Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

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 )

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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

 

 

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 Publishes More Information About Medicine Formulations

To improve access to important medicine information, the Therapeutic Goods Administration (TGA) now publishes additional formulation details of medicines and biological products on its website. This means anyone can check the ingredients contained in medicines, helping people make better-informed choices about the products they use. Every therapeutic good approved for supply in Australia has an ARTG summary on the TGA website. Previously, these summaries only showed information about active ingredients, which are the ingredients responsible for a product's medicinal effect. ARTG summaries for all medicines and biologicals now list both the active ingredients and non-active (excipient) ingredients. You will be able to see if a product contains a flavour, fragrance or colour ingredient mix, but not the individual ingredients in that mix. These medicines and biologicals have not changed - instead the TGA is increasing the transparency of this information to help consumers in their discussions with their health professionals.    Source: Ingredient transparency

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

The TGA has recently received a number of 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 full 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 and can be read here:   Source: Covid-19 disinfectants    

Western Australian Fined for Alleged Breaches In Relation To COVID-19 Test Kits

The TGA has issued a $2,250 infringement notice to a woman in Western Australia for alleged breaches of the Therapeutic Goods Act 1989 (the Act). The woman allegedly breached a condition of the Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020  by importing COVID-19 test kits that were not included in the Australian Register of Therapeutic Goods (ARTG) and were not being imported in relation to an authorised pathology laboratory as required by the Exemption.   Source: Covid19 - test kit fine

Promedical Equipment Fined $63,000 for Alleged Unlawful Advertising of a COVID-19 Rapid Test Kit

The TGA has issued five infringement notices totalling $63,000 to Queensland company Promedical Equipment Pty Ltd. It is alleged that the company claimed or implied on its website and via social media that the TGA and the United States Food and Drug Administration (FDA) had endorsed or approved a COVID-19 Rapid Test kit. Advertisements for therapeutic goods must not make any statement that implies the goods have been recommended or approved by government, except in very limited circumstances. This includes statements that therapeutic goods have been approved by the TGA or international regulators such as the FDA.   Source: Covid19 test-kit fail  (Please also see related stories: Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG ; COVID-19 test kits included in the ARTG for legal supply in Australia)

Company Issued $12,600 Infringement Notice for Alleged COVID-19 Advertising Breach

Melbourne based company NutriPATH Pty Ltd has been issued with a $12,600 fine for the alleged unlawful advertising of a COVID-19 Polymerase Chain Reaction (PCR) test collection kit in breach of the Therapeutic Goods Act 1989 (the Act).   Source: False advertising penalty

Doctor Fined $37,800 for Alleged Advertising Breaches Including References to COVID-19

A doctor in Perth, has been fined $37,800 for alleged unlawful advertising of therapeutic goods in relation to COVID-19 on his website.   Source: Covid19 advertising breech

TGA Q & A: End of Advertising Pre-Approval Scheme

Up 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. This advertising pre-approval scheme will be stopped in favour of a more self-regulatory regime. This Q & A fact sheet will assist all advertisers of ‘designated therapeutic goods’ to comply with the new regulations.   Source: Advertising therapeutic goods  (Please see also further reading: End of pre-approval process for ads in specified media )

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RFA Regulatory Affairs has decades of experience advising clients on complying with advertising code requirements – for complementary medicines, foods and cosmetics. We also offer training in all these areas, refer to our website Training Courses or contact Kate Durey  This email address is being protected from spambots. You need JavaScript enabled to view it. for more information.

TGA Safety Advisory - Andrographis paniculata

Andrographis is a herb commonly used in Indian and Chinese medicine and is known as the 'King of bitters'. Consumers and health professionals are advised that products containing the herb Andrographis paniculata may be associated with changes in the sense of taste (also known as taste disturbance), including complete loss of taste.    Source: Safety advisory - Andrographis

TGA Social Media Advertising Guide

Advertising therapeutic goods in social media poses unique challenges. This guide is designed to help advertisers apply the legislative requirements for advertising therapeutic goods on social media platforms. Not all information about therapeutic goods is advertising; however, the definition of 'advertise' in relation to therapeutic goods is broad. Any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods is an advertisement. A social media post that promotes the use or supply of therapeutic goods is an advertisement. Whether an advertisement for therapeutic goods appears on social media or in any other media, the advertisement must comply with therapeutic goods legislation.   Source: Social media advertising

Guide to Using Scientific or Clinical Claims (Representations) in Therapeutic Goods Advertising

It is important to understand how to correctly use scientific or clinical claims when advertising therapeutic goods to the public. This information is for those involved in the marketing of therapeutic goods who use scientific or clinical representations or claims in advertisements by: using scientifically framed claims (i.e. scientific claims); citing research studies (explicitly or impliedly), or, using scientific (and pseudoscientific) terminology. A 'scientific' or 'clinical' representation is one that: uses scientific or medical terminology that is not generally used in the everyday language of the audience to whom the advertisement is directed, or necessarily and overtly relies on scientific or clinical research (such as 'clinically demonstrated to ...' or 'studies show...'). Compliant scientific claims are just the first step to a compliant advertisement. Remember to ensure that your advertising complies with the other applicable requirements in the Therapeutic Goods Act 1989 and the Code.   Source: Scientific or clinical references

