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This news is posted on our website on a regular basis. Visit us often to keep informed. www.robert-forbes.com

Complementary Medicines (“Dietary supplements”):

Very Important Information for All Sponsors of Listed Complementary Medicines

Details of all products listed on the Australian Register of Therapeutic Goods (ARTG) must now be changed to ensure that:

  • Previously permitted ‘free text’ indications are removed.
  • All indications must be selected from the revised list of permitted indications https://www.legislation.gov.au/Details/F2018L00215
  • These changes are mandatory. Updates to change indications will not incur a TGA fee until 6th September 2019. Each product not revised before 6th September 2019 will incur a TGA fee for the change.
  • The transition period to relist ALL products with permitted indications expires on 6th March 2021. Listed medicines not transitioned by 6th March 2021 will be cancelled!

Updated Therapeutic Goods Act is Now Law

As detailed in the last two recent editions of this newsletter, the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 was passed by both houses of Parliament on 15th February 2018. The compilation of the Therapeutic Goods Act 1989 (‘the Act’), which now incorporates the amendments from the Therapeutic Goods Amendment Bill No. 1 of 2017 legally effective from 6 March 2018, has now been uploaded onto the Federal Register of Legislation (FRL). The new Act incorporates significant amendments to the regulatory framework for complementary medicines, including introduction of the permitted indications, relevant changes to sponsor certifications under the Act, the introduction of the new pathway for complementary medicines, and a new advertising framework.    Source: TGAact 1989

TGA Announces Updates to the Permissible Ingredients Determination For Listed Medicines

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in March 2018. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018. A total of 64 changes have been made in the updated Determination. These changes include: The addition of 4 new ingredients; changes to 56 existing ingredient entries (including, making requirements for ingredients less restrictive, such as broadening the use to allow oral use when previously only for topical use; making requirements for ingredients more restrictive, such as the inclusion of additional warning messages; and making minor changes to make a number of entries clearer); and, the removal of 4 ingredients that have been determined not to be suitable for inclusion in listed medicines or were synonymous with other existing ingredients to avoid duplication. A complete list of changes to ingredient availability can be read here: Permissible ingredients update  

TGA Releases Assessed Listed Medicines Evidence Guidelines

The assessed listed medicines pathway provides sponsors with a new method of listing a product in the Australian Register of Therapeutic Goods (ARTG). The new pathway sits between the current listed (lower risk) and the registered (higher risk) pathways. It enables sponsors to list products with higher level indications than permitted in standard listed medicines without having to meet the extensive requirements for full registration. This is provided that assessed listed medicines have robust scientific evidence to support the efficacy of the product, and this evidence is pre-market assessed by the TGA. This guidance applies to 'assessed listed medicines' that are eligible for evaluation by the TGA's Complementary and Over-the-counter Medicines Branch (COMB).     Sources: ALM guidelines & ALM pathway

(Editor’s note: These are the most significant changes to complementary medicine legislation in a generation. If you think that your product may be better marketed as an ‘assessed listed medicine’ then please feel free to contact RFA Regulatory Affairs for more detailed and confidential advice).

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Country of Origin Labelling for Complementary Healthcare Products - A Guide For Business

The Australian Competition & Consumer Commission has prepared this guide to assist the complementary healthcare industry to understand how the safe harbour defences set out in section 255 of the Australian Consumer Law apply to their products. It is intended to supplement the information in the ACCC’s Country of origin claims and the Australian Consumer Law publication. (Please note this document does not constitute legal advice. The ACCC always recommends that businesses seek independent advice when deciding which origin claims to make about their products). This guide will assist businesses to understand the application of the Australian Consumer Law (ACL) in relation to country of origin claims and in particular, when businesses can safely make a ‘made in’ claim about their products. In contrast to origin labelling requirements for food products, neither the ACL or the Therapeutic Goods Act 1989 require complementary medicine products to carry country of origin labelling. However, if companies choose to make such claims they must be aware of the laws against false, misleading or deceptive claims.   Sources: CoOL CMeds.pdf & CoOL ACL (Editor’s note: Please see related story under 'Foods', in this newsletter)

