Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

TGA Warns Against Use of Performance and Image Enhancing Drugs

Performance and image enhancing drugs are a diverse group of drugs that some people use with the aim of improving their sporting performance or pursuing a desired look for their body. These may include anabolic steroids, SARMS, beta-2-agonists, stimulants, peptides and even tanning agents. There is concern about both the known and unknown health risks when taking these drugs as well as the illegality of possession and use. The TGA recommends not to buy from overseas websites and to look for an AUST number on the label, which confirms it is a TGA regulated product.   Source: Performance drugs

(Related story: Shayna Jack and the Dilemma of Contaminated Sports SupplementsSource: Triple J Hack Supplement contamination ; & CMA Media Release)

TGA Signals Upcoming Changes to the Permissible Indications Determination

'Indications' are statements that describe the specific therapeutic use for a medicine. They describe a medicine's claimed purpose or health benefit. Indications available for use for listed medicines are now contained in a 'list of permitted indications'. The proposed changes include the addition of 4 new indications, and changes to 32 existing indications to clarify/correct the wording of indications and/or indication requirements.   Source: Permissible indications update

TGA Discusses the Use of ‘Natural’ Claims When Advertising Medicines and Medical Devices

Following on from the previous guidance issued by the TGA (as reported in this newsletter’s June 2019 edition), more detail is provided here. The two main principles involved when deciding on the appropriateness of using the term ‘natural’ in advertising are - advertisers of medicines and medical devices must ensure that they do not mislead consumers when making natural claims, and advertisers must hold evidence that substantiates any claims, and provide this evidence to the TGA if asked.   Source: 'Natural' claims    (See also: Understanding what ‘natural’ means on your medicine)    

TGA Updates Advertising Code for Therapeutic Goods

Minor corrections and clarifications have been made to the Therapeutic Goods Advertising Code (No.2) 2018. These came into effect on 30 July 2019. Some of the changes made concern – clarifying the definition of ‘health warnings’, the use of ‘mandatory statements’, more flexibility in wording of ‘indications’, proper use of ‘health warnings’, and, required advice if pregnant.   Source: Therapeutic advertising

All That You Ever Wanted to Know About the Poisons Standard

The Poisons Standard is the legal title of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) which promotes the uniform scheduling of substances and uniform labelling and packaging requirements throughout Australia. This handbook provides guidance for stakeholders on how the Poisons Standard is amended and provides details of the processes that underpin the scheduling policy.   Source: Know your poison

TGA Safety Advisories- Source: TGA current year alerts

Hong Kong Tianli Biological – power tablet: Contains the undeclared substance Sildenafil

Bali Mojo capsules: Contains the undeclared substance Tadalafil

GMP Clearance Applications Using Health Canada Evidence Attract Special Charge

Australia’s TGA has Mutual Recognition Agreements with many countries, including Canada, concerning Conformity Assessment in Relation to Medicines Good Manufacturing Practice Inspection and Certification. This means that Australian sponsors using manufacturers in Canada have been permitted to use the HC “Inspection Exit Notice” as evidence to demonstrate compliance in place of a GMP Clearance Certificate. However, this MRA is only applicable to inspections of Canadian manufacturing sites. When HC inspect outside their borders, there is insufficient evidence in these reports to demonstrate complete compliance. The TGA now charges an additional liaison fee to cover the extra work involved in processing CV clearance applications submitted using HC 'exit notices'.   Source: Health Canada GMP   (See also: TGA fees & charges )

Botanical Adulterants Prevention Program Wins Editors Award for Industry Initiative of the Year

The ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) received the Editor’s Award for “Industry Initiative of the Year” by NutraIngredients-USA, one of the leading natural products and dietary supplement industry trade publications in the United States. BAPP is an exemplary educational resource about adulteration in the botanical supply chain, with its growing body of peer-reviewed literature, laboratory guidance documents, bulletins, and newsletters.   Source: BAPP wins award ;   (See also: BAPP homepage )

