Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Failing Food Reports – September 2020

These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the month of September. Among the usual pathogens detected in these imported foods are such organisms as E.coli (found in Indonesian and Vietnamese clam) and assorted toxins such as histamine (found in anchovies from the Philippines), and the illegal addition of vitamins to many foods (Vitamin B5 in shakes from the Netherlands). Numerous foods seized due to excessive amounts of caffeine.    Source: Food fails September 2020

 

FSANZ Notifications

Application A1214 – Nicotinamide riboside chloride as Vitamin BS in FSMP: Application to amend the Food Standards Code to permit the use of nicotinamide riboside chloride as a permitted form of Vitamin B3 in food for special medical purposes (FSMPs).    Source: Application A1214

Application A1215 – Cetylpyridinium chloride as washing processing aid: To request the addition of Cetylpyridinium chloride (CPC) to Schedule 18 of the Australia New Zealand Food Standards Code.    Source: Application A1215

Application A1193 – Application to approve the use of irradiation as a phytosanitary measure for all types of fresh fruits and vegetables.   Source: Application A1193

Proposal P1051 – Code Revision (2020) - The purpose of this proposal is to make minor amendments to the Food Standards Code, including the correction of typographical errors, formatting issues and updating of references.    Source: Proposal P1051

Public Consultation

The consultation ‘Public Consultation – Consistency of food regulatory approaches’ is available through the Department of Health’s Consultation Hub.  Survey responses and submissions are due by midnight 18 December 2020. This is part of the plan to reform the Bi-national Food Regulation System and includes a comprehensive review of the Food Standards Australia New Zealand Act 1991 and the Intergovernmental Food Regulation Agreement.    Source: Modernisation of the food regulation system

 

TGA Declares Certain Products Presented as Formulated Supplementary Sports Foods to be Medicines

The Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020) (‘the Sports Supplement Declared Goods Order’) has been released.    Source: Federal Register of LegislationFrom 30 November certain sports supplements are regulated as therapeutic goods (medicines). Department of Agriculture, Water and the Environment imported food notice to advise of requirements released here.

Konjac Restrictions

The Department of Agriculture, Water and the Environment released a reminder imported food notice to advise that mini jelly cups containing konjac having a height or width of less than or equal to 45mm are banned for sale under the Australian Consumer Law within the Competition and Consumer Act 2010.    Source: Konjac imported food notice

 

Product Recall

Pete Evans Healthy Everyday Jamaican Simmer Sauce 330g has been recalled, as Thai Green Curry Sauce 330g has been labelled incorrectly as Jamaican Simmer Sauce 330g which has resulted in the presence of fish (an undeclared allergen).    Source: Food Recall

Made in Australia

Simplot Australia has amended the country of origin labelling on 31 frozen fish products, from ‘Made in Australia’ to ‘Packed in Australia’, following concerns raised by the ACCC. The fish were imported and not substantially transformed in Australia.    Source: ACCC news

Permitted Indications - Reminder

The deadline for all listed medicines to transition to only including permitted indications for their products is 5 March 2021. Any products that are non-compliant after this period will be cancelled. It is a legal requirement for sponsors of listed medicines to hold evidence to support the indications for use. Ask us for advice if you are uncertain of your obligations.

 

TGA Declares Certain Products Presented as Formulated Supplementary Sports Foods to be Medicines

See story under Foods heading below

 

Therapeutic Goods Administration Product Recall

Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil (AUST L 313445) are not suitable for consumers with a milk allergy as it contains milk products and have been recalled.    Source: Safety advisory - Contains undeclared milk products

Adulteration Schemes

Written by members of the American Botanical Council Botanical Adulterants Prevention Program (BAPP)this article details some of the adulteration practices that appear to be attempts at surpassing commonly used analytical techniques for herbs and botanicals. Ingredients for which adulteration has been reported include, extracts of bilberry (Vaccinium myrtillus) fruit, black cohosh (Actaea racemosa) root/rhizome, cranberry (Vaccinium macrocarpon) fruit, ginkgo (Ginkgo biloba) leaf extract, saw palmetto (Serenoa repens) fruit, and St. John's wort (Hypericum perforatum) herb, among others. COVID-19 is only further exacerbating the adulteration problem, the BAPP warns, with sharp increases in demand and supply shortages of certain botanical ingredients causing companies to seek out new suppliers.    Source: Adulteration schemes

