Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Complementary Medicines (“Dietary supplements”):
TGA Revamps Complaints Handling for the Advertising of Therapeutic Goods
The Therapeutic Goods Administration (TGA) is responsible for ensuring that therapeutic goods available for supply and use in Australia are safe and fit for their intended purpose. This includes complementary medicines such as vitamins, herbal and traditional medicines. Advertisers of therapeutic goods should note that the current 2015 Therapeutic Goods Advertising Code expires at the end of this year and that the new 2018 Code will commence on 1 January 2019. Complaints received by the TGA will get classified as low, medium, high or critical, with corresponding actions taken by the TGA depending on the classification. Source: Advertising complaints 2018 code
TGA Changes Advertising Code 2018 Following Public Consultation During April 2018
Advertising to the public for therapeutic goods must comply with the Therapeutic Goods Advertising Code (the Code). The Code ensures that the marketing and advertising of therapeutic goods is conducted in a manner that promotes the quality use of the product, is ethical and does not mislead or deceive the consumer. A draft version of changes to the Code was sent for public consultation in April 2018, with the updated version taking effect from 1 January 2019. The definitional references to 'complementary medicine' and 'listed' have been deleted and a number of new definitions have been included or amended, among several other changes. Source: Advertisng code changes
Negative Advertising Outcome for Gumby Gumby Capsules
Suppliers of Gumby Gumby capsules have been found guilty of illegally promoting their product as a cure for cancer. They promoted their product by way of testimonials claiming not only benefit to cancer sufferers but also to people with arthritis, chronic fatigue syndrome, or skin diseases. Gumby Gumby capsules have never been registered on the Australian Register of Thereapeutic Goods (ARTG), which is a mandatory requirement for all medicines supplied in Australia. Note that ‘advertising’ refers not only to print media but also to all e-media including websites and social media of all sorts. Source: Gumby gumby fail
Pre-Market Evaluation of Herbal Component Names Discontinued
Where a herbal ingredient comprises of chemical constituents, these chemical constituents are referred to as "herbal components". A Herbal Component Name (HCN) for use in listed medicines is a name for a herbal component of its parent herbal ingredient. HCNs are not standalone active ingredients for use in listed medicines. Certain herbal components are mandatory to declare in listed medicine applications. These mandatory herbal components are identified in the Therapeutic Goods (Permissible Ingredients) Determination, and are mandated by the Poisons Standard or for safety reasons. Sponsors will no longer be able to submit new HCN applications for pre-market evaluation effective immediately. After 1 October 2018, sponsors will not be able to select HCNs from the TGA list of approved HCNs for use in new listings. The TGA will continue to work with industry to discontinue pre-market evaluation of HCNs. Source: HCN FAQs
TGA Details Education Priorities for 2018-19
The Therapeutic Goods Administration is committed to delivering a range of educational materials for sponsors, health professionals and consumers in 2018-19. Many of the priority areas for education relate to reforms implemented following the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR). Information is now available detailing the high priority education programs for 2018-19. Source: Education 2018-19
TGA Safety Advisories— Source: https://www.tga.gov.au/current-year-alerts
Mutant YK-11 Capsules: The capsules contain the undeclared substance tadalafil.
Big Penis U.S.A Tablets: The tablets contain the undeclared substances sildenafil & chloramphenicol.
BFB Be Fast Block Capsules: The capsules contain the undeclared substance clenbuterol.
Lanky Genuine Capsules: The capsules contain the undeclared substances sibutramine & phenolphthalein.
Sherb Detox Capsules: The capsules contain the undeclared substance bisacodyl.
You Slim'xs Capsules: The capsules contain the undeclared substance sibutramine.
