Country of Origin Labelling for Complementary Medicines Consultation

In February 2017 amendments were made to the Country of Origin Labelling (CoOL) laws that changed the basis for being eligible to make 'Made in Australia' claims, and subsequently access to the Australian Made, Australian Grown (AMAG) logo. The CoOL law amendments focused mainly on the food industry. However, all other products, including complementary medicines (CMs), and goods that wish to make an AMAG claim are also bound by the CoOL laws. All complementary medicine products sold in Australia are regulated by the TGA. While there have been calls to allow all CMs manufactured under TGA authorisation to be allowed use of the AMAG logo, unintended consequences arise when this authorised CM manufacturer is actually off-shore and still able to use the AMAG logo. (Domestic facilities supplying to the domestic market are ‘licensed’ by the TGA but overseas facilities supplying to the domestic market and domestic facilities which supply export markets only, are ‘certified’ by the TGA. The TGA does not require the manufacturing steps to be carried out in Australia). Consultation closes 5pm (AEDT) Wednesday 30 October 2019.     Source: CoOL consultation  

Summary of Deadlines to Comply with TGA Regulatory Changes

With so many recent changes to the regulation of complementary medicines in Australia, all sponsors should be acutely aware of the following important dates:

January 1st 2019 - New Advertising Code became effective;  

March 2019 - enhanced penalties for addressing non-compliant advertising were introduced;

September 2nd 2019 – Immediate new restrictions on caffeine content implemented;

January 1st 2020 - Last date to transition menthol containing medicines for dermal use to new requirements;

April 30th 2020 – Last date for all labels and packages to carry the updated ingredient name;

September 1st 2020 - The four year period to transition labels ends and all labels must comply;

March 2nd 2021 - Changes to content and warning statements, in caffeine containing LMs, transition ends;

March 5th 2021 - End of the phase in period for the permissible indications list, to avoid cancellation.

Important Notice for Advertisers of Complementary Medicines

If you advertise to the public using print media, cinema, billboards or other public displays, then you need to know about changes coming to advertising pre-approvals. In the lead up to the abolition of the therapeutic goods advertising pre-approval requirements in June 2020, the Complementary Healthcare Council of Australia (CHC), also now known as Complementary Medicines Australia (CMA), will cease accepting applications for pre-approval in November 2019. The TGA is working on alternate arrangements to replace CHC/CMA's services with new arrangements commencing by late November or early December 2019 at the latest.   Source: CM advertising changes

2018-19 Annual Report on Therapeutic Goods Advertising Compliance

On 1 July 2018, the TGA became the single body for handling complaints about the advertising of therapeutic goods in Australia. This is the inaugural report on the TGA's complaint handling activity. During the 2018-19 financial year, the TGA received 1468 complaints about the advertising of therapeutic goods. The report uses case studies to illustrate the types of advertising breaches identified and the actions taken by the TGA to remove non-compliant advertising. Of the top 10 most reported-on categories, the ‘Schedule 4 cosmetic category’ (capturing advertising to the public for prescription medicines used for cosmetic procedures such as wrinkle reduction and filling) was by far the largest. Interestingly, there were more complaints concerning the advertising around head-lice than there were regarding weight-loss, detox/diuretics, and cold/flu products combined!     Source: Advertising compliance report

Consultation: Are Sports Supplements Foods or Therapeutic Goods?

In Australia, food and medicines are regulated under separate legislated frameworks. Whether a product for oral consumption is a food or a medicine in law can depend on the specific combination of ingredients, claims and overall presentation. Two products with the same formulation may be characterised differently—one as a food and the other as a medicine—depending on their claims, artwork and other aspects of their packaging. However, a product cannot simultaneously be both food and medicine in law. ‘Sports supplements’ is a broad category of products that straddles the interface between the food and medicine regulatory frameworks. These products often carry explicit or implied claims relating to sport, fitness or recreational performance, and are likely to be marketed and consumed for therapeutic use, yet some of the products may still be considered to be food under law. This TGA consultation is seeking to resolve much of the uncertainty around the regulatory status of sports supplements to ensure those products are regulated appropriately.    Source: Sports supplements consultation

Turmeric Contamination Under the Spotlight

Turmeric is a flowering plant, Curcuma longa of the ginger family, Zingiberaceae, the roots of which are used in cooking. Its most active component, curcumin, has many scientifically-proven health benefits, such as the potential to prevent heart disease, Alzheimer's and cancer. It's a potent anti-inflammatory and antioxidant and may also help improve symptoms of depression and arthritis. A Stanford-led study has now revealed that turmeric produced in Bangladesh, the world’s largest supplier, is often adulterated with a lead-laced chemical compound. Lead chromate is bright orange and has been frequently used as a colour enhancer in the commercial production of Bangladeshi turmeric. Countries importing turmeric for use as either a medicine or a food are at risk. As Complementary Medicines Australia (CMA) points out, the TGA provides strict guidelines and regulations to ensure the integrity and safety of all Australian medicines, including mandatory Good Manufacturing Practices (GMP), batch testing reports and information on the supplier are documented at every stage. Whereas, Australia’s Department of Agriculture targets and monitors food determined to pose a high or medium risk to public health. Foods found to be at risk are then targeted at the rate of 100 per cent until a history of compliance is established. But what about other jurisdictions that don’t require GMP for their complementary medicines, or that don’t have as strict import testing of their imported foods?    Sources: Adulterated turmeric ; Elsevier turmeric study ; CMA turmeric study response 

