Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

Aussie Santa

Robert Forbes & Associates, T/A RFA Regulatory Affairs wishes all of our clients a Happy and Holy Christmas Holiday break.

Our office will be closed from end of business day on Thursday 21st of December 2017 and reopen on Tuesday 2nd of January 2018

 

 

Training Course Update:

NEW COURSE NOW AVAILABLE

Pharmacovigilance Obligations Training. For details see foot of this newsletter

 

ACCC Sues Voltaren Makers GlaxoSmithKline and Novartis for Misleading Consumers

The Australian Competition and Consumer Commission watchdog is taking GlaxoSmithKline and Novartis to the Federal Court, alleging the global pharma giants misled consumers about their Voltaren Osteo Gel and Voltaren Emulgel pain relief products. GSK and Novartis marketed Osteo Gel as a specific osteoarthritis medication more effective at treating the condition than Emulgel, when the two products had in fact the same pain-relief ingredient, the Australian Competition and Consumer Commission claims. In a similar case, in December 2016, the Full Federal Court ordered the Australian branch of Reckitt Benckiser to pay a $6 million penalty for making false representations that Nurofen Specific Pain products were each formulated to specifically treat particular types of pain.    Source: Voltaren charge

USA Industry Rallies Behind FDA’s Warning on SARMS

The FDA has recently issued a consumer warning about the use of SARMs, or selective androgen receptor modulators, in bodybuilding products. The administration warns against the potentially dangerous ingredients that pose serious health concerns to consumers, including (but not limited to) increased risk of heart attack, stroke, and life-threatening liver toxicity. Five major trade associations serving the natural products industry have banded with the U.S. Anti-Doping Agency (USADA) in solidarity with the FDA. The trade associations in support of the FDA’s consumer warning include the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), the United Natural Products Alliance (UNPA), and the USADA.    Source: WholeFoods Magazine SARMS warning

TGA Updates the 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 November 2017. A total of 85 changes have been made in the updated Determination. These changes include: The addition of 32 new ingredients; &, Changes to 53 existing ingredient entries (including: making requirements for ingredients less restrictive, such as broadening the use to allow oral use when previously only for topical use; making requirements for ingredients more restrictive, such as the inclusion of additional warning messages; and making minor changes to make a number of entries clearer. A complete list of changes to ingredient availability can be found here: Permissible ingredients

TGA Presentations: Complementary Medicine Reforms Information Sessions, November-December 2017

The TGA held a series of information sessions on reforms to the complementary medicines framework. The presentation topics included: Background and progress of complementary medicine reforms; Permitted indications for listed medicines; &, The assessed listed medicines pathway.    Source: Listed medicine presentations

Update on Child-Resistant Packaging Requirements for Medicines 2017 (TGO 95)

TGO 95 makes minor changes, of which there are no perceived changes for complementary medicines.    Source: Child-proof 

TGA Safety Advisories –

Editor’s Note: It has been a big year for Australian Customs (AQIS) & the Therapeutic Goods Administration (TGA) after a record number of bogus medications have arrived on Australian shores in 2017. Far and away the most common offenders are fake-medicines containing varying undeclared amounts of Viagra-like chemicals. The next most common category violators are weight-loss medicines containing undeclared amounts of often banned stimulants and prescription drugs. For this year’s full list go to: 2017 alerts  

 

Aerosol Sunscreens May Leave You Burnt This Summer

After a string of consumer complaints about the mists offering no protection, the Cancer Council has changed its tune and says it will strongly recommend against using aerosol sunscreens this year. The problem is not with the sunscreen's ingredients, which are effective, but with how difficult it is to use them to apply the correct amount of sunscreen. The council has found many people use aerosols to lightly mist sunscreen on, and end up unprotected. About a quarter of an average bottle of aerosol sunscreen needs to be applied every two hours to ensure you are fully protected. Adding to the difficulty of judging how much sunscreen has been applied, consumer watchdog Choice says only 40 to 60 per cent of a typical can is sunscreen. The rest is propellant.    Source: Aerosol sunscreen