RFA Congratulates Michael McGuffin on Celebrating 20 Years as AHPA President

RFA Regulatory Affairs has been a keen supporter of the American Herbal Products Association for many years. As Michael McGuffin celebrates his 20 years of presidency (“I’m 68 years old and I can only do this another 10 or 20 years”), now is a good time to look back on all the success of AHPA during Michael’s tenure – which can be neatly summed up with, “(the role of NHPA is) to promote the responsible commerce of herbal products.”   Source: M. McGuffin turns 20

 

Australia and New Zealand Ministerial Forum on Food Regulation Communiqué

The Australia and New Zealand Ministerial Forum on Food Regulation met on 16 August 2019 to consider a range of food regulation matters. Key outcomes from the meeting include: Health Star rating five-year review (better labelling and more consumer education needed); Links between obesity and chronic disease (‘requires a multi-sectorial approach’); Labelling of sugars (a pictorial approach considered helpful); Fast food menu board labelling (needs to be nationally consistent); Fermented beverages (presence of alcohol is problematic); and, Contamination by salmonella enteriditis (200 x confirmed cases). More generally, modernisation of the food regulation system, and energy labelling of alcoholic beverages were also topics for discussion.    Source: The Forum decides

Government Orders Review to Weigh Up 'Added Sugar' Labels

Australians could finally have access to information about how many "empty calories" are in the soft drinks and packaged foods they buy, after state and federal ministers ordered a review to consider mandatory "added sugar" labelling. State and federal food ministers from Australia and New Zealand, who sit on the Australia and New Zealand Ministerial Forum on Food Regulation, announced the move while releasing the final report of the five-year review of the Health Star Rating System. The ministers "agreed to request that Food Standards Australia New Zealand review nutrition labelling for added sugars, noting that the option to quantify added sugars in the nutrition information panel best met the desired outcome”.   Source: Dana McCauley, SMH Sugar labelling (Please see also: Food Regulations: Sugar )

Ban on Importation of Mini Jelly Cups Containing Konjac

Konjac is a binding food additive that comes from the root of the konnyaku plant. When eaten, it does not dissolve easily. Konjac is also known as ‘konjac flour’, ‘konjaku’, ‘konnyaku’ ‘conjac’, ‘konjonac’, ‘glucomannan’, ‘yam flour’, ‘yam powder’, ‘taro flour’ and ‘taro powder’ and is obtained from the tuber of the Amorphophallus spp. Mini jelly cups containing konjac having a height or width of less than or equal to 45mm are banned for sale under Australian Consumer Law. Mini jelly cups are small confectionery products often sold in multi-packs. A product ban is in place on mini jelly cups containing konjac because there is a risk they may cause serious injury or death from choking.   Source: Konjac ban   (See also: ACCC notice of Konjac ban)

Debrief: Strawberry Tampering Incident

In September 2018, a food tampering incident occurred involving sewing needles inserted into Australian strawberries. Initially an isolated event in Queensland, the incident escalated involving multiple tampering events in strawberries and other fruit across the country. Only a few instances were believed by authorities to be associated with the original event with most other instances believed to be multiple hoax or 'copycat' events. Queensland Health and the Queensland Police Service led the incident investigation and response. State and territory food regulatory agencies and the Australian Government have also responded with a range of measures including removing implicated strawberries from sale, introducing and strengthening penalties for food tampering, and imposing stricter conditions for strawberry export. FSANZ released its report on the strawberry tampering incident including key recommendations focusing on the need for improved communication during incidents, particularly those involving criminal matters.   Source: The strawberry incident

Imported Food Inspection Scheme Publishes Inspection Data Results Summary for 2018

The Department of Agriculture is responsible for managing Australia's biosecurity system. Food Standards Australia New Zealand (FSANZ) advises them on food that poses a medium or high risk to human health and safety. The inspection and control of imported food through the Imported Food Inspection Scheme (IFIS) is a risk-based border inspection program. This report provides summary data from imported food inspections conducted under the IFIS from 1 January to 31 December 2018. To help contextualise the inspection data, this report includes information on food trade, such as the composition of Australian food imports and countries of origin.   Source: Imported food inspections 2018 summary

