Latest News

The latest news is posted on our website on a regular basis. Visit us often to keep informed. www.robert-forbes.com

 

Complementary Medicines (‘Dietary supplements’):

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

Foods:

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

 

Cosmetics and TGA Listed Sunscreens:

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

Marketing News:

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

 

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