Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
RFA Sends Condolences:
Robert Forbes and all of our associates are aware of the great tragedy that has recently unfolded in USA. As regular visitors to Supply Side West at the Mandalay Bay, Las Vegas we have been personally saddened at this great loss. We send all of our readers our love and best wishes as we all try to come to terms with this senseless suffering and immense pain. Let the healing begin.
The Rise of Vegan, Gluten-Free and Kombucha
Fancy a vegan steak with a gluten-free beer? It appears you’re not alone. Over the past few years, the number of veggie and vegan foods available in Australia has soared. According to Mintel Global New Products Database (GNPD), between 2014 and 2016 there was a 92 per cent increase in the number of food products launched in Australia carrying a vegan claim, and an eight per cent increase in the number of products launched carrying a vegetarian claim. While meat and regular alcoholic drinks may be off the menu, the hottest drink trend – kombucha – is well and truly on. Australia played host to the second highest number of kombucha drink launches globally in 2016, just behind the USA. Kombucha is proving to be far more than a fad and its popularity is gradually spreading amongst health-conscious consumers globally. Source: (for link) The Vegan supremacy
9 Surefire Ways to Supercharge Your Strategic Planning
‘Dwight Eisenhower once said, “In planning for battle, I have always felt that plans are useless, but planning is indispensable.” I love that quote, because it speaks to the priority of the planning process over even the plan itself. But even if plans are seen as useless, or our skills as planners are marginal, we still must respect the process of planning. In my experience, this is exactly where most companies fall short. Companies are not very strategic about being strategic; they lack a planning process for their planning process … …’ Source: Brett Duncan, via World of Direct Selling Strategic planning
Quote for the month:
“If the plan doesn’t work, change the plan but never the goal” Anon.
FSANZ Food Allergen Portal
Food allergies can be life threatening. For people who have a food allergy the only way to manage the allergy is to avoid the food allergen. For this reason there are laws in place, for example mandatory labelling requirements to help people who have a food allergy avoid food allergens. This food allergen portal was created by the Allergen Collaboration to provide different sectors in the community with links to best practice food allergen resources and key messages to promote in the different sectors. Source: Allergy portal
Lupin Added To Mandatory Allergen Labelling List
Food Standards Australia New Zealand (FSANZ) has added lupin to the list of 9 allergens that currently must be declared on food labels. From 25 May 2018, the 10 foods or ingredients that must be declared are peanuts, tree nuts, milk, eggs, sesame seeds, fish, shellfish, soy, wheat and now lupin. These ingredients must be declared on the food label whenever they are present as ingredients or as components of food additives or processing aids. Sulphites in concentrations of 10mg/kg or more must also be declared on food labels of packaged foods. Source: (Pg.5) Lupin allergy
Department of Agriculture Failing Food Report
This latest report details food that was found to fail under the Imported Food Inspection Scheme during the month of July. The department operates a five per cent random surveillance scheme to monitor a range of food imported into Australia for compliance to some standards in the Australia New Zealand Food Standards Code. These tests are applied as part of a rolling program of surveillance on the Australian food supply. The following report details where results were found to be noncompliant with food standards. Future consignments of this food are subject to an increased rate of testing until a history of compliance is achieved. Source: Food fails
NSW Food Authority Recalls— Source: Food recalls
Chung Jung One Seasoned Bean Paste: Imventure24 Pty. Ltd has recalled Chung Jung One Seasoned Bean Paste due to the presence of an undeclared allergen (peanut, shellfish & fish).
Chuan Qi Hot Pot Sauce: Tek Shing Trading Pty Ltd. has recalled Chuan Qi Hot Pot Sauce due to the presence of an undeclared allergen (peanut, shellfish & fish).
Rafferty's Garden Happy Tummies Vegetable Risotto: PZ Cussons Australia Pty Ltd has recalled Rafferty’s Garden Happy Tummies Vegetable Risotto due to the potential presence of foreign matter (glass).
Treat Dreams Chocolate Bars: North Foster Pty Ltd trading as Treat Dreams Australia has recalled Treat Dreams Chocolate Bars products due to the potential presence of undeclared allergens (wheat/peanut).
