Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

When are ‘Naturals’ not Natural? When you’re in Aldi

Products marketed by supermarket giant Aldi using the term "naturals" don’t need to be made of mostly natural ingredients if the word is less prominent on the packaging and sold in a discount bin, the Federal Court has ruled. Aldi’s popular Protane Moroccan Argan Oil hair treatments promise a "naturals" formula on the bottle, referring to the ingredient "argan oil" found in the product, even though many of the ingredients are not natural. But because the writing is small, below the name of the product, and because it’s often found in a discount bin in a discount supermarket, the court found that ordinary consumers would understand the "Naturals" label refers only to the presence of the ingredient "argan oil" and not whether the product is composed of mostly natural elements.   Source: David Estcourt, SMH Aldi naturally

Sigma Hit by Competitor’s Blow

In a body blow to the pharmaceutical wholesaler, Sigma is set to lose its biggest retail customers in June next year. Sigma has been unable to reach agreement on a new supply contract for the 400 stores in the Chemist Warehouse retail chains, which command around a 23 percent share of the total retail pharmacy market. The Chemist Warehouse Group, which includes My Chemist Group, My Beauty Sport and ePharmacy, an online pharmacy, has opted instead for a five-year supply contract with Ebos Group. Ebos, which is listed on both the Australian and New Zealand stock exchanges and is currently the supplier for the Terry White Chemmart pharmacy chain, estimates the new contract will generate around $1 billion in wholesale sales in its first year.   Source: Inside FMCG Sigma dumped

 

Quote for the month:

“Competition is the keen cutting edge of business. Always shaving away at costs”   Henry Ford

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New Product Development

RFA Regulatory Affairs can now guide you from initial concept to successful product launch. We provide technical advice, product development expertise, and regulatory experience to assist you in the launch of your listed complementary medicine or food product. We work closely with your team, ingredient suppliers and contract manufacturer to ensure that your ideas successfully transition from conception to commercial reality.

What we can do for you:

New Concept Identification  

  • Fresh concept ideas
  • Identify ingredients and suppliers
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  • Assistance in defining your concept for efficient product development

Product Design  

  • Development of evidence-based formulations by degree qualified nutritionists and herbalists
  • Recommended permitted indications (therapeutic claims) and marketing claims
  • Raw material evaluation
  • Claim substantiation packages
  • Full regulatory evaluation for suitability
  • Assessment of product viability (dosage forms, costs, batch size)

Project Management  

  • Guidance on product development timeline
  • Direct & manage stakeholders
  • Identification of suitable contract manufacturers
  • Management of tender process
  • Manage pilot trials

Regulatory Support

  • TGA listing applications
  • Product label preparation or review
  • Coordinate and review QC / GMP documentation
  •  Review advertising

If you’ve got an idea, for either a complementary medicine or food product that you want to explore, then we can help you. Talk to us today:

T: +61 2 9660 8027

E: This email address is being protected from spambots. You need JavaScript enabled to view it.

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 Art & Music Can Build Healthy Communities

Fundraising event, ART OF MUSIC, is held every two years. A group of Australia's top musicians and visual artists come together to create an original exhibition where each artist chooses an iconic Australian/NZ song to inspire a piece of artwork.  The artwork is then auctioned during a gala dinner in the spectacular Grand Court of the Art Gallery of NSW. All proceeds go to Nordoff-Robbins Music Therapy, an inspirational charity that uses the power of music to transform lives.  Music is used in live and interactive sessions to help people cope with the struggle of living with a wide range of needs.  These include children and adults with physical and intellectual disability, autism, trauma, illness, dementia, behaviour disorders and learning difficulties.  For more information visit noro.org.au.

RFA Regulatory Affairs is proud to be a Gold sponsor of Nordoff Robbins Music Therapy

 

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018 – Update

The Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018 was registered on the Federal Register of Legislation (FRL) on 15 June 2018. Changes include - Addition of 9 new excipient ingredients with associated requirements relating to their use; Changes to 75 existing ingredient entries; and, Removal of 4 ingredients. The TGA has included an 18-month transition period for most changes to the Permissible Ingredients Determination. Consequently, the new Determination includes transitional arrangements for existing medicines that are currently listed in the Register to comply with some new requirements for ingredients. The transitional provisions do not apply to new products that are entered into the Register. The transition period ends on 1 January 2020.   Source: Permissible ingredients 2018

