current affairs
Issue 242 | November 2023
Up to and including 12th December
If you would like to promote your service to our worldwide subscribers, contact us info@regulatorytrainingdirect.com
Training news
USA dietary supplements: Written and presented by US Dietary Supplement law specialist and lecturer, Rend Al-Mondhiry Partner at Amin Talati Wasserman, LLP. Rend is a resident expert, she provides many practical examples and is a lecturer at Georgetown University Law Center RISE on the topic of dietary supplement regulation. This course is now available for you to purchase and study when it suits you. After you register you will be given a password that will expire in 60 days. You can view the agenda here, and register for the course. This course is not available live via Zoom.
Our course 1.02. Evidence Packages is now also available to do online, as well as “live” via Zoom. You can do this in your own time. See the agenda and purchase the course here.Alternatively, for a live Zoom course agenda is here and here is the booking form.
Advertising and Social Media in Australia and New Zealand – this course has been updated as new regulations and policies around social media, testimonials and endorsements, and “influencers” are published. Also links to food regulations are being revised due to the new FSANZ website (see below). The agenda remains the same. See stories below in Regulatory News.
All our courses can be viewed here: https://www.regulatorytrainingdirect.com/#course-summary
Follow us on LinkedIn: We hope you like our newsletter. If you want to receive up-to-the-minute announcements on new courses, new content and vital regulatory updates follow us on LinkedIn
Note from the editor.
Our November newsletter has been delayed by a few days. Food Standards Australia New Zealand (FSANZ) had announced that they were launching a new website in mid December, and we wanted to wait for that to happen.
Regulatory news
Complementary Medicines and Medical Devices:
“Create content that plays by the rules” – TGA guide to creating social media content. Discusses disclosure of gifts or payments for creating content about products, with a focus on promotion of medicines and protecting vulnerable members of the public. Source: TGA. Our training course “Advertising and Social Media in Australia and New Zealand” covers these issues, see agenda here.
Changes to the Permissible Ingredients Determination. Why and how often are changes made to the list of ingredients permitted in listed medicines, transition times, and list of final decisions to update the list. Source: TGA. The current list of permitted ingredients is here. Full report in pdf version “Proposed changes to requirements for listed medicine ingredients: Annual low-negligible risk changes 2023-2024 Final Decisions” available here.
New regulations on import of “vapes”. The importation of disposable single use vapes will be banned from 1 January 2024, subject to very limited exceptions. The importation of all other vapes, irrespective of nicotine content or therapeutic claims, would be banned from 1 March 2024 unless certain conditions are complied with. From that time, importers will need to hold licences and permits from the Office of Drug Control (ODC) to lawfully import vapes. At the same time, the personal importation scheme for therapeutic vapes will cease to operate. Further reforms will come into place during 2024. Source: TGA.
Varying your product details on the Australian Register of Therapeutic Goods. Updated guidance to how you can vary the details of non-prescription medicines, including registered and listed complementary medicines, OTC medicines and primary sunscreens. Sone changes create a “separate and distinct good” which requires a new AUST L or AUST R number on the label and a new application to the TGA. Minor changes that are low risk require a notification. A summary page is here. This page includes links to other resources including changing an OTC medicine, changing a listed or assessed listed medicine: application levels and change tables, checklists for correcting an omission or mistake made at the time the medicine was listed or replacing a proprietary ingredient with the individual ingredients, plus other checklists and guidance for varying a registered medicine where quality safety and efficacy and not affected, and varying or changing a registered medicine.
Quality standards for MDMA and psilocybin – open consultation. TGA has developed two new quality standards for MDMA and psilocybin and is seeking feedback from patients, psychiatrists, health practitioners, pharmacists, manufacturers, and other interested stakeholders. Brief summary here. More details including specific feedback required: assay limits and specified tests for MDMA and psilocybin – limits for impurities, residual solvents and heavy metals – a specific requirement for compounders to use an active pharmaceutical ingredient (API) tested in an Australian Good Manufacturing Practice (GMP)-licensed laboratory. Source: TGA
Boundary and combination products. Recently released TGA guidelines cover products that cross over the categories of medicines, medical devices and biologicals. Examples of boundary products included in the guidance are alcohol swabs, nasal decongestion products, eye lubricating products, and disinfectants. Combinations products are also discussed – medicine and medical device combinations, biological and medical device combinations, and biological and medicine combinations. The guidance document can be viewed here (PDF) or you can download the MS Word version here.