Kettle Fried Potato Chips: Snack Brands Australia has recalled Kettle Sea Salt and Kettle Rosemary and Sea Salt due to the potential presence of foreign matter (white rubber pieces).
Hans Spanish Chorizo: Hans Continental Smallgoods Pty Ltd has recalled Hans Spanish Chorizo due to microbial (E. coli) contamination.
Mishka Mixed Vodka: Pinnacle Drinks has recalled assorted Mishka Mixed Vodka products due to a packaging fault resulting in the potential for glass bottles to break when opening.
Single Selection Classic Original Pate: Pure Foods Tasmania no. 1 has recalled its Single Selection Classic Original Pate due to the presence of an undeclared allergen (fish).
Application A1125 – Endo β(1,4) Xylanase as a Processing Aid (Enzyme): The purpose of the Application is to permit the use of a new enzyme sourced from Bacillus subtilis containing the gene from endo β(1,4) xylanase isolated from Pseudoalteromonas haloplanktis for use as a processing aid in baked cereal products. Source: Xylanase
Application A1126 – Pectins & Carrageenan as Processing Aids in Wine (Fining Agent): The purpose of the Application is to seek permissions for pectins and carrageenan as processing aids to remove heat-unstable proteins from Australian produced wine. Source: Fining agents
Application A1135 – Beta-galactosidase as a Processing Aid (Enzyme): The purpose of the Application is to permit the use of a new source of beta-galactosidase from a genetically modified strain of Bacillus licheniformis to be used as a processing aid during the production of reduced lactose or lactose free milk and dairy products. Source: B-galactoside
Application A1136 – Protein Glutaminase as a Processing Aid (Enzyme): The purpose of the Application is to permit the use of protein-glutaminase from Chryseobacterium proteolyticum as a processing aid to improve protein functionality in baking, noodle, dairy, meat, fish and yeast products. Source: Glutiminase
Application A1143 – Food derived from DHA Canola Line: The purpose of the Application is to seek permission for food derived from canola line NS-B50027-4, genetically modified to produce omega-3 long chain polyunsaturated fatty acids, particularly DHA, in the seed. Source: GM canola
Application A1152 - Clarify the definition of fruit and vegetable wine: The purpose of this Application is to amend the definition of fruit and vegetable wine in Standard 1.1.2-3 of the Australia New Zealand Food Standards Code (“the Code”). Source: Wine definition
Proposal P1046 – L-amino acid acetate in Food for Special Medical Purposes: This proposal has removed a negative impact on trade by enabling the sale of food for special medical purposes (FSMP) containing L-arginine acetate. Source: L arginine
Complementary Medicines (“Dietary supplements”):
TGA Consultation: Business Process Improvements Supporting Complementary Medicines Assessment Pathways
The TGA is seeking comments from interested parties on a range of reforms to the regulatory framework for complementary medicines to address Government-agreed recommendations arising from the Review of Medicines and Medical Devices Regulation. The purpose of this consultation is to provide an opportunity for consumers, health professionals and sponsors to contribute to the development and implementation of a range of business processes aimed at improving the regulation of complementary medicines in Australia. Interested parties should respond by close of business Tuesday, 7 November 2017. Source: Consultation pathway
TGA presentation at the 2017 ARCS Annual Conference, August 2017
ARCS Australia is a professional development association representing individuals involved in the development of therapeutic products. Transcripts and slide-shows from all of the TGA presentations delivered at this annual conference can be viewed here: 2017 ARCS conference
Medicinal Cannabis 'Red-Tape' Pushing Doctors and Patients Back to Illegal Products
In last month’s edition of this newsletter, we covered a story titled “TGA Addresses Issues Related to Supply of Medicinal Cannabis in Australia” which generated a considerable amount of interest in our readers, not least because it seems that in spite of legislative changes that aimed to increase the availability of medicinal cannabis to Australian health consumers, the health bureaucracy has sought to frustrate the government’s initiatives by insisting that supply be dependent on evidence of effectiveness. But, as with the chicken-&-egg paradox, if supply remains severely curtailed, how can the evidence be accumulated? Sydney GP Brad McKay, Brisbane father Steve Peek, and Teresa Nicoletti, a partner at the law firm Mills Oakley, all explain the impact that this impasse is having on theirs and others’ lives. Source: ABC News Green tape
Australia Government Backs Evidence Based Research for All Health Care