Australian Government Specifies Cannabis Import / Export Controls

The Office of Drug Control (Dept. of Health) has detailed the conditions that some cannabis products may be imported and exported from and to Australia. Export is permissible for ‘medicinal cannabis products manufactured in Australia under a GMP licence’; for ‘medicinal cannabis products listed as export-only, or registered, on the Australian Register of Therapeutic Goods (ARTG)’; & for ‘extracts of cannabis (or extracts of cannabis resin) manufactured under a Narcotic Drugs Act 1967 licence and permit that are not in the final dosage form’. For Imports, ‘approval must be granted by the national governments of both the importing and exporting countries before shipment can occur. Food grade/nutritional products derived from hemp may not meet Australian manufacturing requirements’.   Source: Medicinal cannabis

Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)

This guidance for advertisers applies to the current Therapeutic Goods Advertising Code 2015. The guidance for the proposed Therapeutic Goods Advertising Code 2018 is still under development and will be consulted on from mid-June 2018.   Source:  Advertising medicines

TGA Fees and Charges From 1 July 2018 Summary

For a complete summary of the latest fees and charges for non-prescription medicines, listed medicines (including for export only), registered complementary medicines and the newly established ‘assessed listed complementary medicines’, please visit this site.   Source: Non-prescription medicines      Manufacturing inspections and GMP clearance fees can be read here: Manufacturing fees

TGA Safety Advisories—   Source: https://www.tga.gov.au/current-year-alerts

Solve Botanical Slimming capsules: contains furosemide (frusemide), phenolphthalein and paracetamol.

Meltz – Instant Energy For Males tablets: contains the undeclared substance vardenafil.

Bulbao Male Enhancer tablets: contains the undeclared substances sildenafil, tadalafil and yohimbine.

Platinum - Male Enhancer capsules: contains the undeclared substances sildenafil, sulfosildenafil and sulfoaildenafil.

Camellia sinensis (green tea) extract   (potential risk of harm to the liver!)

Consumers and health professionals are advised that rare cases of harm to the liver have been associated with products that contain Camellia sinensis (green tea) extracts. Medicines containing C. sinensis extracts have been associated with a number of cases of liver toxicity world-wide, although the incidence appears to be rare and unpredictable. The majority of C. sinensis use (including green tea in beverage form) is unlikely to cause harm, therefore the TGA considers that a recall of C. sinensis products is not warranted. The underlying reasons why liver injury has occurred are not well understood at this stage. Twenty adverse events have been reported to the TGA associated with both C. sinensis-containing products and liver injury. All but one of these events involved products containing concentrated extracts of the ingredient. Most cases (17) involved multiple suspected products and/or multi-ingredient products. In three cases, the sole suspected product contained C. sinensis as the only active ingredient.   Source: Green tea risk

TGA Outlines the Future Regulation of Low Risk Products

The Government required the Therapeutic Goods Administration (TGA) to examine whether the regulatory oversight applied to a range of products that represent a very low safety risk to consumers was consistent with the principles of best practice regulation, and further whether there were any opportunities for streamlining or simplifying current regulatory requirements for these products. The status quo will prevail for ‘Water soluble vitamins and minerals, as well as for sunscreens’. Products which are changing include: Tampons and menstrual cups (exempt goods); Nappy rash creams / treatments (exempt goods) (only if they are currently listed or Class 1 devices, but not if they are currently registered); Hard surface disinfectants - exempt goods (if currently listed as hospital grade without specific claims), but registered hard surface disinfectants with specific claims will be moved from the registered to listed other therapeutics goods (OTG); Antiperspirants (excluded); and, Ear candles (excluded).   Source: Low risk products

TGA Updates the Listed Medicines Application & Submission User Guide

Do you want to prepare an application to list a medicine? Then this latest guide is just for you. Most listed medicines are complementary medicines, such as: vitamin and mineral formulations, herbal preparations, homeopathic preparations, and essential oils. The TGA Business services (TBS) portal provides an electronic facility for the listing of medicines on the Australian Register of Therapeutic Goods (ARTG). All necessary tools required to lodge, change and maintain an application for a listed medicine are accessible via TBS. This guide is intended to be used as a step‐by‐step description of each process of the application and submission process. Each section will outline the functionality and describe how each section should be completed.   Source: DIY listed medicines

Editor’s note: Please remember that if you get stuck, you can always try one of our own in-house training courses via http://www.rfaregulatoryaffairs.com/training-courses or failing that, engage with us directly and we can do all of the work for you. www.rfareg.com

Turmeric Adulteration Bulletin

Jointly published by the American Botanical Council (ABC), American Herbal Pharmacopoeia (AHP), and the National Center for Natural Products Research (NCNPR), the Botanical Adulterants Prevention Program has recently highlighted the widespread practice of adulteration of global turmeric (Curcuma longa rhizome) supplies. Few herbal dietary supplement ingredients have seen such a steep sales increase over the past five years as turmeric. Turmeric has been the top-selling dietary supplement in US natural food stores since 2013, and it ranked fifth in sales in mainstream retail outlets in 2017. The new bulletin, written by Ezra Bejar, PhD, an expert in botanical research in San Diego, California, lists the known adulterants, details analytical approaches to detect adulterants, and provides information on the nomenclature, cultivation, harvest, and market importance of turmeric.   Source: Turmeric bulletin

 

 

Microbeads Now Banned in New Zealand: Is Your Product Affected?