TGA Safety Advisories—

LIPRO Dietary capsules – the capsules contain the undeclared substances sibutramine and diphenhydramine   Source: LIPRO caps

Gold Viagra 9800mg capsules - the capsules contain the undeclared substance sildenafil.   Source: Gold viagra caps

ViaGro 500mg Male Enhancement capsules - the capsules contain the undeclared substances theophylline and caffeine.   Source: ViaGro 500 caps

Black Ant King tablets - The Therapeutic Goods Administration has tested a product labelled Black Ant King tablets and found that the tablets contain the undeclared prescription only substances sildenafil and chloramphenicol.   Source: Black ant tabs

Vegetal Vigra capsules - the capsules contain sildenafil.   Source: Vegetal vigra caps

Stree Overlord Strong tablets - the tablets also contain sildenafil.   Source: Stree tabs

 

Foods:

ACCC Specifies Country of Origin Labelling Laws

The Australian Competition & Consumer Commission (ACCC) has stressed that under Australian Consumer Law (ACL), certain food products offered or suitable for retail sale will be required to display country of origin information. The ACL doesn’t require non-food products to carry country of origin labelling, although other laws may do so. All businesses, whether they are legally required or choose to display country of origin labelling, are prohibited from making false or misleading representations or engaging in misleading or deceptive conduct about the origin of goods (both food and non-food). It’s up to individual businesses to work out what type of origin claim they can make about their products. From 1 July 2018, businesses must label their products according to the requirements of the Food Standards Code.   Sources: CoOL claims & CoOL foods (Editor’s notePlease see related story under "Complementary Medicines", in this newsletter)

Australian Department of Industry to Apply Country of Origin Requirements to NZ Products

The Department of Industry says that it intends that the new Australian Country of Origin requirements will apply to products from New Zealand, despite a free trade arrangement existing between the two countries. This article, by FoodLegal, examines the extraneous nature of the points made by the Department of Industry and the ineffectual aspects on New Zealand imports. FoodLegal maintains the view that New Zealand remains an advantageous jurisdiction to make and sell products destined for the Australian market without bearing the same regulatory burden as Australian products face under the new Country of Origin regime applicable to Australian packaged foods.   Source: Joe Lederman, Food Legal CoOL NZ

Agriculture Department Gets Tough on Foods Arriving Without a Permit

The Department of Agricultur & Water Resources has alerted importers of conditionally non-prohibited goods that require an import permit and agents acting on importers’ behalf, of recent changes. From 9 April 2018, the department will no longer facilitate the clearance of conditionally non-prohibited goods that arrive without the required import permit. Goods that require a permit, but arrive without one, including where an application is currently under consideration, will be directed for export from Australian territory or required to be destroyed in an approved manner.   Source: Food permits

NSW Food Authority RecallsSource: Current recalls

Washed Rind Cheeses - Washed Rind Pty Ltd has recalled a variety of cheeses made in France due to potential Listeria monocytogenes contamination.

Inghams Sweet Chilli Chicken Breast Tender - Ingham’s has recalled Ingham's Sweet Chilli Chicken Breast Tenders as the product may contain pieces of hard plastic.

Creative Gourmet Pomegranate - Entyce Food Ingredients is conducting a precautionary recall of its Creative Gourmet Pomegranate Arils 180g, due to potential Hepatitis A contamination. (Editor's note: Check your freezer!)

