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Reckitt Benckiser Facing Fines Over Misleading Claims for Nurofen 

The Australian Competition and Consumer Commission took Reckitt Benckiser to the Federal Court in March over products in its Nurofen specific-pain range, which are advertised as being specially formulated to treat either back pain, period pain, migraines or tension headaches. The consumer watchdog argued that in reality, each of the products had exactly the same active ingredient – 342 milligrams of ibuprofen lysine – and that none were any better at treating one type of pain than other products in the range. Source: SMH / The Age, Patrick Hatch


Prominent Public Health Advocates Discuss Improvements Required in Australia’s Regulation of Complementary and Over-the-Counter Medicines 

A triumvirate of Ken Harvey, Amy Yan and Ned Latham published an opinion piece on their website regarding how complaints about advertising of medicines are handled. Even when a complaint is upheld, it can take years before misleading and deceptive claims are removed. The Federal Court finally ordered Reckitt Benckiser to remove its pain-specific Nurofen products from the shelves because of misleading claims. But this occurred four years after the first complaint. The advocates state that the current system is based on trust. Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), does not assess the claims of the vast majority of complementary medicines (labelled AUST L) before they go to market. Rather, the company simply promises that it holds evidence to support any health claims it makes. Companies also promise that the product only contains ingredients the TGA regards as relatively safe and that production follows good manufacturing practice. Source:The Conversation &


NSW Food Recall: Flaxseed with Cocoa and Berries 

The NSW Food Authority advises that Flavour Makers Pty Ltd has recalled a flaxseed product sold in Coles in NSW, ACT and QLD. The product is being recalled due to the presence of undeclared allergens (tree nuts – almonds, Brazil nuts and walnuts) in the product. Source:


Uncle Toby’s Fined $32,400 Over False Protein Claims in Oats 

Uncle Toby’s Oats has been fined $32,200 in penalties for alleged false or misleading representations about the protein content in its Traditional and Quick Sachet oats. The label “Natural Source of Protein Superfood” on the Quick Sachets, and “Naturally Rich in Protein* Superfood” on Traditional boxes of oats, contained the disclaimer “*when prepared with [1/2 or 2/3] cup of skim milk” in fine print below the misleading statements. The ACCC did not consider the disclaimer contained on the packaging as sufficient to correct the dominant impression created by these statements and their presentation. “Business should be aware that a fine print disclaimer is insufficient to correct or qualify a prominent representation on packaging or in advertising that is false or misleading,” ACCC Chairman Rod Sims said. “Truth in advertising, particularly where misleading claims are made by large businesses, is a priority enforcement area for the ACCC”. Sources: &


NSW Food Recall: Coconut Yoghurt (No Udder/Alpine) 

The NSW Food Authority advises that NulacFoods Pty Ltd has recalled Coconut Yoghurt sold nationally in Coles, Woolworths and other independent retailers. The product is being recalled due to the presence of an undeclared allergen (dairy). Editor’s note: RFA Newsletter readers will note that in previous newsletters we have reported the recall of a great many coconut based products containing undeclared dairy product, following the death of a 10-year-old child attributed to an allergic reaction after drinking a "natural" coconut drink – see RFA Newsletter October 2015. Source:


FSANZ Reminds Importers About Mandatory Allergen Labelling Requirements 

Food Standards Australia New Zealand (FSANZ) reminds all businesses, including importers, about the need to meet mandatory allergen labelling requirements. FSANZ Chief Executive Officer Steve McCutcheon said there has been a number of coconut product recalls due to a lack of mandatory allergen (milk and milk products) labelling. Source:


Complementary Medicines: TGA Cancellations from the ARTG for 2015 

The Therapeutic Goods Administration regularly reviews the products listed on Australian Register of Therapeutic Goods. So far, 15 products have been cancelled in 2015. Products are delisted for varying reasons, the most common being: not providing information or documents about the certifications made in relation to the goods; they contained a substance which is not permitted by Schedule 4 of the Therapeutic Goods Regulations; The goods have changed so that they have become separate and distinct from the goods included in the ARTG; & The goods do not conform to a standard applicable to the goods.  For a full description of this year’s cancellations:


TGA Presentation: Regulatory Reform – “Are we Heading in the Right Direction?” 

Presented by Trisha Garret, Complementary and Over the Counter Medicines Branch, Therapeutic Goods Administration at the Australian Self Medication Industry (ASMI) Annual Conference, this presentation provided an overview of recent and upcoming regulatory reforms. The five main topics addressed in this presentation were: TGA restructure; Government agenda on “Innovation and Competitiveness, and regulatory reform”; Improving Complementary Medicines processes within the existing framework; Complementary and OTC medicines manufacturing; & Labelling and Packaging review.   Source:


NSW Food Recall: Gourmet Organic Herbs Ground Coriander 

The NSW Food Authority advises that Gourmet Organic Herbs has recalled its Ground Coriander sold in fruit and vegetable shops, health food stores and independent retailers, including IGA supermarkets in NSW, QLD, VIC, TAS, SA and WA. The product is being recalled due to microbial (salmonella) contamination. Source:


FSANZ Proposal P1024 – Revision of the Regulation of Nutritive Substances & Novel Foods 

Food Standards Australia & New Zealand invites written submissions on the draft variations to the Code, seeking to develop an alternative framework for the regulation of nutritive substances and novel foods. Source:


FSANZ Application A1121 – Oryzin (Protease) from Aspergillus melleus as a Processing Aid (Enzyme) 