Keep informed via social media. The TGA has a presence on social media platforms to enable you to keep up to date, including Facebook, X (Twitter), LinkedIn, YouTube and Instagram. You can find all the links at this TGA webpage.
GMP clearance of overseas manufacturers. Developments in Early December:
1. A new GMP clearance Sponsor Information Dashboard provides industry with current information relating to GMP clearance. The new page will be updated monthly and provide information on processing timeframes for each application stream; current work on hand in the GMP clearance section; current priorities; key messages and updates. Information here.
2. GMP clearance guidance for sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site used in the manufacture of a medicine. PDF and MS Word versions available here.
3. A step-by-step guide on submitting a GMP clearance application in TBS portal. Includes creating a new application; Completing Application Details; Selecting your scope; Providing your evidence; Submitting your complete application and paying fees; Maintaining your active GMP clearance; Withdrawing GMP clearance applications no longer required – and more. PDF and MS Word versions available here.
4. GMP clearance: Mutual Recognition Agreement (MRA) and Compliance Verification (CV) pathway updates. Includes MRA GMP clearance expiring between 31 December 2023 and 31 December 2024; and CV Pathway -Where the last onsite inspection of a manufacturer occurred prior to the Covid-19 pandemic (2020-2023) sponsors may continue to use the GMP clearance questionnaire. Source: TGA
Bulgaria has been added to the list of countries from which the TGA will accept GMP certification, depending on the type product and some other criteria. Read more on TGA site here.
Product recalls
Interpharma is recalling all batches of Sodium Chloride 0.9% 30mL ampoules due to potential contamination with Ralstonia pickettii. Source: TGA
ResMed is updating the safety information and warnings for their masks that have magnets as they may interfere with some implantable devices. For a list of devices that may be affected refer to this TGA page.
FIT-BioCeuticals is recalling two batches of BioCeuticals Zinc Drops due to separation of the zinc from the liquid in the product resulting in an inconsistent dose being delivered. Source: TGA
Kin Fertility is recalling several batches of The Prenatal Capsules due to leaking, seepage and spotting on the capsules. There is no indication of any safety or efficacy concerns. Source: TGA
Compliance action
TGA has commenced proceedings in the Federal Court against CDA Clinics Qld and former director Dr Benjamin Jansen for illegal advertising of medicinal cannabis. Prescription medicines cannot be advertised to the public; and as well, the product was being promoted for the treatment of serious diseases. The products were also not entered on the Australian Register of Therapeutic Goods. Court proceedings are commencing because the company ignored previous warnings. More information hereincluding links to court documents.
TGA and Australian Border Force have seized more than 307,000 units of unlawfully imported medicines and medical devices, with an estimated value of over $2 million. The products ranged from large amounts of pain killers, anti-cancer medications, erectile dysfunction medications, prescription medications and other medicines with a potential for abuse, through to 36kg of border-controlled drugs, including performance and image enhancing drugs, narcotics and benzodiazepines. A significant number of counterfeit, falsified and substandard medicines were also seized and over 370 Australian-hosted online advertisements unlawfully promoting therapeutic goods were removed. Source: TGA
TGA has issued 45 infringement notices totalling $742,500 to InstantScripts for the alleged unlawful advertising of prescription-only medicines including antibiotics, insulin, blood thinners, and blood pressure and cholesterol medications. Source: TGA
Safety advisories
TGA has tested products that have been found to contain sildenafil not declared on the label: BAIWEI Maximum Powerful tablets; Bigger Longer More Time More Sperms capsules; and Ying Da Wang tablets. Supply of these products is illegal. Source: TGA
TGA has tested Li Da Daidaihua capsules and found that the tablets contain the undeclared substance sibutramine. Sibutramine was withdrawn from world markets in 2010 due to increased risk of cardiac events and stroke. Source: TGA
Botanical adulterants programme
A presentation given at SupplySide West addresses what to do if you find you have been supplied with defective or adulterated herbal raw materials. Interesting to see the ingredients commonly adulterated include CBD, turmeric, elder berry, ashwagandha, aloe, milk thistle, oregano, echinacea, cranberry, saw palmetto and maca. The presentation also discusses common methods used to adulterate botanical ingredients. Very important reading for anyone supplying botanical ingredients, and a reminder of the importance of testing the ingredients your suppliers deliver to you. Read more here.