Sydney Pharmacist Charged Over Illegal Supply of Cancer Drug
A pharmacist on Sydney's lower north shore, and her alleged accomplice, have been charged over allegations that she supplied $500,000 worth of a cervical cancer vaccine to the man, before it was illegally exported for resale in Hong Kong. The Gardasil 9 Human Papillomavirus 9-valent vaccine is used for the prevention of cancers in men and women, including cervical and anal cancers, as well as other diseases caused by human papillomavirus. Gardasil is administered by a course of three injections over six months. Administration of the drug in Australia has been funded through the National Immunisation Program since 2007, which has seen it supplied to girls aged 12-13 years at school. Source: Lucy Cormack, SMH Cancer vaccine
Botanical Adulterant Program Expands
The American Botanical Council (ABC)-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Prevention Program is an international consortium of nonprofit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants. The program advises industry, researchers, health professionals, government agencies, the media, and the public about the various challenges related to adulterated botanical ingredients sold in commerce. In its most recent expansion of activities, this consortium’s latest proposal wishes to set up a new program: “Best Practices SOP for the Disposal/Destruction of Irreparably Defective Articles.” If you would like to review and comment on the proposal, please go to http://abc.herbalgram.org/site/MessageViewer?em_id=41987.0&dlv_id=96250 ; Related conference (Germany): Adulteration and Fraud of Botanical and Natural Health Ingredients: Issues, Challenges and Prevention Tools for the Industry
Botanical Adulterants Prevention Program Publishes Guidance for Tea Tree Oil
As the previous story explains, the ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) actively works to minimise adulteration of botanical ingredients in the global marketplace. As part of its most recent efforts, the program has released a Laboratory Guidance Document (LGD) on tea tree oil, the essential oil obtained from tea tree (Melaleuca alternifolia and M. linariifolia) leaves. Australia is the major producer of tea tree oil, providing an estimated 80% of the global supply. In 2018, Australian tea tree oil exports reached a market value of AU$35 million (roughly US$21 million). “In the past three decades, tea tree oil has become a significant ingredient in many consumer health products, particularly topical products used for their antibacterial, antifungal, and other beneficial health effects,” said Mark Blumenthal, founder and executive director of ABC and founder and director of BAPP. “The rise in tea tree’s popularity has motivated unscrupulous suppliers to add cheap, sometimes synthetic chemicals to materials that are fraudulently being marketed as ‘tea tree oil’ in international commerce. The Tea Tree Oil Laboratory Guidance Document, when utilized by reputable company laboratories, will enhance the quality control process and help protect responsible companies from being victimized by sellers of fraudulent material.” Source: Tea tree oil adulteration
FDA Warns of Fraudulent Dietary Supplements
USA Federal regulators continue to warn consumers about tainted, dangerous products that are marketed as dietary supplements. These fraudulent products can cause serious injury or even death. The Food and Drug Administration (FDA) has found nearly 300 fraudulent products—promoted mainly for weight loss, sexual enhancement, and bodybuilding—that contain hidden or deceptively labelled ingredients. Unlike Australia’s TGA (which categorises these products as ‘complementary medicines’), dietary supplements, in general, are not FDA-approved. Under USA law (Dietary Supplement Health and Education Act of 1994), dietary supplement firms do not need FDA approval prior to marketing their products. It is the company’s responsibility to make sure its products are safe and that any claims are true. Just because consumers see a supplement product on a store shelf does NOT mean it is safe or effective. When safety issues are suspected, FDA must investigate and, when warranted, take steps to have the product removed from the market. However, it is much easier for a firm to get a product on the market than it is for FDA to take a product off the market. Sources: Fake supplements ; Keep supplements clean
USA: Psychedelic Mushrooms are Closer to Medicinal Use (It’s Not Just Your Imagination)
Researchers from Johns Hopkins University have recommended that psilocybin, the active compound in hallucinogenic mushrooms, be reclassified for medical use, potentially paving the way for the psychedelic drug to one day treat depression and anxiety and help people stop smoking. The study comes as many Americans shift their attitudes toward the use of some illegal drugs. The widespread legalization of marijuana (in USA) has helped demystify drug use, with many people now recognizing the medicinal benefits for those with anxiety, arthritis and other physical ailments. Psychedelics, like LSD and psilocybin, are illegal and not approved for medical or recreational use. But in recent years scientists and consumers have begun rethinking their use to combat depression and anxiety. Source: Laura Holson, NYT Magic mushrooms
Reminder: Changes to Complementary Medicine Claims – TGA Fee Free Period Available
Do you have complementary medicines listed with the TGA? We remind you that you must revise the indications for use (“claims”) to only include those on the permitted indications list by 6 March 2021 or products will be cancelled. Currently the TGA has a fee free period. Click here for our website and contact details.
