Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Complementary Medicines (“Dietary supplements”):
TGA Releases Updated Australian Regulatory Guidelines For Complementary Medicines (ARGCM)
The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provide information for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia. As reported in recent issues of this newsletter, the TGA has undertaken the biggest review of regulations regarding the supply of CMs since its inception. This latest version, ARGCM Version 8, includes amendments to ARGCM Part C to incorporate legislative changes for new substance evaluations. Other parts of the ARGCM will be amended in 2018 to reflect other legislative changes arising from the Government's complementary medicines reforms. This newsletter will keep you informed as more information comes to hand. Source: ARGCM version 8
TGA Details Upcoming Changes To The Permissible Ingredients Determination
All ingredients available for use in listed medicines in Australia and any restrictions pertaining to them are listed in the Therapeutic Goods (Permissible Ingredients) Determination. The Determination is continually reviewed by the TGA to ensure that all ingredients are safe for use in low-risk medicines. It is updated quarterly through the addition or removal of ingredients, and the clarification, removal or addition of restrictions or warning statements. This document outlines changes that have been made to the Determination in the first half of 2018 and the upcoming changes for June. As well as there being a new herbal naming standard for new herbal ingredients and addition of 4 new ingredients, other changes include removal of 2 previously permissible ingredients and removal of several required warning statements. Of particular interest is the ‘correction of restrictions relating to coumarin’. (The requirements for coumarin in a number of herbal ingredients have been amended to correctly align with the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) in referring to concentration, rather than maximum daily dose). 11 ingredients are affected by this change. By June 2018 there will be further changes affecting the therapeutic role of menthol, herbal name changes, and the addition of 4 new ingredients. Of special note is clarification of ‘SUSMP requirements for arbutin’. (Ingredients known to contain arbutin will have arbutin listed as a mandatory component with associated specifications in line with the Poisons Standard. There are 11 affected ingredients). Finally, there are also ‘new restrictions on poliglusam’ and ‘new restrictions on methyl salicylate’ with 9 ingredients affected, and ‘new restrictions on cysteine’. Changes regarding ‘curcuminoids’ and caffeine restrictions have been delayed for further review. Source: Permissible ingredients
TGA Proclaims Changes to Evaluation of Substances for Use in Listed Complementary Medicines
The process for evaluation of substances for use in listed complementary medicines has changed. The TGA has introduced new application categories and legislated timeframes for evaluation of substances for use in listed complementary medicines. There is also a new mechanism to permit a successful applicant of a new complementary medicine substance to have exclusive use of that ingredient for a specified period of time. Implementation of this reform aims to support innovation and improve the evidence base for complementary medicines. Source: LM substance evaluation
TGA Publishes Outcomes of the Consultation on the Draft List of Permitted Indications
On 6 March 2018, the TGA implemented a list of permitted indications for medicines. Indications available for use for listed medicines are now contained in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination. Sponsors can still apply to have new indications considered for inclusion in the Permissible Indication Determination. A full outcome summary can be read at this site. Source: Permitted indications
TGA Consultation: Advertising Therapeutic Goods To The Public
The TGA is seeking comments from interested parties and the views of stakeholders on the proposed advertising complaints handling model. As the single agency for therapeutic goods advertising complaints management from 1 July 2018, the TGA is undertaking this public consultation to seek stakeholder's views on its proposed complaints handling model. The public consultation paper outlines the proposed model of advertising complaints handling which aligns with best practice models of complaints handling by comparative Commonwealth regulators. This complaint handling model is intended to ensure that non-compliance remedies are appropriate, proportionate, timely and consistent with contemporary practice. This consultation closes on 4 June 2018. Source: TGA product complaints
TGA Seeks Input: Options for the Implementation of a Claimer for Efficacy of Assessed Non-Prescription Medicines
The TGA is seeking comments from interested parties on the use of a claimer for efficacy assessed non-prescription medicines. In the February 2017 consultation paper, ‘Reforms to the framework for complementary medicines: Assessment Pathway’, the TGA consulted on a proposal to allow sponsors to claim (‘the claimer’) that their medicine has been assessed by the TGA for efficacy where that medicine has undergone pre-market evaluation by the TGA. This was supported by the majority of respondents. Now, further feedback is requested, specifically related to the types of medicines that should be allowed to carry a claimer; options to implement the claimer as a visual identifier and/or label statement; and, how the claimer can be used on medicine labels. TGA will also conduct consumer focus group testing on the options presented in this paper to confirm whether the potential options will achieve the objectives of the recommendation. Source: Claimer consultation
