Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Reforms to the Regulatory Framework for Complementary Medicines

In February 2017 the TGA announced a public consultation, ‘Consultation: Reforms to the regulatory framework for complementary medicines: Assessment pathways’. A total of 60 submissions were received. All submissions that gave permission to be published on the TGA website are now available in PDF format.    Source: TGA reforms

Broad Support for New ‘Third Way’ Supplements (Complementary Medicine) Health Claims in Australia: TGA

Australian regulator the Therapeutic Goods Administration (TGA) says there is broad support for plans to introduce a ‘third level’ of health claims for supplements (complementary medicines).    Source: Gary Scattergood+, NutraIngredients TGA 3rd way

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 July 2017. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 3 of 2017. A total of 67 changes have been made in the updated Determination. These changes include the addition of 4 new ingredients; Changes to 55 existing ingredient entries; and, the removal of 8 ingredients that have been determined not to be suitable for inclusion in listed medicines. A complete list of changes to ingredient availability is available here: Permissible ingredients

TGA Announces Electronic Signatures to Replace 'Wet Ink' Signatures

All Licences and Certificates of GMP Compliance issued by the TGA will be signed "electronically" and no longer contain a wet ink signature. This initiative will position industry for a future move to online self-service.    Source: e-Signatures

TGA Safety Advisories –

V8 tablets; & Sirrori Green Viagra Tablets: the tablets contain the undeclared substance sildenafil    Source: V8 tabs ; Sirrori tabs

Jing Pin Heijin Gang Tablets: the tablets contain the undeclared substances sildenafil and paracetamol    Source: Jing tabs

RUFF Natural Formula capsules: the tablets contain the undeclared substances tadalafil, sildenafil and dapoxetine    Source: Ruff tabs

NSW Food Authority Name and Shame Serves Up Nine Years of Food Safety

The NSW Food Authority’s 'Name and Shame' register reaches another important milestone this month, chalking up nine years of operation and more than 11 million views of its webpage. Minister Primary Industries, Niall Blair said more than 7,000 food retail businesses have appeared on the register since its establishment in July 2008. "It’s the list consumers can’t get enough of, but the one no business wants to be on," Mr Blair said. "I am pleased to say the vast majority of food businesses in NSW do the right thing – however those which don’t face the significant sanction of featuring on the well-read register. At its peak in 2009/10, 3.4 per cent of food businesses were placed on the register however that figure has fallen to just 1.6 per cent in the past financial year.    Sources: Name & Shame ; Penalty notices

Egg Producer Penalised $750,000 for Misleading 'Free Range' Claims

The Federal Court has ordered Snowdale Holdings Pty Ltd (Snowdale) to pay penalties totalling  $750,000 for making false or misleading representations that its eggs were ‘free range’, in proceedings brought by the Australian Competition and Consumer Commission. “This is the highest penalty that a Court has ordered in relation to misleading ‘free range’ egg claims. It reflects the seriousness of Snowdale’s conduct and the importance of egg producers being truthful about marketing claims they make,” ACCC Commissioner Mick Keogh said. “Consumers pay a higher price for free range eggs, so when a ‘free range’ claim is made, it’s important that consumers are purchasing eggs laid by chickens in free range conditions.”    SourceBad eggs        Further reading: This case forms part of the ACCC’s broader work in the area of free range claims made by egg producers, which include: $300k penalty for "free range eggs" 1 ; $300k penalty for "free range eggs" 2 ;  $250k penalty for "free range eggs"    (In April 2017, Commonwealth, State and Territory Consumer Affairs Ministers introduced a national information standard under the Australian Consumer Law. The standard requires eggs labelled as ‘free range’ to have been laid by hens with meaningful and regular access to the outdoors and with a maximum outdoor stocking density of 10,000 hens).

