Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

Australian Cosmetic Animal Test Ban Bill Passes Senate

The Australian Senate has recently passed the Government's Industrial Chemicals Bills 2017, including measures to prohibit reliance on new animal test data for chemicals introduced into Australia for use as ingredients in cosmetics. The Ministerial Rules that accompany the bill will prohibit new animal test data for all cosmetic uses of chemical ingredients introduced to Australia.There are further measures to increase compliance with the ban once implemented, as well as measures which extend beyond the cosmetics ban, and will contribute even more significantly to a reduction in animal testing.    Source: HSI Animal testing

 

DSA Warns of Dangers in Using Affiliate Marketing

Direct Selling Australia (DSA) is the industry association for direct selling in Australia of retail products. ‘Affiliate marketing’ is a type of performance-based marketing in which a business rewards one or more ‘affiliates’ for each visitor or customer brought by the affiliate's own marketing efforts. Direct Selling Australia is deeply concerned by the legitimacy of some of these models and urges that extreme caution be exercised by anyone looking to join a scheme that claims to use affiliate marketing as the primary form of marketing a product offering. Of particular concern is whether these companies may be misleading and involved in deceptive conduct which is illegal under Australian Consumer Law. Globally, the direct selling industry is committed to preventing illegal activity and to protect individuals from scams. Work is on-going in many jurisdictions to track the use of affiliate marketing models within the direct marketing channel so that best practice guidance can be issued.   Source: Affiliate marketing

Australian Natural Healthcare and Wellbeing Snapshot

The domestic Australian complementary medicine industry is robust and significant . Market research shows that the popularity of complementary medicines is increasing with a growth rate of seven per cent year on year. Three-quarters of Australians, including 92 per cent of women aged 20-24; take at least one complementary medicine and a quarter of the population visit complementary healthcare practitioners each year. In Australia, the fastest growth areas are nutritional oils, men’s health and eye health. Products are manufactured to some of the highest standards in the world based on GMP validation and stringent therapeutic regulations. These standards are maintained by the Therapeutic Goods Administration (TGA) through a transparent approval process, strict manufacturing compliance guidelines and effective post-market monitoring. The TGA register also supports the complementary medicine industry with evidence-based research, monitoring and safety data. These elements combine to allow Australian manufacturers to supply world-class products at globally competitive prices.   Source: Austrade snapshot

 

Quote for the month:

“Health is a state of mind. Wellness is a state of being”   Anon

 

Naturally Good Expo Coming to Sydney in June 2019

Attention to all of our colleagues and customers from outside Australia! This might be just the business opportunity you’ve been waiting for to visit sunny Sydney, Australia.

Naturally Good Expo is not open to the public and is ‘trade only’. It’s a total business event that’s 100% devoted to all things healthy, organic and natural. As the largest annual event for healthy retailers, brands and practitioners in the Southern Hemisphere, it’s the place where serious buyers meet with suppliers for two days of business, networking, education and to celebrate the latest exciting opportunities within the health and wellness retail market. RFA Regulatory Affairs has enjoyed being an exhibitor at Naturally Good Expo in previous years and once again we will be part of the action, helping to support our industry. Plan your calendar now. This is your chance to not only get a first-hand look at the current state of our industry in Australia but also a wonderful opportunity to meet with colleagues and friends down-under. When you do get here, make sure to call in to our Booth #B43 to chat with us about your latest plans.

 

The Six Need-To-Know Regulatory Developments Set to Shape APAC’s Food and Beverage Industry in 2019

From sugar taxes to plastic waste bans, here are six regulation and policy updates that look set to heavily influence the APAC food industry in 2019, with the help of insights from major brands, academics and trade associations.   Source: Pearly Neo and Tingmin Koe, Food Navigator-Asia Asia food regs 2019

FSANZ Notifications—

Application A1129 – Monk Fruit Extract as a Food Additive: The purpose of the Application is to permit monk fruit extract as a food additive, specifically as an intense sweetener.   Source: Monk fruit

Application A1156 – Food derived from Super High Oleic Safflower Lines 26 and 40: The purpose of this Application is to seek approval for food derived from SHO safflower lines 26 and 40, genetically modified to produce high levels of oleic acid in the seed.   Source: Oleic safflower

Application A1157 – Enzymatic production of Rebaudioside M: The purpose of this Application is to seek approval for a new specification for rebaudioside M produced by an enzymatic biosynthesis method.  Source: Rebaudioside M

Application A1158 – Rosemary extract as a food additive: The purpose of this Application is to seek approval to permit the use of rosemary extract as a food additive (antioxidant)   Source: Rosemary

Application A1174 – Xylanase from Trichoderma reesei as a PA (Enzyme): The purpose of this Application is to permit the use of Xylanase from Trichoderma reesei as a processing aid.   Source: Xylanase