June 2019 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 June. Among the usual pathogenic organisms detected in these imported foods are such organisms as Staphylococci E coli, Bacillus cereus, and Salmonella, and assorted toxins such as hydrocyanic acid, chlorpyrifos, aflatoxin and many more. Of particular note are the number of foods ‘failing’ due to the illegal presence of added vitamins and or minerals and also irradiation.   Source: Latest failed foods

NZ Biosecurity Boost

Biosecurity New Zealand has recruited 101 new officers to help secure the country’s borders from invasive pests and diseases. Biosecurity New Zealand now has 600 officers, up from 450 in 2013. The new 101 officers will be split between Auckland (70), Wellington (15), Christchurch (12) and Queenstown (4). New Zealand’s main international airports are based in these locations.   Source: NZ biosecurity strengthened

FSANZ Notifications—

Proposal P1052 – Primary Production and Processing Requirements for High-risk Horticulture: The purpose of this proposal is to consider the development of a primary production and processing (PPP) standard for high-risk horticulture as part of a broader review of chapter 3 and 4 of the Food Standards Code.   Source: PPP horticulture

Proposal P1053 – Food Safety Management tools: The purpose of this proposal is to consider food safety management requirements for the food service and retail sector.   Source: Food safety

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: MRLs food

Application A1176 – Enzymatic production of Steviol Glycosides: The purpose of this application is to seek approval for a new specification for steviol glycosides produced by an enzymatic conversion method using enzymes derived from genetically modified strains of Escherichia coli (E. coli).   Source: GM steviol

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: Pichia pastoris enzyme

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 glucoamylase

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

Application A1186 – Soy Leghemoglobin in meat analogue products: The purpose of the application is to allow the use of soy leghemoglobin derived from P.pastoris as a component in meat analogue products.   Source: Meat analogue

 

The 3 Most Notorious Ponzi Schemes in History

Direct selling companies can often appear to be similar in structure to Ponzi Schemes. The difference being that bona fide multi-level marketing (MLM) companies derive genuine profit from real world sales, whereas Ponzi schemes make no real profit and exist only as long as new investors keep up the payments to earlier investors. Read about 3 infamous examples of what can go wrong for individuals, companies and even countries when investment eggs are all placed in the Ponzi basket.   Source: Hakki Ozmorali, World of Direct Selling Ponzi history

RFA Provides Comprehensive Training In Regulatory Affairs - Late Winter Special! 20% discount on September and October bookings

Are you looking to expand your knowledge or are you new to Australian regulations related to the supply of foods, cosmetics and/or complementary medicines? Then check out the full list of courses we offer on the Robert Forbes & Associates website www.rfaregulatoryaffairs.com/training-courses . There are 20 courses to choose from and any of these can be undertaken either singly or in groups, from within our Glebe, Sydney office, at your office or remotely via Skype. We are offering a special 20% discount on all courses if you enrol in the month of September or October. Contact our training manager Kate Durey This email address is being protected from spambots. You need JavaScript enabled to view it.  to receive the latest information on these training courses at this discount offer. See you in the classroom!

Quote for the month:

“I never liked training, but I said ‘Don’t quit’. Suffer now and live the rest of your life as a champion”   Mohammed Ali

 

View: RFA Regulatory Affairs You Tube Video (Cosmetics Regulation)

 

ACCC Appeals 'Flushable' Wipes Decision

The Australian Competition & Consumer Commission has appealed the Federal Court’s decision to dismiss part of the ACCC’s case against Kimberly-Clark which relates to claims it made to consumers about its Kleenex Cottonelle ‘flushable’ wipes. The ACCC had alleged that in representing its products as ‘flushable’ on product packaging and its website, Kimberly-Clark had misled consumers about the suitability of its wipes to be flushed down the toilet. In June 2019, the Court found that Kimberly-Clark’s ‘flushable’ claims were not false or misleading. In the same judgment, the Court also found that Kimberly-Clark had misled consumers when it claimed its Kleenex Cottonelle ‘flushable’ wipes were made in Australia, when they were in fact variously made in Germany, South Korea and the UK.   Source: Un-flushable wipes