Honey Scandal Rolls on: Almost 20 per cent of Australian Honey Samples Found to Not be Pure
As reported by this newsletter in September 2018, Australia’s honey is not always what is claimed on the label. Almost one in five Australian honey samples, including some expensive boutique honey, are fake, according to a ground-breaking study that tested samples of local and international branded honey. The study, conducted by a team of scientists at Macquarie University, used 100 samples of honey sourced globally, including 38 Australian-branded honey samples. Imported honey was widely known to be adulterated with grain sugars but the big shock was Australian honey. Of the 38 honey samples sourced from supermarkets and markets, 18 per cent, or almost one in five, showed adulteration. Source: Ferguson & Gillett, ABC News Oz honey now funny
Fresh Stawberry Contamination – Fallout
Australia has experienced a rash of malicious tampering with fresh fruit in September, with over 100 reported cases of forign objects being placed in fresh fruit. This has resulted in damage to Australia's export trade and particular damage to the Australian Strawberry industry.The Prime Minister of Australia has increased the maximum jail term to 15 years from 10 years for anyone convicted of tampering with food and criminalized hoax claims. This attack on the strawberry industry with deliberate placing of needles in fruit is likely to see an increase in compliance requirements to manage vulnerability to such threats, across all industry sectors in 2019.
Editor’s note: At time of this newsletter’s publication no arrests have been made and police are still investigating.
How to CSI your Tea: ‘Fingerprint’ Authenticity Technology Aims to Revolutionise Sector
As ‘food fraud’ becomes an ever increasing problem, new technology can ensure that what you pay for is what you get, at least when it comes down to buying your favourite tea. New Singaporean retail-tech startup, Teapasar, aims to use unique new ‘tea-fingerprinting’ technology revolutionise the way the world buys and consumes their tea. Source: Pearly Neo, Food Navigator-Asia Real tea
Joint Food Regulation System Recommends Pregnancy Warning Labels on Packaged Alcoholic Beverages
The Australian and New Zealand joint food regulation system uses scientific evidence and expertise, to protect the health and safety of their consumers. It is a complex system that involves all levels of the Australian and New Zealand governments (The Forum). Different roles are met by local, state and national government, and international obligations are respected. In its latest communiqué, The Forum recognised that Fetal Alcohol Spectrum Disorder is a life-long disability which can be prevented if pregnant women do not consume alcohol. Pregnancy warning labels on packaged alcoholic beverages have been applied on a voluntary basis since late 2011. The Forum recently agreed that, based on the evidence, a mandatory labelling standard for pregnancy warning labels on packaged alcoholic beverages should be developed and should include a pictogram and relevant warning statement. Source: Alcohol labelling
Sports Supplements Down-Under
Sports supplements are regulated through the Australia New Zealand Food Standards Code, or therapeutic goods regulations, depending on how they are presented in the market (either as a ‘food’ or as a ‘therapeutic product’). The Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) has agreed to a plan which includes regulatory actions, targeted education and improved labelling to enhance the safety of consumers who choose to use sports supplements. As part of this action plan, Forum Ministers requested that FSANZ undertake a full review of Standard 2.9.4 – Formulated Supplementary Sports Foods as a matter of priority to modernise the Standard to capture the expanding sports supplement market. The Food Regulation Standing Committee will work with the Therapeutic Goods Administration on the implementation of the action plan due to the crossover of products in this area. Source: Sports supplements
Academics and Industry Disagree Over Health Star Rating for Aussie Beverages
A recent Australian study has identified the selective and partial uptake of the voluntary Health Star Rating (HSR) system for beverages as ‘shortcomings’, a finding that has received 'short shrift' from the nation’s beverage sector. Source: Pearly Neo, Food Navigator-Asia Health star rating
September 2018 Failing Food Report
The Department of Agriculture and Water Resources targets and monitors food determined to pose a high or medium risk to public health. Risk food is targeted at the rate of 100 per cent until a history of food safety compliance is established. When an emerging human health and safety hazard is identified in food, the department may temporarily increase monitoring and testing. This latest report details food that was found to fail under the Imported Food Inspection Scheme during the month of August. Among the pathogenic organisms detected in these imported foods were, Listeria monocytogenes, Vibrio cholera, & Salmonella, as well as the toxins Aflatoxin, Lead, Dimethoate and more. Source: Latest failed foods
