Media Releases

The proud winner of the 2019 CMA Industry Contributor Award is Lucy Lang. Lucy leads regulatory affairs for CMA, liaising with various Government agencies and, in particular, the TGA. She also works with industry members to develop policy positions, identify future problems with newly proposed Government policies, and seek technical improvements to the regulatory scheme.

Lucy Lang takes the 2019 CMA Industry Contributor Award

Pressing the industry forward

Lucy works in a secretariat capacity for CMA’s regulatory committees for sponsor members, manufacturers and raw material suppliers. She elicits and collates views to press the industry position forward. It has been an incredibly active time of late with the implementation of the MMDR major regulatory reforms progressing at a rapid pace our industry quickly develops into overseas markets. Keeping the bigger picture in mind helps Lucy to ensure that the best long-term outcomes are achieved.

Positive advances

Asked about the significance of the Industry Contributor Award, Lucy said: “It is a really positive affirmation of the regulatory and Government work we do; a reflection of the positive advances achieved over the last year. More than that, our industry has always been held together by those who truly understand and believe in how important it is – and that complementary medicines are powerful, even critical components of ‘true’ health and wellbeing. I feel really honoured to be counted within that category of industry contributors. People demand our industry because they understand its safety, efficacy, and sustainability as part of everyday life, and they always will – it is our job to keep advancing that, even in the face of adversity.”

Regulatory work can be challenging explains Lucy, since it often questions the position proposed or set out by Government who have access to a comparably vast range of resources. Thinking outside the box and planning is necessary to ensure that there won’t be any unexpected surprises. Questioning whether the correct path is being taken is easy to do and it can be a challenging path. “So to have the affirmation that outcomes we have achieved were recognised made me feel very grateful and thankful,” says Lucy.

Surprise honour

Lucy was taken by surprise by the awards, saying: “I did not have the faintest idea that I might be awarded this honour. I was in shock when it was announced it – so much so that I feel quite embarrassed because I forgot to make a speech! But I am so grateful for those who listened, and stepped up to the plate to help get these changes across the line. I was very humbled to later hear that it was many of my hardworking friends and colleagues in industry who nominated me for the award.”

“Everyone at CMA makes such an incredible contribution; everyone supports everyone else,” says Lucy. “We not only had achievements in the regulatory space, Healthplex this year was an astonishing outcome, as were the changes to the Australian Made laws.”

Invaluable support

CMA relies on senior industry members, political, technical, and Board members who are always willing to join in with Government meetings as a show of unity for the CMA positions. “The cooperation and involvement of all CMA members is invaluable. It’s a really positive way to work. I hope our industry cohesion, underpinned by a shared knowledge in the importance and efficacy of complementary medicines, remains a feature of our industry. Together we are much stronger,” ends Lucy.

Sally Townsend, Head of Sustainability at Blackmores talks about the award, Blackmores’ historical, present and future commitment to sustainability plus the need for our industry to partner in order to lift supply chain transparency. 

Sally Townsend and Brett Friedman hold the inaugrual CMA Sustainability Award

The Blackmores team is so proud to be recognised with the inaugural CMA Sustainability Award and even though this is the first year for this category, it reflects the passion for sustainability that has been part of Blackmores’ culture for more than 87 years.

When I first joined Blackmores (at the previous head office at Balgowlah) the first stop on the site tour was to see the worm farm and the solar panels.  Since then the program has matured and in the last year, we’ve shared clear targets to drive our progress.

This has been timely because there is a shifting global landscape and we’re seeing sustainability as a focus for a growing number of investors, consumers and those upstream and downstream in our value chain. 

Climate change is central to the agenda which is very important for us given our reliance on natural resources.

The CMA Sustainability Award recognised the work that’s been done across our Group to take climate action. This included the release of Sustainable Nutrition, a literature review to grow understanding of the impact of climate change on natural medicine that was led by Blackmores Institute.

This work was used to inform some key initiatives, in particular our adoption of a clean energy strategy that will see Blackmores Campus move to use a minimum of 50% renewables within 12 months.

Our amazing Strategic Sourcing team has begun a program of work to explore the risk and resilience of key ingredients impacted by global warming.

The award reflects the collaborative efforts across our teams including Blackmores Institute, Sustainability and Group Operations.