December 2018 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 August. Among the pathogenic organisms detected in these imported foods were, Listeria monocytogenes, E coli, Bacillus cereus and Salmonella, as well as the toxins aflatoxin, lead, dimethoate and more.   Source: Latest failed foods

FSANZ Biennial Stakeholder Forum - 5 March 2019

Food Standards Australia New Zealand (FSANZ) is a statutory authority in the Australian Government Health portfolio. FSANZ develops food standards for Australia and New Zealand and is holding its biennial forum on 5th March 2019, in Sydney. Titled, ‘Fit For Purpose - Food Regulation Now And In The Future’, experts representing key stakeholders will explore topics relating to the food regulation system and will take a look into the future of food regulation, food safety and food science. The one day event will be followed by a cocktail reception.   Source: FSANZ forum 

 

 

TGA Provides Technical Guidance on GMP Compliance for Listed Complementary Medicines

Recent TGA news releases have highlighted some of the important responsibilities mandated for both sponsors and manufacturers of listed complementary medicines. The TGA guidelines, although not mandatory or enforceable under law, provide interpretation and clarification of a number of issues and are very useful in understanding compliance with the PIC/S guide to GMP for medicinal products, which is mandatory. New and updated guidance documents:   Assessment, approval and qualification of suppliers of starting and packaging materials  ; Sampling and testing requirements ; Product Quality Reviews (PQR) ; Process validation ; On-going stability programmes

RFA Regulatory Affairs provides training courses for individuals, manufacturers, sponsors and their nominated pharmacovigilance staff via Skype or in person at our office in Glebe. We cover a range of topics, including product quality reviews, stability and TGA pharmacovigilance obligations and mandatory reporting requirements. To book a course, enquire about pricing, or if you have any questions on the topics covered, contact us at +61 2 96608027; or This email address is being protected from spambots. You need JavaScript enabled to view it..

TGA Time Vs Industry Time When Processing GMP Clearance Applications

When assessing GMP Clearance (CV) applications the TGA has discovered that approximately 40% of these applications are incomplete. Historically, significant efforts were made to contact applicants and request them to provide the outstanding evidence, which involved several rounds of correspondence before it was provided to the TGA for assessment. This significantly contributed to the creation of a backlog of applications and led to extended processing times for CV's. In order to further improve the efficiency and transparency of the GMP Clearance process, and to ensure that applicants who provide complete applications are not disadvantaged, the TGA has started to accurately capture the processing times of CV applications by consistently applying a ‘stop clock process’ throughout the entire application and not just during the assessment stage.   Source: GMP clearance times (See also latest GMP guidance document   GMP clearance guidance update - Version 18.1 ).

TGA Answers Questions Regarding the Advertising Code

During recent TGA training sessions and webinars on the Therapeutic Goods Advertising Code (No.2) 2018 (the Code), a large number of queries were received by the TGA organisers. Initially, a small number of answers to some of the most common questions are now being provided. These will be added to on a regular basis.   Source: Advertising code Q&A

TGA Consultation: Standards for Disinfectants; and Associated Guidance

This consultation reviews Therapeutic Goods Order 54. Hard surface disinfectants must meet all regulatory requirements as set out in TGO 54: Standard for Disinfectants (TGO 54) and associated guidance. This Order will sunset (cease) on 1 April 2019, therefore the TGA invites comments on their proposed update. This consultation closes on 12 February 2019.    Source: Disinfectant consultation

Australian Government Consultation: Complementary Medicine Country of Origin Labelling

The Department of Industry, Innovation & Science is coordinating a multi-agency taskforce, investigating the impact of use of the ‘Australian Made, Australian Grown’ logo in the complementary medicine sector. In particular, they are looking at vitamin, mineral and supplement products. They are currently seeking comments from Australian businesses directly involved in producing vitamins, minerals or supplements and/or those selling these products under a private label or brand. The survey will let them know your views on the use of the logo and country of origin labelling in general. Your views will help inform our assessment of the impact of the recent Country of Origin Labelling changes on the Australian complementary healthcare sector.   Source: CoOL consult

TGA Summarises Recent Important Developments in Therapeutic Goods Advertising Regulation

There have been many important developments in therapeutic goods advertising regulation over the last six months. This update provides a recap of some of the TGA's key achievements and outlines what they will focus on next. These recent regulatory changes include: a new advertising code; improved comprehensive training and resources; ministerial appointment of the Therapeutic Goods Advertising Consultative Committee; embedding a new risk-based approach to handling advertising complaints; publishing all 750 advertising complaint outcomes on our website in a searchable portal; &, addition of new enforcement powers.   Source: TGA advertising reforms

TGA Takes Action Against Peptide Clinics Pty Ltd for Alleged Advertising Breaches