Application A1146 – Thermolysin (Protease) as a Processing Aid (Enzyme): The purpose of this Application is to permit the use of thermolysin (protease) from Anoxybacillus caldiproteolyticus as a processing aid in protein, dairy, egg, meat and fish processing and flavour production. Source: ThermolysinApplication A1149—Addition of Steviol Glycosides in Fruit Drinks: The purpose of the Application is to seek approval to include the addition of steviol glycosides in Fruit Drinks at a level of 200 mg/kg steviol equivalents. Source: Steviol levels
Natural Health Products Account For One In Every Three Dollars Spent on Non-Prescription Medicines
The latest report on Australia's health showed that nearly $1.5 billion was spent on natural health products in 2015-16, which includes herbal medicines, homeopathic preparations and probiotics. Spending on natural health products grew by 21 per cent from 2014-15, making it the fastest growing category of over-the-counter medications. Foot care products and medicines for digestion experienced the next highest growth in spending. Source: Catherine Hanrahan, ABC News Oz health spending
Quote for the month:
“Don’t worry about people stealing your idea. If it’s truly original, you will have to stuff it down their throats” Walter Isaacson
Cosmetics and household cleaning products:
The Cosmetics Standard 2007 “Sunsetted” on 1 October 2018
The Cosmetics Standard ceased to have effect on 1 October 2018, due to "sunset" provisions in the Legislation Act 2003. The new Determination specifies certain goods to be excluded goods for the purposes of that Act. The exclusion may be absolute in nature or only when used, advertised or presented for supply in a particular manner specified in the Determination. The new Determination reproduces the relevant content of the Cosmetics Standard to maintain the regulatory status quo. To the extent that these products are also therapeutic goods, the TGA will continue to have oversight of those goods which do not meet the terms of their exclusion. The take-home message for importers or manufacturers of cosmetic in Australia is that their obligations around cosmetic ingredients and cosmetic products are essentially the same as before. Source: Cosmetic changes only
Complementary Medicines (“Dietary supplements”):
Australians Rewrite Complementary Medicine Rulebook
Times are changing in the world of Australian complementary medicine regulations and New Zealand producers will need to act fast or risk losing out to their competitors for sales across the ditch. That is the advice Australian regulatory consultant Robert Forbes gave the audience at the Natural Health Products New Zealand Suppliers Day in Auckland. Recent TGA changes include removal of the free text option when making product claims/indications (applicants will need to select their product claims/indications from a drop-down list of over 1000 approved indications) and changes to regulations related to new ingredient assessments. There is a new approval pathway for non-prescription medicines to be sold in Australia (called Aust L Assessed; AUST L A whichsits in between Listed and Registerd medicine categories and allows manufacturers to make slightly more powerful claims about their products’ health effects if they have the supporting evidence. Source: Jonathan Chilton Towle, pharmacytoday.co.nz (Subscription) Australian V NZ regulations
TGA Rules on the Implementation of a ‘Claimer for Efficacy Assessed Non-Prescription Medicines’
The TGA has ruled on a proposal to allow sponsors to claim (‘the claimer’) that their medicine has been assessed by the TGA for efficacy where that medicine has undergone pre-market evaluation by the TGA. Eligible products will be ableto carry higher level health claims than current Listed (AUST L) products, including health benefits for more serious health conditions. Government-recognised status of the efficacy of Complementary Medicines (CMs) which hold higher level health claims puts Australia at the cutting edge of global regulation of CMs. The claimer, to be applied voluntarily by the sponsor of the approved product, will appear in the form of a diagram on the product label. The optional statement on the label will be: ‘Evidence for the approved indications has been assessed by the TGA’). The claimer will be introduced for assessed listed medicines (which may include complementary and OTC medicines) and registered complementary medicines only. Source: Efficacy claimer ruling
TGA Publishes Current List of Evaluated Registered Complementary Medicines