CMA Publishes Australia’s Complementary Medicines Industry Audit for 2019

As the peak body for the complementary medicines industry, Complementary Medicines Australia (CMA) has been conducting annual reviews of the industry for 10 years. Some of the critical highlights of the 2019 industry audit are: the sector is now a $5.2 billion per annum industry, outpacing Australia’s general economic growth; Australian exports have grown to $1 billion per annum, overtaking the USA to become the largest exporter of Nutrition and Health Food to China; most Australians (7 out of 10) have used at least one form of complementary medicine in the last year and a third of complementary medicines users do so to manage the symptoms of chronic disease.     Source: CMA industry audit

Australian Supplements Regulatory Regime Not World Class…Yet: TGA Chief Warns Industry

The Australian supplements industry may have a much lauded regulatory regime on the global stage, but a leading figure at regulator the Therapeutic Goods Administration (TGA) has argued it is “not yet world class”.    Source: [Copyight] Gary Scattergood, Nutra Ingredients-Asia Oz Regs progress

IADSA International Regulatory Summary

The International Alliance of Dietary / Foods Supplement Associations has summarised the latest regulatory changes now impacting on the food and complementary medicine sectors around the wold. Countries and topics covered include: China (The Chinese State Administration for Market Regulation has issued “Guideline on Warning Statements for Health Food Labeling” which comes into force on 1 January 2020); Japan (Japan’s Consumer Affairs Agency announced the revision of the “Food Labelling Standard”); South Korea (The Korean Ministry of Food and drug safety has revised its Health Functional Food Code); European Union (Empty gelatine capsules could be exempted from border inspections; Italy (Issues curcumin warning); United Kingdom (Helpful links to prepare for No-Deal Brexit); and many more updates affecting Australia, USA, South Africa and others.  Source: IADSA newsflash

Medical Cannabis: Hydrogen Cyanide Could be the Missing Link in Vaping Illnesses

An electronic cigarette or e-cigarette is a handheld battery-powered vaporiser that simulates smoking, but without burning. This form of ingestion has become a popular delivery mode of THC and CBD for recreational and medical users of cannabis, as well as tobacco smokers. Using an e-cigarette is known as "vaping" and the user is referred to as a "vaper." Instead of smoke, the user inhales an aerosol, commonly called vapour, that’s formed after electronically heating the initial liquid. A spike in recent vaping related illnesses and deaths around the world has regulators worried. An early concern has been the effects of inhaling the oils of Vitamin E acetate, used to dilute the primary oils, which can adversely coat the airways. A more recent culprit now appears to be a pesticide residue found in unregulated vaping cartridges. Testing of unregulated or bootlegged vaping devices in one recent USA study showed that all contained myclobutanil, a fungicide that can transform into hydrogen cyanide when burned.    Sources: THC vaping danger ; FDA warning & NYT Vaping deaths   (Please see also: TGA advice on e-cigarettes ;  NICNAS vaping facts ; & Dept. Health warning )

TGA Update to Poisons Standard to Impact Some Cosmetics Ingredients

This October, the TGA has released an updated version of the Standard for the Uniform Scheduling of Medicine and Poisons No. 25 (SUSMP) a.k.a. The Poisons Standard. One of the changes is tighter restriction on methylisothiazolinone in Schedule 6 which may affect some rinse off cosmetic preparations or topical rinse off therapeutic goods. These preparations were previously exempt from Schedule 6 of the SUSMP if they contained 0.01% or less of methylchloroisothiazolinone and methylisothiazolinone in total. The new exemption has been reduced to a total concentration of 0.0015%. If your products have been affected, contact us for further regulatory guidance.    Source: SUSMP update

View: RFA Regulatory Affairs You Tube Video (Cosmetics Regulation)

Amendments to Imported Food Regulations

Recent changes to the Imported Food Control Regulations 2019 take effect on 1 October 2019 and will impact on the operation of the Imported Food Inspection Scheme (IFIS). The 3 changes are: 1. Commercial imports taken to be for private consumption are now reduced from 10 kilograms or 10 litres to 1 kilogram or 1 litre; 2. All commercial imports (even if for ‘personal use’) of prohibited plants and fungi will be subject to the IFIS, regardless of weight; and, 3. Clarification of powers of authorised officers.    Source: Imported food amendments

NZ’s MPI Reviews Folic Acid Fortification of Food

The New Zealand Ministry of Primary Industries is seeking feedback on options for strengthening fortification of bread or fortifying wheat flour, including the addition of folic acid. Folic acid is an essential B vitamin important for the healthy development of babies early in pregnancy. There is overwhelming evidence that consuming sufficient folic acid before conception and during early pregnancy can prevent many cases of neural tube defects such as spina bifida. The consultation runs from 1 October to 12 November 2019.    Source: Folic acid consultation 1 & Folic acid consultation 2  

