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 )

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