Peptide Clinics Australia is alleged to have advertised compounded prescription only therapeutic goods, including 'peptides', on its website and other social media platforms, accessible to both registered customers and the public. It included references to serious forms of diseases, and to conditions such as anxiety and depression. These references require approvals or permissions, for which it is alleged there are none. The advertising is also alleged to be in breach of the Advertising Code because it contained statements, claims and implications that the advertised peptides were safe or alternatively could not cause harm, and encouraged inappropriate use of the medicines. The promotion of these peptides to consumers is also alleged to have contained scientific information that was inaccurate, imbalanced and misleading. Peptide Clinics Australia has given an undertaking to the Court that it would remove the relevant advertisements from its website pending final hearing of the matter. When the matter is heard by the Court later this year, the Court will be asked to impose financial penalties, and to issue declarations and final orders requiring the removal of any references for which approvals or permissions are required, as well as the removal of any other information in breach of the Advertising Code.   Source: Peptide advertising breach

South Australian Man Faces Criminal Charges for Dealing with Counterfeit and Unapproved Medicines

Following investigations by the Therapeutic Goods Administration (TGA) in November 2018, the Adelaide Magistrates Court has recently sentenced a South Australian man in relation to illegal acts involving counterfeit therapeutic goods. The man was charged with the following: 1 criminal charge of dealing with counterfeit therapeutic goods; 1 criminal charge of use of therapeutic goods in reliance of advertising that causes harm or injury to a person; 1 criminal charge of supply therapeutic goods in Australia not included on the Australian Register of Therapeutic Goods (ARTG); and 8 criminal charges of import therapeutic goods for use in humans not included on the ARTG. The man pleaded guilty to all of the above charges. The man was convicted of all counts, fined and sentenced to five months imprisonment that was suspended upon the man entering into a good behaviour bond for a period of two years. He was also ordered to pay prosecution costs.   Source: Counterfeit drugs crime

TGA Advises "Extreme Caution" After Detecting Cancer-Causing Contaminants in Chinese Herbal Pills

Australian regulator the Therapeutic Goods Administration (TGA) is advising "extreme caution" when purchasing health supplements online, after discovering cancer-causing contaminants in a Chinese herbal cough product.   Source: Cheryl Tay, Nutraingredients-Asia Toxic herbal pills

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

Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi) – Contains sildenafil.

OA/RA capsules – Contains aristolochic acid.

NZ Consultation: Therapeutic Products Regulatory Scheme

The New Zealand Ministry of Health is seeking feedback on the draft of Therapeutic Products Bill. The Therapeutic Products Bill would replace the Medicines Act 1981 and establish a new regulatory scheme for therapeutic products. This includes medicines (including cell and tissue products) and medical devices. Natural Health Products (including rongoā Māori) will be excluded, as far as possible, as the Government is considering options for how these could be regulated as a separate process. Recognising the complexity of the Bill, and the impact of the holiday period, the consultation period will run for four months, ending 18 April 2019.   Source: NZ Bill consultation

 

 

Industrial Chemicals Reforms: Update on Implementation

The current regulatory scheme for industrial chemicals (NICNAS) will continue until the Australian Industrial Chemicals Introduction Scheme (AICIS) commences. The passage of the Industrial Chemicals legislation for the new scheme is now expected to be debated in the Senate in the first half of 2019. To assist regulated entities to adequately prepare for implementation of AICIS, the Government has decided to change commencement of the scheme to 1 July 2020. Government amendments to change the commencement date will be moved at the time of debate in the Senate. The Australian Government looks forward to implementing the ban on the testing of cosmetics on animals, that is included in the Industrial Chemicals Bill 2017. This ban will also commence on 1 July 2020.   Source: NICNAS legislative update

Latest News on Plastic Microbeads Use in Australia

Microbeads are small, solid, manufactured plastic particles that are less than 5mm and don’t degrade or dissolve in water. They may be added to a range of products, including rinse-off cosmetics, personal care and cleaning products. Once flushed away, microbeads can have a damaging effect on marine life, the environment and human health. This is due to their composition, ability to adsorb toxins and potential to transfer up the marine food chain. The best way to reduce their impact is to prevent them from entering the environment. At a 2016 Meeting of Environment Ministers, ministers agreed to support a voluntary industry phase-out of plastic microbeads found in ‘rinse-off’ personal care, cosmetics and some cleaning products by July 2018.   Source: Microbeads (See also Accord website  Bead recede ; &, Environment ministers follow-up: Monitoring assurance protocol ).  

Accord Initiative: What to do About Wipes

Accord Australasia is the peak national industry association representing manufacturers and marketers of hygiene, cosmetic and specialty products, their raw materials suppliers and service providers. Wet wipes are single-use disposable cleaning cloths. Wipes continue to grow in popularity as a very convenient, hygienic and effective way to clean – whether it be a baby's bottom, household surface or for a specific commercial/industrial application. Unfortunately, where wipes are used – and what they are used for – can encourage flushing. This can lead to problems! Here’s everything you wanted to know about wipes and how best to dispose of them: Wipesmart

 

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