Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Therapeutic goods advertising compliance: 2020-21 Annual Report

Summarises compliance outcomes including examples, infringements and court actions. 55% of complaints originated from consumers, 18% from other companies. We recommend all suppliers of complementary medicines read this report.    Source: TGA


Compliance enforcement

HealthHub247 Pty Ltd and its director have been convicted of the unlawful manufacture, counterfeit, advertising and supply of sports supplements that contain prohibited substances, including substances banned by the World Anti-Doping Agency such as DMAA and DMBA, which are of danger to health. The company and its director Mr Croucher pleaded guilty to all charges. The director was sentenced to 12 months imprisonment and released on a two-year good behaviour bond. The Court noted that if not for Mr Croucher's serious ill-health, he would have served time in custody.    Source: TGA

Unlawful importation of face masks – court action initiated in the Federal Court against Enviro Tech Holdings Pty Ltd (Enviro Tech), and its executive officers (Connie and Jerry Triantos). In December 2020, Enviro Tech was issued with a $13,320 infringement notice for the alleged breach. However, as Enviro Tech did not pay the infringement notice, further legal action is now being taken.     Source: TGA, Notices of Filing and Hearing here and here.

Melbourne-based individual fined $18,648 for alleged unlawful advertising of nicotine vaping products.    Source: TGA


Former export manager of pharmaceutical ingredient company pleads guilty to criminal cartel charges

On the 26th October Christopher Kenneth Joyce, formerly of Alkaloids of Australia Pty Ltd, pleaded guilty to three criminal cartel charges and admitted his guilt in respect of seven further offences, relating to his conduct involving price fixing, bid rigging and market allocation cartel arrangements between Alkaloids of Australia and overseas suppliers of scopolamine N-butylbromide, manufactured from the Duboisia plant, which is native to Australia.    Source: ACCC


Listed medicines compliance reviews

Applications for listed medicines are not reviewed by the TGA at the time of submission. However a listed medicine can be selected for a compliance review after it has been placed onto the parket. Review can be targeted or random. Information about the reviews is contained in this TGA webpage. You can view the results of the compliance reviews here.


Revised list of ingredients permitted in listed medicines

Has just been published, includes changed ingredients and fice new ingredients including hydrolysed chicken cartilage extract.     Source: Federal Register of Legislation.


Guidance on the regulation of software-based medical devices.

Guidance document published to assist manufacturers of active medical devices, including software-based medical devices, in correctly classifying their devices.    Source: TGA


Responses to consultation on proposed amendments to the Poisons Standard

The TGA has published 402 responses received from various individuals, professional and industry associations to proposed amendments for 12 substances.     Source: TGA


Revised poisons standard published

Electronic version is now available for SUSMP No. 34 (Poisons Standard October 2021).     Source: Federal Register of Legislation.


Interim decisions on proposed amendments to the Poisons Standard

Including ethanol and isopropanol in hand sanitisers, methanol in hand sanitisers, and eugenol.    Source: TGA


Publication of expert panel report on psilocybin and MDMA

This is a systematic literature review of the roles of MDMA and psilocybin for the treatment of mental health conditions. The full panel report is available.    Source: TGA


Are your Finished Product Specifications (FPS) up to date?

All FPS should be reviewed withing a reasonable time frame such as 3 years, and should take into account changes to various limits and mandatory tests – such as heavy metals - that have occurred since the FP was last written or revised.    Contact RFA for assistance.


Selling products in China?

In April this year, the General Administration of Customs of China issued new regulations for the “Registration and Administration of Overseas Producers of Imported Food” and “Administrative Measures on Import and Export Food Safety”, which will come into force from 1 January 2022. For information, contact your industry association.

Four-part series on the science behind beauty products

The Australian Broadcasting Commission has published four articles on the ingredients in skin care products. Part 1 - what is an active ingredient (discusses vitamin C, niacinamide, hyaluronic acid, AHAs, BHAs; Part 2 (retinol, tretinoin, retinaldehyde); Part 3 (chemical peels, microdermabrasion, laser); Part 4 - collagen.


AICIS publishes "roadmap" for evaluating chemicals

This outlines the strategic approach for evaluating the human health and environmental risks of introducing and using industrial chemicals in Australia. The roadmap includes an explanation of what chemicals could be evaluated, evaluation goals and six action areas to achieve those goals, and targets for 2024 and beyond.     Source: AICIS here and here.


List of chemical evaluations in progress, under public consultation or recently completed

Includes the subject of the evaluation - typically the chemical name or chemical group name, reason for the evaluation, time it takes to do the evaluation, focus of the evaluation - chemical identity, and human health or the environment (or both), current status of the evaluation - for example, in progress, public consultation, completed, and amendments to the list of evaluation candidates.    Source: AICIS


What are the rules on using new animal test data?

Information sheet explains the key points about using animal testing data.    Source: AICIS


Chemicals added to the Inventory 5 years after issue of assessment

Six chemicals added in September 2021.    Source: AICIS


New Zealand News

General quantity labelling requirements

Describes labelling requirements for all packaged goods sold by weight, measure or number which must have their quantity marked or labelled using one of the units of the metric system.    Source: NZ Ministry of Business, Innovation and Employment.


Changes to the Fair Trading Act

New obligations on businesses and providing new protections for consumers and small businesses, prohibiting unconscionable conduct in trade, extending unfair contract terms provisions to cover standard form small trade contracts, and enabling people to direct uninvited direct sellers to leave or not enter their property.    Source: Commerce Commission of New Zealand


Report an Influencer Ad Identification Breach

Advertising content must be clearly identified, regardless of where it might be seen. This includes ad content posted by influencers. The Advertising Standards Authority has received over 200 complaints and enquiries since the release of the influencers AdHelp Information.    Source: Advertising Standards Authority.

