based individual, for the alleged unlawful importation of unapproved prescription-only medicines in contravention of the Therapeutic Goods Act 1989.

We will implement process enhancements to the Prescription Medicines Minor Variation (PMMV) form by 31 January 2026.

We have issued an infringement notice, to the value of $19,800, to PERDAY'S HEALTH FUNCTIONAL FOOD (AU) PTY LTD (Perdays Australia) for the alleged unlawful advertising of a listed medicine.

The TGA has updated its Advertising therapeutic goods on social media guidance to help advertisers to understand their responsibilities when promoting therapeutic goods via these platforms.

We have issued 5 infringement notices, totalling $99,000, to ACPharm Queensland Pty Ltd (ACPharm Queensland) for the alleged unlawful advertising of therapeutic goods.

The delegate believes, on reasonable grounds, that it is in the interests of public health or safety to give Hwangbo SS Pty Ltd and [REDACTED] directions under section 42YT of the Therapeutic Goods Act 1989.

We have issued a warning to online delivery service providers not to breach Australian laws regarding the supply and advertising of vaping goods.

A coordinated crackdown on illegal vapes in southeast Queensland has led to a seizure of illegal vaping and tobacco products with a street value exceeding $8.8 million.

This Legislation Amendment makes changes to the way testing of goods is conducted under the Therapeutic Goods Regulations 1990.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2025, which commenced on 19 September 2025.

The TGA has identified a discrepancy between the wording of the ‘POTAS1’ warning statement available in the Code Tables compared to the requirements for potassium chloride and glucosamine sulfate potassium chloride in the Therapeutic Goods (Permissible Ingredients) Determination (the Determination).

The TGA has issued a direction notice to Cholrem Pty Ltd and its executive officer to cease advertising a therapeutic good not entered in the Australian Register of Therapeutic Goods (ARTG). They were also directed to cease advertising such goods in a way that contravened the Therapeutic Goods Advertising Code, and for indications relating to heart disease and stroke, amongst others.

We have issued 10 infringement notices, totalling $198,000, to Midnight Health Pty Ltd (Midnight Health) for the alleged unlawful advertising of prescription-only weight-loss medicines.

We have accepted a court-enforceable undertaking from Midnight Health Pty Ltd in relation to the alleged unlawful advertising of prescription-only weight-loss medicines.

There has been an increase in Australians purchasing melatonin products from online stores, particularly for use in children. These products are often sold as gummies but are also available as tablets or capsules marketed as dietary supplements.

A blitz undertaken on Chapel Street retailers over two days this week has resulted in seizures of illegal vaping goods with a street value of over $40,000 and more than 24,000 nicotine pouches.

We have issued 3 infringement notices totalling $11,268 to a Victorian-based individual for allegedly importing unapproved prescription-only medicines.

We initiated targeted compliance reviews of selected listed medicines containing Lysine Hydrochloride to verify whether sponsors had appropriate evidence to support their cold sore-related claims.

A review of the GMP Clearance backlog reduction strategies that have been implemented and ongoing monitoring and reporting communication.

We have issued 6 infringement notices, totalling $118,800, and a direction notice to Dispensed Pty Ltd (Dispensed) for the alleged unlawful advertising of medicinal cannabis.

As per our previous statement on 21 August 2025, the TGA is currently investigating a CHOICE report on Sunscreen SPF testing. This update provides information for consumers.

We have published a list of medical devices in the ARTG that incorporate artificial intelligence (AI) or machine learning (ML) technologies.

Know how we manage compliance of AI and software products that meet the definition of a medical device.