Complementary Medicines and Medical Devices:

Poisons standard: “Interim Decisions” in relation to substances including cannabis and tetrahydrocannabinols, choline salicylate, chromates and chromium trioxide, and other ingredients.    Source: TGA.

 

Listed medicine compliance reviews. Updated 22nd March. Some medicines reviewed can still be supplied. There are issues with others.    Source: TGA

 

Revised guidelines for evidence to support indications for use/claims for listed medicines. Members of our tech team attended a recent TGA webinar. The deadline for comments on the proposed new guidelines is 1st April. Stakeholders affected by the recent floods or disasters may submit a request for a two-week extension to the Complementary and OTC Medicines Branch via email: This email address is being protected from spambots. You need JavaScript enabled to view it.. The TGA presentation is available here.

 

Medicinal cannabis reforms. On the 6th April the TGA is hosting a webinar on changes to the manufacturing, labelling and packaging requirements for medicinal cannabis products. For information and to register go here.

 

Testing of nicotine vaping products. This is an update to the results of TGA testing of 214 vaping products. Products are tested for presence of nicotine, the concentration of nicotine, presence of prohibited ingredients and compliance with labelling regulations.    Source: TGA

 

In the media:

Doctors call for ban on all vaping products including non-nicotine products. Concern is that advertising is designed to appeal to children. The black market is thriving, even though the TGA has commenced 288 investigations and issued 49 infringement notices totalling $450,216.    Source: Sydney Morning Herald.

 

Compliance enforcement

Getafix Café Pty Ltd fined $13,320 for alleged advertising of COVID-19 Rapid Antigen Test Kit on its website. The advertisements did not comply with the advertising requirements. The company was contacted by the TGA multiple times but failed to come into compliance.    Source: TGA

Gold Coast company FuturePro, trading as Inet Herbal has pleaded guilty to seven breaches of the Therapeutic Goods Act 1989 for the unlawful import, export, manufacture, supply, and advertising of herbal medicines with claims relating to the prevention and treatment of illnesses including various types of cancers. The illegally advertised therapeutic products included Zenith Salve with DMSO (a Schedule 4 prescription-only medicine), commonly known as bloodroot salve or black salve, Zenith Gentle Salve with DMSO, bloodroot capsules, Gumby Gumby and others. Black salve is a corrosive topical paste and can burn and destroy layers of skin and surrounding tissue. A sentencing hearing has set for 28 April 2022 at Southport Courthouse in Queensland.    Source: TGA

Melbourne pharmacist fined $7,992 for the alleged unlawful advertising of nicotine vaping products which are Schedule 4 prescription only medicines and cannot be advertised to the Australian public.    Source: TGA

DPD Stores Pty Ltd fined $26,640 for alleged counterfeit nicotine vaping products that did not declare on the labels and packaging that they contained nicotine.    Source: TGA

MEPH Pharmacy fined $39,960 for the alleged unlawful advertising of nicotine vaping products which are prescription only and cannot be advertised to the public.    Source: TGA

Healy World Australia fined $26,640 for alleged unlawful advertising of a TENS device for a purpose not included for the device in the Australian Register of Therapeutic Goods. The advertising contained a prohibited reference to a serious condition, with references to depression, anxiety and associated sleep disturbances, without the relevant regulatory permission from the TGA.    Source: TGA

Herbal medicine practitioner fined $2,664 for making 'miracle' claims. It has long been the case that a medicine cannot be advertised as a “miracle”. In this case the product was advertised as "a miracle covid treatment that no-one is speaking about".    Source: TGA

Vaxine fined $13,320 for alleged unlawful advertising of an unapproved COVID-19 vaccine on Facebook and YouTube. Apparently the TGA communicated with Vaxine by phone and in writing but the concerns were not addressed.    Source: TGA
 

Pharmacovigilance: this is an often overlooked responsibility. RFA offers a 1.5 hour course which includes a full set of documents and procedures. Courses are conducted by via Zoom, by appointment. Contact us for details.

 

 

Foods:

Do you import kava for sale or wholesale in NSW? From 1 December last year, commercial imports of kava from Pacific Island nations resumed. From this date, importers have been able to apply for a permit to bring kava into Australia. There are important regulatory requirements and steps that must be taken in order to comply with the Food Act 2003 (NSW) (the Act) and the Australia New Zealand Food Standards Code (the Code) for the labelling and sale of kava in NSW.    Source: NSW Food Authority

 

Definition of “meat”, and labelling of plant based proteins. This is a report of a federal government committee. It states “The perception of competition between the traditional category of meat protein and manufactured plant-based protein was not borne out in consumption or consumer trends”. The committee looked for clarity on labelling terms such as “plant-based burger”. A list of 9 recommendations is contained in their 111 page report.    Source: Australian Federal Parliament.

