Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

GMP for Overseas Manufacturers of Medicines and Biologicals During the COVID-19 Pandemic

The Therapeutic Goods Administration has updated information for foreign manufacturers and the remote GMP Inspections of their facilities. Manufacturers of medicines and biologicals are routinely inspected using a risk-based approach against the appropriate Manufacturing Principles. Following the suspension of on-site inspections due to COVID-19 restrictions, the TGA has developed new arrangements to allow continued and flexible oversight of licenced domestic manufacturers by performing remote GMP inspections. The domestic program demonstrated that it would be possible to replicate this approach for overseas medicine and biological manufacturers. However, it is recognised that broadening this program may bring additional challenges and the same number of manufacturers cannot be inspected using this approach. From July 2020, the TGA will begin the remote GMP inspections program for some overseas manufacturers.    Source: COVID-19 GMP inspections    (Also refer to: Expectations for overseas manufacturing sites hosting remote inspections during covid-19 pandemic )

*** Please contact RFA Regulatory Affairs if you need assistance with your GMP ***

System for Australian Recall Actions

The System for Australian Recall Actions (SARA) provides consumers, health care professionals, sponsors, wholesalers, hospitals, and retailers with access to information about recall actions occurring in Australia for therapeutic goods. The Database holds information on recall actions that have been undertaken in Australia since 1 July 2012. In July 2020, the TGA completed an enhancement to SARA database's search facility. Users are now able to download search results of summary recall data in editable, MS Excel format, in addition to the existing PDF reports. This project was undertaken in response to requests from a range of external stakeholders to provide better access to TGA recall data.    Source: SARA database

Regulation of Thermometers and Other Temperature Measuring Medical Devices for COVID-19

Any temperature measuring product for use on humans, for the intended purpose of screening potentially febrile individuals during a pandemic, meets the legal definition of a medical device and is required to comply with the Australian regulatory requirements, including listing in the Australian Register of Therapeutic Goods (ARTG), before importing or supply. Should the product not be intended by the manufacturer for a medical purpose, suppliers and retailers cannot represent the product as a medical device and cannot promote the product for the purpose of screening potentially febrile individuals. Additionally, it is an offence to advertise to any person a medical device for purposes other than the manufacturer's intended purpose. Before sponsors submit an application for inclusion of a thermometer or any other temperature measuring medical device in the ARTG, they should establish the classification of their product. An online classification tool is available to help determine the classification of a particular device.    Sources: COVID19 medical device & Medical device classification tool 

TGA Consultation - Therapeutic Goods Order 106 - Data Matrix Codes and Serialisation of Medicines

The TGA is seeking feedback on proposed requirements for serialisation and the use of data matrix codes on the labels of certain medicines in the Australian supply chain. Data matrix codes are an important first step towards a medicine traceability system. To make sure the standard is clear, meaningful and fit for purpose, the TGA is seeking feedback on its suitability and potential impacts. This consultation closes 13 August 2020.  Source: TGO 106 consultation

Review of Listed Medicines with Traditional Indications

Over the remainder of 2020, the TGA will be initiating targeted compliance reviews on listed medicines that are based on TCM, Ayurveda or other traditional paradigms. If you are a sponsor of a listed medicine with traditional indications, you are encouraged to re-evaluate the evidence you currently hold, particularly in relation to the active ingredients in your products and their dosages; and also to reconsider the indications made for your medicines with reference to the ‘Evidence guidelines for listed medicines’.    Source: Traditional medicines review

Pharmacovigilance Inspection Program Risk Assessment Survey

The TGA's Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open for medicine sponsors to complete and will remain open until 30 September 2020. The TGA's PVIP Risk Assessment Survey is designed to inform the TGA about a sponsor's medicine portfolio, pharmacovigilance processes, inspection history and compliance with Australian pharmacovigilance legislation and guidelines and will serve as a tool to help prioritise and schedule pharmacovigilance inspections. Any sponsor who has at least one medicine included in the Australian Register of Therapeutic Goods (ARTG) should complete this survey. Medicine sponsors that do not complete this survey will be assigned the highest survey risk score. Please also note that the survey questions relate only to sponsor’s medicines (not medical devices or biologicals) in the ARTG. This includes all listed, registered and provisionally registered medicines.    Source: Pharmacovigilance inspection program