Adulteration of olive oil. This excellent laboratory guidance document provides a review of (1) analytical methods used to determine whether olive products have been adulterated and, if so, (2) methods to identify the adulterants. Read the guidance document here.
Adulteration of Hydrastis canadensis root and rhizome. Includes references to both historic adulterants and recent adulterants. Possible therapeutic/safety issues and analytical methods to detect adulteration. Source: ABC media
BEST PRACTICES SOP ENDORSEMENT. The BAPP Best Practices SOP For The Disposal / Destruction Of Irreparably Defective Articles” (“BAPP SOP”) offers proposed contract language and SOP templates that buyers and sellers of ingredients and finished products can adjust and integrate into Quality and Service Agreements. Source: ABC Herbalgram.
Mark Blumenthal gets the recognition he deserves. Editor’s note: Mark is the only lecturer I have heard where I feel disappointed when the lecture ends. I smile all the way through. Read about this amazing man here.
In the press:
“Do probiotic supplements effectively boost your gut microbiome with ‘good’ bacteria?” Source: Australian Broadcasting Corporation news site.
“Federal government releases timeline for major crackdown on vaping in Australia”. Discusses concerns that vaping is introducing a new generation of your people to nicotine addiction. The importation of refillable non-therapeutic vapes will be banned from March next year. Tighter rules around flavours, nicotine concentration levels and packaging will also be enforced. Source: Australian Broadcasting Corporation news.”
“New research finds advertisers are regularly making meaningless claims that their products are ‘clean’, ‘green’ and ‘sustainable‘” An issue of concern to the ACCC and many consumers, this article asks “… exactly how environmentally friendly are the goods you are buying? And how true are the big “green” claims advertisers are making in online ads?” and “But what does a recycling emoji, or a word like “sustainable” mean in the context of an ad? A lot of the time, nothing at all.” Includes a list of the frequent environmental claims found in Australian Ad Observatory, and the most frequently occurring emojis in ads with green claims. Read more at ABC news.
New Zealand
Therapeutic Products Act repealed. A controversial decision by the new government was to repeal the Therapeutic Products Act 2023. This means the outdated Dietary Supplements Regulations 1985 will remain in place. Read more in this press release from SimpsonGrierson
Foods:
Food Standards Australia New Zealand has just changed the website.
The home page remains at the same address, but the look is very different. Some links remain the same. In a recent announcement FSANZ stated There will be no change to the business tools and applications below. If you are a regular user, you may like to bookmark these links:
Australian Food Composition Database
Nutrition Profile Scoring Calculator
Notified food-health relationships
The new home page does seem a lot cleaner. The menu bar at the top is:
Food recalls – Business guidance – Consumer information – Science and data – Food Standards Code.
Each of these has a drop down menu. One item that looks significantly different is the Food Standards Code. In the drop down menu under “Food Standards Code” you have to select “Food Standards Code Legislation” (which at the time of writing this newsletter appears twice in the drop down list). This may take some getting used to, as the old table format has been replaced with a list of standards, and when you select a standard it takes you direct to the “Federal Register of Legislation”. To read about the code from New Zealand, there are two web pages on the Ministry for Primary Industries (Manatū Ahu Matau) website, one is here, and this is the other. When you select a food standard, it directs you to the same new FSANZ site and then the same “Federal Register of Legislation”.