Microbeads are tiny plastic particles, including plastic-based glitter, that are added to products to increase their cleaning or scrubbing power, or to make the product look fun or appealing. From 7 June 2018 onwards, it is illegal to manufacture or sell some products containing microbeads in New Zealand. This guide tells you which products are affected, and what to do if you own products containing microbeads.     Source: NZ EPA NZ microbead ban

What is Australia Doing About Microbeads?

The Department of the Environment and Energy (DoEA) is working with industry and state and territory governments to ensure a voluntary phase-out of microbeads from personal care and cosmetic products by July 2018. The phase-out focusses on microbeads in rinse-off products, which would be reasonably capable of entering the marine environment through normal use. The Department conducted an assessment of progress toward the voluntary phase-out and found that industry is on track to successfully phase out microbeads by 1 July 2018. Source:  Australian microbeads phase-out      For further information on marine debris pollution generally see DoEA site Marine debris

 

 

Lupin Allergen Declaration Now Mandatory

Food Standards Australia New Zealand (FSANZ) is reminding food businesses that mandatory allergen labelling requirements for lupin began on 26 May 2018. FSANZ CEO Mark Booth said in a press release lupin is a legume which belongs to the same plant family as peanuts, and has the potential to be an allergen. “In Australia, lupin has not typically been used in food, however, due to its high protein and fibre content we are seeing an increase in its use,” Booth said. “In 2017, lupin was added to the list of allergens that must be declared on food labels. Food businesses were given 12 months to meet these requirements. Any foods that contain lupin must declare it on the label from 26 May 2018 – even if it’s already on the shelf. Correct allergen labelling can mean the difference between life and death for people with food allergies so it is vital that food businesses get it right.’ Booth continued. “Even if the food is not in a package (for example, food prepared at and sold from a takeaway shop), allergen information must be displayed in connection with the food or provided to the purchaser if requested” he said.   Source: AusFoodNews Lupin allergy

Stakeholder Roundtable Trial Evaluation Report

The Food Regulation Standing Committee (FRSC) undertook an evaluation of the FRSC Stakeholder Trial Roundtables held between late 2017 and early 2018. In May 2018 FRSC accepted all of the recommendations and the report is now available on the Food Regulation website.   Source: Food roundtable report

Country of Origin Food Labelling Surveillance to Commence

After 1 July 2018, Australian consumers will have much greater certainty about the origins of the food they buy, due to the introduction of mandatory Country of Origin food labelling. The Australian Consumer & Competition Commission (ACCC) will conduct market surveillance checks on 10,000 food products to ensure businesses are correctly displaying the new labels. All businesses–including manufacturers, processors and importers that offer food for retail sale in Australia–will need to comply with the Country of Origin Food Labelling Information Standard, which specifies how claims can be made about the origin of food products. The new requirements will apply to most food offered for retail sale in Australia, including food sold in stores or markets, online or from a vending machine. It does however exclude food sold in restaurants, cafes, take-away shops or schools.   Source: CoOL food

Jenny Craig Pays Penalty for “10kg for $10” Ads

Jenny Craig Weight Loss Centres Pty Ltd (Jenny Craig) has paid $37,800 in penalties following the ACCC issuing three infringement notices for alleged false or misleading representations in breach of the Australian Consumer Law. From December 2017 to February 2018, Jenny Craig represented in television advertisements people could lose up to 10kg of weight for a $10 program fee, without adequately disclosing customers also had to purchase food at an additional cost. Jenny Craig also failed to disclose that a person featured in an online testimonial video for its services was a Jenny Craig employee. In addition, Jenny Craig’s standard form membership agreement represented that customers’ refund rights in relation to faulty products required the customer to notify Jenny Craig within three days and return faulty products within 10 business days in their original packaging.   Source: Jenny Craig loss