Australian Traveller Fined for Importing Unapproved Products in Luggage

An individual has been fined for the alleged importation of unapproved therapeutic goods to be used in cosmetic procedures after returning from an overseas trip to China. Australia's therapeutic goods legislation prohibits the import, export, manufacture and supply of therapeutic goods for human use that are not included in the Australian Register of Therapeutic Goods (ARTG) or otherwise the subject of an exemption, approval or authority.   Source: Traveller luggage bust

Medical Devices: The LED Light Fantastic

LED (light-emitting diode) works by exposing skin cells to light which stimulates them and helps boost efficiency and repair damage. When it comes to cosmetic use, the red light, for example, is typically used to boost collagen and elastin while the blue light is used to reduce inflammation and kill bacteria. LED lights don't have UV light. Dr Min Yeo, a functional medicine general practitioner, recommends that if you do use them, to ensure that the devices are TGA approved and that the operator is qualified/insured.    Source: Annie Brown, SMH LED light therapy

USA Sunscreen Testing Company Boss Arrested for Allegedly Defrauding Clients

AMA Laboratories owner, Gabriel Letizia Jr, has been accused of falsely representing panellist numbers to customers. For more than 30 years, AMA, based in Rockland County, New York, has tested the safety and efficacy of cosmetics, sunscreens and other products on specified numbers of volunteer panellists for a range of consumer product companies. From 1987 to 2017, Letizia, AMA’s owner and Executive Director, along with other senior staff members are alleged to have defrauded AMA customers out of tens of millions of dollars by testing products on materially lower numbers of panellists than specified or paid for by its customers, according to the indictment.   Source: Cosmetics Business Cosmetic testing fail

 

TGA Advises on Updating Medicine Ingredient Names

In order to bring the naming of medicine ingredients in line with international standards, the TGA instituted a programme in 2017 to harmonise Australia’s ingredient nomenclature with other jurisdictions. All medicines released for supply must carry the updated ingredient names by the time the transition period for updating medicine names ends on 30 April 2020. Sponsors need to be aware of which medicines will be affected by these changes and to ensure that all labelling and promotional materials are compliant by 1 May 2020. A complete list of affected ingredients can be read here Ingredient names affected .   Source: Updating ingredient names

Changes to Permissible Ingredients

As mentioned in last month’s edition of this newsletter the TGA has issued an updated version of Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019. As well as the changes to the 19 existing and 4 new ingredients referred to in that story, a number of changes to specific further ingredients should also be noted. Sponsors of products containing any of the following ingredients should take note: ingredients containing arbutin (arbutin will need to be disclosed as a component with associated specific requirements), poliglusam (maximum daily dosage of 1750 mg will apply), cysteine (its salts and cystine), caffeine (100 mg per dosage unit and 600mg total per day), methyl salicylate (not greater than 25% concentration), and menthol (oral, not more than 1g per day; topical, must not deliver more than 25% total menthol when administered according to the directions for use, label warnings required)   Source: Permissible ingredient update

TGA Updates Guidance on Medicines Labelling (TGO 91 & TGO 92)

Medicine label requirements are specified in two separate labelling Orders depending on whether they are for labels on prescription medicines (TGO 91) or for non-prescription medicines (TGO 92). These new Orders come with a transition period that ends on 31st August 2020. Listed medicines that are released for supply on or after 1 September 2020 must be fully compliant with TGO 92.    Source: TGO 92 label requirements

REMINDER: Very Important Information for All Suppliers of Listed Medicines. Don’t Let Your Product Get Cancelled!