Our future focus

The CMA conference was an opportunity to share some insights on our corporate sustainability journey in this rapidly evolving space. The UN Sustainable Development Goals have given us a strong north star, but there are many challenges and opportunities for complementary medicines.

There’s no doubt natural health products have an important role to play in addressing the health needs of the community and we need to meet that growing demand in a way that is protective of natural resources and sourced ethically.

The Australian Modern Slavery Act 2018 has put greater responsibility on everyone in our supply chain to take greater responsibility for the liberties of people that are involved in making their products.

I think the natural healthcare industry has a real opportunity to lead in ensuring ethical supply and production because, for many of us, we’re passionate about improving people’s lives and so there’s an innate humanity in people in this category.

We invited our colleagues across the CMA membership to form a working group to address an industry-wide approach to address the risk of modern slavery. Partnering on a single framework will make it easier for our business partners to comply with the reporting requirements and will lift supply chain transparency across our industry. 

Sustainability is definitely a team sport and we can have a greater impact when we work together.

A study from the USA’s Stanford University has shown that adulterated turmeric root and powder grown in Bangladesh is responsible for high levels of lead in low income, rural Bangladeshis. The study, published in Environmental Research, includes interviews with farmers and spice processors in several districts in Bangladesh. Here are 15 fast facts about turmeric, Bangladesh and the study.

1. Turmeric is a potent anti-inflammatory – it has been used for over 6,000 years in Ayurvedic medicine.
2. Turmeric is native to the Indian subcontinent, and most of the world’s turmeric is still grown in developing countries such as Bangladesh because of the favourable climatic conditions.
3. Studies have shown that lead exposure in communities in Bangladesh.
4. Studies have traced lead contamination of turmeric to the 1980s. Flooding in Bangladesh had left turmeric crops soggy and dull in colour. Farmers added lead chromate to restore the brilliant yellow colour during spice processing.
5. Lead is a potent neurotoxin; exposure increases the risk of heart and brain disease in adults and interferes with brain development in children.
6. Researchers writing in Environments Science have found about 90 per cent of studied children with elevated blood lead levels were from lower-income families.
7. Over 30% of the pregnant Bangladeshi women studied had high blood levels of lead.
8. Outside Bangladesh, turmeric has not been linked to lead contamination
9. Stringent safety checks on imported turmeric have encouraged spice processors in Bangladesh to reduce the amount of lead added to turmeric intended for export.
10. In Australia, the TGA provides strict guidelines and regulations to ensure the integrity and safety of Australian products.
11. Rigorous checks are made throughout the supply chain, batch testing reports and information on the supplier are documented at every stage.
12. Australian supplements are made following Good Manufacturing Practices and incorporating sampling and testing programs into quality procedures.
13. CMA actively supports a range of programs that facilitate the trade of safe and high-quality complementary medicines.
14. Importing-country food safety standards influence largescale food processors, not the practices of processors providing informal and domestic markets.
15. Public health authorities, producers and consumers of turmeric should engage in a productive dialogue, along with other stakeholders, to scope solutions to this issue.

Reference https://www.sciencedirect.com/science/article/pii/S0013935119305195?via%3Dihub

The Morrison government has announced the use of stopgap regulation to reinstate Australia’s complementary medicines industry's right to access the ‘Made in Australia’ logo. 

The Industry, Science and Technology Minister Karen Andrews announced the interim plans until legislation to change consumer laws can pass federal Parliament. 

The $5 billion dollar industry has been impacted since mid-2018 when reviews to Australian Made licensees commenced for medicines manufactured locally, affecting around 200 license holders. 

The change to Country of Origin laws inadvertently created a contradiction to the sector where a product is deemed to be manufactured in Australia under one law (regulated by the TGA), but not Australian Made under consumer law. 

The CMA called on the Government to expedite a regulation update to ensure advanced manufacturing of health products could continue in Australia. 

The announcement this week means that complementary medicines manufactured in Australian facilities regulated by the Therapeutic Goods Administration, can once again qualify to use the Made in Australia logo. 

CMA has strongly advocated for this decision, a decision which means that once again, Australian businesses can take advantage of access to new and bigger markets, including through free-trade agreements with China, Japan, Korea and Indonesia. 

Carl Gibson, Chief Executive of Complementary Medicines Australia (CMA), revealed that CMA continues to work collaboratively with stakeholders throughout the reforms with the Government and the Australian Competition and Consumer Commission (ACCC), but swift implementation of the regulation amendment must be delivered. 