Chemicals Added to the AICS Following Issue of Assessment Certificate

Ten chemicals have been added to the ‘non-confidential’ AICS database as a result of being issued with an assessment certificate.    Source: AICS update 1

Chemicals Added to the AICS 5 Years After Issue of Assessment Certificate

Three chemicals have been added to the Australian Inventory of Chemical Substances (AICS) in accordance with section 14(1) of the Industrial Chemicals (Notification and Assessment) Act 1989.  Editor’s Note: (these would have been on the confidential AICS database during this time at the request of the company who made the submission)    Source: AICS update 2

NZ Government Bans Production and Sale of all Microbeads

Newly elected New Zealand Prime Minister, Jacinda Ardern, said Cabinet had approved the regulation to ban microbeads. It would come into force in six months, following a transition period. Microbeads are tiny plastic beads – less than 5mm in size – used to give products texture, act as an abrasive, or provide visual interest. About 100 personal care products in New Zealand contain the tiny plastic beads. It is estimated about 10,000 tonnes a year of plastic microbeads are used globally. They are usually used for exfoliation or polishing.    Source: Laura Walters, Stuff.co.nz Microbead ban

 

 

Food Regulation in Australia and New Zealand

This website provides information about the activities and processes in the joint Australia and New Zealand food regulation system, including roles and responsibilities of the relevant food standards setting and regulatory authorities. The current activities of the food regulation system are divided into the three key priorities: Reducing foodborne illness, particularly related to campylobacter and salmonella; supporting the public health objectives to reduce chronic disease related to overweight and obesity; &, maintaining a strong, robust and agile food regulation system.    Source: ANZ food priorities

Country of Origin Food Labelling Update

If you sell food in retail stores in Australia, new Country of Origin Labelling (CoOL) laws have applied to your products from 1 July 2016. The reforms become mandatory on 1 July 2018 following a two-year transition period. This means food products packaged from 1 July 2018 must display the new labels.    Source: CoOL foods

Australia & NZ Updates on Sugar Regulation

In April 2017 Australia and New Zealand Ministerial Forum on Food Regulation (Forum) agreed to a Stage 1 work program on sugar. The Forum agreed that information about sugar provided on food labels does not provide adequate contextual information to enable consumers to make informed choices in support of dietary guidelines. The Forum also noted the range of existing complementary initiatives outside of the food regulation system that address sugar intakes, such as the five year review of the Health Star Rating system, policy work underway on the labelling of fats and oils, and the work of the Healthy Food Partnership. The Forum intends to take a whole-of-diet, holistic approach to food labelling.    Source: Oh, sugar sugar

Australia & NZ Updates on Alcohol With Pregnancy Warnings on Labels

Pregnancy warning labels were a recommendation from Labelling Logic: Review of Food Labelling Law and Policy (2011) (Labelling Logic). Recommendation 25 of that report was: That a suitably worded warning message about the risks of consuming alcohol while pregnant be mandated on individual containers of alcoholic beverages and at the point of sale for unpackaged alcoholic beverages, as support for ongoing broader community education. In response to this recommendation, the alcohol industry was provided with a two-year period, commencing December 2011, to adopt the voluntary initiative to place pregnancy health warning labels on alcohol products. The findings of the voluntary labelling initiative to place pregnancy health warnings on alcohol products was presented to the Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) at its meeting on 24 November 2017.    Source: Alcohol warning

NZ MPI Reminds Food Businesses to be Vigilant About Gluten-Free Claims

New Zealand’s Ministry for Primary Industries is reminding food businesses which make claims that their food is gluten-free to ensure their suppliers provide evidence of any claims they are making about the presence of allergens. The reminder follows MPI's recall of buckwheat flour supplied by Davis Food Ingredients this week. The affected buckwheat flour has been found to contain gluten and has been used as an ingredient in products advertised as gluten-free or products consumers consider to be gluten-free. To protect people who are gluten intolerant or have coeliac disease, these products have been or are being removed from shelves.    Source: Gluten free NZ