 

Adulteration of Milk Thistle (Silybum marianum)

A bulletin from the American Botanical Council identifies issues of adulteration of milk thistle (Silybum marianum, Asteraceae) fruit and its extracts. In an estimated 30–50% of milk thistle products, the label claims of active ingredients do not hold up in the actual product, when analysed with methods such as HPLC-UV.    Source: Adulteration of Milk thistle

 

Pharmacovigilance

The TGA's Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now closed. This program is designed to facilitate the collection and evaluation of safety information relating to all medicines on the ARTG. It involves TGA representatives interviewing sponsors and reviewing documents in order to assess the sponsor's compliance with pharmacovigilance requirements. To read more about your obligations refer to the TGA responsibilities document.and inspection program guidance.

Notification of a New Proprietary Ingredient

There is a revised form and guidance on the TGA website for a proprietary ingredient notification. This is for suppliers of ingredient mixtures, such as flavours or fragrances, who do not wish to disclose the mixture's formulation details (such as ingredient quantities) to sponsors of the therapeutic goods on the Australian Register of Therapeutic Goods (ARTG).    Source: Proprietary ingredient Post

 

Therapeutic Goods Administration Face Mask Review

The TGA is undertaking a post-market review of all face masks included in the ARTG. Concerns have been raised about the quality and effectiveness of some face masks, including that they are on the ARTG but do not meet the legislative requirements for medical devices, or do not, perform as intended.    Source: Post Market Review

 

Therapeutic Goods Administration Product Defect Alert

The TGA has issued a Product Defect Alert notice for Softmed branded surgical masks manufactured by Wuhan Topmed following a post market review. These face masks have been supplied under the Australian Register of Therapeutic Goods (ARTG) entry 333133 by the sponsor M House. TGA testing showed the masks did not perform, in relation to fluid resistance claims, as labelled. When tested by the TGA Laboratories, some batches of the masks did not perform at Level 3 but passed at Level 2. Others did not perform at Levels 2 and 3 but passed at Level 1. The TGA is awaiting further information from the sponsor regarding some of the Softmed masks and will consider if further regulatory action will be required. The masks have not been imported into Australia by the sponsor since July 2020, and there are no plans to supply them in the foreseeable future.    Source: Product defect alert for some Softmed branded surgical masks

 

Therapeutic Goods Administration COVID-19 Proceedings

The TGA has issued an infringement notice for $13,320 to Target Australia Pty Ltd for the alleged importation of surgical face masks not on the Australian Register of Therapeutic Goods (ARTG). Source: TGA Notice  

Victoria-based company Manningham Corporation Pty Ltd was fined $13,320    Source: TGA Notice and a woman based in Victoria fined $2,664 for the alleged unlawful importation of medical face masks in relation to COVID-19    SourceTGA Notice. Nafara Australia has been fined $13,320 for unlawful supply of face masks   Source: TGA Notice.

 

Therapeutic Goods Administration Proceedings

In other TGA actions, Australian Beauty Group Pty Ltd has been fined $26,640 for alleged advertising breaches in which they advertised on their websites non-contact thermometers and implied the TGA had endorsed the medical devices. Promoting products as "TGA approved" or "TGA registered", or including other government endorsements, whether they are included in the Australian Register of Therapeutic Goods (ARTG) or not, is a breach of the Therapeutic Goods Act 1989 (the Act).    Source: TGA Notice

 

Alleged Unlawful Advertising of Hydrogen Peroxide

Analytical Products & Services Pty Ltd (ANPROS) has received three infringement notices totalling $39,960 for advertising hydrogen peroxide as a treatment for cancer and emphysema Source: TGA Notice.  a Sydney man has been fined $10,656 for unlawful advertising of hydrogen peroxide and Condy’s crystals for treatment of coronavirus and cancer.    Source: TGA Notice

