Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.


Failing Food Reports – May and June 2020

These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the months of May and June. Among the usual pathogens detected in these imported foods are such organisms as Salmonella (found in Si Lankan chili), Bacillus cereus (found in Chinese tofu – again!), Listeria monocytogenes  (found in French cheese – again!), and assorted toxins such as Tebuconazole (found in USA oranges),  histamine (found in many varying dried seafoods), lead (found in Taiwanese salted plums) and the illegal addition of vitamins to many foods.      Sources: May 2020 failed foods ; June 2020 failed food

ANZ Ministerial Forum on Food Regulation Communiqué

The Australia and New Zealand Ministerial Forum on Food Regulation is a joint organisation that makes the laws, policies, standards and processes used to make sure our food is safe to eat. The Forum has published two important outcomes from its most recent meeting held on 17 July 2020:

Proposal P1050 - Pregnancy warning labels on alcoholic beverages: The Forum accepted the proposed draft standard for pregnancy warning labels, subject to two amendments: a change to the signal words from ‘HEALTH WARNING’ to ‘PREGNANCY WARNING’, and an extended transition period for implementation, from two years to three years;

Health Star Rating (HSR) Five Year Review: Ministers endorsed the Review Implementation Plan (concerning definitions of ‘fresh’ foods, Health Star Rating calculator, and interim update targets), and an implementation start date of 15 November 2020.     Source: Forum communique

Winemaker Backs Tough New Pregnancy Warning Label Ahead of Tight Vote

Winemaker Chris Carpenter has broken ranks with alcohol industry lobbyists to back the food regulator's proposed new mandatory pregnancy warning label for alcohol bottles, as politicians prepare to vote on the hotly contested issue. State, territory, federal and New Zealand food ministers are expected to be closely split when they next meet to weigh up the label recommended by Food Standards Australia and New Zealand. It has black, white and red text stating "PREGNANCY WARNING: Alcohol can cause lifelong harm to your baby".    Source: Dana McCauley, SMH Alcohol and pregnancy warning statement    (Please see also Alcohol pregnancy warning debate )  

Community Detention and Fine for Selling Potentially Hazardous Goat Meat in NZ

A dairy owner, Ananda Krishna, and a company, Shop ND Save Limited, have been sentenced in Christchurch District Court for processing and selling goat meat outside of food safety rules and having unhygienic practices. Mr Krishna, 54, was convicted and sentenced to 200 hours' community work and the company was fined $2,250. During a search of the premises on 19 June 2019, 50 kilograms of diced goat meat were found in a freezer. Mr Krishna admitted processing goat meat himself on the band saw. Maggots fell out from the band saw equipment when it was opened. The equipment also contained bird faeces, which are known to harbour pathogenic bacteria.    Source: NZ food fail

FSANZ Notifications –

P1050 – Pregnancy warning labels on alcoholic beverages (REVIEW): Following the latest review, FSANZ has reaffirmed the amendment with a change to the signal words from 'HEALTH WARNING' to 'PREGNANCY WARNING', and an extended transition period for implementation from two years to three years.    Source: Alcohol pregnancy label warning


AICIS Fees and Charges for 2020

The Australian Industrial Chemical Introduction Scheme (AICIS) has now officially replaced NICNAS as the official regulator of industrial chemicals, including those chemicals used in cosmetics and human hygiene products. The new registration charges are based on an 8-level system that is determined by the value of the industrial chemicals introduced in the previous financial year. A charge of $72 applies to all registration levels. Businesses that introduced industrial chemicals with a total value of less than $50,000 in the last financial year will not pay a registration charge. Find out more about AICIS fees and charges.


Olive Oil Botanical Adulterants Prevention Bulletin Published

The American Botanical Council (ABC) examines the quality of commercially available olive oil and finds it to be among the most frequently adulterated food ingredients worldwide. The fraud includes mainly substitution with lower-cost vegetable oils, lower-grade olive oils such as refined olive oil or pomace oil (the pomace is the solid material remaining after pressing the fruit to remove the oil), and inaccurate country-of-origin labelling.   Source: Olive oil scams

Failing Food Report – April 2020

These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the month of April. Among the usual pathogens detected in these imported foods are such organisms as Bacillus cereus (found in Chinese tofu), Listeria monocytogenes  (found in French cheese), and assorted toxins such as hydrocyanic acid (found in Indian tapioca chips),  histamine (found in many varying dried seafoods), lead (found in Indian tamarind) and the illegal addition of vitamins to many foods.      Source: April 2020 failed foods