Box Village Bakery Fined for Food Safety Breaches

The owners of a Sylvania bakery at the centre of a Salmonella outbreak that affected more than 200 people in January 2016 have been fined a total of $122,000 and ordered to pay $7,199 professional costs after each was convicted of ten breaches of the Food Act 2003. The owners of the Box Village Bakery, Thi Thu Ngo and Hung Son Le each pleaded guilty to five breaches of selling unsafe food, and five breaches of failing to meet food safety standards and were fined $61,000 each.    Source: Bakers bugs

NSW Food Authority Recalls—

'Berg Smallgoods' American Style Skinless Hot Dogs: Aldi Stores has recalled ‘Berg Smallgoods’ American Style Skinless Hot Dogs due to potential microbial contamination and presence of foreign matter (bone fragments).    Source: Hot dogs

Warburn Estate Bottled Wine: Warburn Estate has recalled assorted wine due to a packaging fault resulting in the presence of glass.    Source: Wine glass

FSANZ Notifications—

Proposal M1014 – Maximum Residue Limits (2016): The purpose of the Proposal is to consider varying certain maximum residue limits for residues of agricultural and veterinary chemicals that may occur in food.    Source: Residue maximums

Application A1139 – Food derived from Potato Lines: The purpose of the Application is to seek approval for food derived from genetically modified potato lines F10, J3, W8, X17 and Y9, which haslate blight protection, low acrylamide potential, reduced browning (black spot) and lower reducing sugars.    Source: GM potatoes

Application A1140 – Food derived from Herbicide-tolerant Canola: ​​The purpose of the Application is to seek approval for food derived from herbicide-tolerant, male-sterile canola line MS11, genetically modified to provide tolerance to the herbicide glufosinate-ammonium.    Source: GM canola

Editor’s note:  A complete list of current proposals prepared by FSANZ to considering changes to the Food Standards Code can be found here Current proposals

What Are The Latest Trends In The Personal Care Sector?

Bans, restrictions, ingredient disclosure: these are the key chemical issues the personal care industries in Europe, the US and the rest of the world have grappled with throughout the past year. And they will remain hot topics on the 2018 agenda. Specific topics to keep an eye on for 2018 include: Looking for safer preservatives (Trends to watch are multifunctional additives and formulations based on organic acids.); Mineral oil hydrocarbons and health concerns (eg: consider whether dietary exposure to certain mineral oils in lip care products is a health concern); Microplastics (see story above re. NZ ban); &, Increasing transparency (Under rising demands for transparency, large corporations and retailers are beginning to make information on the chemicals in their products more easily available to consumers).    Source: Vanessa Zainzinger, ChemicalWatch  Personal care trends

 

All Oils Ain’t Oils: Moroccanoil Israel Ltd v Aldi Foods Pty Ltd

A recent Federal Court decision has found Aldi made misleading and deceptive representations about the natural content and performance benefits of its “Moroccan Argan Oil” products. Aldi’s products in question were its “Moroccan Argan Oil” oil treatments, shampoos and conditioners which were sold under Aldi’s “PROTANE®NATURALS” brand. The case concerned, among other things, claims that the products contained only or substantially ‘natural ingredients’ and that representation was false; and Aldi represented that the benefits of its “Moroccan Argan Oil” products were due to the presence of Argan Oil (such as strengthening hair etc.) and that these “performance benefits” were misleading given the minute quantities of Argan Oil in the products. This case demonstrates that: trade mark holders need to be aware that their trade-marks can, in certain circumstances, amount to representations about the products to which the marks are applied; and that they also need to be able to back up any claims to the performance of a product with empirical evidence relevant to the content of the product.    Source: CowellClarke blog  Aldi argan oil

 

Quotes for the month:

"A quiet and modest life brings more joy than a pursuit of success bound with constant unrest."

This advice, on the secret of happiness, written on a note by Albert Einstein 95 years ago, was given to a hotel porter when Einstein was caught short of cash. It sold for $1.7 million at an auction in Israel in October 2017.   Source: The Guardian Wise advice

 

“Do not save what is left after spending, but spend what is left after saving".     Warren Buffet

 

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