The National Health and Medical Research Council (NHMRC) has a responsibility to inquire into, issue guidelines on, and advise the community on, matters relating to: the improvement of health; the prevention, diagnosis and treatment of disease; the provision of health care; public health research and medical research; and ethical issues relating to health. All health treatments, whether conventional, traditional or complementary, should be subject to a rigorous evaluation of the evidence for effectiveness. In the NHMRC Strategic Plan 2010–2012, ‘examining alternative therapy claims’ was identified as a major health issue for consideration by the organisation, including the provision of research funding. In the current Strategic Plan 2013–2015, NHMRC has broadened its focus to investigate the general issue of ‘Claiming benefits for human health not based on evidence'. Source:Complementary research
Nutrient Reference Values for Sodium Updated
The sodium nutrient reference values (NRVs) for the Suggested Dietary Target and Upper Level of Intake for adults were approved by the National Health and Medical Research Council (NHMRC) on 13 July 2017 and have now been published. Excess sodium intake continues to be strongly associated with increased risk of hypertension and some cardiovascular and kidney events. Source: Sodium intake
Exposure drafts: Therapeutic Goods Amendment Bill 2017 and Therapeutic Goods (Charges) Amendment Bill 2017
The TGA sought comments from interested parties on the exposure draft Bills amending the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989. This consultation closed at 9am on 5 September 2017. Source: TGA consultation
TGA Consultation: Therapeutic Goods Advertising Code
The TGA is seeking comments from interested parties on proposed changes to improve the Therapeutic Goods Advertising Code (the Code) and a possible framework for the advertising of pharmacist-only (Schedule 3) medicines to the public. Closing date 13th October 2017. Source: S3 adverts Editor’s note: See also Complementary Medicines Australia (CMA) detailed response: CMA submission
TGA Fees and Charges: Summary - From 1 July 2017
The TGA is required to recover its costs through fees and charges for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities. The 2017-18 fees and charges schedule for non-prescription medicines applies to applications submitted to the TGA on or after 1 July 2017. Source: TGA fees
TGA Consultation: Proposed Amendments to the Poisons Standard
The TGA is seeking comments from interested parties on the following proposed amendments to the Poisons Standard referred by the delegate for scheduling advice to the Advisory Committee on Chemicals Scheduling (ACCS), the Advisory Committee on Medicines Scheduling (ACMS) and the Joint ACCS-ACMS. This consultation closes on 6 October 2017. (Please note in particular the proposal for the scheduling of “salts of boric acid”). Source: Poisons standard
TGA Updates Manufacturing Principles for Medicines, APIs and Sunscreens
The TGA uses internationally harmonised manufacturing standards to allow manufacturers to operate in an international environment. The TGA maintains its GMP standards in line with updates issued through the PIC/S. Regular updates are necessary to maintain mutual confidence with regulators overseas and to promote quality assurance of inspections and harmonisation of technical standards and procedures with international inspection standards for the production and testing of medicinal products. This initial adoption of the PIC/S Guide to GMP is scheduled to commence on 31 December 2017 at which point, GMP inspectors will use the new Guide to GMP during inspections. Source: Manufacturing principles
TGA Revises Pharmacovigilance Responsibilities of Medicine Sponsors
Pharmacovigilance is defined by the World Health Organization as the science and activity related to detecting, assessing, understanding and preventing adverse effects and other medicine-related problems. The Therapeutic Goods Administration (TGA) collects and evaluates information related to the benefit-risk balance of medicines in Australia to monitor their safety and, where necessary, take appropriate action. This guidance sets out the pharmacovigilance responsibilities of sponsors of medicines included on the Australian Register of Therapeutic Goods (ARTG) and regulated by the TGA. It outlines the mandatory reporting requirements and offers recommendations on pharmacovigilance best practice. TGA has confirmed that only the Administrator of the EBS account can add the pharmacovigilance contact person and that agents (i.e. consultants) can’t do it on behalf of sponsors. New sponsors have 15 calendar days after they list their first product, to nominate their pharmacovigilance contact. Sources:Pahrmacovigilance ; Responsibilities