TGA Webinar: Supplying and Advertising Therapeutic Goods for COVID-19: Information for New Sponsors

If you are looking to import, supply, manufacture, export or advertise a product to help test for, prevent or treat COVID-19, you are a potential sponsor of a therapeutic good and need to meet certain requirements under the Therapeutic Goods Act 1989. This webinar assists new and potential sponsors of therapeutic goods to meet their regulatory and legislative obligations in relation to COVID-19, and will include an interactive question and answer session with TGA staff. It covers the basics of therapeutic goods regulation with a focus on hand sanitisers, disinfectants, personal protective equipment and advertising. This webinar will be held on Thursday, 28 May 2020, 12:30pm-3:30pm AEST.   Source: Covid-19 webinar

Hand Sanitisers: Information for Manufacturers, Suppliers and Advertisers

This information is intended to help manufacturers, suppliers and advertisers of hand sanitisers to understand their regulatory obligations under therapeutic goods legislation. Specifically, this information covers: hand sanitisers that are excluded from TGA regulation because they meet specified formulation, manufacturing, labelling and advertising requirements; hand sanitisers that are excluded from TGA regulation because they are cosmetics; hand sanitisers that are regulated as therapeutic goods by the TGA; and, advertising requirements for hand sanitisers. Hand sanitisers that are regulated as therapeutic goods must be approved by the TGA before they are supplied, while hand sanitisers that are excluded from TGA regulation (either because they meet the specified requirements or because they are cosmetics) do not require TGA approval before they are supplied. All hand sanitisers are subject to advertising requirements.   Source: Hand sanitisers   (Please see also related legislation: Legislation: hand sanitisers 2020 and Sanitiser info for consumers  ).

Notice of Final Decisions to Amend the Current Poisons Standard – Caffeine

The TGA has made a final decision to affirm the interim decision and amend the current Poisons Standard in relation to caffeine. The decision will take effect on 1 June 2020. The reasons for those final decisions can be read here: TGA caffeine verdict

Vitamin B6 Rules Change? Australia’s TGA Reviews Low-Dose Intake Link to Peripheral Neuropathy

Australian regulator, the TGA is reviewing recent reported cases of vitamin B6 intake and the possible side effect of peripheral neuropathy.   Source: (Copyright) Tingmin Koe, NutraIngredients Asia Vit B6 concerns  (Please see also TGA B6 safety advisory ) .

TGA Recall: Blackmores Professional Duo Celloids S.C.F. Tablets

Fit-BioCeuticals, in consultation with the TGA, is recalling all current batches of Blackmores Professional Duo Celloids S.C.F. tablets due to the potential for contamination with mould.   Source: Celloid recall

MMS Australia Fined $151,200 for Alleged Unlawful Advertising

The TGA has issued twelve infringement notices totalling $151,200 for the alleged unlawful advertising of Miracle Mineral Supplement (also referred to as Miracle Mineral Solution) (MMS) and other medicines by Southern Cross Directories Pty Ltd trading as MMS Australia. There is no clinical, scientifically-accepted evidence showing that MMS can cure or alleviate any disease. The use of MMS presents serious health risks, and can result in nausea, vomiting, diarrhoea and severe dehydration, which in some cases can result in hospitalisation. The TGA is monitoring non-compliance, particularly in relation to the advertising of products that claim to prevent or cure COVID-19 and will continue to take action in relation to any advertisements that do not meet the requirements.    Source: MMS massive fine   (Please also see further reading: Safety Advisory: MMS tabs )

The ‘Innovation Nation’ for Supplements: Australian Industry Hails Five-Year Protection for Clinical Trials

Industry leaders in Australia have hailed cross-party agreement that will lead to five years protection for clinical trials for complementary medicines and supplements, a world-first move that trade body Complementary Medicines Australia says will reward companies at the cutting edge of research.   Source: (Copyright) Gary Scattergood, NutraIngredients (Asia) Oz clinical trials

Artemisia annua Extract to Become Prescription-Only Medicine in New Zealand

New Zealand’s Ministry of Health has declared that Artemisia annua extract is now classified as a prescription medicine, following a recommendation from the Medicines Classification Committee (MCC). The new classification means it will no longer be able to be sold in pharmacies or online. This classification affects the artemisia annua extract only, not the plant. All products containing artemisia annua extract can now only be supplied on a prescription given by a health care professional authorised under the Medicines Act 1981. There are no approved products containing artemisia annua extract currently available in New Zealand.    Source: NZ artemesia extract ban   (Please also see NHPNZ response to this development: NHPNZ response to artemesia extract restriction ) (Editor note: This new classification does not affect its status in Australia and it is still permitted in complementary medicines)

 

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

 

 