FSANZ Issues its Annual Report for 2018-19

Food Standards Australia & New Zealand’s annual report provides a snapshot of what they’ve been up to in the past year and the many activities delivered to support the food regulation system. Apart from its primary focus on developing food standards generally, it was also an important year for stakeholder engagement, with FSANZ’s first biennial stakeholder forum. 2018–19 also saw more than 100 food incidents and recalls coordinated by the food safety team. This was a record number for the agency and included the strawberry tampering incident of September 2018.    Source: FSANZ annual report

FSANZ Weighs in on Caffeine Controversy

Following on from recent major health concerns regarding pure caffeine supplements (please see reports in the July and September 2019 issues of this newsletter), FSANZ has produced an infographic and other helpful material related to caffeine consumption and its safety, or otherwise. If your supplement contains caffeine as an ingredient, or even if you want to know more about your own caffeine consumption, then please go to: FSANZ caffeine controversy

FSANZ Notifications—

Application A1181 – Maximum residue limits for Imazapyr in Barley Grain: The purpose of this application is to increase the maximum residue limit for imazapyr in barley grain from 0.05ppm to 0.7ppm   Source: Barley residue

Application A1184 – Glucoamylase from GM Aspergillus niger (donor Trametes cingulata): ​​​The purpose of the application is to approve the use of glucoamylase sourced from GM Aspergillus niger containing the gene from Trametes cingulata.    Source: GM aspergillus enzyme

Application A1185 – Alpha-amylase from Aspergillus niger as a Processing aid (enzyme): The purpose of this application is to approve the use of Alpha-amylasee sourced from Rhizomucor pusillus in GM Aspergillus niger.   Source: GM aspergillus enzyme 2

Application A1189 – White Mineral Oil as a Processing Aid for dust suppression in grain: The purpose of this application is to allow for White Mineral Oil to be used for dust suppression in grain handling at a level not greater than 200ppm.    Source: White mineral oil

Application A1190 – 2'-FL in infant formula and other products: The purpose of this Application is to permit the use of Endo-Inulinase produced from a GM modified strain of Aspergillus oryzae as a Processing aid.    Source: Aspergillus oryzae

Proposal P1050 – Pregnancy warning labels on alcoholic beverages:  The purpose of this Proposal is to seek feedback on warning labels aimed at raising awareness of the risk of health consequences when consuming alcohol during pregnancy.    Source: Pregnancy and alcohol warning label proposal

‘Hugely Disproportionate’? Singapore to Ban SSB Ads Alongside Colour-Coded Nutrition Label Plan

Singapore is set to introduce mandatory colour-coded front-of-pack nutrition label and ban advertising for pre-packaged sugar sweetened beverages (SSB), a move that has caused the industry to voice doubts, while health policy experts have welcomed the move.    Source: (Copyright) Pearly Neo, Food Navigator-Asia Singapore food law

Regulatory Review: See the Regulatory Developments Happening in the Health and Nutrition Industry

In this round-up of the latest regulatory developments taking place in the health foods industry, topics span from Foods for Special Medical Purposes (FSMPs), food fortification in India, to the sales of energy drinks in New Zealand.   Source: [Copyright] Tingmin Koe, Nutra Ingredients-Asia International regs update

7 Clear Signals That Today’s Direct Sales Company Should Embrace

(This is an article by Rick Loy, Senior Vice President of US Sales and Training at AdvoCare since 1998. Rick helps companies update their sales efforts taking into account the quickly moving landscape from a regulatory perspective). As Rick says, “’I’m not a lawyer; I’m a traveller alongside you, suggesting things I believe merit attention. My areas of expertise and passion have more to do with equipping and empowering the field, and helping the Home Office strategize how to best support those efforts. But I recognize that, for me to do that well and appropriately, I must be clear on what is and is not acceptable in today’s direct selling environment”.   Source: World of Direct Selling Direct selling tips

[Sponsor Content]: Social Engineering isn’t Just a Buzz Word

This article by Insurance Made Easy Brokers provides our readers with an understanding of the new language surrounding cyber-crime and its possible impact on your business. As they say in the information age, it isn’t a matter of if my business will be hacked but when? Read on to learn more about the new age cyber-terms; how your business could be adversely impacted; and how cyber-Insurance should be considered as a means of reducing your potential financial risk and hardship: IME cyber-insurance

RFA Provides Comprehensive Training in Regulatory Affairs

Are you looking to expand your knowledge or are you new to Australian regulations related to the supply of foods, cosmetics and/or complementary medicines? Then check out the full list of courses we offer on the Robert Forbes & Associates website www.rfaregulatoryaffairs.com/training-courses . There are 20 courses to choose from and any of these can be undertaken either singly or in groups, from within our Glebe, Sydney office, at your office or remotely via Skype. Contact our training manager Kate Durey This email address is being protected from spambots. You need JavaScript enabled to view it.  to receive the latest information on these training courses at this discount offer. See you in the classroom!

Quote for the month:

“Oaks grow strong in contrary winds, and diamonds are formed under pressure”.   Anonymous