TGA Concerned Claims About Hemp and CBD Oils Are Misleading Consumers
The Therapeutic Goods Administration is aware of false and misleading claims being made by some companies supplying products containing cannabidiol (CBD). Companies located in the United States have been illegally exporting cannabidiol (CBD) and hemp products to persons in Australia without import permission. The TGA is aware of at least one company who has claimed that the TGA has invited them to register their CBD and hemp products on the Australian Register of Therapeutic Goods (ARTG) due to growing demand. This is incorrect. The TGA does not 'invite' businesses or sponsors to register a product on the ARTG. The onus is on the sponsor to apply to the TGA and follow due process. The importation of these products is illegal unless the importer holds a licence and permit to import from the Office of Drug Control (ODC). Imports of these goods that do not have the relevant import permissions will be seized at the border. Individuals and businesses in Australia importing CBD/hemp oils are also breaking State/Territory laws on supply and use of prescription medicines. Source: Cannabis claims
‘TGA Proposal To Change The Medicine GMP Fees And Charges’: Submissions Summary
The TGA has published the combined submissions from respondents to the February 2018 public consultation paper, ‘Consultation: Proposal to change the current Good Manufacturing Practice (GMP) fees and charges’. Consultation closed on 5 March 2018 and a total of 31 submissions were received. All submissions that gave permission to be published on the TGA website are now available in PDF format. Source: GMP charges responses
Important Dates for TGA Compliance
22nd July 2018 - Annual Charge Exemption (ACE) declarations will be available from 1 July 2018. The deadline to provide declarations in relation to your entries (whether active or cancelled) that had an ACE in 2017-18, must be submitted between 1 July and 22 July 2018. A declaration of $0 turnover has the effect of confirming the 2017-18 exemption, and ensuring the entry will continue to be ACE in 2018-19; Early August 2018 - Annual charge invoices issued for 2017-18 (unless exempt) and for 2018-19; 15 September 2018 - Deadline to pay annual charges.
TGA Safety Advisories—
SLIM BODY Advanced capsules - The Therapeutic Goods Administration (TGA) has tested a product labelled SLIM BODY Advanced capsules and found that the capsules contain the undeclared substance sibutramine. Source: Slim body caps
Lishou Strong Slimming capsules - contain the undeclared substance sibutramine. Source: Lishou caps
JAGUAR 30000 capsules -contain the undeclared substance tadalafil. Source: Jaguar caps
Medsafe NZ Warns That Turmeric / Curcumin Containing Products Can Interact With Warfarin
The Centre for Adverse Reaction Monitoring (CARM) recently received a case report describing a patient taking warfarin who began taking a turmeric containing product. The patient had stable INR measurements, but within a few weeks of commencing turmeric their INR increased to over 10. There is a risk of serious bleeding when the INR gets this high. The reporter considered that the turmeric containing product had interacted with warfarin. Source: Turmeric safety
Traditional Vs ‘Modern’ Medicine Debate Continues
As reported in our February 2018 newlsetter , as part of the TGA Complementary Medicines Reforms, regarding ‘Permitted Indications’ , there is scope to also include ‘Traditional Indications’. This has raised the ire of many who view scientific modern medicine as the only authority as to what makes humans sick and what can therefore make humans healthy. Chair of the RACGP Expert Committee – Quality Care, Dr Evan Ackermann, is quoted as saying, “The 860 claims that will be legally permitted on complementary medicine under this new legislation have no scientific basis and can cause harm”. This is inspite of the guidelines for traditional medicines being in line with World Health Organisation guidelines on the role of complementary medicines. The proposed legislative changes are intended to make it easier for consumers to differentiate between traditional or complementary medicines which have had scientific evidence assessed and those that have not. Once the new system is in place any companies which make claims that are found not to have the evidence to support their statements, will have their products removed from the Australian Register of Therapeutic Goods unless corrective action is taken. Culture clash? Sources: Megan Haddan, AJP Doctor's disquiet &, TGA evidence
Failing Food Report
This report details food that was found to fail under the Imported Food Inspection Scheme. The noncompliant 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 and at the importer’s expense. Future consignments continue to be targeted at 100 per cent until a history of compliance is established. Typical microbiological contamination was by E. coli, salmonella, and Listeria monocytogenes. Toxin testing showed repeated instances of aflatoxin and histamine contamination, especially in peanut butters and dried anchovies. Of particular interest to suppliers of ‘formulated sports supplements’ was that 4 USA sourced products were found, after random sampling of imports, to contain either non-permitted ingredients or ingredients that were deemed to be ‘in excess of levels permitted’. Let the food importer beware. Source: Failing foods
Does the New Country of Origin Labelling Apply to Inner Packs?