 

Unlawful Advertising of a Complementary Medicine

Cat Media has been fined $13,320 for advertising a product called Fat Baster Apple Cider Vinegar and Garcina Max that was not included in the Australian Register of Therapeutic Goods (ARTG).    Source: TGA Notice

 

TGA Provides Latest Guidance on Advertising Requirements

The TGA has published guidance on how advertisers can lawfully advise consumers that a product is included in the ARTG.    Source: TGA Advertising therapeutic goods

 

*** Do you need your advertisement checked? ***

Our team has decades of experience advising clients on complying with advertising requirements – for complementary medicines, foods and cosmetics. Contact us for more information about our advertising review services or for information on our training courses by calling +61 2 9660 8027 or emailing This email address is being protected from spambots. You need JavaScript enabled to view it.

 

TGA Manufacturing Webinar  

A webinar the TGA presented at RACI NSW Pharmaceutical Science Group is now available on the TGA website. The topic is “Remote Inspections from TGA perspective - Impact of Covid-19 Restrictions on Manufacturers and Test Laboratories”.    Source: TGA Webinar 

 

Remote Inspections of Overseas Manufacturers

The TGA has published guidance for overseas manufactures on how they conduct remote GMP inspections here and here.

 

Government Program to Support Manufacturing

A $1.5 billion investment in a Modern Manufacturing Strategy has been announced with funding for eligible manufacturers for key manufacturing initiatives. Manufacturers can apply for co-funding under the Modern Manufacturing initiative. To be eligible for grants businesses will need to demonstrate expected job growth and the upskilling of their existing employees. Applicants will also need to demonstrate alignment with the National Manufacturing Priorities. Subscribe to updates at the Department of Industry, Science and Energy – here.

TGA Declares Certain Products Presented as Formulated Supplementary Sports Foods to be Medicines

The Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020) (‘the Sports Supplement Declared Goods Order’) has been released.     Source: Federal Register of Legislation

From 30 November certain sports supplements are regulated as therapeutic goods (medicines). In response to these changes, SME Assist has published a new decision tool to help those supplying sports supplements determine whether they have a therapeutic good.   See ‘Is my sports supplement a therapeutic good?

 

Failing Food Reports – August 2020

These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the month of August Among the usual pathogens detected in these imported foods are such organisms as

Salmonella (found in United Arab Emirates tahini), Listeria monocytogenes (found in Chinese crayfish), and assorted toxins such as histamine (found in Sri Lankan dried balaya tuna), and the illegal addition of vitamins to many foods.      Source: Food fails August 2020

FSANZ Notifications

Proposal P1051 – Code Revision (2020) – minor amendments to the Food Standards Code. Source: Proposal P1051

Application A1155 – 2'-FL and LNnT in infant formula and other products – Approved. FSANZ re-affirm the approval of the voluntary addition of 2′-O-fucosyllactose (2′-FL) alone or in combination with Lacto-N-neotetraose (LNnT), produced by microbial fermentation, in infant formula products and formulated supplementary foods for young children.    Source: Application A1155

FSANZ Calls for Submissions on Food Derived from Herbicide-Tolerant and Insect-Protected Corn Line DP23211

Submissions are due by 6pm 12 November 2020 in relation to Application A1202 to permit the sale and use of food derived from genetically modified (GM) corn line DP23211, which has tolerance to the herbicide glufosinate and is protected against corn rootworm insect pests.    Source: Application A1202

Ingredients added to the Inventory

The AICIS (previously NICNAS) is the regulator responsible for industrial chemicals and cosmetic ingredients.

