Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

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.

Draft evaluations open for comment:

10 draft evaluation statements that AICIS has:

  • identified as possibly posing a risk to human health and/or the environment
  • are unlikely to require further regulation in Australia to manage environmental risks
  • are not considered for in depth evaluation because they are not commercially active in Australia

Source: AICIS

 

Equivalent CAS names and numbers. AICIS has published a list of 6 ingredients that have different CAS numbers and names but are actually identical.    Source: AICIS

 

Additional information published by AICIS on their website

Call for information: chemicals with no known commercial use in Australia – AICIS has identified chemicals on the Inventory that they believe are not being manufactured, imported or used in Australia for commercial purposes. Read draft evaluation provide comments by 28 March 2022 if you are using any of these chemicals.

Call for information on chemicals unlikely to need further environmental risk management controls – AICIS completed a draft evaluation on certain chemicals that they believe do not require further regulatory controls to manage environmental risks. Read draft evaluation and provide comments 28 March 2022 if you have relevant use and hazard information.

Final evaluations and updates to the Rolling Action Plan – AICIS has finalised and published 24 evaluations in January, which covered 1,382 unique chemicals. Evaluations focused on human health and environmental risks associated with the use of certain chemicals listed on Inventory.

Withdrawing pre-introduction reports online – AICIS has updated AICIS Business Services so users can now withdraw a PIR they've already submitted in certain circumstances.

Chemicals added to the Inventory 5 years after issue of assessment certificate.

Updated list of ingredients permitted in listed complementary medicines

A revised list has been published. You can find it here: https://www.legislation.gov.au/Details/F2022L00173. There is one new ingredient - Euglena gracilis whole cell dry; an updated name - ‘Cistus ladaniferus’ becomes ‘Cistus ladanifer’; and there are changes to requirements for several ingredients. To see these, open “Explanatory Statement” at https://www.legislation.gov.au/Details/F2022L00173/Download. If your products contain Andrographis paniculata, inorganic magnesium salts, ‘benzalkonium chloride’, mollusc and mollusc-derived ingredients, ‘pyridoxal 5-phosphate’, ‘pyridoxal 5-phosphate monohydrate’, or ‘pyridoxine hydrochloride’, or Artemisia species, you should note these important changes.

 

New Compositional guideline: Euglena gracilis whole cell dry    Source: TGA

 

Compliance enforcement

JMIT Distributors fined $79,920 for alleged advertising breaches involving nicotine vaping products. The company was contacted on multiple occasions but failed to come into compliance and continued to advertise nicotine vaping products for supply.    Source: TGA

NSW based executive officer fined $10,656 for alleged unlawful advertising of nicotine vaping products. The individual failed to bring the company's advertising into compliance with the Act.    Source: TGA

TGA has issued an infringement notice of $13,320 to Victorian-based company TCF Trading for alleged unlawful importation of 70,000 COVID-19 rapid antigen tests that were not included in the Australia Register of Therapeutic Goods (ARTG).    Source: TGA

The TGA has issued two infringement notices totalling $5,328 to a Melbourne-based individual for alleged unlawful importation more than 19kg of nicotine vaping products which were not registered on the ARTG to the individual and were not exempt from being registered.    Source: TGA

 

Should it be mandatory for healthcare facilities to report adverse events/safety problems with medical devices to the TGA? Feedback on discussion paper closed in December 2021. Almost three quarters of respondents were in favour of introducing mandatory reporting of medical device related adverse events.    Source: TGA. You can read responses from stakeholders here.

 

Recall: SFI Australasia, in consultation with the TGA, has initiated a recall for one batch of Ellura capsules (active ingredient: Vaccinium macrocarpon) due to the presence of ethylene oxide.    Source: TGA.

 

Supplying medicinal cannabis in Australia: this is a recording and transcript of a TGA webinar presentation in October 2021.    Source: TGA

 

TGA is seeking feedback on a proposed priority pathway for assessment of certain novel and life-saving biologicals.    Source: TGA

 

A new Poisons Standard has been published. The changes are detailed in the explanatory statement to SUSMP No. 35 February 2022.    Source: TGA. Explanatory statement is here.