Notified food-health relationships This is where you can see food-health relationships that have been notified to FSANZ. Since mid November there have been 8 notifications made for claims relating to extra virgin olive oil, dietary fibre and partially hydrolysed guar gum. Source: FSANZ
Labelling of alcoholic beverages. This is a consumer information page. Topics include statement of alcoholic content with a useful explanation of labelling of low alcohol beverages; standard drinks; pregnancy warning labels; nutrition information and claims; and proposals to change the code including sugar, carbohydrate and energy claims. Source: FSANZ
What to eat with a weakened immune system. This is a very interesting summary table for people with a weakened immune system – which foods are high risk, which ones are low risk. (Note for readers in the USA: a rockmelon is what you call a cantaloupe). Source: NSW Food Authority.
Annual food testing report 2022 – 2023. Published by the NSW Food Authority, this summarises testing done on foods supplied in the state of New South Wales. Includes ongoing testing of oysters for Vibrio parahaemolyticus, mandatory and surveillance testing for Salmonella enteritidis, inspections of food business, and targeted food business sectors. Source: NSW Food Authority.
A Granville bakery wholesale facility – L’Oven Bakery Supplies Pty Ltd, which supplies products to several retail outlets was recently prosecuted and fined $82,500 by the Food Authority after pleading guilty to 23 charges for offences under the Food Act 2003. The same 23 charges were also put to the Company Director on the basis of executive liability. This person was also issued with $82,500 in fines after pleading guilty to all charges. The offences related to hygiene, cleanliness, food storage, maintenance of premises, pest access and labelling of food products. Source: NSW Food Authority, and also refer to the Name and Shame register – prosecutions.
Public consultations
To permit D-allulose manufactured by an enzymatic conversion of fructose to D-allulose using Microbacterium foliorum SYG27B-MF containing allulose-3-epimerase (novel food application) Call for submissions, closes 20th December 2023. More details, and form for making a submission, found here.
Australian native bee honey – This application seeks to amend the Australia New Zealand Food Standards code to include a definition, compositional requirements and requirement for a prescribed name, for honey produced by stingless bees native to Australia. Submissions due 6 pm Canberra time 17th January 2024. More information here.
To amend the Australia New Zealand Food Standards Code to permit steviol glycosides to be used as a food additive (intense sweetener) in Food for special medical purposes. Submissions close 15th December 6 pm Canberra time. More details here.
Proposals
Proposal P1062 – Defining added sugars for claims assessed changes to conditions for making voluntary nutrition content claims about added sugars in food. The Australia New Zealand Food Standards Code will be amended to incorporate the revised standard which will not permit ‘no added sugar(s)’ claims when a food (a) contains, or is, an ‘added sugar’ as defined in the Code, (b) does not contain ‘added sugar’ but contains more sugars (i.e. monosaccharides and disaccharides) than 10.0 g /100 g for solid food or 7.5 g /100 mL for liquid food. For approval report and public presentation delivered by webinar in September 2023 is available here.
Proposal P1059 – Energy labelling on alcoholic beverages. More information here and read the Consumer research report – Energy Labelling on alcoholic beverages: The effects of various labelling formats on consumer perceptions and behavioural intentions, here.
New applications
A1282 This application seeks to modify Schedule 18 of the Code to permit the use of subtilisin from genetically modified Bacillus subtillis as a processing aid. The intended use is for protein processing. Typical processes which may employ subtilisin include baking, and dairy, egg, meat and fish processing. Administrative assessment here, and executive summary available here.
A1275 This application seeks to amend the Code to permit transglutaminase from genetically modified Bacillus licheniformis to be used as a processing aid in a range of food manufacturing processes. To read more open these links:
Call for submissions – 10 October 2023 (pdf 402 kb)
Supporting document – Risk and technical assessment (pdf 346 kb)
Administrative Assessment – 23 June 2023 (pdf 141 kb)
Executive Summary (pdf 446 kb)
Call for comment
To permit the use of cultured quail cells as a novel food – to be an ingredient in food products. More information here: first call for comment, statement on cultured quail as a novel food application, and A1269 cultured quail as a novel food.
Amendment to the Code
Amendment No. 223 to the Australia New Zealand Food Standards Code was published by FSANZ on 30 November 2023 (FSC 163). It included amendments resulting from the following applications.