Seven new industrial chemicals have been added to the Australian Inventory of Industrial Chemicals in accordance with section 83 of the Industrial Chemicals Act 2019 this month.    Source: Chemicals added

 

Accord's 'Hand Sanitiser Industry Benchmark for non-therapeutic products'

Accord has published a “Hand Sanitiser Industry Benchmark for non-therapeutic products” providing requirements for the quality of hand sanitiser ingredients, guidance on product performance (efficacy), safety, record keeping and quality assurance considerations, and guidance on packaging type, product claims and labelling.    Source: Industry benchmark

 

*** Learn more about AICIS and cosmetic regulatory changes***

We offer a 1 hour zoom training course on the new AICIS regulatory requirements for cosmetics and ingredient assessments. Contact us for more information by emailing This email address is being protected from spambots. You need JavaScript enabled to view it.

Permitted Indications - Reminder

The deadline for all listed medicines to transition to only including permitted indications for their products is 5 March 2021. Any products that are non-compliant after this period will be cancelled. It is a legal requirement for sponsors of listed medicines to hold evidence to support the indications for use. Ask us for advice if you are uncertain of your obligations.

 

NSW Government Program to Support Domestic Manufacturing of Personal Protective Equipment (PPE)

The program includes a $5 million grants scheme to establish a reliable, domestic supply of PPE products that have been critical in the response to COVID-19 including masks, gowns, disinfectant, handwash and soap or their components. The key objective is to enable the supply of PPE for industry, private health care, NGOs, government and the community more broadly. This will allow industry to restart in a COVID-safe manner without relying on disrupted and volatile international source markets. Applications closed 12 October. This is a limited program available during this financial year only or until the funds are allocated, whichever comes first.    SourcePPE Manufacturing Grants

 

Medical Device Reforms 

The TGA is undertaking a program of reform to continue to improve the safety, performance and quality of medical devices in Australia. The TGA has published the following consultations:  Consultation 1: Proposed Enhancements to Adverse Event Reporting for Medical Devices - one for industry and one for consumers. Consultation 2: Exploring options for the introduction of an Australian Unique Device Identification [UDI] System [UDI Consultation paper 2].    Source: Consultation Hub

The TGA is implementing changes to the inclusion process for Class I non-sterile, non-measuring medical devices. These changes will include enhancements to the application for inclusion in the Australian Register of Therapeutic Goods (ARTG) form; and modification of the process by which the TGA reviews applications for inclusion in the ARTG. The changes are designed to make it easier for sponsors to provide the information the TGA needs to assess Class I applications. It will also make it easier for the TGA to assess applications and reduce the need to ask sponsors for more information to inform the decision to include a device in the ARTG.    Source: TGA

 

Medical Device Post Market Compliance Dashboard

Post-market reviews are conducted by the TGA on device applications to check product compliance with legislative requirements. If you have a product included in the Australian Register of Therapeutic Goods (ARTG), it may be selected by the TGA for post-market review at any time. Previously, you would respond to a post-market review by email.  A new Post Market Review Compliance Dashboard has been developed by the TGA to replace this existing process. You can find the dashboard and a user’s guide at the TGA website.    Source: New Compliance Dashboard

 

Therapeutic Goods Administration COVID-19 proceedings

The TGA continues to be busy with the prosecution of people and companies that unlawfully use the Coronavirus pandemic in their product advertising or to market products. TTB International was fined $13,320 for alleged unlawful importation of surgical face masks    Source: Unlawful import Sydney Tools Pty Ltd was issued with two infringement notices totalling $26,640 for the alleged unlawful importation of medical face masks in relation to COVID-19 . A pharmacist was fined $2,664 and Simply Elements was fined $13,320 for alleged unlawful importation of medical face masks and Livingstone International was fined $13,320 for alleged unlawful importation of infrared thermometers Source: Unlawful import.