 

Country of origin labelling. This recent report states that the current regulations are well planned and implemented and should be retained.    Source: Australian Government Department of Industry, Science, Energy and Resources.

 

Food Recalls

Uncle's Smallgoods is conducting a recall of sliced ham due to microbial contamination (listeria monocytogenes).    Source: FSANZ

 

Failing imported food reports for December 2021

Risk food test results – five products seized (Japan, Zambia, Sri Lanka, India, Thailand) problems included excess iodine and histamine, insect infestation, mould, and a prohibited plant.    Source: Dept Agriculture, water and Environment

Surveillance food tests – 15 products, problems included non-permitted ingredients, adulterated honey, and prohibited plants.    Source: Dept Agriculture, water and Environment

 

Food Standards Development Work Plan

A comprehensive summary of applications received, and proposals prepared, before and from 1 October 2007 onwards.    Source: FSANZ

 

Call for comment: The use of Cetylpyridinium chloride (CPC) as a processing aid for the antimicrobial treatment of raw poultry.    Source: FSANZ

FSANZ has approved the following draft variation Proposal P1057– Review of the kava standard:​    Source: FSANZ

FSANZ has approved variations arising from the following applications and proposals and has notified these approvals to the Food Ministers' Meeting:

A1212  – Beta-fructofuranosidase enzyme from Aspergillus fijiensis 

A1230 – Very Low Energy Diets (VLED)​

A1231 - Maltogenic alpha-amylase from GM Escherichia coli as a processing aid (enzyme)​

 

In the media:

Reading food labels. Interesting article on what claims are regulated, and which are not (such as "wholesome", "natural", "free" and "nutritious"). How to read a food label.    Source: Sydney Morning Herald/Good Food Guide.

Popular diet rules: Fact or Fiction? Includes carbs, calories, fats, and when to eat.    Source: Body and Soul.

Are protein bars healthy? How much protein do you need and from what source?    Source: Sydney Morning Herald.

Plant based protein: cost and taste issues.    Source: Sydney Morning Herald.

 

 

Cosmetic, Personal Care and TGA Listed Sunscreens:

Download a list of chemicals on the inventory. AICIS has published a downloadable spreadsheet containing all the chemicals on their database. However this may not be very useful as it contains the database up until 10th February 2022 and will not be updated until later this year. AICIS says it “may not be complete, accurate and up-to-date, should not be relied on for the latest information about a chemical – you must search the online Inventory to see if your chemical is listed and what any terms of its listing are, does not include chemicals that cannot be disclosed to the public because the terms are confidentially listed on the Inventory”. Anyway, you can find it here.

 

No longer need your AICIS registration? If you have stopped importing industrial chemicals (includes ingredients in cosmetics) and don't wish to continue your registration there is a way to notify AICIS so you do not receive reminders when it's time to renew.    Source: AICIS.

 

Chemicals added to the Inventory 5 years after issue of assessment certificate – update as of 4th March.    Source: AICIS.

 

New Zealand

Sunscreens with SPF greater than 15+ will now be regulated. The Sunscreen (Product Safety Standard Bill) has been passed and industry has 18 months to comply with the AS/NZS 2604:2012 standard. New Zealand and Australia have the world’s highest incidence of skin cancer and melanoma.    Source: NZ Parliament. The legislation is here.

 

Update on Therapeutic and Natural Health Products legislation. The bill will be introduced to NZ parliament by the end of 2022. NHPs won’t be regulated as therapeutic products or as foods, they will have their own regulations under the Bill.    Source: New Zealand Ministry of Health and also here

 

Natural Health Products NZ comments on the Therapeutic and Natural Health Products legislation. The industry association is concerned that the Bill is not permitting “Therapeutic” claims, only “Health Benefit” claims. They believe that the bill should be amended to permit all the claims allowed in Canada and Australia.    Source: Natural Health Products NZ.

 

A guide to advertising Rapid Antigen Test Kits. There is a prohibition on importing, manufacturing, supplying, selling, packing, or using a point-of-care test for SARS-CoV-2 or COVID-19 unless the Director-General of Health has authorised the person’s activity or exempted the point-of-care test from the prohibition. This link also links to a list of permitted RAT kits.    Source: NZ Advertising Standards Authority

 

Comparative Advertising. Comparative ads must only compare like with like, must not disparage competitors and must be factual and accurate.    Source: NZ Advertising Standards Authority

 

A message from our friends at Natural health Products New Zealand:

NZ government recognises natural health products for symptomatic relief. Paradoxically the NZ government is recommending natural health products for symptomatic relief, whilst they've been telling the sector for years that the regulations don't permit these sorts of claims. Natural Health Products NZ has been asking them to fix this issue for decades. Are they finally realizing that consumers have a right to know this information? We hope so! Read more here: https://www.naturalhealthproducts.nz/government-recognises-natural-health-products-for-symptomatic-relief/

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