Sydney Chicken Processor Falls Foul of Food Safety Laws

A Sydney chicken producer was convicted and fined a total of $34,000 and ordered to pay more than $6,000 in professional costs after he pleaded guilty to twelve charges relating to failures in hygiene, maintenance and Food Safety Program monitoring in the Downing Centre Local Court.    Source: Poultry fine

'Nano Scare': Scientists Blast Friends of the Earth for 'Facile' Infant Formula Claims

Reports that some infant formula products on sale in Australia and New Zealand contain potentially 'dangerous' nanoscale particles have been dismissed by regulators and scientists — with one branding it blatant 'scaremongering'.    Source: Gary Scattergood+ NutraIngredients FoE fail ; FoE Claim

A National Approach to Better Combat Biosecurity Threats

The National Biosecurity Committee (NBC) has endorsed new national biosecurity Research, Development and Extension (RD&E) priorities, giving a more unified, strategic and nationally-consistent focus to biosecurity research. Head of biosecurity policy at the Department of Agriculture and Water Resources, Matthew Koval, said the new priorities would support improved national biosecurity outcomes.    Source: Bio-security

Editor’s note: For information about what can and can’t be sent to Australia go to Travelling or sending goods to Australia.

Further Setback to New Zealand's Natural Health Products Bill as Parliamentary Time Dwindles

New Zealand's long-awaited Natural Health Products Bill is unlikely to be put before parliament before September's election, according to the Ministry of Health.    Source: Gary Scattergood+, NutraIngredients NZ NHP Bill

FSANZ Notices –

Application A1123 – Isomalto-oligosaccharide as a Novel Food: The purpose of the Application is to permit isomalto-oligosaccharide as a novel food for use as an alternative (lower calorie) sweetener and bulk filler in a range of general purpose and special purpose foods    SourceNovel food

A1131 – Aqualysin 1 (Protease) as a Processing Aid (Enzyme): The purpose of the Application is to permit the use of aqualysin 1 sourced from Bacillus subtilis containing the aqualysin 1 gene from Thermus aquaticus for use as a processing aid in the manufacture of bakery products.    Source: Aqualysin 1

Probiotics in China — ‘The market is set to explode’

The probiotics sector is forecast to soar by 23% in China to 2020 and even greater long-term growth beckons if the industry unites to better educate consumers and regulators.    Source: By Gary Scattergood+, NutraIngredients China probiotics

Influencing the Influencer

It’s important to note that when you align with an influencer, not only do they bring their audience, they also bring their audience’s network. Because of the loyalty of their audience, an influencer could drive traffic to your website, increase your social media exposure, and help sell your product or service through their recommendation or story about their experience. With the drop in traditional outbound promotion, influencer marketing is becoming one of the most effective ways to attract customers and clients. Twenty-first century consumers can be blind to outdoor advertising, even those new electronic boards, and unresponsive to television and radio commercials and print ads. A great majority of people want to research a brand on their own and learn about it from a family member or friend. Simply put, someone they trust. Consumers trust recommendations from a third-party more often than a brand itself.    Source: Sheldon Baker, The Garner Group Influence

 

Quote for the month –

“The key to successful leadership today is influence, not authority”    Kenneth Blanchard

Dishwasher Tablets: Campaign to Eradicate Products that aren't Squeaky Clean

In a move to protect Australia's waterways and wildlife from algal blooms, the environment pressure group DoSomething today launches a campaign to ban phosphates in automatic dishwasher detergents. All manufacturers have removed the chemical from tablets and powders sold in the US and Europe. However, many products have yet to clean up their act by introducing the phosphate-free formula in Australia.    Source: Tim Barlass, SMH Phosphate free