The new Country of Origin Food Labelling Information Standard takes mandatory effect as of 1 July 2018. As with any new piece of legislation, there any many concerns and uncertainties as to how the Information Standard will be interpreted and enforced. However, this article does not tackle a grey area but rather a regulatory issue that appears to have been forgotten by the Department of Industry in drafting the Standard and currently ignored by the ACCC in guiding the food industry to achieve compliance. Namely: does the new country of origin labelling apply to inner packs? Source: Charles Fisher, Food-Legal CoOL foods
Mandatory Labelling for Lupin Starts Soon
Food Standards Australia New Zealand (FSANZ) is reminding food businesses that mandatory allergen labelling requirements for lupin begin on 26 May 2018. FSANZ CEO, Mark Booth, said lupin is a legume which belongs to the same plant family as peanuts, and has the potential to be an allergen. “In Australia, lupin has not typically been used in food, however, due to its high protein and fibre content we are seeing an increase in its use,” Mr Booth said. “In 2017, lupin was added to the list of allergens that must be declared on food labels. Food businesses were given 12 months to meet these requirements. “Any foods that contain lupin must declare it on the label from 26 May 2018 – even if it’s already on the shelf. “Correct allergen labelling can mean the difference between life and death for people with food allergies so it is vital that food businesses get it right. Source: Lupin labelling
UK Supermarket Chain Tesco to Ditch Best-Before Dates – Australia to Follow?
Supermarket chain Woolworths has indicated it is open to the possibility of removing best-before dates from some products following Tesco (UK) chain’s decision to ditch the labelling. Tesco said best-before dates would no longer appear on packaged produce because the labels were leading to shoppers throwing away “perfectly edible” food. Campaigners have welcomed the move by Tesco. Food donation organisation Oz Harvest told news.com.au it was a “bold move” and encouraged Australian retailers to do the same. It has called on Australia’s food labelling regulations to be reassessed. Source: Best-before
Australian (NSW) Food Authority Recalls – Source: Current recalls
Sweet Bondi Tapioca Coconut Milk Puddings - due to the presence of an undeclared allergen (milk).
Mini Classics Ice Creams - due to potential contamination with metal fragments.
oh so natural Wholefoods Almond, Cashew and Cranberry Bites - due to the presence of an undeclared allergen (peanut).
Red Kellys Tasmania Creamy Caesar Dressing - due to the presence of undeclared allergens (egg, dairy and fish).
FSANZ Notifications —
Proposal P1048 – Code revision 2018 - The purpose of the Proposal is to make minor amendments including the correction of typographical errors, inconsistencies and formatting issues and updating of references. Source: Code revision
Application A1136 – Protein Glutaminase as a Processing Aid (Enzyme) - The purpose of the Application is to permit the use of protein-glutaminase from Chryseobacterium proteolyticum as a processing aid to improve protein functionality in baking, noodle, dairy, meat, fish and yeast products. Source: Protein enzyme
Application A1142 – Addition of Prescribed Method of Analysis for Resistant Starch - The purpose of the Application is to add a method of analysis for dietary fibre and other fibre content for specifically named fibre content of food (resistant starch). Source: Resistant starch
A1147 – Food derived from Herbicide-tolerant Cotton Line GHB811 - The purpose of the Application is to seek approval for food derived from cotton line GHB811, genetically modified to provide resistance to isoxaflutole and glyphosate. Source: Tolerant cotton
Application A1161 – Potassium Polyaspartate as a food additive in wine - The purpose of the Application is to permit the use of Potassium Polyaspartate as a food additive in wine at levels of good manufacturing practice (GMP). Source: Polyaspartate in wine
'Unofficial' Exports Of Aussie Supplements To China Estimated At $800m
Daigou shoppers are believed to have accounted for $800m of 'unofficial' supplement exports from Australia to China in the past year, dwarfing the $320m figure for official exports. ‘Daigou’ are personal shoppers who buy products overseas to ship back to China to sell, usually via e-commerce. Source: Garry Scattergood, Food Navigator-Asia Daigou shoppers
Organic Growth: Australian Industry Tops $2.4bn With Exports To China And Japan Skyrocketing
The Australian organic industry has been ‘conservatively’ estimated to stand at $2.4bn this year, an 88% increase from 2012, with exports to Asia – most notably China and Japan – enjoying strong growth. Source: Gary Scattergood, Food Navigator-Asia Oz organics in Asia