 

TGA Declares Certain Products Presented as Formulated Supplementary Sports Foods to be Medicines

The Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020) (‘the Sports Supplement Declared Goods Order’) has been released.    Source: Federal Register of Legislation

From 30 November sports supplements with therapeutic claims containing higher-risk ingredients must be included in the Australian Register of Therapeutic Goods (ARTG). Sports supplements with therapeutic claims that are presented as tablets, capsules or pills as long as they do not contain higher risk ingredients, have 3 years (by 30 November 2023) to comply with the requirements.    Source: TGA

 

TGA Conviction for Unlawful Advertising of Sports Supplements

As part of the TGA's investigation targeting image and performance enhancing drugs a former owner of a Canberra-based sports supplements company has been convicted on four charges, for advertising therapeutic goods (sports supplements) not included in the Australian Register of Therapeutic Goods (ARTG), and those goods were neither exempt nor excluded from the operation of the Act.    Source:Unlawful advertising of sports supplements

 

Therapeutic Goods Advertising Compliance Annual Report 2019-20 Published

During the 2019-20 reporting period, the TGA received 2,227 complaints. This is a 52% increase on 2018-19, which is attributable in part to the increase of non-compliant adverting in relation to COVID-19. The advertising of illegal therapeutic goods and the use of references to serious forms of diseases, conditions, ailments or defects (prohibited and restricted representations) without TGA authorisation were the most common breaches of the Act. The TGA issued 155 infringement notices for alleged advertising contraventions, totalling nearly $1.6 million.    Source: TGA

 

Database of TGA Listed Medicine Compliance Reviews

The TGA has published the results of the outcomes of 36 listed medicine compliance reviews.    Source: TGA

 

TGA Provides Latest Guidance on Advertising Requirements

This guidance is to help sponsors and manufacturers of medicines meet the Australian advertising requirements. This page provides guidance on submitting an application for approval to use a restricted representation and a checklist for label compliance.    Source: TGA Advertising Code

 

*** Do you need your advertisement checked? ***

Our team has decades of experience advising clients on complying with advertising requirements – for complementary medicines, foods and cosmetics. Contact us for more information about our advertising review services or for information on our training courses by calling +61 2 9660 8027 or emailing This email address is being protected from spambots. You need JavaScript enabled to view it.

 

TGA Valerian Safety Alert

Valeriana officinalis is permitted for use in listed medicines in Australia with no restrictions on dose, concentration, or type of preparation. Since 1983, the TGA has received 15 reports of liver injury in consumers taking products containing Valeriana officinalis. In ten of these cases, the products contained other ingredients that were considered likely to be responsible for the liver injury. However, in three cases, Valeriana officinalis was the only ingredient, and in two cases the other ingredients were considered to be unlikely to cause liver injury. Most cases of liver damage resolved after the use of Valeriana officinalis was discontinued. However, three cases had markers for severe liver injury, and two required hospitalisation. In response to these reports, the TGA has initiated a safety investigation.    Source: TGA Safety Alert

 

TGA Artemisia Species Safety Alert

The TGA is warning consumers and health professionals that listed medicines containing herbal ingredients from the Artemisia species should not be taken by women who are pregnant, think they may be pregnant, or intend to become pregnant. The TGA is currently further investigating this issue.    Source: TGA Safety Alert

 

Herbs containing safrole

The TGA is reviewing listed medicines that may contain safrole. Listed medicines must contain no more than 0.1% of safrole when it is for internal use, and no more than 1% when it is for topical application. The TGA has identified 12 ingredients approved for use in listed medicines, which may contain safrole as a constituent.    Source: Listed medicines at risk of containing safrole.

 

Botanical Adulterants Programme

The American Botanical Council continues it work on identifying adulteration of herbal ingredients supplied to manufacturers, this time focussing on milk thistle (Silybum marianum) fruit, with many extracts found to have negligible amounts of the important compound silymarin.    Source: Botanical Adulterants Monitor

 

Manufacturers of medicinal cannabis

Clarifications of the type of licensing required for manufacturers has been released along with technical guidance on the interpretation of the PIC/S Guide to GMP in relation to cannabis.    Source: https://www.tga.gov.au/publication/medicinal-cannabis-manufacture

 

Proposal to change the way nicotine is regulated

This is to address concerns that simple and legal access to nicotine containing e-cigarettes for smoking cessation (an “OFF RAMP” for smokers) should be permitted but there is concern about the rapid growth of youth uptake (“an “ON RAMP” for non-smokers).    Source: TGA webinar

 

 

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