End of Advertising Pre-Approval Scheme: Questions and Answers

Up until 1 July 2020, advertisements for 'designated therapeutic goods' that are to appear in 'specified media' required approval under the Therapeutic Goods Regulations 1990 before they could be published or broadcast. This advertising pre-approval scheme has been stopped in favour of a more self-regulatory regime. Please note, all advertisements for therapeutic goods are still required to comply with the therapeutic goods regulatory requirements. This helpful Q & A page responds to sponsor queries regarding the new scheme: Therapeutic advertising Q&A

*** Do you need your advertisement checked? ***

Our team has decades of experience advising clients on complying with advertising requirements – for complementary medicines, foods and cosmetics. Contact us for more information about our advertising review services or for information on our training courses by calling +61 2 9660 8027 or emailing This email address is being protected from spambots. You need JavaScript enabled to view it.

TGA Guidance on Directing Advertising Exclusively to Health Professionals

This information explains how to direct therapeutic goods advertising exclusively to health professionals so that the consumer advertising requirements do not apply. Any advertisement for therapeutic goods that is accessible by consumers must meet the Act's requirements for advertising to consumers, even if the goods are not available for purchase by consumers or you think the content clearly targets health professionals.    Source: Ads for health professionals

Consent to Import, Supply or Export Therapeutic Goods That Do Not Comply with TGA Standards

Medicines and other therapeutic goods must comply with applicable standards to be supplied in Australia and it is an offence to import, supply or export therapeutic goods that do not comply unless an exemption is given. Consent to not complying with an applicable standard will not be given unless the TGA is satisfied that the safety, quality, safety and efficacy and/or the safe and effective use of the product will not be adversely affected. Special processes have been set up for medicines affected by COVID-19 delays.   Source: Non-standard consent

Cochlear Calls for Low-Risk Health Apps to be Exempt from TGA Register

Australian company, Cochlear Ltd. has called for some low-risk health apps to be exempt from the therapeutic goods register, joining a push by medtechs, including Roche Holding AG, for greater certainty on the regulation of medical and healthcare software. Over the past two years regulators have been grappling with the oversight of medical software amid a boom in healthcare apps, clinical products and health trackers. Last year a new set of requirements was established that categorised software based on the level of risk the product poses to patients. In June 2020, the government flagged it would delay the rollout of new medical device regulation, including for software, until next year due to COVID-19. It is not clear which health app products are set to be excluded or exempted from regulation, however. In March the TGA asked businesses where they thought the line should be drawn.    Source: Emma Koehn, SMH Health apps exemptions

TGA Issues Fines of Nearly $1.8 Million for Alleged Illegal Activity In 2019-20

The TGA has taken strong action against alleged illegal import, manufacture, supply and advertising of therapeutic goods in Australia during 2019-20 when 187 infringement notices were issued for alleged breaches of the therapeutic goods legislation, totalling almost $1.8 million. In the same period, the TGA pursued civil court action against three companies, with the Federal Court of Australia ordering one company to pay the Commonwealth $10 million for breaches of therapeutic goods advertising requirements. A further five criminal matters were referred to the Commonwealth Department of Public Prosecution.    Source: TGA acts on lawbreakers    (Please see also TGA infringement notices ; Database of TGA listed medicine compliance review results   and this example case: False evidence claim )

Pfeffer Contracting Fined $25,200 for Alleged Advertising Breaches in Relation to COVID-19