Sugar Tax: Australian Sugar Sweetened Beverage Consumption Slumps as Obesity Rates Continue to Soar

Volume sales of sugar-sweetened beverages (SSBs) have declined over the past 22 years in Australia by almost one-third despite the country's ongoing obesity problem, with industry leaders claiming this calls into question repeated calls for a sugar tax.   Source: (Copyright) Guan Yu Lim, Food Navigator-Asia Sugar tax concerns

FSANZ Notifications -

Application A1184 – Glucoamylase from GM Aspergillus niger (donor Trametes cingulata): ​​​The purpose of the application is to approve the use of glucoamylase sourced from GM Aspergillus niger containing the gene from Trametes cingulata.   Source: GM aspergillus

Application A1185 – Alpha-amylase from GM Aspergillus niger as a processing aid (enzyme): ​​​​The purpose of this application is to approve the use of Alpha-amylasee sourced from Rhizomucor pusillus in GM Aspergillus niger.   Source: GM aspergillus 2

Application A1194 – Glucoamylase from GM Trichoderma reesei as PA (Enzyme): The purpose of the Application is to permit the use of glucoamylase sourced from GM Trichoderma reesei as a processing aid.   Source: GM trichoderma

Application A1195 – Alpha-amylase as a processing aid (enzyme): The purpose of the application is to permit the use of Alpha-amylase as a processing aid in brewed beverages and potable alcohol production.    Source: Alcohol enzyme

Proposal P1050 – Pregnancy warning labels on alcoholic beverages: FSANZ seeks to reaffirm the proposed amendment to alcoholic beverages with two changes: the signal words HEALTH WARNING are changed to PREGNANCY WARNING; and, the transition period for implementation of the pregnancy warning label is extended from two to three years.   Source: Pregnancy alcohol warning



TGA Lists Disinfectants for Use Against COVID-19 in the ARTG for Legal Supply in Australia

The Therapeutic Goods Administration (TGA) has recently received many enquiries seeking to know which disinfectants have been entered into the Australian Register of Therapeutic Goods (ARTG) for use against COVID-19. 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 ARTG with specific claims against SARS-Cov-2 (COVID 19) or COVID-19 on the product label: Legal anti-viral disinfectants    (Please see related story - Emma Koehn, SMH  'Snake Oil Salesmen': COVID-19 Claims Under Microscope As Disinfectants Boom )

Australian Chemical Research Fined $25,200 for Alleged Breaches in Relation to Hand Sanitiser

The TGA has fined Sydney-based company Australian Chemical Research Pty Ltd $25,200, for alleged breaches of the Therapeutic Goods Act 1989. Australian Chemical Research allegedly manufactured and supplied antibacterial/anti-viral hand sanitiser not included in the Australian Register of Therapeutic Goods (ARTG), and which was neither an exempt good nor a good that is excluded from the operation of the Act The company allegedly claimed the hand sanitiser kills 99.99% of germs, viruses and bacteria on hands, including the flu virus, the common cold virus and HIV. The label also stated that the active ingredients of the hand sanitiser included 80% iso-propanol. However, the product contained a large percentage of n-propanol, which is a less effective and potentially hazardous alcohol. Australian Chemical Research was not licenced to manufacture therapeutic goods and did not have approval to do so.    Source: Hand sanitiser penalty

Presentation: Supplying and Advertising Certain Therapeutic Goods For COVID-19

Information for new sponsors of hand sanitisers, disinfectants and personal protective equipment. This presentation by the TGA was held as a webinar on 28th May 2020 and contains all notes, links and tables of that event, in a PDF document format.    Source: COVID19 webinar notes 

Post-Market Review of Face Masks: Cancelled ARTG Entries

The TGA is undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). During the review many face masks have been cancelled from the ARTG with the latest list displayed here: Face-mask cancellations   (Please also see general overview: Post-market face mask review

Warning About Advertising that Conflicts with ‘Stay-at-Home When Sick’ Advice

The TGA is reminding advertisers that therapeutic goods advertising must not undermine public health campaigns, as the cold and flu season begins in Australia and COVID-19 restrictions are eased. If sponsors advertise cold and flu medicines, they must ensure that the advertising is consistent with the current public health advice about COVID-19. Promoting a product as enabling someone to attend a workplace, school or other activity outside of home while experiencing cold and flu symptoms (even if temporarily controlled) conflicts with the Department of Health's advice to stay home when unwell, ensuring that important public health messages are not undermined. If you are advertising therapeutic goods directly in relation to COVID-19, you should be aware that there are sanctions and penalties for any advertising that does not comply with the current regulations. Claims about COVID-19 are not permitted in consumer advertising, except for certain disinfectants.    Source: COVID-19 advertising

