TGA Provides Latest Guidance on Medicine Label Requirements

This guidance is to help sponsors and manufacturers of medicines meet the Australian labelling requirements described in the new labelling Order TGO 92 (for non-prescription medicines).  The transition period for this Order ended on 31 August 2020. Non-prescription medicines (which includes all complementary medicines) that are released for supply on or after 1 September 2020 must comply with TGO 92.   Source: Medicine labels

TGA Lists Disinfectants for use against COVID-19 in the ARTG for Legal Supply in Australia

Claims that a disinfectant has an effect against any virus must be expressly permitted by the TGA before being used in consumer advertising (including on the label). In response to the COVID-19 pandemic, the TGA has permitted SARS-CoV-2 and COVID-19 virus claims. The following list is comprised of disinfectant products that have been entered into the Australian Register of Therapeutic Goods (ARTG) with specific claims against SARS-Cov-2 or COVID-19 on the product label.    Source: Covid sanitiser list    (Please see also story by consumer group CHOICE rating the efficacy of alcohol-based hand sanitisers ).

Post-Market Review of Face Masks: Overview

The Therapeutic Goods Administration (TGA) is undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). This page introduces the review and provides guidance for suppliers and users of face masks.    Source: Face-mask review.    (Please see also face-masks non-compliance notices ).

Medicine Advertiser Reminder: Additional Allergen Warnings Effective 1 September 2020

The TGA is reminding advertisers that additional mandatory health warnings for medicines containing specific allergens are required in certain advertising from 1 September 2020. The allergens, including tree nuts and tree nut products, are specified in Part of 4 of Schedule 1 of the Therapeutic Goods Advertising Code (No.2) 2018 (the Code).    Source: Allergen label warnings

Oxymed Australia Director Now in Court for Unlawful Advertising and Ignoring TGA Orders

The TGA has initiated proceedings in the Federal Court of Australia in response to Oxymed Australia Pty Ltd and its sole director, Mr Malcolm Hooper, for the alleged unlawful advertising of hyperbaric oxygen-therapy chambers. The TGA alleges the advertising promoted the devices for the treatment of serious diseases and medical conditions, including coronavirus (COVID-19), cancer, post-traumatic stress disorder and autism spectrum disorders. The TGA recently issued Oxymed Australia with five infringement notices totalling $63,000 in relation to alleged unlawful advertising. Oxymed Australia did not pay the infringement notices, and the alleged unlawful advertising continued to be present on the Oxymed Australia website after the notices were issued.     Source: Oxymed director charged

Brisbane Company Director in Court for Alleged Illegal Activity Relating to Performance Enhancing Drugs

The TGA has initiated criminal court proceedings in response to alleged breaches of the Therapeutic Goods Act 1989 by Brisbane-based company HEALTHHUB247 PTY LTD and its director. The court will hear thirty-five charges in relation to the alleged manufacture, counterfeit, supply and advertising (across the company's website, eBay, Facebook and Instagram) of performance enhancing products including Selective Androgen Receptor Modulators (SARMs). Under the Act, the manufacture and supply of therapeutic goods that are likely to result in harm or injury to any person attracts a maximum penalty of 5 years imprisonment and/or a fine of $888,000 for offences occurring on or after 1 July 2020. The Act also provides for similarly significant penalties for unlawful advertising and dealing with counterfeit goods where harm or injury is likely to result.     Source: Healthhub247 charged    (Please see also: TGA page to report breaches or questionable practices ; How to spot a dodgy health product advertisement )

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TGA and ACCC Continue Crackdown on Companies Seeking to Profit on COVID-19 ‘Therapies’

The TGA and the Australian Competition and Consumer Commission have been kept busy in recent months as they continue their prosecution of people and companies that use the Coronavirus pandemic in their product advertising:

Markson Sparks fined $26,640 for alleged unlawful advertising of a medical device in relation to COVID-19

Notice of Final Decision to Amend the Current Poisons Standard in Relation to Melatonin

