Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

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

 

 

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/

 

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

 

 

TGA Releases Updated Australian Regulatory Guidelines For Complementary Medicines (ARGCM)

The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provide information for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia. As reported in recent issues of this newsletter, the TGA has undertaken the biggest review of regulations regarding the supply of CMs since its inception. This latest version, ARGCM Version 8, includes amendments to ARGCM Part C to incorporate legislative changes for new substance evaluations. Other parts of the ARGCM will be amended in 2018 to reflect other legislative changes arising from the Government's complementary medicines reforms. This newsletter will keep you informed as more information comes to hand.   Source: ARGCM version 8

TGA Details Upcoming Changes To The Permissible Ingredients Determination

All ingredients available for use in listed medicines in Australia and any restrictions pertaining to them are listed in the Therapeutic Goods (Permissible Ingredients) Determination. The Determination is continually reviewed by the TGA to ensure that all ingredients are safe for use in low-risk medicines. It is updated quarterly through the addition or removal of ingredients, and the clarification, removal or addition of restrictions or warning statements. This document outlines changes that have been made to the Determination in the first half of 2018 and the upcoming changes for June. As well as there being a new herbal naming standard for new herbal ingredients and addition of 4 new ingredients, other changes include removal of 2 previously permissible ingredients and removal of several required warning statements. Of particular interest is the ‘correction of restrictions relating to coumarin’. (The requirements for coumarin in a number of herbal ingredients have been amended to correctly align with the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) in referring to concentration, rather than maximum daily dose). 11 ingredients are affected by this change. By June 2018 there will be further changes affecting the therapeutic role of menthol, herbal name changes, and the addition of 4 new ingredients. Of special note is clarification of ‘SUSMP requirements for arbutin’. (Ingredients known to contain arbutin will have arbutin listed as a mandatory component with associated specifications in line with the Poisons Standard. There are 11 affected ingredients). Finally, there are also ‘new restrictions on poliglusam’ and ‘new restrictions on methyl salicylate’ with 9 ingredients affected, and ‘new restrictions on cysteine’. Changes regarding ‘curcuminoids’ and caffeine restrictions have been delayed for further review.   Source: Permissible ingredients

TGA Proclaims Changes to Evaluation of Substances for Use in Listed Complementary Medicines

The process for evaluation of substances for use in listed complementary medicines has changed. The TGA has introduced new application categories and legislated timeframes for evaluation of substances for use in listed complementary medicines. There is also a new mechanism to permit a successful applicant of a new complementary medicine substance to have exclusive use of that ingredient for a specified period of time. Implementation of this reform aims to support innovation and improve the evidence base for complementary medicines.   Source: LM substance evaluation

TGA Publishes Outcomes of the Consultation on the Draft List of Permitted Indications

On 6 March 2018, the TGA implemented a list of permitted indications for medicines. Indications available for use for listed medicines are now contained in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination. Sponsors can still apply to have new indications considered for inclusion in the Permissible Indication Determination. A full outcome summary can be read at this site.   Source: Permitted indications

TGA Consultation: Advertising Therapeutic Goods To The Public

The TGA is seeking comments from interested parties and the views of stakeholders on the proposed advertising complaints handling model. As the single agency for therapeutic goods advertising complaints management from 1 July 2018, the TGA is undertaking this public consultation to seek stakeholder's views on its proposed complaints handling model. The public consultation paper outlines the proposed model of advertising complaints handling which aligns with best practice models of complaints handling by comparative Commonwealth regulators. This complaint handling model is intended to ensure that non-compliance remedies are appropriate, proportionate, timely and consistent with contemporary practice. This consultation closes on 4 June 2018.   Source: TGA product complaints

TGA Seeks Input: Options for the Implementation of a Claimer for Efficacy of Assessed Non-Prescription Medicines

The TGA is seeking comments from interested parties on the use of a claimer for efficacy assessed non-prescription medicines. In the February 2017 consultation paper, ‘Reforms to the framework for complementary medicines: Assessment Pathway’, the TGA consulted on a proposal to allow sponsors to claim (‘the claimer’) that their medicine has been assessed by the TGA for efficacy where that medicine has undergone pre-market evaluation by the TGA. This was supported by the majority of respondents. Now, further feedback is requested, specifically related to the types of medicines that should be allowed to carry a claimer; options to implement the claimer as a visual identifier and/or label statement; and, how the claimer can be used on medicine labels. TGA will also conduct consumer focus group testing on the options presented in this paper to confirm whether the potential options will achieve the objectives of the recommendation.   Source: Claimer consultation