A1264 Food derived from drought-tolerant and herbicide-tolerant soybean line IND-00410-5
Food Recalls
Capital 555 – Bean Sprouts 5kg – due to microbial (Salmonella) contamination (FSANZ)
Quality Food World – Fifya Greek Tzatziki – non compliant labelling as the product states dairy free on the lid, however milk is included in the ingredients list and product. (FSANZ)
General Mills Australia – Old El Paso Hard ‘n Soft Taco Kit 350g – some taco kits containing an incorrect sachet, which contains an undeclared allergen (milk) (FSANZ)
B.-d. Farm Paris Creek – Bio-dynamic fresh butter unsalted, 200g – due to microbial (Yersinia enterocolitica) contamination. (FSANZ)
Tassal Operations – tassal Salmon with Coconut Kaffir & Lime Marinade – presence of undeclared allergens (milk, soy) (FSANZ)
Vegan Delight – CIGKOFTE 1kg and 250g – presence of an undeclared allergen (treenut-walnut) (FSANZ)
Coles Supermarkets Australia – Sydney City Oysters Pacific Oysters 12 pack – due to incorrect Use by date. The product was incorrectly labelled with a Use By date of 30 November 2023, instead of 10 November 2023 (FSANZ)
More food news from Lisa and Gary at Correct Food Systems
Reminder about Plain English Allergen Labelling FSANZ 1.2 3. Businesses have until 25 February 2024 to adjust their product information and labels to meet the new requirements. There is a further 2 years stock in trade period. Read more here
Country of origing labelling is coming to hospitality. Read more: Department of Industry, Science and Resources
PROPOSAL P1062 – DEFINING ADDED SUGARS FOR CLAIMS FSANZ has approved a variation arising from proposal P1062 – Defining Added Sugars for Claims and has notified this approval for the Food Ministers’ Meeting taking place on Friday, 1 December 2023. Once notified, the Food Ministers’ have 60 days to either request FSANZ to review the approved standard or to inform FSANZ that it does not intend to request a review. Within the approval report FSANZ is proposing that food and beverages which contain intrinsic sugars will not be permitted to make a ‘no added sugar claim’ if their sugar content exceeds 10g/100g for solid food, or 7.5g/100ml for liquid food. Information here.
In the press:
Advocates band together in fight against food waste with focus on use-by, best-before dates. Another discussion about the poorly understood difference between “use by” and “best before” and whether this is contributing to food waste. Under the FSANZ rules, foods should not be eaten after the use-by date and cannot be legally sold, but products past their best-before date can be sold if still fit for human consumption. In a statement to the ABC, FSANZ said there were “no plans to change the best-before or use-by date marking requirements in the Food Standards Code”. Source: Australian Broadcasting Corporation.
Food safety regulator says meat grown from cells ‘safe to eat’ in Australia-first analysis. A discussion on the story above about lab-grown quail meat. Source: Australian Broadcasting Corporation
Cosmetics, Personal Care and TGA Listed Sunscreens:
Sunscreen regulation. The TGA is currently in the process of removing the exemption provisions in the Regulations for sunscreens with less than SPF 4. This is a newly published information which helpfully summarises the types of sunscreens the TGA regulates – primary sunscreens: products that are used primarily for protection from UV radiation, and some secondary sunscreens: products with a primary purpose other than sun protection, that contain sun screening agents but are not excluded from therapeutic goods legislation for example, sunbathing and moisturising skin care products with an SPF of over 15. TGA does not regulate cosmetic sunscreens. This helpful information is published here. (RTD has a training course in pharmacovigilance which is delivered by an expert in the field. See course agenda here)
“Missing the SPF target”. Another excellent article by global sunscreen expert John Staton. John discusses why a new requirement to nominate the “Target” SPF many not be a good idea. John points out the problems with this approach, and suggests how this could be approached in a different way. Read this article on LinkedIn here.
Voluntary industry code to support the Australian ban on testing cosmetics on animals. This is a press release from ACCORD Australia, the industry association representing cosmetics manufacturers and suppliers. They have published an excellent summary of the policy and are inviting submissions by 12th January 2024. If you are supplying cosmetics in Australia you should consider joining ACCORD if your aren’t already a member. Read about the voluntary code to support the ban on testing cosmetics in animals on their website here.