Vegan Trend Takes Hold in Australia
"Every man and his dog is interested in veganism," says Sydney dietitian Nicole Dynan, who predicts the rise in veganism in Australia will only grow. It's backed by market research firm Euromonitor International which predicts that by 2020, Australia's packaged vegan food market would be worth $215 million. It also found Australia was the third fastest growing vegan market in the world after the United Arab Emirates and China. The diet, which excludes the use of animal products, is particularly popular with female millennials in Australia, Ms Dynan says. The Dietitian's Association of Australia spokeswoman says the veganism trend is starting to trickle into older age groups. The hype around gut- and micro-health has made everyone more aware of the value of plant foods, she says. Source: Aussie vegans
Quote for the month:
“If it came from a plant, eat it; If it was made in a plant, don’t!” Michael Pollan
RFA Regualtory Affairs is proud to be a Gold sponsor of Nordoff Robbins Music Therapy https://www.noro.org.au/
Cosmetics (& Household cleaning products):
NICNAS Calls for Consultation on General Rules, Categorisation Guidelines and Transitional Rules
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) helps protect the Australian people and the environment by assessing the risks of industrial chemicals and providing information to promote their safe use. This covers a broad range of chemicals including those used in cosmetics, soaps and many other personal hygiene products. As part of the Australian Government's reforms, NICNAS is seeking comments on the draft changes to the Industrial Chemicals (General) Rules 2018 (General Rules); the Industrial Chemicals Categorisation Guidelines (Categorisation Guidelines); and to the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2018 (Transitional Rules). Submission deadline is 31st May 2018. Source: NICNAS changes
Voluntary Phase - Out of Microbeads a “Success”
In April 2018, the Department of the Environment and Energy, conducted an assessment of progress toward the voluntary industry-led phase-out of microbeads from rinse-off cosmetic, personal care and cleaning products. Australian Federal and State Environment Ministers have expressed satisfaction with the achievements of the voluntary industry phase out; and, have quoted the ‘94 percent microbead-free’ finding of this report’s independent in-store survey of personal care products. Source: Microbeads phasing out
Two Chinese private equity firms, JIC Investments and Tamar Alliance Fund, have bought a majority stake in Australian vitamin manufacturer Nature's Care for a reported A$800m. Source: Cheryl Tay, Nutraingredients-Asia Nature's Care sale
Blackmores Buys Catalent Tablet-Making Plant as Profit Rises
Vitamins company Blackmores has acquired a tablet and soft-gel capsule making plant in Melbourne from United States giant Catalent to gain more control over its supply chain after frustrations with supply shortages for some products. The acquisition was recently announced as Blackmores also revealed that its sales into China were below expectations because of supply constraints and the impact of re-negotiations of trading terms with customers. But its Australian business made market share gains, strengthening its hold as the No.1 brand in the Australian market. Blackmores chief executive Richard Henfrey said the acquisition of the 30,000 square metre tablet-making facility at Braeside in Melbourne would give the company much greater control and flexibility after frustrations over the past six months. Source: Simon Evans, AFR Blackmores new plant
The industry needs to do more to bust three common myths around supplements, namely that products lack evidence of efficacy, that a healthy diet removes the need for supplementation and that products can lead to health risks. Watch this short video. Source: Gary Scattergood, Nutraingredients-Asia Supplement myths
Quote for the month:
“The good physician treats the disease; the great physician treats the patient who has the disease” William Osler
RFA Looks Forward to Naturally Good Trade Expo 2018 in Sydney
Far more than just a tradeshow, Naturally Good Expo is a total business event (‘trade-only’) that’s 100% devoted to all things healthy, organic and natural. As the largest 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. To be held in the Sydney Convention Centre, Darling Harbour on April 29th and 30th, RFA Regulatory Affairs will have our own booth C 43 and we hope to see you there.
Pharmacovigilance Obligations Training
In September 2017, the TGA released guidance on the pharmacovigilance responsibilities of sponsors. TGA guidance. Newly developed, this training course is for sponsors and their nominated pharmacovigilance staff with complementary medicines (AUST L) 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.