New Zealand in Focus: Exports, Regulations and Innovation Take Centre Stage at NHPNZ Summit

RFA Regulatory Affairs was delighted to participate in the recent Natural Health Products New Zealand, Annual Summit, held in Nelson. We not only met with friends old and new but also learnt so much about NZ’s booming exports, the sector's commitment to innovation, and ongoing frustration over a lack of domestic regulatory advances.     (An excellent summary of the NHPNZ Summit can be read here via this Special Edition - Nutraingredients Asia NHPNZ Summit )

Busy Summer for Frontline Biosecurity Officers in New Zealand

New Zealand's border biosecurity defenders have just been through their busiest summer on record, says the Ministry for Primary Industries (MPI). MPI biosecurity officers screened some 2 million passenger arrivals for risk goods between December 2017 and February 2018, a 5% increase on last summer.   Source: NZ bio-security

FSANZ Notifications—

Proposal P1044 – Plain English Allergen Labelling: The aim of this proposal is to make allergen labelling requirements clearer, which will help food allergen-sensitive consumers and food businesses. The Food Standards Code already contains a mandatory requirement to label 10 allergens; however it does not include requirements for the terminology that should be used. Submissions on this proposal have been extended to 6pm (Canberra time) 10 May 2018.   Source: Plain English allergens

Proposal P1047– Review of regulatory nutrient reference values: ​The purpose of the Proposal is to review and update the regulatory nutrient reference values in the Australia New Zealand Food Standards Code in light of the 2006 and 2017 Australia/New Zealand nutrient reference values.   Source: Nutrient reference values

Call for submissions on new processing aid: Food Standards Australia New Zealand (FSANZ) has called for submissions on an application to allow the use of thermolysin as a processing aid. The enzyme would be used in the manufacture or processing of foods including dairy, egg, meat, fish, yeast, protein products and flavourings. The closing date for submissions is 6pm (Canberra time) 24 May 2018.   Source: Thermolysin enzyme

Call for requests: 2018 Maximum Residue Limits (MRLs) harmonisation requests [Australia only]: FSANZ considers changes to maximum residue limits in the Code to harmonise with MRLs established by Codex Alimentarius Commission or by a regulatory authority in a recognised jurisdiction where the food commodity is produced. These changes are considered through an MRL harmonisation proposal and FSANZ usually undertakes one harmonisation proposal a year. The call for MRL harmonisation requests is now open for 2018 for all stakeholders and interested persons. Requests must be lodged with FSANZ by 6pm (Canberra time) Wednesday 6 June 2018.   Source: MRL harmonisation

NZ Vineyard Workers Pay the Price for Labelling Banned Pork Sausages as Squid

Two Thai vineyard workers have both been fined NZ$1,900 and ordered to pay court costs of NZ$130 each after bringing in high-risk pork sausages to New Zealand from Asia. The pair's offending came to light after they arrived in New Zealand on separate flights directly from Singapore one day apart from each other in October last year. The court heard that when biosecurity staff checked both women's luggage, they discovered a sealed package labelled 'dried squid' but which actually contained pork sausages as well as dried squid. The women denied knowledge of the hidden sausages and both blamed their mothers for putting the product into the same packet as the dried squid. Pork is prohibited from entry into New Zealand and is considered especially risky due to the prevalence of foot-and-mouth disease in Thailand.   Source: Prohibited pork

 

Cosmetics (& Household cleaning products):

False Flush: Company Behind White King 'Flushable Wipes' Fined $700k

Pental Limited and Pental Products Pty Ltd is the manufacturer behind White King's "flushable" toilet and bathroom cleaning wipes. It's been ordered to pay penalties totalling $700,000 for making false and misleading representations about its product; namely, that it would disintegrate in the sewage system "just like toilet paper". Packaging and promotional materials for the White King wipes included statements like “flushable”, “Simply wipe over the hard surface of the toilet … and just flush away”, and “White King Toilet Wipes are made from a specially designed material, which will disintegrate in the sewage system when flushed, just like toilet paper”. Those statements, the Federal Court ruled, are false.     Source: Jenny Noyes, SMH False flushable wipes

 

Marketing News:

Nature's Care Sale: Chinese Private Equity Firms Take Majority Stake In Aussie Supplement Brand

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

Three Myths to Bust About Supplements — Blackmores Institute

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

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