Chemicals added to the inventory following issue of assessment certificate (early listing) as of 7th December (five):
(CAS number refer to link for chemical name)
2411391-25-6; 2411391-27-8; 2952782-14-6; 2952782-15-7
The above four ingredients are fragrance ingredients used in body lotion, face cream and hand cream at up to 0.1% concentration; deodorant spray at up to 0.03% concentration; fine fragrances at up to 0.11% concentration; hairspray at up to 0.44% concentration; air fresheners at up to 5% concentration; other leave-on and rinse-off cosmetic and household products at up to 0.6% concentration.
And no CAS number but approved chemical name: Amines, polyethylenepoly-, reaction products with 2-[(carbopolycyclicoxy)methyl]heteromonocycle and succinic anhydride monopolyisobutenyl derivs. A polymer for use by workers only Source: AICIS
As of 10th November (seven):
2989897-59-6 ; 1902936-62-2; 1395069-30-3; 1812871-32-1; 800399-69-3; 187348-14-7; 1374645-21-2
Correction of chemicals names 23rd November. These names have been updated from the names in the Australian Inventory of Industrial Chemicals to the Chemical Abstracts Service (CAS) name. There are about 27 chemicals, if they were all listed here it would make this newsletter so boring you would probably unsubscribe. You can view them here on the AICIS website
ACCC NEWS:
Eight principles to guide businesses’ environmental claims. Just published as part of their final guidance on environmental claims, the eight key principles are 1. Make accurate and truthful claims; 2. Have evidence to back up your claims; 3. Don’t hide or omit important information; 4. Explain any conditions or qualifications on your claims; 5. Avoid broad and unqualified claims; 6. Use clear and easy-to-understand language; 7. Visual elements should not give the wrong impression; 8. Be direct and open about your sustainability transition. Source: ACCC
Online reviews and testimonials. This contains findings of the ACCC’s internet sweep of online reviews and testimonials. There are various ways businesses may distort online reviews to mislead consumers. For example, a business (or others acting on their behalf) may: Publish false or misleading positive reviews or testimonials about their own goods or services – Offer incentives to others to publish positive reviews or testimonials – Publish false or misleading negative reviews or testimonials about their competitors – Prevent, edit or remove negative reviews or testimonials – Display ratings and reviews in a misleading way. This full report contains many interesting statistics and is a “must read” for anyone involved in social media advertising. Read the PDF on the ACCC site here.
Social media influencer testimonials and endorsements. Findings of the ACCC’s internet sweep of testimonials and endorsements by influencers. Some of the key issues looked at include not disclosing brand relationships in posts, vague or confusing attempts at disclosing brand relationships, and false or inaccurate statements about a brand, product or service. The ACCC targeted seven sectors in which influencer marketing is particularly widespread: – Fashion – Beauty and cosmetics – Food and beverage – Travel and lifestyle – Health, fitness and wellbeing – Home and parenting – Gaming and technology. Once again, a must read if you are involved with this sector. PDF version of report is on ACCC website.
Proposed new regulation of digital platforms. ACCC recommendations, made in its September 2022 Digital Platform Services Inquiry report, called for mandatory codes of conduct for certain digital platforms to prevent anti‑competitive conduct. Anti-competitive conduct identified in the report included self-preferencing, where platforms favour their own services in search results and app stores, and tying, for example with developers being forced to use app stores’ in-app payment systems that charge commissions of up to 30 per cent. The recommendations include new service-specific mandatory codes of conduct for particular ‘designated digital platforms,’ based on principles set out in legislation. Source: ACCC
Scrutiny of influencers and businesses for misleading advertising and online reviews continues. A 7th December update on the ACCC’s ongoing work to scrutinise misleading online reviews and influencer endorsements. Source: ACCC
Online national retailer Riff Raff Baby Pty Ltd has paid penalties of $132,000 after the ACCC issued it with eight infringement notices for allegedly making false or misleading statements about its comforter toys being safe for sleep from birth. Riff Raff advertised its sleep aid comforters for sale on its website, and Facebook and Instagram pages, with frequent images of sleeping babies and prominent statements including “we always recommend the introduction of your Riff Raff Sleep Toy from birth where possible” ,“…Did you introduce your Riff Raff from birth? If you didn’t…, do you wish you had?” and “designed with safety in mind.” This is contrary to public health advice, which indicates that toys or other objects, particularly soft toys, should not be placed in a sleep environment with a baby less than seven months old. Source: ACCC