Due to the importance of this information we are repeating the story that we placed in previous month’s newsletters. Suppliers of listed complementary medicines will already know that they must now only use indications included in the list of pre-approved 'permitted indications' and must comply with any requirements for the use of these indications in listed medicines. The new permitted indications requirements apply to all medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). This includes complementary medicines and sunscreens. The key transition dates to note are: 6th September 2019 when the 'fee-free' period for sponsors to transition existing listed products ends. After that date an application fee will apply to all transitioning products in accordance with the TGA's Schedule of fees and charges (currently  $840 per product); and 6th March 2021 when any ARTG entries that have not transitioned to Permitted Indications will be automatically cancelled. So please ensure that your product’s indications are compliant before these dates, otherwise you will face significant costs or possible cancellation of your product from the ARTG.   Source: Permitted indications

RFA Regulatory Affairs provide training on preparing and reviewing permissible indications for your products so you can make these changes. To book a course, enquire about pricing, or if you have any questions on the topics covered or your suitability for training, contact us at +61 2 96608027; or This email address is being protected from spambots. You need JavaScript enabled to view it.

What Does 'TGA Assessed' Mean on my Medicine Label?

Regular readers of this newsletter will know that the “TGA assessed” claimer is now available for implementation. This new claimer indicates that a medicine has been assessed by the TGA for efficacy related to its indications. This claim is only applicable to ‘assessed listed’ and ‘registered’ complementary medicines, and not to those complementary medicines that have not undergone pre-market assessment. A sponsor seeking to use the TGA assessed claim on its label must seek pre-approval by providing a medicine label with the TGA assessed claim. For an existing registered complementary medicine, sponsors must have a new label assessed by the TGA before the claim can be used.    Source: 'TGA Assessed' fact sheet

TGA Rules on Advertising Health Products

The TGA reminds suppliers that the Therapeutic Goods Advertising Code (No.2) 2018 prevents advertisers from claiming that therapeutic goods (including medicines and medical devices) are safe, that their use cannot cause harm, or that they have no side-effects. Safety claims in advertising may be explicit or implicit - both are prohibited. The therapeutic goods legislation specifically prohibits the advertising of therapeutic goods as 'safe' or having 'no side effects', even for specific patient populations or particular dosages. This requirement applies even if suppliers think there is evidence to substantiate such a claim. Care must also be taken to ensure that using the term ‘natural’ does not imply that a product is safe, safer than other products or that excessive use cannot cause harm. Care is also needed to ensure that comparisons with other therapeutic goods do not imply that the other therapeutic goods are harmful or ineffective. For example, use of the word 'organic' may be acceptable if substantiated. However, it is not acceptable to compare the 'organic' product with non-organic products in a way that states or implies that the non-organic products could harm the consumer.    Source: Rules for advertising

TGA Issues Guidance on Use of Restricted Representations

The term ‘restricted representation’ refers to when a “serious form of disease, condition, ailment or defect” cannot be referred to in advertising on any medicine in any context, unless specifically approved, or permitted for use by the TGA prior to use. Generally, if an advertiser wishes to make reference to a restricted representation in advertising, including on labels, then a formal application to the Delegate of the Secretary is required. However, this guidance makes clear that applications to make restricted representations/reference to serious diseases or conditions are not required where the reference is contained or required in a mandatory label warning, contraindication or advisory statement.     Source: Restricted representations

TGA Provides e-Learning Modules on Permitted Indications for Listed Medicines

'Indications' are statements that describe the specific therapeutic use for a medicine. They describe a medicine's claimed purpose or health benefit, for example: 'relieves coughs'. Indications can be specific (e.g. refer to a named non-serious condition); or non-specific (e.g. refer to general health maintenance). Indications available for use for listed medicines are now contained in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination. The list of permitted indications is maintained by the TGA and provides a comprehensive list of indications currently accepted for listed medicines, provided appropriate evidence is held by the medicine sponsor. This set of three e-learning modules provide information on the transition arrangements for permitted indications and instructions on how to create an application on the TGA Business Services portal to include permitted indications for listed medicines.    Source: e-Learning modules for permitted indications

TGA Issues Compositional Guidelines for Resveratrol and Calcified Lithothamnion species