COVID-19: Eligibility to Request Consent to Supply Therapeutic Goods that Do Not Comply with the New Labelling Requirements of TGO 92

The COVID-19 pandemic has placed unprecedented pressures and challenges on the pharmaceutical industry, including difficulty in implementing new medicine labels that comply with the new labelling orders (TGO 91/92) for medicines that come into force on 1 September 2020. In recognition of these challenges, the TGA has established a temporary process for sponsors of listed, registered complementary, and over-the-counter (OTC) medicines to request consent to supply products that do not comply with TGO 92 due to adverse business impacts of COVID-19. The end date for this consent will be 6 March 2021.   Source: Covid-19 impact on TGO 92

Urgent Recall: Gin Bottles Filled with Hand Sanitiser Sold

An Australian liquor distiller has issued an urgent recall on bottles of gin after finding they had been filled with hand sanitiser. The company, Apollo Bay Distillery, says it has sold a number of the bottles with no seal, which have been labelled as gin but actually contain the sanitiser. Hand sanitiser is not safe to drink and should not be consumed.   Source: Gin hand sanitiser

Listed Medicines Referencing Macular Degeneration Reminder

Macular degeneration is a restricted representation and not permitted in listed medicines. In 2017, the TGA initiated targeted compliance reviews for 13 listed medicines that inappropriately referenced macular degeneration. During the reviews, they determined that none of the sponsors of these medicines held sufficient evidence for the indications related to eye health. Sponsors were required to amend the listing of these products on the ARTG to remove any unsupported claims or cancel their product from the ARTG.  Source: Macular degeneration reminder

End of Advertising Pre-Approval Scheme: Q & A

Until 1 July 2020, advertisements for 'designated therapeutic goods' that are to appear in 'specified media' require approval under the Therapeutic Goods Regulations 1990 before they can be published or broadcast. The TGA outsourced the processing of applications for advertising approval to Consumer Healthcare Products Australia until 30 June 2020. Pre-approvals will not be required after 30 June 2020. If sponsors are unsure whether their products’ advertising is compliant, once pre-approvals end and a new more self-regulatory regime begins, then they are recommended to seek advice from a regulatory affairs consultant, a lawyer who specialises in therapeutic goods, or engage the services of an independent vetting service that assesses the advertising of therapeutic goods for compliance.    Source: Pre-approval scheme ends    (Please also see related story: TGA social-media advertising guide )

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How to Spot a Dodgy Health Product Advertisement

Ads for health products are everywhere, but don't believe everything you read. Some ads break the law, whether it's by offering a miracle cure or advertising an unapproved medicine. Other ads just need a little extra scrutiny, such as a fad treatment promoted by a social media influencer. These TGA tips can help you avoid dodgy health products and challenge bogus advertisements when you see them.   Source: Dodgy ad detector

Consultation: Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines

The revised Australian regulatory guidelines for listed medicines and registered complementary medicines (published May 2020) replaces ARGCM V8.0. The new version reflects recent reforms to the regulatory framework and presents guidance in separate documents to facilitate timely updates. This is an interim step towards a new landing page, which will be modelled on that for the Australian Guidelines for Prescription Medicines. The TGA welcome feedback on the revised guidance, using the feedback form on the web-page.    Source: ARGCM consultation

Reminder: Update to Manufacturing Principles for Medicines, APIs & Sunscreens Effective 1 July 2020

The TGA's Manufacturing Quality Branch (MQB) is responsible for the assessment, inspection and licensing/certification of manufacturers of medicines supplied to, or exported from, Australia. The intent of this notice is to provide early notification that the TGA intends to adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-14) issued, 1 July 2018, as the Manufacturing Principles for medicines, active pharmaceutical ingredients and sunscreens. The transition to PIC/S GMP PE009-14 will commence 1 July 2020 with a 12-month transition period.   Source: Manufacturing principles

Net Pharmacy Fined $214,200 for Alleged Unlawful Advertising

The TGA has issued seventeen infringement notices totalling $214,200 to Net Pharmacy Pty Ltd, a company based in Victoria, for alleged unlawful advertising of therapeutic goods. The advertisements, published on two websites, were for prescription only therapeutic goods that included peptides, Selective Androgen Receptor Modulators (SARMs) and hormones. Therapeutic Goods Act 1989 prohibits advertising to the general public of prescription only medicine. One of the websites also allegedly promoted the use of stem cells. Stem cells are a type of human cell and tissue product that are regulated as biologicals and cannot be advertised to the general public. It is also alleged that one of the website advertisements included a reference to cardiovascular disease. Under the Act, representations concerning a serious form of a disease, condition, ailment or defect, such as cardiovascular disease, are restricted representations. The use of restricted representations in advertisements for therapeutic goods is unlawful without the express permission of the TGA.    Source: Unlawful advertising

