Face Masks and Respirators that are Regulated by the TGA

This advice provides consumers, health professionals, and state and territory government officials with guidance to help determine when a face mask is a medical device and therefore must be included in the Australian Register of Therapeutic Goods (ARTG). Non-sterile face masks (including respirators) that are intended, by their manufacturer, to prevent the transmission of disease between people, or are intended to be used in a healthcare environment, are medical devices and are regulated by the TGA. Face masks which are non-sterile and designed as safety or personal protective equipment (PPE) for use in the home or for recreational or occupational activities, and do not make healthcare claims, are excluded from regulation by the TGA under the Therapeutic Goods (Excluded Goods) Determination 2018.  However, labelling, or other information accompanying a face mask which identifies the mask as 'not for medical use' does not preclude it from being a 'medical device'.   Source: Face-mask regulation   (For a comprehensive review of all Coronavirus (COVID-19) information on medicines and medical devices, the TGA has published this helpful page: https://www.tga.gov.au/collection/covid-19 )

Complaints Handling for the Advertising of Therapeutic Goods to the Australian Public

As the rules related to the advertising of therapeutic goods continues to perplex many sponsors of medicines and medical devices, the Therapeutic Goods Administration has dedicated an extensive summary of supplier’s responsibilities and the reasoning these regulations. To protect the health and safety of Australian consumers, the advertising of therapeutic goods is subject to the 2018 Therapeutic Goods Advertising Code. Consumers are also protected from false or misleading advertising of products and services by the Competition and Consumer Act 2010, administered by the Australian Competition and Consumer Commission (ACCC), and associated state and territory laws. The ACCC also prioritises product safety issues which have the potential to cause serious harm to consumers.    Sources: Advertising complaints handling ; Advertising education

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Review of the Therapeutic Goods Advertising Framework

The independent review of the advertising framework, led by Ms Rosemary Sinclair AM, has now concluded, with 22 recommendations which have all been accepted by the Australian Federal Government. The recommendations and outcomes are of relevance to all who engage with therapeutic goods advertising, including advertisers (sponsors, retailers, and other advertisers) and consumers. Key outcomes of this review indicate that the TGA will remain as the single complaints-handling body, which will introduce an updated complaints model and performance measures.    Source: Advertising framework review

Applications for New Substances in Listed Medicines

This guidance is for applicants requesting evaluation of a substance for use as an ingredient in listed medicines [AUST L listed medicines and AUST L(A) assessed listed medicines]. All listed medicines may only contain ingredients included in the Therapeutic Goods Permissible Ingredients Determination. Applications for evaluation of a substance to be used in listed medicines are categorised into four application levels (IN1, IN2, IN3 and IN4). Each application category has defined submission requirements. Less supporting information is required and shorter evaluation times apply to lower level applications.     Source: New substance application 

TGA Consultation: Permissible ingredients Changes Focus on Magnesium salts and Andrographis Herb

The purpose of this consultation is to provide an opportunity for consumers, health professionals, industry and other interested parties to comment on these proposed changes which are due to commence on 1 March 2021. Firstly, the TGA is proposing new restrictions for listed medicines, not indicated for laxative use, where those medicines contain higher doses of easily dissociable magnesium salts. Secondly, Andrographis paniculata is a herb commonly used in Indian and Chinese medicine and the TGA has advised that evidence indicates an association between Andrographis paniculata and loss of taste/taste disturbance, which may require further warnings on all labelling.    Source: Permissible ingredient consultation

Notice of Final Decisions to Amend the Current Poisons Standard

Of particular interest to sponsors of herbal products with ingredient herbs containing beta-arbutin (such as Bearberry - Arctostaphylos uva-ursi and Turnera diffusa – Damiana), is the introduction of acceptable limits for arbutin in listed medicines. Under the new changes, beta-arbutin has been classified as a Schedule 4 (Prescription Only) medicine and a Schedule 6 Poison EXCEPT when in oral preparations that are herbal preparations containing 500 mg or less beta-arbutin per recommended daily dose. The change in Scheduling will be effective from 1 October 2020.   Source: Pages 14-15 of this PDF Arbutin re-scheduling

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:

Companies fined for alleged unlawful importation and advertising of covid-19 infrared thermometers

Australian companies, Beauty Group Pty Ltd and VeraTemp Pty Ltd for the alleged unlawful importation and advertising of medical devices in relation to COVID-19.   Source: COVID19 thermometer fines

A “quantum physics” based medical device that he claims prevents the transmission of the COVID-19 virus

Celebrity publicist Max Markson is under investigation by the health regulator.   Source: Quantum healing

Cleaning company fined for unlawful advertising of a disinfectant product in relation to COVID-19

Melbourne-based company Yarra Valley Cleaning Co Pty has been issued three infringement notices totalling $39,960 for unlawful advertising of a disinfectant product in relation to COVID-19.    Source: Disinfectant