Registered complementary medicines are considered to be of relatively higher risk than listed medicines, based on their ingredients or the indications made for the medicine. Registered medicines are fully evaluated by the TGA for quality, safety and efficacy prior to being accepted on the Australian Register of Therapeutic Goods (ARTG) and able to be marketed. Medicines registered on the ARTG are assigned a unique AUST R number, which must be displayed on the medicine label. The following link sets out the registered complementary medicines on the ARTG that have been evaluated by the TGA for safety, quality and efficacy: Registered comp meds
TGA Considers Comparable Overseas Regulators for Medical Device Applications
The TGA is expanding the range of international assessments and approvals from comparable overseas regulators that sponsors can choose to provide when submitting their applications for inclusion of medical devices in the ARTG. As soon as legislation is finalised, the number of comparable overseas regulators and assessment bodies will be expanded to include peak European, Canadian and Japanese regulatory agencies. Source: Medical device regulation
TGA Updates Permissible Ingredients Determination for Listed Medicines
An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in September 2018. A total of 10 changes have been made in the updated Determination. These changes include: the addition of 5 new ingredients; changes to 5 existing ingredient entries; and, correcting the approved ingredient name. Source: Permissible ingredients update
TGA Recalls NET Remedies Homeopathic Products
Consumers and health professionals are advised that NET Remedies, in consultation with the TGA, is recalling all unexpired aqueous-based products currently in the supply chain due to possible microbial contamination. It has been identified that a fault in the water filtration system from the North Carolina manufacturer resulted in four batches being contaminated by Pseudomonas spp. Source: Homeopathic recall
TGA Safety Advisories— Source: https://www.tga.gov.au/current-year-alerts
For the first time, in many years, this month there have been no reported illegal medicines containing Viagra / Cialis like substances imported into Australia!
Weight-Loss 'Shredder' Drugs Containing Toxic DNP Linked to Deaths
Health authorities are warning the public against weight-loss products containing a toxic chemical that have caused multiple deaths in Australia and overseas. The drugs containing the chemical 2,4 dinitrophenol (DNP) are marketed as "shredders" to the fitness, weight-loss and body-building communities. The toxic substance used to make herbicides and explosives causes serious illness and death. Several young people have died after taking the drugs in Australia and internationally according to NSW Health. DNP prevents energy from being stored as fat; instead it releases energy as heat, which increases body temperature. That can damage the cells of organs including the kidney and brain. Source: Kate Aubusson, SMH Weight-loss shredder
TGA Provides Update on the Compliance Verification (CV) GMP Clearance Applications Backlog
In 2017-18 a total of 5,327 GMP Clearance applications were received. This compares with over 5,400 applications in 2016-17 and over 5,600 in 2015-16. This has created a backlog of applications and has extended the processing times for CV clearance applications. To address the backlog, in September 2017 the TGA implemented a range of GMP Clearance process improvements and a streamlined compliance verification process. Analysis of the CV GMP Clearance applications shows that there has been a substantial reduction in the number of CV applications across the board. Source: GMP backlog
TGA Facebook Has Officially Launched
Facebook is a popular forum for consumers to discover and share information, with 60% of Australians being users of social networks including Facebook. The TGA Facebook page extends its reach with these consumers, increasing awareness of its role as Australia’s regulator of medicines, medical devices, blood, cell and tissue products. Consumers can use the page to find information and tips on the safety of medicines and medical devices, while health professionals can use it to follow the latest news and guidance on the regulation of therapeutic goods. Source: TGA Facebook
TGA Publication of Interim Decisions Proposing Amendments to the Current Poisons Standard
Affected substances include: Sildenafil; Budesonide; Alkyl nitrites; Codeine; Cannabidiol and tetrahydrocannabinols (THCs); Paracetamol combined with ibuprofen; 2-Butoxyethanol; Dimethyl sulfoxide (DMSO); Aliphatic allyl esters; &, Astodrimer sodium. Further comments are due to the TGA by 11 October 2018. Source: SUSMP scheduling
The Rhetoric Around What Constitutes 'Good' Evidence Has Become Increasingly Polarising
The debate about what constitutes 'good evidence', always a controversial point, has recently become even more heated, writes complementary medicines consultant Michael Smith. Source: Gary Scattergood, Nutraingredients-Asia 'Good' evidence