TGA Concerned Claims About Hemp and CBD Oils Are Misleading Consumers

The Therapeutic Goods Administration is aware of false and misleading claims being made by some companies supplying products containing cannabidiol (CBD). Companies located in the United States have been illegally exporting cannabidiol (CBD) and hemp products to persons in Australia without import permission. The TGA is aware of at least one company who has claimed that the TGA has invited them to register their CBD and hemp products on the Australian Register of Therapeutic Goods (ARTG) due to growing demand. This is incorrect. The TGA does not 'invite' businesses or sponsors to register a product on the ARTG. The onus is on the sponsor to apply to the TGA and follow due process. The importation of these products is illegal unless the importer holds a licence and permit to import from the Office of Drug Control (ODC). Imports of these goods that do not have the relevant import permissions will be seized at the border. Individuals and businesses in Australia importing CBD/hemp oils are also breaking State/Territory laws on supply and use of prescription medicines.   Source: Cannabis claims

‘TGA Proposal To Change The Medicine GMP Fees And Charges’: Submissions Summary

The TGA has published the combined submissions from respondents to the February 2018 public consultation paper, ‘Consultation: Proposal to change the current Good Manufacturing Practice (GMP) fees and charges’. Consultation closed on 5 March 2018 and a total of 31 submissions were received. All submissions that gave permission to be published on the TGA website are now available in PDF format.   Source: GMP charges responses

Important Dates for TGA Compliance

22nd July 2018 - Annual Charge Exemption (ACE) declarations will be available from 1 July 2018. The deadline to provide declarations in relation to your entries (whether active or cancelled) that had an ACE in 2017-18, must be submitted between 1 July and 22 July 2018. A declaration of $0 turnover has the effect of confirming the 2017-18 exemption, and ensuring the entry will continue to be ACE in 2018-19;     Early August 2018 - Annual charge invoices issued for 2017-18 (unless exempt) and for 2018-19; 15 September 2018 - Deadline to pay annual charges.

TGA Safety Advisories—

SLIM BODY Advanced capsules - The Therapeutic Goods Administration (TGA) has tested a product labelled SLIM BODY Advanced capsules and found that the capsules contain the undeclared substance sibutramine.   Source: Slim body caps

Lishou Strong Slimming capsules - contain the undeclared substance sibutramine.   Source:  Lishou caps

JAGUAR 30000 capsules -contain the undeclared substance tadalafil.   Source: Jaguar caps

Medsafe NZ Warns That Turmeric / Curcumin Containing Products Can Interact With Warfarin

The Centre for Adverse Reaction Monitoring (CARM) recently received a case report describing a patient taking warfarin who began taking a turmeric containing product. The patient had stable INR measurements, but within a few weeks of commencing turmeric their INR increased to over 10. There is a risk of serious bleeding when the INR gets this high. The reporter considered that the turmeric containing product had interacted with warfarin.   Source: Turmeric safety

Traditional Vs ‘Modern’ Medicine Debate Continues

As reported in our February 2018 newlsetter , as part of the TGA Complementary Medicines Reforms, regarding ‘Permitted Indications’ , there is scope to also include ‘Traditional Indications’. This has raised the ire of many who view scientific modern medicine as the only authority as to what makes humans sick and what can therefore make humans healthy. Chair of the RACGP Expert Committee – Quality Care, Dr Evan Ackermann, is quoted as saying, “The 860 claims that will be legally permitted on complementary medicine under this new legislation have no scientific basis and can cause harm”. This is inspite of the guidelines for traditional medicines being in line with World Health Organisation guidelines on the role of complementary medicines. The proposed legislative changes are intended to make it easier for consumers to differentiate between traditional or complementary medicines which have had scientific evidence assessed and those that have not. Once the new system is in place any companies which make claims that are found not to have the evidence to support their statements, will have their products removed from the Australian Register of Therapeutic Goods unless corrective action is taken. Culture clash?   Sources: Megan Haddan, AJP Doctor's disquiet &, TGA evidence

 

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