ACCC Statement on Aldi Flushable Wipes

The Australian Competition & Consumer Commission has raised concerns with ALDI regarding its promotion of ALDI Green Action Flushable Bathroom Cleaning Wipes (100pk) in its Special Buys catalogue. The ACCC’s concerns stem from the use of the term ‘flushable’, in particular the concern that such a claim may mislead consumers if the claim cannot be substantiated. The ACCC is already pursuing alleged misleading ‘flushable’ claims more generally, with two proceedings currently before the Federal Court against Pental and Kimberly-Clark Australia Pty Ltd. Part of the ACCC allegations around those two proceedings are the products do not, for example, disintegrate like toilet paper when flushed. The ACCC says Australian water authorities face significant problems when non-suitable products are flushed down the toilet as they contribute to blockages in household and municipal sewerage systems.    Sources: Un-flushable wipes ; Un-flushable wipes 2

TGA Results Confirm Effectiveness After Sunscreen Testing

In response to reported concerns during the past Australian summer that sunscreens were failing to provide adequate sun protection, the TGA undertook laboratory testing of 31 commonly used products, including lotions, creams and aerosol sprays, sourced from pharmacies and supermarkets. Between 1 January and 31 December 2016 the TGA received a total of 27 reports of adverse reactions to sunscreens. Of these 15 were reports of allergic reactions (rash) and 12 reports of a product not being effective. It was found that all products tested contained the correct levels of ingredients, as specified on their labelling, and complied with the Australian regulatory guidelines for sunscreens for content of sun protection ingredients (90-120% of the labelled claim).    Source: Sunscreen testing

TGA Changes Policy on Vitamin A – Betacarotene Naming

For many years, it has been generally understood that early TGA advice indicated that suppliers could not refer to betacarotene as provitamin A or state the equivalent IU of Vit A. However, the TGA seems to have changed this policy, and now betacarotene may be stated in retinol equivalents. Furthermore, the NHMRC Nutrient Reference Values for Australia and New Zealand note that the term vitamin A includes provitamin A carotenoids that are dietary precursors of retinol and retains 6 µg all-trans ß-carotene as being equivalent to 1 RE (retinol equivalents). When Vitamin A is declared as an equivalent of Betacarotene and the medicine is for oral or sublingual use in adults the medicine also requires specific warning statements on the medicine label.    Refer: Vitamin A

TGA Form Update - Notification of a New Proprietary Ingredient

The role of the 'Notification of a new proprietary ingredient' form is to allow the TGA to enter formulation details and other relevant information relating to a proprietary ingredient into the Proprietary Ingredient Table in TGA Business Services. This allows for the capture of complex formulation details and other relevant information, and the provision of a unique name and number for each proprietary ingredient. Applications for new therapeutic goods that are to be included on the Australian Register of Therapeutic Goods (ARTG) can then include these complex formulations in a single step using the allocated proprietary ingredient number (rather than the full formulation details of the proprietary ingredient).    Source: New ingredient

TGA Targets Macular Degeneration Claims

Macular degeneration is a restricted representation and not permitted in listed medicines. The TGA will examine the unauthorised reference of macular degeneration in listed medicines. If a supplier’s medicine is included in the targeted project, the TGA will write to you in July 2017 and request information such as your product label and the evidence you hold to support claims and indications. Be Prepared!   Source: Macular degeneration

TGA Q&A on the Code of Good Manufacturing Practice for Medicinal Products

Everything that you wanted to know about how and why the TGA regulates Good Manufacturing practice in Australia.    Source: GMP Q&A

Regulatory Battle: New Zealand Manufacturers Hit Out at Health Bill ‘Detractors’

Five major New Zealand manufacturers – backed by trade body Natural Products New Zealand (NPNZ) – have hit out at a "small group of detractors” which they claim is creating "misinformation" about the country's proposed Natural Health Products Bill.    Source: Gary Scattergood+, Nutraingredients-Asia NZ Health Bill

TGA Safety Advisories:   SourceAlerts

Dragon Power (Yong Gang Tablets) - the tablets contain the undeclared substance sildenafil.

Slimming Capsule - Reduce Fat - the capsules contain the undeclared substances sibutramine and phenolphthalein.

7-Days Herbal Slim-Extra capsules - the capsules contain the undeclared substance sibutramine.

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