ACCC Targets Misleading Organic Claims

Dreamz Pty Ltd, trading as GAIA Skin Naturals (GAIA), has paid $37,800 in penalties for alleged false or misleading representations after the ACCC issued three infringement notices. GAIA described its Natural Baby Bath & Body Wash, Baby Shampoo and Baby Moisturiser as “Pure ★ Natural ★ Organic”. However, these products contain two synthetic chemical preservatives: sodium hydroxyl methyl glycinate and phenoxyethanol. “Businesses making organic claims must be able to substantiate those claims. GAIA’s claims may have misled consumers into thinking these products are free from synthetic chemicals when they are not,” ACCC Commissioner Sarah Court said.   Source:  Pure natural organic not

FSANZ Notifications—

Proposal M1015 – Maximum Residue Limits (2017). The purpose of this proposal is to consider varying certain maximum residue limits (MRLs) for residues of specified agricultural and veterinary chemicals that may occur in food commodities.   Source: Ag/Vet MRLs

Application A1137 – Polysorbate 20 as a Food Additive. The purpose of the Application is to permit the use of polysorbate 20 as an emulsifier.   Source: Polysorbate emulsifier

Application A1144 – Re-categorising Coconut Milk for Food Additive Permissions. The purpose of the Application is to consider whether the food category for food additive permissions for coconut milk products is more appropriate under fruits, rather than beverages   Source:  Coconut category

Application A1151–Beta-Galactosidase from Papiliotrema terrestris as a Processing Aid (Enzyme). The purpose of the Application is to include ß-Galactosidase from Papiliotrema terrestris as a Processing Aid.   Source: Papiliotrema enzyme

Application A1153 – Endo xylanase from T. reesei as a Processing Aid. The purpose of the Application is to include a genetically modified strain of Trichoderma reesei as a permitted source for Endo-1,4 (3) - ß -xylanase (E.C.3.2.1.8).   Source: Trichoderma enzyme 1

Application A1154 – Food derived from insect-protected cotton line MON88702. The purpose of the Application is to seek approval for food derived from a genetically-modified insect-protected cotton line, MON88702   Source: GM cotton food

Application A1156 – Food derived from Super High Oleic Safflower Lines 26 and 40. The purpose of this Application is to seek approval for food derived from SHO safflower lines 26 and 40, genetically modified to produce high levels of oleic acid in the seed.   Source: GM safflower

Application A1163 - Food Irradiation definition of herbs and spices. The purpose of this Application is to vary Food Standard 1.5.3 Irradiation of Food to remove the reference to Schedule 22 in relation to the definition of Herbs and Spices.   Source: Food irradiation

Application A1164 – Pullulanase from a recombinant strain of Bacillus licheniformis as a processing aid (Enzyme). The purpose of this Application is to seek approval to permit the use of the enzyme Triacylglycerol lipase from Trichoderma reesei as a processing aid in the manufacturing of cereal-based products.   Source: Trichoderma enzyme 2

9% of 'Gluten-Free' Dishes In Melbourne Restaurants Do Contain Gluten

The findings, published in the Medical Journal of Australia, found that of 158 samples of “gluten-free” dishes from 127 randomly selected restaurants within the city of Melbourne council, 9% contained detectable gluten and were not compliant with the Food Standards Australia New Zealand definition of gluten free. Coeliac disease is an autoimmune disorder, not a food intolerance or allergy. It causes the immune system to attack the bowel after the ingestion of gluten, a protein found in grains such as wheat, spelt and barley. The only way to treat coeliac disease and avoid serious complications is to adhere to a lifelong, strict, gluten-free diet.   Source: The Guardian Gluten study

 

 

5 New Rules for Direct Selling Success

It used to be that choosing how you wanted to sell your products using a direct selling method was a fairly simple proposition. Direct sellers employed two basic selling approaches: one-on-one and one-to-many (usually referred to as “party plan”). Not so today. Price and whether the product is consumable or non-consumable are still important considerations, but the direct selling marketing options and distribution channels have changed dramatically. Here are 5 ‘New Rules’ (guidelines really) to assist all direct sellers supplying product in the early 21st century.   Source: Alan Luce, World of Direct Selling Direct selling rules

ABN Guidelines for Direct Selling Businesses

Direct Selling Australia has published a handy summary of the impact of the new withholding tax exemption. The main point to note is that from 1 July 2018, the withholding variation for DSA members, making payments to distributors who do not quote an ABN, will be increased from $10,000 to $15,000. DSA members will not need to withhold tax from payments made to distributors below this amount. In FY19 and FY20,Independent Sales Persons (ISPs) who earn less than $15,000 from a DSA member, will not need to quote an ABN as they will be covered by the DSA’s exemption.   Source: DSA ABN

 

Quote for the month:

“The food you eat can either be the safest and most powerful form of medicine or the slowest form of poison”   Ann Wigmore

 

RFA Regulatory Affairs is a Gold sponsor of Nordoff Robbins Music Therapy https://www.noro.org.au/

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