The ACCC has accepted a court-enforceable undertaking from yoghurt manufacturer MOO Premium Foods Pty Ltd (MOO) following an investigation into MOO’s ‘100% ocean plastic’ representations on its yoghurt packaging, website, and social media pages. MOO claimed that its yoghurt tubs were made from ‘100% ocean plastic’, which the ACCC was concerned gave the impression they were made from plastic waste collected directly from the ocean, when this was not the case. Source: ACCC The Federal Court has ordered US-based Fitbit LLC to pay penalties of $11 million after it admitted making false, misleading or deceptive representations to 58 consumers about their consumer guarantee rights to a refund or a replacement after they claimed their device was faulty. More interesting details on the ACCC site here
Additional cosmetics and personal care news provided by Rita Sellars from pH Factor:
(Rita is the trainer for our Australia cosmetics regulatory courses, her bio is here and the course agenda is here)
The accurate substantiation of claims in the homecare and cosmetics industry is essential, particularly under the strict oversight of the ACCC and Australian consumer laws. It’s not just a legal obligation; it’s a commitment to the trust and safety of Australian consumers. As the industry continues to grow and evolve, the need for transparent, evidence-based claims becomes increasingly paramount, reflecting a dedication to quality and consumer respect in the Australian market.
We know as consumers, the value and appeal of a product are significantly influenced by the claims it makes. Whether it’s promising anti-aging effects or eco-friendly ingredients, these claims are more than marketing strategies; they are commitments to quality and effectiveness.
As brand owners and marketers, one need to be mindful of the importance of accurate claims and rigorous claims substantiation, especially under the guidelines set by the Australian Competition & Consumer Commission (ACCC) and relevant Australian laws.
The Importance of Accurate Claims
1. Consumer Trust: For consumers, trust in a brand is built on the reliability and truthfulness of its product claims. Accuracy in these claims leads to consumer satisfaction and brand loyalty.
2. Competitive Fairness: Accurate claims ensure fair competition in the marketplace, where products succeed based on their actual merits rather than exaggerated or false claims.
3. Regulatory Compliance: In Australia, the ACCC oversees and enforces regulations to ensure that businesses do not make false, misleading, or deceptive claims about their products. Compliance is not only a legal requirement but also key to maintaining a brand’s integrity and reputation. This is where RTD can assist.
The Role of Claims Substantiation in Australia
Claims substantiation is vital for compliance with ACCC guidelines and Australian consumer laws. This process includes:
1. Scientific Evidence: Any claim, especially those related to health, safety, or performance, must be supported by robust scientific evidence. This may include clinical trials, laboratory testing, and other relevant scientific research.
2. Documentation and Transparency: Keeping detailed records of tests and studies is crucial for verifying claims, especially if reviewed by regulatory bodies like the ACCC.
3. Expert Consultation: Involving experts in relevant fields (such as dermatology, testing laboratories or environmental science) is essential for validating claims.
4. Adherence to Australian Consumer Law: Australian Consumer Law (ACL) protects consumers from misleading and deceptive conduct. It’s essential that claims are not only scientifically substantiated but also presented in a way that is clear and not misleading to consumers.
At RTD, we understand that there are some challenges in Claims Substantiation. The process, while crucial, faces several challenges:
1. Cost Implications: Comprehensive testing and research for substantiating claims can be expensive, posing a challenge for smaller brands.
2. Keeping Up with Regulatory Changes: Regulations, including those set by the ACCC and under the ACL, can evolve, requiring brands to stay informed and adaptable.
3. Scientific Rigor: The complexity of scientific testing and evidence-gathering demands specialized knowledge and resources.
Integrity and honesty in product claims are not just best practices but legal requirements. Brands are expected to uphold the highest standards in advertising and product representation. This segment explores what happens to brands when they fall short of these expectations and are faced with allegations of false and misleading claims. There are consequences of False and Misleading Claims!