MMS Australia and Director Charles Barton Charged Over Alleged Unlawful Advertising

The TGA has initiated proceedings in the Federal Court of Australia in response to the alleged unlawful advertising of Miracle Mineral Supplement (also referred to as Miracle Mineral Solution) (MMS), dimethyl sulfoxide (DMSO), and other medicines by Southern Cross Directories Pty Ltd trading as MMS Australia. As reported in last month’s issue of this newsletter, the TGA recently issued MMS Australia with twelve infringement notices totalling $151,200 for alleged unlawful advertising. The TGA also informed MMS Australia that it must immediately remove all advertisements in breach of the Therapeutic Goods Act 1989 and warned that court action may be initiated if the advertisements were not removed within two days. MMS Australia did not remove the allegedly unlawful advertising. The TGA has therefore initiated court proceedings to obtain an injunction restraining MMS Australia and its director, Charles Barton, from advertising or supplying the relevant goods. The TGA will also seek orders that MMS Australia and Mr Barton pay penalties for alleged contraventions of the Act.    Source: MMS now in court

Allpulse Technologies Fined $50,400 for Alleged Advertising Breaches

The TGA has issued four infringement notices totalling $50,400 to Brisbane based company Allpulse Technologies Pty Ltd. In May 2020, the company allegedly advertised on its website a medicine containing hydrogen peroxide for internal therapeutic use that was not included in the Australian Register of Therapeutic Goods (ARTG). Hydrogen peroxide is a substance used to bleach human hair and sometimes for topical first aid or dental purposes. However, the TGA is not aware of any accepted clinical or scientific evidence to substantiate therapeutic claims in relation to the ingestion of hydrogen peroxide. The TGA is particularly concerned about potentially harmful effects from internal administration. The company's website also allegedly advertised other unapproved goods using unauthorised representations. These goods included 'Stabilized Electrolytes of Oxygen' (SEO), which was promoted for the treatment of serious conditions such as cancer and Alzheimer's disease. Under the Therapeutic Goods Act 1989, cancer is a prohibited representation and Alzheimer's disease is a restricted representation.  Source: Allpulse breach     (Please see also related story on USA President Trump’s proposal to combat COVID-19 with internal use of disinfectants) .

Queensland Woman Fined $7,560 for Alleged Unlawful Advertising in Relation to COVID-19

The TGA has issued three infringement notices totalling $7,560 to a woman based in Brisbane for alleged unlawful advertising in relation to COVID-19. The woman allegedly advertised, through her website and eBay store, a hydrogen peroxide product for therapeutic use that is not included in the Australian Register of Therapeutic Goods (ARTG). Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully advertised to the general public in Australia.   Source: COVID19 advert penalty

GSK and Novartis to Pay $4.5 Million in Penalties Over Voltaren Osteo Gel Claims

The Federal Court has ordered that the makers of pain relief product Voltaren Osteo Gel pay $4.5 million in penalties for breaches of the Australian Consumer Law. From 2012 to 2017, initially Novartis and then GSK marketed Osteo Gel as being specifically formulated and more effective than Emulgel in treating osteoarthritis related pain and inflammation even though both had the same active ingredients. The recommended retail prices for Osteo Gel were set up to 16% above that of Emulgel, and consumers were potentially misled into paying more for an identical product believing it was more effective.   Source: Voltaren gel penalty  

Recurring Issues in the Importation of Biological Products

The Department of Water, Agriculture and the Environment (DAWE) have published a notice, alerting importers to the requirement to hold valid import permits for a variety of products, including medicines and foods. Importers of most biological products must have a valid import permit before their goods arrive in Australia. If a permit, including documentary requirements, is required and those products arrive without one, then the importer will likely be directed to export or destroy them, or there could be significant delays.   Source: Importing biological products

Planned Prohibition on Importing E-Cigarettes Containing Vaporiser Nicotine

The Australian Government has announced that they intend to amend the Customs (Prohibited Import) Regulations from 1 July 2020 prohibiting the importation of e-cigarettes containing vaporiser nicotine (nicotine in solution or in salt or base form) and nicotine-containing refills unless on prescription from a doctor.   Source: e-cigs import ban  (Please see related story: Accessing e-cigs ) [Late News Update: Health Minister Gives Bows to Backbench Pressure On Vaping Ban  ]