Sydney company fined for unlawful importation of KN95 face masks in relation to COVID-19

Sydney-based company, GenesisCare Clinical CRO Pty Ltd, has been issued an infringement notice for $12,600 for the alleged unlawful importation of KN95 face masks in relation to COVID-19.   Source: Face-masks 1

Brisbane company fined for unlawful importation of medical face masks in relation to COVID-19

Brisbane-based company Cordelia International Pty Ltd has been issued an infringement notice for $13,320 for the alleged unlawful importation of medical face masks in relation to COVID-19.    Source: Face-masks 2

TGA Clarifies the Use of Disinfectants During Coronavirus Pandemic

This page provides guidance for new sponsors in relation to the supply, import, and export of disinfectant products. Some sponsors may be seeking to supply disinfectants for the first time during the COVID-19 pandemic. This page answers frequently asked questions for new sponsors in relation to the supply, import, and export of disinfectant products. This page provides consumers with answers to frequently asked questions in relation to disinfectants.

Adelaide Woman Fined $5,040 for Alleged Unlawful Importation of Cosmetic Injectables

The TGA, has issued two infringement notices totalling $5,040 to an Adelaide woman for the alleged unlawful importation of cosmetic injectables. As part of a TGA compliance initiative, the Australian Border Force detected and intercepted two separate deliveries of imported cosmetic medical devices. The woman allegedly imported medical devices that were not, at the time of the relevant importation, included in the Australian Register of Therapeutic Goods (ARTG) and those goods were neither exempt nor excluded from the operation of the Therapeutic Goods Act 1989 (the Act). Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully imported and supplied in Australia.    Source: Cosmetic import fine    (See also related background information regarding TGA penalties and how they are calculated and administered: TGA infringement notices )

Product Recall - BioCeuticals Vitamin D3 Drops Forte Liquid 20mL

Consumers and health professionals are advised that FIT-BioCeuticals, in consultation with the TGA, is undertaking a recall of one batch of BioCeuticals Vitamin D3 Drops Forte Liquid 20 mL due to inconsistent mixing of the medicine. A manufacturing issue led to some samples from the batch being insufficiently mixed and separating into its component liquids. The variation in Vitamin D3 content across the batch may affect consumers who rely on the correct dose for treating health conditions. The affected batch number is 002918 and it was manufactured in November 2019. No other batches are affected by this issue.    Source: FIT product 'unfit'

American Botanical Council Warns Consumers about High Toxicity of Oleander

The non-profit American Botanical Council (ABC) recently warned the public about the substantial toxicity associated with all parts of the oleander (Nerium oleander) plant. ABC warns consumer not to ingest any parts of the plant, or capsules, tablets, teas, or extract preparations made from leaves or other parts of the oleander plant because it contains chemicals that can cause serious effects to the human heart, including death. The ABC warning came as a result of recent media reports that USA President Trump may be considering asking (or may have asked) the Food and Drug Administration (FDA) to approve the drug product called oleandrin as a potential treatment for COVID-19.     Source: Oleander toxicity

USA Brands Top List of Problematic Supplements in South Korea’s Online Market Inspection

An inspection and review conducted by South Korea’s authorities found that most of the supplements of questionable quality being sold were from USA brands.   Source: (Copyright) Tingmin Koe, FoodNavigator-Asia USA brands fail

Robert Forbes Acknowledged in CANI Lifetime Achievement Awards

The Consultants Association for the Natural Products Industry (CANI) in the USA, recently announced Lifetime Achievement award honours for four of its members. Robert Forbes, managing director and founder of RFA Regulatory Affairs and the publisher of this newsletter, was one of the recipients of this prestigious award.    Sources: Wholefoods Magazine Robert Forbes honour ; &, Nutraceuticals World CANI awards


RFA Breaking News

Cosmetics, Personal Care and TGA Listed Sunscreens:

New chemical report as at 15th April. This lists the new chemical public reports published for three new chemicals.    Source: AICIS.   Unregistered importer fined. The imported chemical is…



Review of the Australia New Zealand Food Standards Code The review commenced in July 2020. The plan is to reform the bi-national food regulation system to ensure it remains strong,…


Complementary Medicines and Medical Devices:

TGA conducting forum on GMP This will be a virtual event, to be held from Wednesday 12th to Friday 14th May, free of charge for members of the industry. More…


Cosmetics, Personal Care and TGA Listed Sunscreens:

Conditions placed on sunscreens that were tested by AMA Laboratories in the USA. Sunscreens must be tested to validate the SPF claims. In August 2019 the US FDA announced that…



Review of the 2013 Australian Dietary Guidelines The National Health and Medical Research Council (NHMRC) has received $2.5 million from the federal government to review the guidelines. The first step will…


Complementary Medicines and Medical Devices:

Artemisia annua and Artemisia absinthium updated product recalls A further 8 products have been cancelled and recalled. It seems there is an unacceptable risk if these products are used during…


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