Issue 241 | October 2023
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USA dietary supplements: this course will shortly be available online as a pre-recorded course. It will not be available via a Zoom appointment. The agenda includes: Ingredient requirements: Defining “Dietary Supplement”, Allowable Dosage Forms, Drug Exclusionary Clause, New vs. Old Dietary Ingredients; Labelling: Required Labelling Elements, Additional Labelling Considerations, Misbranding, California’s Proposition 65; Quality and Safety: Adulteration Standard, Good Manufacturing Practices (GMP) Requirements, Inspections & Enforcement, Adverse Event Reporting, Food Safety Modernization Act (FSMA), FSMA Rules, FSMA Enforcement Tools. You can read more about the course here.. The course has been prepared by and is delivered by Rend Al-Mondhiry, a partner in US law firm Amin Talati Wasserman, and guest lecturer at Georgetown University Law Center on the topic of dietary supplement regulation. Contact us if you wish to be alerted when the course is uploaded – hopefully in a few days.
New Product Development – Stage Gate process: This is an exciting new course developed by Abbie Harris, the NPD expert. Agenda includes: Part 1 – Foundations: What is a stage gate process? Why have a stage gate process? The gatekeepers, Potential gate decisions, The innovation funnel; Part 2 – Stage Gate Document Stream: Stage 0: Ideation (initiate), Stage 1: Project brief (define, scope), Stage 2: Active formulation (develop), Stage 3: Final formulation (validate), Stage 4: Commercialise (launch), Post launch review. The course comes with a set of eight templates and forms. Read more about this course here.
All our courses can be viewed here: https://www.regulatorytrainingdirect.com/#course-summary
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Note from the editor. Abbie Harris: My fellow director of Regulatory Training Direct is attending and presenting at Innovation Expo in Auckland New Zealand on 16th November. If you would like to meet with her email email@example.com
Complementary Medicines and Medical Devices:
Sports supplements. The three year transition period to comply with the changed regulations ends on 30th November. To quote from TGA: sports supplements that make claims relating to performance in sport, exercise or recreational activity and are in a medicinal dosage form (i.e. tablet, capsule or pill) will be regulated as therapeutic goods. We offer a one hour course AU Sports Supplements – medicine or food? – this will help you understand if your product will be acceptable as a food, or if it must be submitted to the TGA as a medicine..
Changes to ingredients permitted in listed complementary medicines: two new ingredients added: Cyclocarya paliurus leaf extract dry (compositional guideline here) and calcium fructoborate tetrahydrate (compositional guideline here), a change to sugar cane wax alcohols, and eight ingredients removed. Explanatory web page here and the latest list of permitted ingredients is here.
Webinar on 21st November: TGA is presenting an update on the Australian UDI implementation and a guest speaker will present on the real-world benefits of the UDI adoption in the US healthcare system. More information, and to register – see here.
Poisons schedule – An applicant proposed an exemption for the Schedule 10 and Schedule 4 entries for amygdalin and hydrocyanic acid, respectively, when in ARTG listed preparations containing Wild Cherry Bark (Prunus serotina). Amygdalin and hydrocyanic acid are naturally occurring constituents of Wild Cherry Bark which is used in traditional medicine as an oral treatment for various self-limiting conditions, including cough suppression. Amygdalin is currently listed in the Poisons Standard as a Schedule 10 substance for therapeutic use. Hydrocyanic acid is currently listed in the Poisons Standard as a Schedule 7 substance except when used as a therapeutic (Schedule 4). Interim decision a delegate of the Secretary has made an interim decision not to amend the current Poisons Standard in relation to amygdalin and hydrocyanic acid. Read the reasons for the decision here – click to view either the MS Word or PDF versions.