The TGA has issued two infringement notices totalling $25,200 to Sydney-based company Pfeffer Contracting Pty Ltd for alleged unlawful advertising in relation to COVID-19. Advertisements on the company's website for a test kit and surgical masks allegedly referred to COVID-19. Under the Therapeutic Goods Act 1989, any claims or references to COVID-19 (and related terms) about therapeutic goods are restricted representations. A restricted representation refers to a serious form of a disease, condition, ailment or defect. The use of restricted representations in advertisements for therapeutic goods is unlawful without an approval or permission from the TGA.    Source: Pfeffer fail

Lorna Jane Fined for Alleged Advertising Breaches in Relation to COVID-19 "Anti-Virus Activewear"

The TGA has issued three infringement notices totalling $39,960 to Brisbane clothing company Lorna Jane Pty Ltd for alleged unlawful advertising in relation to COVID-19. Lorna Jane allegedly claimed, on its website, that its 'anti-virus activewear' prevents and protects against infectious diseases, implying it is effective against COVID-19. The TGA alleges that Lorna Jane represented its 'anti-virus activewear' for therapeutic use and therefore believes that it is a therapeutic good within the meaning of the Therapeutic Goods Act 1989. Therapeutic goods, including advertising, are subject to the regulations administered by the TGA. The advertisement referred to therapeutic goods that were not included in the Australian Register of Therapeutic Goods (ARTG). This is required before they can be lawfully supplied or advertised in Australia.    Source: Therapeutic clothing fail

Arborvitae Health And Wellbeing Fined $12,600 for Alleged Advertising Breaches in Relation to COVID-19

Arborvitae Health And Wellbeing allegedly claimed, on the company's website, that Arborvitae Health and Wellbeing Supplement (Arborvitae) is an effective treatment for COVID-19. Under the Therapeutic Goods Act 1989, any claims or references to treating COVID-19 (and related terms) are restricted representations.    Source: Arborvitae advertising fail

Strapit fined $37,800 for alleged advertising breaches in relation to COVID-19

The TGA has issued three infringement notices today totalling $37,800 to Melbourne-based company Strapit Medical and Sports Supplies Pty Ltd, for alleged unlawful advertising in relation to COVID-19. Strapit Medical and Sports Supplies allegedly claimed, on its website, that a Zafe Zone product for use on surfaces and skin killed COVID-19, without having the necessary authorisations from the TGA.    Source: Strapit hit with fine

Zafe Zone fined for alleged advertising breaches for disinfectant products in relation to COVID-19

The TGA has issued three infringement notices today totalling $39,960 to Melbourne-based company Italian Princess Coffee Brands Pty Ltd (trading as Zafe Zone), for alleged unlawful advertising in relation to COVID-19. Zafe Zone allegedly promoted its disinfectant as effective against coronavirus, without having the necessary authorisation from the TGA.    Source: Zafe Zone fined

TGA Safety Advisories-

AuLion Energy Candy: The candies contain the undeclared substance sildenafil.    Source: AuLion energy candy

Fostering innovation in Australia’s Listed Medicines’ Industry

The Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020, which amends the Therapeutic Goods Act 1989, was passed by both houses on 25 June. This amendment introduces a mechanism to protect new research data for low risk complementary medicines that have proven novel efficacy claims. This represents regulatory innovation that the sector has been striving to achieve for many years.  The usual intellectual property patenting process is not as readily amenable to protect research investment for ingredients that are already in the public domain. “This extraordinary regulatory reform represents one of the most exciting improvements in the complementary medicine landscape that we have witnessed in decades," said Professor Alan Bensoussan, Director, NICM Health Research Institute.     Source: LM regulatory innovation

 

 

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

 

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: News.com.au 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 )

*** Do you need your advertisement checked? ***

Our team has decades of experience advising clients on complying with advertising requirements – for complementary medicines, foods and cosmetics. Contact us for more information about our advertising review services or for information on our training courses by calling +61 2 9660 8027 or emailing This email address is being protected from spambots. You need JavaScript enabled to view it.

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

 

 

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

 

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