A TGA compositional guideline is a summary of descriptions, tests and appropriate acceptance criteria that define the characteristics and specify the composition of an ingredient permitted for use in listed medicines. The TGA have recently published compositional guidelines for Resveratrol (an ingredient used widely in complementary medicines and manufactured by bacterial fermentation of genetically modified baker’s yeast - Cerevisiae), and also for Lithothamnion species (AAN) and Calcified Lithothamnion tophiforme (AAN). ‘Lithothamnion spp.’ is derived from skeletal deposits of Lithothamnion spp (L. corallioides, L. tophiforme) sourced from the Atlantic Ocean. ‘Calcified Lithothamnion tophiforme', is the skeletal deposits of Lithothamnion tophiforme sourced from Arnarfjordur fjord in Iceland.     Sources: Resveratrol & Lithothamnion-species

TGA Issues Compositional Guideline for Streptococcus salivarius M18

Streptococcus salivarius is a gram-positive bacterium found as part of the normal human oral microflora, predominately colonising the oral cavity (teeth, tongue). BLIS M18™ is a freeze-dried culture of Streptococcus salivarius M18 (NLT 1 x 1011 CFU/g) in a protective matrix of food-grade maltodextrin, trehalose dihydrate and lactitol. S. salivarius can be cultivated and used as an ingredient in listed medicines. The compositional guideline lists the appearance, particle size, morphology, biochemical profile and virulence of this organism.    Source: Compositional guideline for s. salivarius

TGA Issues Guidance on the Regulation of Exempt Disinfectants in Australia

The regulation of disinfectants depends on the claims made by the product on labels, packaging and product information leaflets. The following guidance relates to products that meet the definition of an exempt disinfectant. Exempt disinfectants are not required to be included in the Australian Register of Therapeutic Goods (ARTG) before they are supplied, but must still meet all regulatory requirements including The ‘Poisons Standard’ (The SUSMP) and The Australian Dangerous Goods Code.    Source: Exempt disinfectants guidance . (Please see also related articles concerning ‘Listed Disinfectants’ which are disinfectants that make specific claims and must be included in the ARTG.     Sources: Listed disinfectants guidance and Specific and non-specific disinfectant claims )

TGA Changes Rules Concerning Nappy Rash Products

Changes will be made to the regulation of nappy rash products commencing 1st January 2020. These changes will apply to listed medicines and Class I medical devices which are indicated for the relief of nappy rash symptoms via a barrier effect only. The exemption will not apply to nappy rash preparations that are also indicated for other skin conditions, such as psoriasis, eczema or dermatitis. If relief of nappy rash symptoms are provided via another mechanism of action (e.g. the product has a physiological effect) it would not be exempt. The nappy rash products that are declared exempt will still be subject to any applicable standards for product quality, labelling and packaging, and with advertising requirements. They will also be subject to TGA recall provisions.    Source: Nappy-rash changes

TGA Safety Advisories- Source: https://www.tga.gov.au/current-year-alerts

GoLean Detox capsules: contain the undeclared substances sibutramine and phenolphthalein.

Slim Perfect Legs + High Fiber capsules: contain the undeclared substance sibutramine.

TGA Recall: Neutrogena Visibly Clear Light Therapy Acne Mask and Activator

Consumers and health professionals are advised that Johnson & Johnson Pacific, in consultation with the TGA, is recalling Neutrogena Visibly Clear Light Therapy Acne Mask and Activator. The device is also being withdrawn from the market. This product is a reusable non-sterile device, intended for home-use to treat mild to moderate acne on the face. The device comprises an ‘acne face mask’ and detachable corded ‘activator’. It delivers a combination of red and blue light via light-emitting diodes (LEDs). It has been identified that, for a small subset of potentially susceptible people, repeated exposure may cause varying degrees of retinal damage that could be irreversible and could accelerate peripheral vision impairment or loss. Other potential adverse events that may be associated with use of this device are eye pain, eye discomfort, eye irritation, tearing, blinding, blurring of vision, seeing spots/flashes and other changes in vision (for example vision colour).    Source: Light-mask fail

Caffeine Supplement Death Triggers Health Warning

The Australian government has ordered an urgent review of the open sale of pure caffeine powder following the freak overdose death of a young man. Lachlan Foote collapsed on the bathroom floor of his family’s Blackheath home and never regained consciousness after making himself a protein drink that contained powdered caffeine. Just one teaspoon of the extremely potent but legal and widely available substance — popular among fitness enthusiasts — is enough to kill.    Source: Shannon Molloy, News.com.au Caffeine powder fatality