Systematic literature search for complementary and OTC medicine applications. This is a presentation given by the TGA at the ARCS 2023 conference. Source: TGA
Metagenics (Aust) is recalling batch 007764 of Ethical Nutrients Mega Magnesium Raspberry Powder (Exp: 07/2025) due to high pyridoxine (Vitamin B6) content – the product contains twice what is claimed on the label due to a manufacturing error. Source: TGA
Bondi Sands Everyday Protection Face SPF 50+ Sunscreen Mist – the label instructions are to spray the mist directly on to the face. Aerosol sunscreens should not be sprayed directly onto the face as this may cause accidental inhalation, local irritation of nose, mouth, and throat, as well as coughing and sneezing. Source: TGA
TGA warns consumers not to take “Haytox” which is advertised as a treatment for nasal allergies, such as hayfever. ‘Haytox’ has not been approved by the TGA or included in the Australian Register of Therapeutic Goods (ARTG). ‘Haytox’ may contain the botulinum toxin (botox). Businesses are warned that advertising, importing, exporting, manufacturing or supplying these products is illegal and can lead to prosecution. Source: TGA
TGA seizes 70,000 vapes with street value of $2.1 million in storage units in Sydney. The products will be tested at the for scheduled and other dangerous ingredients. Source: TGA
Six infringement notices totalling $86,632 issued to Ovira and an individual for the alleged unlawful advertising of an analgesic TENS system for the treatment of several serious diseases, including endometriosis, without approval or permission from the TGA. The advertising code was breached by refences to the product being “safe” and that competing products could be harmful or ineffectual. Source: TGA
The Federal Court of Australia has ordered Vapor Kings to pay $4.9 million for unlawfully advertising nicotine vaping products. A company Director was also ordered to pay $100,000 in penalties. Source: TGA
Safety alert: coronial inquiries into 2 deaths have highlighted the need for consumers and carers to be alert to the risks of using baclofen. The risks of overdose are particularly pronounced when using high doses for off-label treatment of alcohol-use disorder. The brand-name baclofen product in Australia is Lioresal and there are various generic versions available. Source: TGA
Pharmacovigilance obligations: FAQs web page updated 25th October, includes:
Collecting and reporting adverse drug reactions
Post-registration studies and post-marketing initiatives
Searching Australian and worldwide medical literature
Identifying and reporting safety issues
Updating Australian Product Information (PI) and Consumer Medicines Information (CMI) documents
Australian pharmacovigilance contact person (A-PVCP) and Qualified Person for Pharmacovigilance in Australia (QPPVA)
Submission of periodic safety update reports (PSURs) to the TGA
Botanical Adulterant Prevention Programme (BAPP)
Lavendar oil laboratory guidance document – evaluates laboratory analytical methods to authenticate English lavender essential oil and detect adulteration with lower-cost materials Source: Herbalgram
Interview with Stefan Gafner explains the purpose and goals of the ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP). You can view it on their LinkedIn page here.
In the press:
“Possible Ozempic side effects investigated by Australian drug regulator” – headline in press article and states “Australia’s medicine regulator is investigating several reports of intestinal obstructions in patients using the diabetes turned weight-loss drug Ozempic, in a step that could lead to a change to the drug’s product information.” Source: Sydney Morning Herald
“Researchers link popular weight loss drugs to serious digestive problems for ‘hundreds of thousands’ worldwide” – similar article in CNN news
NHPNZ Innovation Expo. Natural Health Products New Zealand is presenting the Innovation Expo 2023 on 16th November in Auckland. Information including speakers and registration details are here. Abbie Harris from Regulatory Training Direct will be presenting, contact her at firstname.lastname@example.org if you would like to connect with her.
Updates to Therapeutic Products Bill
New Zealand Ministry of Health is inviting expressions of interest from individuals with significant and relevant experience and expertise to join a Natural Health Products (NHP) Advisory Group, to support the development of secondary legislation. Source: NZ Ministry of Health
FSANZ Annual Report 2022 – 2023 has been published. This contains four parts, but it in the appendices that there is some interesting information:
Report against the FSANZ Act requirements
2o22–23 summary report on emerging issues
List of requirements
Australian Public Service Net Zero 2030 Reporting
The report is available here
2023 Stakeholder Satisfaction Survey is now open. This feedback helps FSANZ to continue improving its client and stakeholder engagement services. You can complete the online survey here.
NSW Health warns the public of high-dose MDMA (ecstasy) tablets currently in circulation:
A blue diamond shaped tablet with ‘punisher’ logo contained 216 mg MDMA
Blue skull shaped tablets with ‘MYBRAND’ logo and text contained 216 mg MDMA
Yellow square tablets with ‘SpongeBob’ smiley face markings contained 160 mg MDMA.