“We welcome this interim measure which provides Australian manufacturers, industry and consumers with a sensible and practical resolution. The ability to use Made in Australia claims for complementary medicines manufactured in Australia to the highest standards in the world, has become a significant competitive advantage for Australian companies. Because of their reputation for quality and safety, our products are recognised and sought after globally. We should be proud that consumers around the world look to and trust these Australian credentials." 

This world-class reputation has resulted in Australia overtaking the United States to become the number one exporter of nutrition and health food products into China[1]. 

“I urge the Government to continue to support our industry’s remarkable export success by ensuring Australian-based manufacturers can continue to use ‘Made in Australia,’ for their Australian made products," ends Carl Gibson. 

Media Interviews Contact: CMA, Ravinder Lilly Ravinder.lilly@cmaustralia.org.au 

[1] Import of Nutraceutical and Health foods into China in 2018, CCCHMPIE, March 2019.

​The study: Are over-the-counter fish oil supplements safe, effective and accurate with labelling? analysed 10 New Zealand fish oil supplements attempting to assess the accuracy of labels.

The researchers initially claimed that over half the supplements were not correct their labels as far a concentration is concerned. They thus said that fish oil supplements were unlikely to provide the claimed health benefits.

The authors, Julia Rucklidge, Shelby Hantz and Ian Shaw were about to have the paper published in the New Zealand Medical Journal. But have retracted the paper admitting that they had made errors. Errors were thus made in calculating the amounts of EPA and DHA in five of the fish oil supplements. The authors, therefore, underestimated the doses.

Julia Rucklidge said the authors apologised for the error.

"As soon as we realised our error, we contacted the editor of the New Zealand Medical Journal to request that our paper be retracted," she said.

The study from Canterbury University NZ stated that 60 per cent of fish oil supplements didn't contain the advertised amount of omega-3 fatty acids.

A fundamental blunder

But the experts point out that there was a basic error in the calculation of omega-3s in the products.

"The study authors made a fundamental blunder in the calculation of the concentration of omega-3s in the range of capsules studied," said Lorraine Moser Chairperson of Natural Products New Zealand, the national industry organisation representing New Zealand's natural products and complementary medicines.

"Due to the calculation errors, the paper mistakenly concluded that 40% of the products tested for omega-3 fatty acids were accurate and true to label, while five others contained between 48 and 89 per cent of the amount listed. The paper stated that just one of the products contained the amount listed on the label.

“Though, 90% of the products met their label claims. The samples of 10 products were analysed by a reputable independent laboratory, which always conveys its results as the amount per gram.

However, the tested fish oil products were in different capsule sizes – some were 1 gram, others were 1.5 grams and 2 grams.

Not extrapolating the results = flawed results

When the laboratory analysed these capsules (according to its normal testing practices), it stated all findings in terms of the amount of omega-3 per gram.

But, when calculating the quantity of active ingredient in each capsule, the researchers failed to take account of the fact that the test results were in 1-gram units.

Inaccurate results

The results should have been extrapolated for larger capsule sizes. When assessing the label claims for products with 1.5-gram capsules, the researchers did not multiply the test results by 1.5 which would have given an accurate result.

Correctly extrapolating the test results for each capsule size has shown that all but one of the tested products were well within acceptable amounts related to their label claims.

Presenting fiction as fact

Ms Moser says the paper has presented label inaccuracy fiction as fact, needlessly damaging the industry's reputation and concerning consumers.

"New Zealand's natural health products industry has incredibly high standards in terms of product quality and ethical behaviour," said Ms Moser. "Ensuring natural health products are safe, effective and contain what is stated on the label lies at the very heart of what our members and we do. So, it is incredibly frustrating to see shonky research like this not only being published but also publicised," she says.

Australian complementary medicines – the benchmark for the world

Some of the tested products were cited to be of Australian origin.  Carl Gibson, CEO of Complementary Medicines Australia said: “Australian complementary medicines, are produced according to the code of Good Manufacturing Practice and regulated by the Therapeutic Goods Administration (TGA). The TGA sets exceptionally high quality and safety standards, standards that are viewed as the consumer protection benchmark. Consumers can rightly have every confidence in complementary medicines manufactured in Australia.”

A public apology is called for

Natural Health Products NZ wants the NZ Medical Journal to immediately retract the paper, remove it from their website, and issue a media statement to this effect.