Aussie Company in Deep Yoghurt for Failing to Disclose Ingredient

The Australian Competition and Consumer Commission (ACCC) has recently issued an infringement notice and penalty of AUD$12,600 to Queensland Yoghurt Company Pty Ltd (QYC) for failing to disclose the fact that some of its yoghurt products contain gelatine. The ACCC alleged that, from at least 2 July 2019, QYC had omitted gelatine as an ingredient in several of its products when in fact they contained the compound ingredient CFT-1, of which gelatine is a component. This raised key issues around the misleading of consumers, who may choose to buy gelatine-free products based on dietary, religious, environmental or ethical reasons.   Source: Yogurt labelling

Failing Food Report – March 2020

These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the month of March. Among the usual pathogens detected in these imported foods are such organisms as Salmonella (found in Kashmiri chili powder), Listeria (found in Japanese frozen crab), and assorted toxins such as histamine (found in Ghanian herring), aflatoxin (found in Thai curry paste), and illegal addition of vitamins to many foods.  Of particular note are the number of foods ‘failing’ due to the illegal presence of caffeine (found in formulated supplementary sports foods from USA).    Source: March 2020 food fails

Department of Agriculture, Water and the Environment Seeks Feedback

This new Australian Government department was established on 1 February 2020. Before this, they were the Department of Agriculture and the Department of Environment and Energy. Every year they are assessed against how they perform against the Australian Government’s Regulator Performance Framework. Before machinery of government changes took effect, the former Department of Agriculture and Department of Environment and Energy prepared self-assessments of their regulatory performance in 2018–19. They are now seeking your feedback on 8 self-assessments. Seven from the agriculture portfolio and 1 from the environment portfolio.   Source: Department assessment

NZ Dietary Supplements Regulations 1985 Are Due to Expire on 1 March 2021

The new Zealand, Food (Continuation of Dietary Supplements Regulations) Amendment Bill was introduced in to the House of Representatives yesterday to ensure the current regime can continue while a new regulatory regime for natural health products (which include dietary supplements) is being developed. The Bill extends the Regulations by five years until 1 March 2026. The Ministry for Primary Industries has advised that it does not anticipate needing the entire length of the proposed extension to implement a new regime. It is set at five years to ensure that the necessary work to implement an improved regulatory regime can be done without requiring further extensions if unforeseen circumstances arise.   Source: NZ Food Safety

FSANZ Sugar Labelling Consultation

Foods Standards Australia and New Zealand, via the Australia and New Zealand Ministerial Forum on Food Regulation (the Forum), has been looking at sugar labelling and how to give Australian and New Zealand consumers' better information about added sugar in food to help them make informed and healthier choices. In August 2019, the Forum asked FSANZ to review nutrition labelling for added sugars. The request was in response to a policy paper on the labelling of sugars on packaged foods and drinks which found that information about added sugars on food labels is limited and/or unclear, which limits consumers' ability to make food choices consistent with dietary guidelines. The current review is looking at whether and how the Food Standards Code should be amended to help consumers make more informed choices about added sugars in food.    Source: Sugar labelling review

Health Star Rating System Five-Year Review Report

In December 2019, the Australia and New Zealand Ministerial Forum on Food Regulation (Forum) published its Response to the Health Star Rating (HSR) system five-year Review Report (Review Report) and its ten recommendations for enhancing the HSR system. The Forum is now seeking to update stakeholders on progress and obtain views on the appropriateness of a proposed implementation start date of 1 October 2020.   Source: Health Star Rating update

FSANZ Notifications -

Application A1159 – Triacylglycerol lipase from Trichoderma reesei as a processing aid (enzyme): The purpose of this application is to permit the enzyme lipase, triacylglycerol from Trichoderma reesei as a processing aid for the production of bakery products and cereal-based beverages.   Source: Bakery enzyme 1

Application A1174 – Xylanase from GM Trichoderma reesei as a PA (enzyme): The purpose of this Application is to permit the use of Xylanase from GM Trichoderma reesei as a Processing Aid.    Source: Bakery enzyme 2

Application A1182 – Glucose Oxidase from GM Trichoderma reesei as a Processing Aid (Enzyme): The purpose of this application is ​to approve a Glucose Oxidase enzyme preparation from Trichoderma reesei for use as a processing aid in cereal based products (baking) and egg processing.   Source: GM enzyme

Application A1183 – Enzymatic production of Rebaudioside E: The purpose of this application is ​to seek approval for a new specification for the steviol glycoside Rebaudioside E produced by an enzymatic conversion method, using enzymes derived from a genetically modified strain of the yeast, Pichia pastoris.   Source: GM glycoside

Application A1193 – Irradiation as a phytosanitary measure in food: The purpose of this Application is to extend the option of phytosanitary irradiation to all types of fresh fruits and vegetables.   Source: Food irradiation

Application A1199 – Food derived from Innate potato lines V11 & Z6: The purpose of this Application is to seek approval for food derived from genetically modified potato lines V11 & Z6, which have lower reducing sugars, low acrylamide potential, reduced browning (black spot) and late blight protection.   Source: GM potato

Proposal M1017 – Maximum Residue Limits (2019): The purpose of this proposal is to consider varying certain maximum residue limits (MRLs) for residues of specified agricultural and veterinary chemicals that may occur in food commodities.   Source: MRL proposal

 

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