These tablets contain up to twice the average amount of MDMA usually contained in tablets circulating in NSW. Other drugs including cathinones, ketamine and ketamine analogues have recently been detected in some MDMA tablets and capsules. Source: NSW Health
Call for submissions due by 21st November:
Application A1275 Transglutaminase from GM Bacillus licheniformis as a processing aid:
Application A1277 2′-FL from GM Escherichia coli K-12 (gene donor: Helicobacter enhydrae) in infant formula products:
Application A1278 Beta-Fructofuranosidase from GM Trichoderma reesei as a processing aid:
Due by 11th December:
Application A1276 – Food derived from herbicide-tolerant soybean line MON94313
Application A1261 – Increase in the maximum energy level: to increase the maximum permitted energy of X-rays permitted to irradiate food from 5 to 7.5 megaelectronvolts.
Application A1283 – 2′-FL from GM Corynebacterium glutamicum in infant formula products: To amend the Australia New Zealand Food Standards Code to permit a new genetically modified source organism Corynebacterium glutamicum for the production of 2′-Fucosyllactose (2′-FL) for use in infant formula products.
Application A1287 – Food derived from short-stature corn line MON94804: To seek approval for the sale and use of food derived from corn line MON94804, genetically modified to have reduced overall plant height.
Application A1284 – Triacylglycerol lipase from GM Trichoderma reesei as a processing aid: To seek permission for triacylglycerol lipase from a genetically modified strain of Trichoderma reesei to be used as a processing aid in baking and cereal-based processes Source: FSANZ and also here
SNOWBRAND AUSTRALIA trading as Unicorn Cheese is conducting a recall of Unicorn Classic Camembert – 125g and Community Co French Style Camembert – 125g – due to potential microbial (Listeria monocytogenes) contamination. Source: NSW Food Authority
Brand Solutions Australia is conducting a recall of: Performance Inspired Protein Water Ready 2 Go Whey Protein Isolate Blueberry Lemonade Flavour 500 mL and Performance Inspired Energy Water Go Time Energy + Protein = Go Time Fruit Punch Pow Flavour 500 mL – due to microbial (Aureobasidium melanogenum) contamination. Source: NSW Food Authority
Exim Marketing PTY LTD is conducting a recall of Naz Pan Masala – due to presence of a prohibited botanical (Betel nut). Source: NSW Food Authority
Tempo Foods is conducting a recall of their Full Cream 2L, Light 2.5% 2L and Skim 0% 2L Fresh Milk – due to microbial (E. coli) contamination Source: NSW Food Authority
More food news from Gary Kennedy at Correct Food Systems
The NSW Food Authority has issued a warning to the public that pre-cooked shredded chicken sold in the food service industry has been recalled due to the presence of the pathogen Listeria moncytogenes. The product has sold including into hospitals, notably in Queensland, where the issue was first identified. In NSW, electronic information has also been sent to the food service industry who serve vulnerable persons, to Food Authority food safety auditors and to seniors groups. More from NSW Food Authority
Cosmetics, Personal Care and TGA Listed Sunscreens:
Temporary record-keeping provisions for NICNAS introducers extended to 1 April 2024. This is for introducers that transitioned from NICNAS to AICIS. To be eligible to use this record keeping provision until 1st April 2024 you must meet all these criteria: you imported or manufactured (introduced) a chemical under NICNAS (before 1 July 2020); the chemical you introduced was listed on the NICNAS Inventory and you continued to introduce the same chemical under AICIS after 1 July 2020; and you don’t know your chemical’s CAS name or CAS number. More information here.
Webinar videos now available on-line, three webinars included:
Overview of proposed changes to categorisation, reporting and record keeping – 21 September 2023
Details of proposed changes to categorisation, reporting and record keeping – 17 October 2023
Details of proposed changes to categorisation, reporting and record keeping (focus: end use in cosmetics) – 19 October 2023 These videos can be viewed here.
Chemicals (two) added to the inventory following issue of assessment certificate as of 2nd November: two chemicals listed here
Chemicals added to the Inventory 5 years after issue of assessment certificate as of 24th October: Seven chemicals listed here
List of new chemical assessment statements published 31st October: four chemicals listed here
If you introduce industrial chemicals into Australia, you need to understand your obligations regarding annual declarations, due by 30th November. NICNAS explains some common misconceptions below and answers your most frequently asked questions here.
AICIS issued an infringement notice of 60-penalty units totalling $16,500 to a Melbourne cosmetic distributor. The business is alleged to have imported industrial chemicals from Denmark without holding an AICIS registration. Source: AICIS
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Published by Regulatory Training Direct www.regulatorytrainingdirect.com
Providing regulatory training courses for complementary medicines, GMP, foods, cosmetics dietary supplements.
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