TGA Confirms that it has no Role in Regulating Fluoridated Drinking Water in Australia

The Therapeutic Goods Administration has clarified that state and territory governments will continue to be responsible for regulating fluoride in reticulated drinking water ('tap water'). Legislative amendments made on 11 July 2019 put an end to any uncertainties about regulatory responsibility by explicitly excluding fluoridated drinking water from the scope of Australia's therapeutic goods legislation.    Source: Fluoridated drinking water

NICM Confirms its Place as a World-Leader in Research

The National Institute of Complementary Medicine (NICM) Health Research Unit, run out of Western Sydney University, is Australia’s leader in integrative and complementary medicine research and policy. The Australian Research Council’s (ARC) latest ‘Excellence in Research for Australia’ (ERA) report confirms, for the third consecutive triennium of rating, NICM as a world-leading research institution, rated the highest possible - ERA 5. The NICM Director, Professor Alan Bensoussan, welcomed the report’s confirmation of NICM’s world-leading research and reputation for excellence. “NICM’s team of interdisciplinary world-class researchers, are included in the world’s best and brightest in the field of complementary medicine. We are thrilled to be recognised for our research in this field, and for our very significant contribution to an additional ERA 5 ranking in Pharmacology at Western Sydney University. We are the only research institute in complementary medicine that has achieved consistent ERA 5 rating since evaluation commenced in 2012 for our field of research”.    Source: NICM a world leader

Associations Forum Declares CMA Winner of the ‘2019 Association of the Year’

Established in 2004, Associations Forum is a commercial, member-based network of 500 associations, charities, clubs, societies and other not-for-profit organisations. The mission of Associations Forum is 'bringing associations together to boost performance', by assisting associations and charities in governance, operations, membership and finances. RFA Regulatory Affairs was very glad to hear that this year’s winner was awarded to the peak body, Complementary Medicines Australia (CMA), working in the complementary medicine space. Congratulations to Carl Gibson and all of the team at CMA for receiving this deserved recognition for all of the excellent work carried out on behalf of this sector. Well done!    Associations Forum website

ConsumerLab Tests Find 19% of B Vitamin Supplements Supplied in the USA Failed Quality Standard

USA based company ConsumerLab LLC. purchased and tested B complexes and individual B vitamins. The tests revealed that five of the 26 supplements selected for testing contained as little as 53% to as much as 223% of the listed amounts of certain B vitamins. This review also summarises the clinical evidence for B vitamin supplementation for uses such as helping to prevent birth defects, lowering cholesterol levels, and slowing age-related cognitive decline. The report goes on to explain important differences among forms of B vitamins, such as those of niacin (nicotinic acid, niacinamide, and inositol hexanicotinate), folate (natural folate, folic acid, and L-5-methyltetrahydrofolate), and B-12 (methylcobalamin and cyanocobalamin).    Source: Nutraceuticals World B-vitamin fails

Civil Penalties Ordered Against Peptide Clinics Pty Ltd for Advertising Breaches

Peptide Clinics Australia (Peptide Clinics Pty Ltd) has been ordered by the Federal Court to pay $10 million to the Commonwealth for breaches of the mandatory rules for advertising of medicines, including the ban on advertising prescription-only medicines to the public. The significant financial penalties serve as a reminder to businesses that prescription-only medicines cannot be advertised to the public without significant consequences. This includes being issued with infringement notices, being charged with criminal offences or having civil court proceedings commenced against them.    Source: Peptide clinics fail

USA Congressional Committee Discusses How to Legalize Cannabis

In a first-of-its-kind hearing, a key congressional committee met recently to discuss how to finally put an end to federal cannabis prohibition. Titled “Marijuana Laws in America: Racial Justice and the Need for Reform,” it was the latest indication of just how far Congress has come on cannabis reform after decades of intransigence.     Source: Cannabis law reform

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