Food Standards Australia & New Zealand has completed an administrative assessment and accepted this Application to permit the use of oryzin (protease) from Aspergillus melleus as an enzyme for use in baking, flavouring production and dairy, egg, meat, fish, protein and yeast processing.  An opportunity to comment will be available at a later date which will be publicly notified. Source:


TGA Safety Advisories - V-MAX Herbal Tablets; 100% Healthy Food For Men Tablets 

The Therapeutic Goods Administration has tested the products labelled V-MAX Herbal Tablets, and, 100% Healthy Food For Men Tablets and found that both products contain the undeclared substance sildenafil (the active ingredient in Viagra). Consumers are advised that sildenafil is a prescription-only substance and that the supply of these products is illegal. Source:


NSW Health Removes Raw Milk from Shelves 

The NSW Government has stripped raw milk marketed as ‘cosmetic’ or ‘bath’ milk from the shelves of a number of Sydney health food shops following recent inspections. Minister for Primary Industries, Niall Blair, said retailers are on notice that claims the product is used for bathing will not wash. "Raw milk is a high food safety risk – the sale of raw milk for human consumption is illegal in Australia and this kind of farcical deception won’t be tolerated. It was apparent to the NSW Food Authority that the sale of raw milk products at these premises was not for cosmetic reasons”. Source:


FSANZ Warns of Dangers in Ingesting Raw Apricot Kernels 

Food Standards Australia & New Zealand has conducted a risk assessment on a number of foods containing cyanogenic glycosides and found only raw apricot kernels (both with and without skin) pose an acute public health and safety risk. Some plant-based foods, such as raw apricot kernels, contain cyanogenic glycosides and can pose a risk to consumers because the cyanogenic glycosides can convert to a type of cyanide and cause cyanide poisoning. In September 2015 the FSANZ Board approved a FSANZ proposal to prohibit the sale of raw apricot kernels. In November 2015 Ministers responsible for food regulation agreed to adopt the changes. The changes were gazetted on 7 December 2015. The retail sale of raw apricot kernels is now prohibited. Source: &


Federal Court finds Against ACCC, and For Lyoness, in Pyramid Scheme Ruling 

The Federal Court has found that a loyalty program operated by Lyoness Australia Pty Ltd does notcontravene the pyramid and referral selling provisions of the Australian Consumer Law (ACL), following action by the Australian Competition and Consumer Commission. Editor’s note: This is an important ruling as it teases apart the sometimes subtle differences between Multi-Level Marketing structures (MLMs) which are legal, and Pyramid Schemes which are illegal; the latter relying on commissions dependent on recruitment rather than on salesSource:


ABC-AHP-NCNPR Botanical Adulterants Program Publishes Black Cohosh Laboratory Guidance Document 

The American Botanical Council, American Herbal Pharmacopoeia and the National Center for Natural Products Research have released the third-in-the-series LGD as part of their ambitious anti-adulterant programme. The new LGD is part of the Programme’s series of comprehensive, authoritative, extensively peer-reviewed, and up-to-date summaries and assessments of analytical methods for the authentication of botanical ingredients and the detection of potential adulterants. “Adulteration of black cohosh, mainly with herbal ingredients from Chinese Actaea species, remains a problem in the dietary supplement industry,” noted Stefan Gafner, PhD, chief science officer of ABC and technical director of the Botanical Adulterants Program.  Source:


Government Releases Failing Food Report for November 2015 

The Department of Agriculture targets and monitors food determined to pose a high or medium risk to public health. Risk food is targeted at 100 per cent until a history of food safety compliance is established. You can view the details where results were detected in excess of food safety limits. The food was not distributed for sale in Australia. It was destroyed by the importer or re-exported to the country of origin under department supervision (at supplier’s expense!). Foods were deemed not suitable to be imported into Australia for three main reasons: Contamination by foreign products; Unsafe levels of various micro-organisms; &, Failure to conform with regulatory compliance legislation. Source:


TGA Acknowledges Deterioration in GMP Clearance Application Process Improvements 

After making some headway in reducing the time taken to process Mutual Recognition Agreement (MRA) GMP clearance applications, as of 4 December 2015, the average processing time taken to complete new applications has now increased from 6 to 9 weeks. The time taken to complete 90% of overall MRA GMP clearance applications has increased to 27 weeks. Source:


TGA Provides Guidance for New Registered Complementary Medicine Applications 

Applicants of new registered complementary can now undertake electronic submission of their application using the new TGA eBusiness Non-Prescription Medicines portal within the ‘Applications’ section of the TGA Business Services on-line services website. This is the only way an applicant can submit an application for a new registered complementary medicine now.  Source:


Accord Provides Update on its Ecolabel for Environmentally Preferable Cleaning Products 

Accord is the national industry association representing manufacturers and suppliers of hygiene, cosmetic and specialty products, their raw material suppliers and service providers.Recognised® is Accord’s ecolabel for environmentally preferable cleaning products. Products undergo third-party assessment against a stringent set of criteria before they are eligible for licencing under the Recognised® scheme. Accord is pleased to announce that the recent probity audit of the Recognised® scheme by RSM Australia found that “the application and assessment process is robust and independent, and was free from any potential influence by Accord throughout the period 27 October 2011 to October 2015”. In 2015 there have been 16 new products licenced under Recognised®. This brings the total number of licenced products to 107 since the scheme began in 2011. For a full list of licensed products go to:


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