Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
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
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
RFA Looks Forward to Naturally Good Trade Expo 2018 in Sydney
Far more than just a tradeshow, Naturally Good Expo is a total business event (‘trade-only’) that’s 100% devoted to all things healthy, organic and natural. As the largest event for healthy retailers, brands and practitioners in the Southern Hemisphere, it’s the place where serious buyers meet with suppliers for two days of business, networking, education and to celebrate the latest exciting opportunities within the health and wellness retail market. To be held in the Sydney Convention Centre, Darling Harbour on April 29th and 30th, RFA Regulatory Affairs will have our own booth C 43 and we hope to see you there.
Pharmacovigilance Obligations Training
In September 2017, the TGA released guidance on the pharmacovigilance responsibilities of sponsors. TGA guidance. Newly developed, this training course is for sponsors and their nominated pharmacovigilance staff with complementary medicines (AUST L) included on the Australian Register of Therapeutic Goods. We cover TGA pharmacovigilance obligations and mandatory reporting requirements, the what, how and when you MUST report. All required documents including SOPs and reporting templates will be provided for your future use.
This one hour training course is available via Skype or in person in our office in Glebe, Sydney. You will receive full course notes, document templates, SOPs and a certificate of attendance. This is all included in the price.
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
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).
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
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 note: Please 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 Recalls – Source: 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
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
Complementary Medicines (“Dietary supplements”):
Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 Summary of Changes
As reported in February 2018 Newsletter, The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 was passed by both houses of Parliament on 15th February 2018. These are the most significant changes to the legislation affecting complementary medicines in Australia since the Therapeutic Goods Act was introduced in 1989. The Bill establishes a new ‘intermediate’ pathway for complementary medicines, sitting between Aust-Listed and Aust-Registered. As well as this new registration pathway, there are changes to the permitted indications (see following story); improved access to new ingredients (there has been a fivefold growth in TGA approved new ingredients in the last few years!); market exclusivity for new ingredients & better IP Protection; closer alignment with overseas regulators; reforms to advertising; and, axing of the Complaints Resolution Panel. Please feel free to contact RFA Regulatory Affiars for more detailed information. Source: Legislation passed (Editor’s note: Key dates to note—8 March 2018 - Permitted indications introduced; market exclusivity for new ingredients introduced. 30 June 2019 - Indications change fee $1,000 waiver expires. 5 March 2021 - transition period to relist ALL products with permitted indications. 6 March 2021 - listed medicines not transitioned will be cancelled.)
TGA Details “Assessed Listed Medicines” Pathway
The Therapeutic Goods Administration has implemented a new ‘assessed listed medicines’ pathway for sponsors to enter their products in the Australia Register of Therapeutic Goods (ARTG). Medicines listed through the assessed listed medicines pathway will be included in the ARTG following self-certification of the safety and quality of the product, and TGA pre-market assessment of efficacy evidence supporting the proposed indications. An interactive decision tree has been developed to assist sponsors in determining which pathway is most suitable for their product. Source: Assessed listed medicines (See also: Pathways for Complementary Medicine Products. This tool will assist potential sponsors of complementary medicines to determine the most suitable pathway to enter their product in the ARTG. CM pathways tool)
Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018 Gets Tabled
The Permissible Ingredient Determination No. 1 of 2018 has been registered on the Federal Register of Legislation. The determination provides for a number of changes and additions of ingredients, their names, content limits and required warning statements. The TGA will be providing industry with a minimum 18 months transition period. Sources: Permissible ingredient legislation; &, LM Guidance doc
'Indications' are statements that describe the specific therapeutic use for a medicine. They describe a medicine's claimed purpose or health benefit. Indications available for use for listed medicines are now contained in a 'list of permitted indications'. The new permitted indications requirements apply to all complementary medicines and sunscreens. However, medicines that are listed for ‘export only’ and medicine kits are not affected by this change. The four main changes in the new legislation are: There is no 'free-text field'; sponsors who apply to list a new medicine will be required to select the indications for their medicine from the list of permitted indications; there is a 3 year transition period for sponsors of existing listed medicines to re-list their products using permitted indications; and, sponsors can apply to have new indications considered for inclusion in the Permissible Indication Determination. The permitted indications reform came into effect on 6th March 2018. Sources: Permitted indications reform & Legislation
Health Canada Issues Warning About Products Containing Yohimbe
Health Canada had extended a warning on dietary supplement products being sold in Canada with Natural Products Numbers and containing illegal ingredients such as yohimbine and sildenafil analogues. Source: Hank Schulz, Nutraingredients-USA Yohimbe warning. Editor’s note: In Australia, the TGA has ruled Yohimbe (an evergreen tree, the bark of which contains yohimbine) is a prescription only substance. Consumers are also advised that yohimbine is a substance included in the Customs (Prohibited Imports) Regulations 1956.
TGA Safety Advisories—
Lida (Plus) capsules: the capsules contain the undeclared substances sibutramine and phenolphthalein. Source: Lida-plus capsules
Slim Trim Gold capsules: the capsules contain the undeclared substances sibutramine and phenolphthalein. Source: Slim trim gold
Nutra Organics Green Tea Extract capsules: the capsules contain the undeclared substance sibutramine. Consumers are advised that sibutramine is a prescription-only medicine (which was the active ingredient in Reductil). It was withdrawn in October 2010 after a study showed an increased risk of major cardiac events. Source: Green tea caps
Arthrem capsules: Arthrem capsules contain the herbal ingredient Artemisia annua extract as the only active ingredient. The New Zealand therapeutic goods regulator, MedSafe, has received 14 reports of liver toxicity associated with the use of Arthrem. Source: Arthrem
Ja Dera Max+ capsules: The capsules contain the undeclared substance lignocaine, also known as lidocaine. Lignocaine is a prescription-only medicine and is widely used as an anaesthetic and antiarrhythmic drug. Source: Ja Dera Max