 

Importing COVID-19 rapid antigen tests (RATs) – a fact sheet.    Source: TGA

 

Surgical mesh devices: information for medical practitioners on “up-classification”.    Source: TGA

 

Post-market review of face masks: the latest outcomes and action taken due to product defects.    Source: TGA.

Import and labelling of kava. Import permit required, mandatory label warnings. Source: Dept Agriculture, water and Environment

 

Australian Food Composition Database: an easy to search database of the nutrient content of Australian foods. Updated data for bread, fruits, cereals, yoghurts, and poultry, plus foods not previously included such as nut based beverages, and plant based meat alternatives.    Source: FSANZ

 

Energy labelling of alcoholic beverages: results of an evidence assessment and consumer literature review. Options include on-label energy content information and a shortened nutrition information panel, containing average energy content only (preferred by most stakeholders)    Source: FSANZ

 

General information on labelling of alcoholic beverages published by FSANZ.

 

FSANZ approvals, general procedures, variations and notifications:

A1240 – Polygalacturonase from GM Aspergillus oryzae

A1246 – Phospholipase A1 from Aspergillus oryzae​

A1248 – Glucoamylase from GM Aspergillus niger

A1226 – Food derived from insect-protected corn line MON95379​​

A1219 – Alpha-amylase from GM Bacillus licheniformis: ​To permit the use of Alpha-amylase from GM Bacillus licheniformis as an enzyme processing aid for use in brewed beverages, potable alcohol production and starch processing.

A1249 – Addition of phytosterols, phytostanols or their esters to plant-based milk alternatives: To seek approval for the addition of phytosterols, phytostanols or their esters as a novel food to plant-based milk alternatives.

The following application has been withdrawn by the applicant: Enzymatic production of rebaudioside I: To seek approval for a new specification for the steviol glycoside, rebaudioside I, produced by enzymatic bioconversion of stevia leaf extract.

 

Food Recalls

Tohato Caramel Corn Original Flavour 80g - presence of an undeclared allergen (tree nut [almond])    Source: FSANZ

Bondi Protein - Vegan Protein Bar Peanut Butter - undeclared allergen (tree nut [cashew]).    Source: FSANZ

L'Artisan Organic Marcel - due to microbial (E.coli) contamination.    Source: FSANZ

EleCare, Similac and Alimentum infant formula products - due to potential microbial contamination (Cronobacter and Salmonella).     Source: FSANZ

Bestow Powdered Drink Products - due to the presence of an undeclared allergen (gluten).    Source: NSW Food Authority

 

Failing imported food reports for November 2021

Risk food test results – similar problems found as last month.    Source: Dept Agriculture, water and Environment

Surveillance food tests – non-permitted ingredients including vitamins and minerals, and caffeine.    Source: Dept Agriculture, water and Environment

“Use by” and “Best before” – do consumers understand the difference? Interesting article on food waste published in the local press.     Source: News.com.au.

Recall: 'Banana Boat' Sunscreen Sprays SPF 50+ (aerosol)

Benzene was detected in 4 batches of three products supplied. Benzene is classified as a human carcinogen, a substance that could potentially cause cancer depending on the level and extent of exposure.    Source: TGA

 

Withdrawing pre-introduction reports

PIRs are once-off mandatory reports only for introductions of chemicals under the reported category. You submit them online through AICIS Business Services. You can now withdraw a PIR online in AICIS Business Services after you have submitted it.    Source: AICIS

 

Notice of completed evaluations - 14 January 2022

24 evaluations about the human health and environmental risks associated with the use of certain chemicals have just been published.    Source: AICIS

 

List of chemicals added to the inventory 5 years after issue of certificate

Three chemicals added to the inventory on 21st December.    Source: AICIS

 

Variation of inventory listing

Two variations published on 21st December.    Source: AICIS

 

Regulatory requirements and obligations that started on 10 December 2021

Includes Pre-introduction report requirement relating to nanoscale chemicals for research and development, permission to use international assessment report, record-keeping for 'designated kind of release into the environment'.    Source: AICIS

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