Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Cosmetics (& Household cleaning products):
An Historical View of Ointments, Creams & Lotions
RFA’s regulatory colleagues in Europe have provided a very interesting article on the historical development of topical applications down the ages. From Hippocrates and Galen, all the way to modern global cosmetic regulations, you can read about the fascinating development of cosmetic applications. Source: CONUSBAT Topical history
Chinese State-Run Sovereign Fund Among Bidders for Australian Supplement Firm Nature's Care
A division of China's state-run investment fund is believed to be among the front runners to snap up Australian vitamin maker Nature's Care, as it embarks on its second sale attempt with a price tag of around $1bn. The Australian supplement company first attempted to find a buyer in 2016. Source: Garry Scattergood, Food-Navigator, Asia Nature's Care
Food Trends to Watch in 2018
Knowing what’s hot and what’s not can help food and beverage companies to better develop, position and market products. Listed are 10 food trends expected to create buzz at retail and foodservice in 2018. Topics include: Colour Is the New Sugar; Cracked Pepper Is the New Sea Salt; Pistachio Country Transcontinental; &, Vegan and Non-GMO Are the New Green Badges of Food Formulation Courage, amongst others. Source: Judie Bizzozero, Food Insider Journal 2018 food trends
Quote for the month:
“Eating organic isn’t a trend, it’s a return to tradition” Anon.
A New Zealander has a “shell” company structure in Australia called Australian Health Products PTY Ltd. (ABN 67 092 335 638). It is maintained through an accountant and all taxes have been paid etc. but this company has not traded for some time and it never had branded products. The name/company is for sale as it’s no longer required. Please contact RFA if you are interested and we can link you to the seller.
RFA Training Courses for Listed Medicines, Foods, Cosmetics – Now Available
RFA Regulatory Affairs offers Skype training so that you can train at home or from your office at a time that suits, or you and your team can come to our office in Glebe for a group-training session. Our courses cover complementary medicines, cosmetics and food products and a range of topics from labelling to GMP requirements.
All courses are presented in a modular format of either two or three hour’s duration. Training resources are provided and certificates are presented to each participant at the successful conclusion of each module.
NEW COURSE NOW AVAILABLE!
Pharmacovigilance Obligations Training
In September 2017, the TGA released guidance on the pharmacovigilance responsibilities of sponsors. Newly developed, this training course is for sponsors and their nominated pharmacovigilance staff with complementary medicines included on the Australian Register of Therapeutic Goods. We cover TGA pharmacovigilance obligations and mandatory reporting requirements, the what, how and when you MUST report. All required documents including SOPs and reporting templates will be provided for your future use.
This one hour training course is available via Skype or in person in our office in Glebe, Sydney. You will receive full course notes, document templates, SOPs and a certificate of attendance. This is all included in the price.
Complementary Medicines (“Dietary supplements”):
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
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
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
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 canolaEditor’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