1. Legal Repercussions: The ACCC rigorously enforces compliance with the ACL. Brands found making false or misleading claims can face significant legal consequences, including hefty fines, mandatory corrective actions, and in severe cases, litigation. This legal scrutiny not only impacts the immediate financial standing of a company but can also lead to long-term regulatory watchfulness.
2. Damage to Brand Reputation: Trust is a critical asset in the consumer market. Once a brand is associated with deception or misleading information, regaining consumer trust can be a challenging and lengthy process. The damage to a brand’s reputation can lead to a decline in sales, loss of market share, and in some cases, irreversible harm to the brand’s public image.
3. Consumer Backlash: In today’s digital age, news of false claims can spread rapidly, leading to immediate consumer backlash. Social media platforms and online reviews can amplify negative sentiments, further eroding consumer trust and loyalty.
4. Competitive Disadvantage: Brands that engage in false advertising can find themselves at a competitive disadvantage. Competitors who adhere to ethical practices can leverage their integrity as a selling point, drawing customers away from brands tainted by misleading claims.
Case Studies and ACCC Actions
Several case studies highlight the ACCC’s role in penalizing and rectifying false claims. For instance, a skincare company falsely claiming organic or natural ingredients, or a cleaning product exaggerating its germ-killing abilities, can be subjected to ACCC investigation. These cases often result in public announcements, reminding both consumers and businesses of the importance of truthful advertising.
A recent example of a company called PLANT EXTRACTS and its cosmetic brand BIOLOGI had recently faced mandatory corrective actions. It can be seen that on 23 October 2023, in the matter of Native Extracts Pty Ltd v Plant Extracts Pty Ltd [2023] FCA 1265 Justice Downes issued an initial judgement and made orders for declaratory relief and the publication of eight (8) corrective notices by Plant Extracts Pty Ltd ACN 613 551 349 (Plant Extracts) and skincare brand Bilogi Pty Ltd ACN 618 697 297 (Biologi).
The Court also issued permanent injunctions against Mr Ross Macdougald and made various declarations that representations made by both Plant Extracts and Biologi in relation to their botanical plant extracts and skincare products published on their own websites and replicated on various third party websites amounted to misleading and deceptive conduct and were in fact, false and misleading.
Earlier this year, another example can be seen In the Home and laundry category. RB (Hygiene Home) Australia Pty Ltd, part of the Reckitt Benckiser group of companies, the manufacturer of FINISH dishwashing products (RB), has secured an urgent interim injunction against Procter & Gamble’s (P&G’s) FAIRY “30 Minute Miracle” dishwashing tablet product (Miracle). The recent Federal Court decision highlights the importance of ensuring claims to superior performance are accurate and the potential risks associated with relying on disclaimers.
The Importance of Compliance and Ethical Marketing highlights that businesses should carefully consider the design and presentation of marketing claims on product packaging and how they would be perceived and understood by ordinary consumers. Claims can be an effective marketing strategy, however, one should ensure that any claims are accurate, having regard to how an ordinary, reasonable consumer would understand the claim, and that the claim is able to be properly substantiated.
The private interests of parties are not the sole consideration in balance of convenience where claims are based on the Australian Consumer Law. Courts will have strong regard to the public interest in protecting consumers from misleading and deceptive claims.
In light of these potential consequences, compliance with ACCC guidelines and the ACL is not just a legal mandate but a strategic business decision. Ethical marketing and honest representation of products are essential for long-term success and sustainability in the competitive landscape of homecare and cosmetics.
Cosmetics New Zealand
Are you selling cosmetics in New Zealand? If you are not already a member, it would be in your best interests to join Cosmetics New Zealand – the industry association that keeps you updated with legislation and regulatory updates globally, and lobbies on your behalf. More information here https://www.cosmeticsnewzealand.org.nz/ or email their general manager Martha Van Arts on gm@cosmeticsnz.org
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Published by Regulatory Training Direct www.regulatorytrainingdirect.com
Providing regulatory training courses for complementary medicines, GMP, foods, cosmetics dietary supplements.
This newsletter is sent at no charge. You are welcome to forward this to any colleagues who may find it useful. To receive this newsletter regularly click this link
Don’t want these emails? Unsubscribe or Manage Email Subscriptions