How can you refer to the TGA when you advertise your products?

The TGA has provided further clarification. You cannot use the term “TGA approved” or “TGA registered”, or use the TGA logo or Commonwealth Coat of Arms, in advertising. This even includes statements such as "U.S. Food & Drug Administration (FDA) approved". However the TGA encourages advertisers to provide the product’s AUST L or AUST R number in advertising to the public.    Source: TGA


Compliance enforcement

Caro white and Carotone products have been supplied illegally as cosmetics while they have had a higher than permitted level of hydroquinone making them prescription medicines, but they have not been submitted to the TGA. Products include Caro White Lightening Oil, Caro White Lightening Beauty Lotion, Caro White Lightening Beauty Cream, Carotone Lightening Body Lotion and Carotone Black Spot Corrector. All future shipments into Australia will be destroyed.    Source: TGA

Tianda Pharmaceuticals fined $26,640 for alleged unlawful advertising of Anti-Epidemic Formula 1 in relation to COVID-19. Listed medicines cannot be advertised for treatment of COVID-19 and in an eBay ad Tianda claimed the products were “approved” by the TGA.    Source: TGA

Invigorate Labs fined $18,648 for alleged advertising breaches relating to medicinal cannabis and CBD. The products included vaping products and creams that had not been submitted to the TGA. Along with the illegal claims for CBD there were also claims for treatment of "palindromic rheumatoid arthritis" and cancer.    Source: TGA.

TGA to take action against political party United Australia Party.  TGA's lawyers allege UAP breached copyright and demand distribution of alleged misleading adverse event reports stop.    Source: TGA


Assessed listed medicines: data protection

Assessed listed medicines fall in between the categories of listed medicine, and registered medicine. For an assessed listed medicine, the TGA reviews the evidence forward to support the indications for use. There have bene very few applications for this category. The data protection keeps clinical trial data submitted to the TGA confidential.    Source: TGA


Export-only medicines

The TGA has revised the guidelines for preparing an application for an export-only medicine or medical device.    Source: TGA – medicines, medical devices.


Nicotine vaping products

As of 1st October all nicotine vaping products will be regulated as Schedule 4 (prescription only) medicines. Both personal importation and domestic purchases require a prescription.    Source: TGA


Rapid Antigen Tests (RATs) for Self-Testing (Home Testing) for COVID-19

The regulations are changing rapidly and the tests will soon be available.    Source: TGA – here and here.


Chattanooga Ultrasound Gel Products and Lotions

All batches are being recalled because of the risk of contamination with a bacteria, Burkholderia cepacia complex.    Source: TGA


Improvements to the Therapeutic Goods Advertising Code

The TGA has summarised the feedback from 67 stakeholder submissions. There was broad support for most proposals with differing views on items such as “who should and who should not be allowed to make product endorsements and testimonials”.    Source: TGA


ACCC grants interim authorisation to medicine wholesalers

The purpose is to co-operate in providing fair and efficient access to essential medication and pharmacy products as the COVID-19 pandemic continues.    Source: ACCC


TGA Navigating therapeutic goods regulation podcast now released on Apple podcasts.    Source: TGA news

Calls for comment on allow the sale and use of food made from a genetically modified (GM) corn.

Food made from this type of GM corn could be imported into Australia and New Zealand in the form of starch, grits, meal, flour, oil and sweetener.    Source: FSANZ


Failing Food Reports – July and August 2021

Foods inspected at the border. Includes risk food test results and surveillance food test results.    Source: Dept Agriculture, Water and the Environment - July and August


Dangers of highly concentrated caffeine products 

One single teaspoon of pure caffeine powder can contain the same amount of caffeine as 25 – 50 cups of coffee.    Source: FSANZ

New video explains the basics of AICIS registration

This 2-minute video explains when you do – and don't – need to register your business with AICIS, and gives a quick overview of the fees and charges.    Source: AICIS


AICIS Consultation on proposed amendments to the General Rules

Includes clarifying criteria for industrial chemicals introduced at the nanoscale - declarations about data ownership - annual declarations - clarifying record-keeping for listed introductions, specified classes, designated releases to the environment, internationally-assessed - the authorisation process for movement of industrial chemicals into or out of Australia that are subject to the Rotterdam Convention - transitional provisions.    Source: AICIS


Annual declaration for all introducers

This is a declaration you make about the industrial chemicals you imported or manufactured during the previous registration year. AICIS has produced a video to explain what is required and how to lodge a declaration.    Source: AICIS


Chemicals added to the Inventory 5 years after issue of assessment

Six chemicals added in August 2021.    Source: AICIS


Correction of chemical names

Over 100 chemicals have had their names updated during August 2021.    Source: AICIS


New Zealand news

Social media “influencers”: The advertising Standards Authority has released a reporting process for advertising breaches. Advertising content must be clearly identified no matter where it is published.    Source: ASA.


Country of origin breach: New Zealand Health Food Company Ltd​ has been fined $377,000 after pleading guilty to engaging in conduct liable to mislead the public about the origin of ingredients in its royal jelly supplements. The royal jelly in the supplements came from China. Most of the other ingredients were sourced from countries other than New Zealand, including Indonesia, Malaysia, China, Papua New Guinea, North America, and Samoa. The royal jelly was put into capsules and packaged in New Zealand, the commission found.    Source: Commerce Commission of New Zealand.


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