Ausganica Soothing Herbs Toothpaste: Ausganica Soothing Herbs Toothpaste is marketed as a herbal medicine that enhances oral health. It has been identified that Ausganica Soothing Herbs Toothpaste 130 g contains comfrey, an ingredient that is included in Schedule 10 of the Standard for the Uniform Scheduling of Medicines and Poisons because it is considered a substance ‘of such danger to health as to warrant prohibition of sale, supply and use’. Comfrey contains pyrrolizidine alkaloids, which are toxic substances that have been associated with liver damage and other health hazards. Source: Herbal toothpaste
7-Day Slim Extreme capsules: the capsules contain the undeclared substance sibutramine. Source: Slim chance
Body Con Plus capsules: the capsules contain the undeclared substances sibutramine and phenolphthalein. Source: Body con
Lax-Sachets: Lax-Sachets contain powder that, after being mixed with water, is taken orally to relieve constipation and treat faecal impaction. There is an error in the dosage/administration instructions printed on the back of the sachets. Following the incorrect instructions on the sachets will result in a larger volume and more dilute solution to drink. Source: Lax information
TGA Reports on Outcomes of Advertising Complaints and Compliance Following TGA Intervention
This report lists the outcomes where the advertiser has taken specific action to address identified breaches of therapeutic goods advertising legislative requirements and is compliant at the date for which the complaint investigation was finalised. The advertiser's actions have been taken following TGA investigations into these complaints. All of these complaints were the subject of a complaint to the Complaints Resolution Panel (the Panel). They were referred to the TGA for follow-up action because the advertiser did not fully comply with the Panel's request to address breaches of the therapeutic goods advertising legislation. Source: TGA advert reports
TGA Annual Performance Statistics Report: July 2016 to June 2017
Each year the TGA provides information on their regulatory performance through the Annual Performance Statistics Report and the Half Yearly Performance Snapshot. They also report annually on their performance under the Regulator Performance Framework through the TGA Self-Assessment (Key Performance Indicators) Report. Source: TGA annual report
Cosmetics (& Household cleaning products):
The Push to Close Animal Cosmetic Testing Loopholes in Australia
A cross-party group of federal senators is pushing to tighten Australia's laws around cosmetic testing on animals, with claims that a loophole in legislation makes any testing ban "meaningless". The Australian Federal Government's plan to ban animal cosmetic testing, a promise made during the 2016 election, features in the Industrial Chemicals Bill 2017, part of a suite of bills to reform the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The bill, which was introduced into parliament in June and has not yet progressed from there, proposes a ban on testing chemicals on animals "if an industrial chemical is to be introduced for an end use solely in cosmetics". Source: Josh Butler, HuffPost Australia Animal testing loopholes
NZ Government Publishes Summary of Microbeads Submissions
“Managing Microbeads in Personal Care Products: Summary of Submissions” was published by New Zealand’s Ministry of Environment. Microbeads are synthetic, non-biodegradable plastic beads, in dimensions of 5 mm or less. Manufacturers add them into personal care products such as bath products, facial scrubs and cleansers, and toothpastes. In these products, they act as abrasive or bulking agents. They also provide added texture, visual interest, or shelf life. Once used, these products go down the drain into local water treatment plants. The filtering systems of these plants only partially capture the microbeads. As a result, microbeads enter the marine environment. There is increasing global evidence that, because they are not biodegradable, they have negative effects on the marine environment. The Ministry for the Environment received 16,223 submissions on this topic during the consultation period. Source: NZ microbeads
US DoJ Fines Essential Oils Company $760,000+ for Lacey Act and Endangered Species Act Violations
The Justice Department announced that YOUNG LIVING ESSENTIAL OILS, L.C., headquartered in Lehi, Utah, pleaded guilty in federal court to federal misdemeanour charges regarding its illegal trafficking of rosewood oil and spikenard oil. The US Government calculates the fair market retail value of the plant products involved in the violations and relevant conduct, including but not limited to product equalling approximately 1,899.75 litres of rosewood oil, to be more than $3.5 million but not more than $9 million. Source: Essential oils conviction