Melatonin is currently approved for monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over. The Schedule 3 entry has been modified to more closely align with the TGA approved indication (in the interests of public safety) through the inclusion of 'monotherapy' and restriction to short-term use in the entry. The decision to restrict the indication for a melatonin medicine to monotherapy was made on the basis that the available data are not adequate to support use in combination with other hypnotic agents. Additionally, it was recommended that treatment should be limited to a maximum duration of three weeks consistent with the evidence from the pivotal efficacy study, Neurim VII.     Source: Melatonin scheduling

TGA Targets Listed Medicines at Risk of Containing Safrole

Safrole is a naturally occurring constituent at low concentrations in certain spices including sassafras, cinnamon, nutmeg, mace, star anise and black pepper. Prior to 1960, safrole was used extensively as a flavouring additive. However, animal and in-vitro studies have shown its genotoxic and carcinogenic effects, on the basis of which the use of safrole as a food and flavouring additive became strictly regulated. There are 12 ingredients approved for use in listed medicines, which may contain safrole as a constituent. Listed medicines including one or more of these ingredients could therefore be at risk of containing safrole in concentrations above the permitted limits. Listed medicines must contain no more than 0.1% of safrole when it is for internal use, and no more than 1% when it is for topical application. Listed medicines may be subject to a compliance review at any time while they remain on the Australian Register of Therapeutic Goods (ARTG). The TGA intends to determine the compliance of medicines at risk of containing safrole with relevant requirements by undertaking targeted compliance reviews.     Source: Safrole risk    (Please see also educational resources at Compliance and education for listed medicines”)

TGA Declares Certain Products Presented as Formulated Supplementary Sports Foods to be Medicines

In Australia, a sports supplement can be legally classified as either a food or a medicine. How it is classified depends on factors including the product's ingredients, marketing claims and how it is presented (including the dosage form - pill, food bar, powder etc.). Many sports supplements are appropriately marketed as Formulated Supplementary Sports Foods in Australia. However, some contain ingredients that have stimulant or other drug-like effects, such as changes to hormone levels, or are in a medicinal dosage form (e.g. tablets, pills and capsules). These products can present a higher risk to the consumer and it is therefore inappropriate to have them available for purchase as foods. A declaration has been made providing legal clarification on which sports supplements are considered therapeutic goods in Australia.   Source: Sports supplements.

Interim Decision in Relation to CBD Supply

The TGA has recently announced its interim decision to down-schedule cannabidiol to Schedule 3 status. The ruling allows for CBD to be administered as an oral, oral-mucosal or sub-lingual preparation for therapeutic use on pharmacist’s advice – no doctor’s prescription required. Total cannabinoids must comprise at least 98% CBD with the remainder being sourced from the cannabis plant only and not elsewhere. The maximum recommended daily dose has been capped at 60 mg, which many consider to be a conservatively low-dose. The real catch is that any proposed CBD products can only be supplied to the Australian market after they have been put on the Australian Register of Therapeutic Goods (ARTG). Hopeful sponsors may have trouble finding the mandatory ‘high-level evidence’, using the maximum 60 mg daily dose, required to receive product listing on the ARTG.    Sources: CBD consultation submissions ; CBD scheduling decisions ; CMA response to CBD rescheduling  (If more cannabis research is required: NHMRC medicinal cannabis clinical trials grant opportunity )

TGA Safety Advisory - Bufexamac Runs Risk of Serious Skin Reactions

Bufexamac is an over-the-counter non-steroidal anti-inflammatory drug, which is used in combination with chlorhexidine and lidocaine (lignocaine) in first aid creams that are applied to the skin. Consumers and health professionals are advised that first aid creams containing bufexamac were removed from the Australian Register of Therapeutic Goods (ARTG) on 18 September 2020 and can no longer be sold in Australia. Bufexamac is associated with a risk of serious skin reactions (also known as allergic contact dermatitis). The TGA has also determined that there is inadequate evidence that the bufexamac ingredient in these products is effective.    Source: Bufexamac removed

TGA Safety Advisory - Manasmithra Vatika (Manasamitram Pills) Ayurvedic Medicine

Ayurvedic medicines are a type of complementary medicine (sometimes known as 'traditional medicine') originating from India. The TGA is aware that Manasmithra Vatika was supplied to practitioners and patients in NSW and Victoria and is investigating a report of the presence of dangerous levels of lead and other heavy metals in this product.    Source: Heavy metal contamination

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