TGA Notice of Interim Decisions on Proposed Amendments to The Poisons Standard

Proposed changes to the Poisons Standard may be of interest to sponsors of products containing any of the ingredients arbutin, melatonin, picramic acid (including its salts), and assorted marker dyes and pigments. This consultation closes on 9 July 2020.   Source: Poisons Standard consultation

ICMRA Community Statement About Confidence in Vaccines

The International Coalition of Medicines Regulatory Authorities has issued a general statement to highlight the importance of vaccines. The public statement reinforces the messages that: Vaccines save lives; Getting vaccinated is an act of responsibility; Vaccines undergo rigorous scientific evaluation by regulatory authorities; Vaccines are medicines of continuously proven pharmaceutical quality; and that, regulators and health authorities continue to rigorously monitor the safety, effectiveness and quality of vaccines after they are approved and released for use.   Source: Public vaccine statement

TGA Reviews Complaints of Alleged Non-Compliant Advertising of Medicinal Cannabis Products

The TGA has commenced a review of complaints received alleging non-compliant advertising of medicinal cannabis products to the public. The TGA has written to a number of entities in relation to non-compliance with the law with instruction to cease unlawful behaviour. The majority of respondents have brought themselves into compliance. For those that have not, further action is being considered.   Source: Cannabis advertising

TGA Publishes Changes to Fees and Charges from 1 July 2020

For a complete list of the new TGA rates please visit: TGA fees and charges summary

USA: AHPA Backs FDA and FTC on COVID19 Marketers

The American Herbal Products Association has supported the warnings sent recently by the Food and Drug Administration, and the Federal Trade Commission to marketers making product claims as to their efficacy related to COVID19. “The regulated dietary supplement industry supports FDA and FTC using their authorities against any company or individual selling products making COVID-19 cure or prevention claims,” said AHPA President Michael McGuffin. “While research supports the use of certain herbs and dietary supplements to maintain healthy immune system responses, AHPA is not aware of evidence that would substantiate a claim that any dietary supplement is effective to prevent or treat COVID-19, and such a claim is not allowed under current U.S. law.”    Source: AHPA USA COVID19 marketers



Sunscreen SPF Testing by AMA Laboratories - Update

In August 2019, the United States Department of Justice announced that an investigation by the United States Food and Drug Administration (FDA) led to several executives and supervising laboratory technicians of AMA Laboratories pleading guilty to wire fraud resulting from alleged fraudulent laboratory testing. Since then, the TGA has been conducting post-market compliance reviews of sunscreens that may potentially be affected by fraudulent testing by AMA Laboratories. All sunscreens on the Australian Register of Therapeutic Goods (ARTG) must be tested to verify the claimed sun protection factor (SPF) rating prior to marketing. The sponsors of some sunscreens on the ARTG have in the past engaged AMA Laboratories. At the present time, the TGA does not have any evidence that those sunscreens that have been tested by AMA Laboratories are less effective than claimed. The TGA now requires sponsors to provide adequate justification for ongoing supply of their products that have been tested by AMA Laboratories. This could include additional supportive testing data on comparable products in their product line or from product development studies, or other robust scientific justification that substantiates the claimed SPF rating.   Source: AMA Labs exposed

NICNAS / AICIS Reminder: No More Annual Reporting for Exemptions

If you are currently introducing a chemical under a NICNAS exemption category, you do not submit an annual report at the end of this registration year. But you must still keep records to demonstrate that you meet the criteria under the NICNAS exemption provisions. Refer to the NICNAS website, due to be archived at the end of this month for more information about the new scheme - The Australian Industrial Chemicals Introduction Scheme (AICIS).  Source: Annual reporting ends  

Contesting Views as Industry Gets More Say in New Safe Chemicals Code

As NICNAS transitions to AICIS, concern has been raised regarding the new industrial chemicals laws that will take effect from 1 July 2020. Decisions about whether new chemicals entering the Australian marketplace pose a danger to consumers or workers will be left in the hands of private industry, as a major overhaul of chemical regulation takes effect. Changes to the rules will allow companies to classify more chemicals as "very low risk", meaning they can be introduced without public disclosure or first telling the regulator. Cancer Council Australia, public health experts, environmentalists, academics, and unions have expressed alarm about the new system, with fears it could unleash the next toxic chemical disaster on the public.   Source: Carrie Fellner, SMH Cosmetic chemicals transition



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