A public apology for damage to the industry's local and international reputation – particularly companies that sell fish oil products is also being called for.

Retailers also deserve an apology because it is possible that publicity surrounding the erroneous research will affect their sales.

Media outlets that have covered the initial research have a moral obligation to balance that coverage with the issues raised here, so that consumers are made aware of the research paper's inaccuracies say Natural Health Products NZ.

The body will also be drawing this matter to the University of Canterbury's attention and requesting that it review processes associated with an earlier thesis upon which this paper is based, as well as on the paper itself.

Reference

Are over-the-counter fish oil supplements safe, effective and accurate with labelling? Analysis of 10 New Zealand fish oil supplements”, authored by Julia J Rucklidge, Shelby Hantzand Ian C Shaw.

The Morrison Government is progressing its 10-year National Preventive Health Strategy. The aim is to help Australians improve their health via early intervention, better information and the targeting of modifiable risk factors as well as the broader causes of poor health. The Strategy will provide clear and measurable proposals to empower Australians to take a proactive approach to their health and wellbeing.

Australia has the 8th highest proportion of overweight or obese adults aged 15 and over among 23. An incredible 67% of adults are overweight or obese, as are one in four children. [i]

Carl Gibson, Chief Executive Officer of Complementary Medicines Australia said that complementary approaches can play an important role in preventive and therapeutic health. He explains: “Where weight-loss is concerned, several complementary approaches may be used. These may help people to make better choices and include mindfulness, healthy nutrition and stress reduction.”

Examples of complementary approaches are:

·         Dietary supplements and herbal preparations – with various functions from increasing the feeling of fullness to inhibiting appetite and antidepressant qualities.

·         Acupuncture – the ancient Chinese therapy that involves the insertion of fine needles into the body at specific points. Acupuncture may enhance body function.

·         Meditation – to help reduces stress and anxiety and may thus help to ease emotional and compulsive eating. Mindful meditation may help enhance clarity and encourage healthier choices.

Trained and experienced practitioners can provide expert knowledge and advice of their own

[i] https://www.aihw.gov.au/reports-data/behaviours-risk-factors/overweight-obesity/overview

It affects around one in five Australians - that’s nearly 4.5 million people – and it’s the result of an allergic reaction[i].

Hay fever causes red, itchy eyes, and a runny or congested nose and it’s most common in people ages 15-59 years according to the Australian institute of Health and Welfare.

Conventional medical approaches fall into three groups: antihistamines which block the release of histamine (the hormone responsible for the swelling and congestion), steroid-based nasal sprays and decongestants such as ephedrine. There are a few more natural or traditionally used approaches too!

1. Vitamin C

Like chimpanzees and guides pigs, we humans can’t make their own vitamin C which is why this delicate but powerful water-soluble vitamin is called an essential nutrient. It’s delicate because vitamin C is lost when exposed to heat and air and leached out in cooking water. It’s powerful it is a powerful antioxidant, protecting cells from free radical damage.

Also known as ascorbic acid, body cells and tissues contain large amounts of this vitamin. White blood cells (leukocytes), the eyes, the adrenal and pituitary glands contain the highest amounts. Research shows that vitamin C supports many aspects of immunity including the production and function of leukocytes involved in immunity. Vitamin C also regenerates other antioxidants including alpha-tocopherol and in this way, it has an indirect positive effect on immunity. Vegetables and fruits are great food sources - citrus fruits, berries, kiwi and capsicums are particularly rich.

2. Quercetin

This bioflavonoid compound is present in many vegetables and fruits green tea and wine. Research suggests that quercetin might be an effective antihistamine, as it restricts histamine from being released from cells[ii]. Its antioxidant properties may help reduce inflammation and allergy symptoms.

Laboratory and animal studies found that quercetin may block enzymes involved in inflammation and suppress inflammation-promoting chemicals, such as histamine.

Quercetin is not well absorbed on its own which is why supplements may include other compounds, such as vitamin C or digestive enzymes like bromelain; these may increase absorption[iii] [iv]. Pineapple is rich in bromelain which has strong systemic anti-inflammatory effects and may help to reduce mucosal inflammation and nasal congestion.

Research indicates that quercetin works synergistically with other flavonoids, such as resveratrol, genistein, and catechins.

Quercetin may interact with some medications, including antibiotics and blood pressure medications.

3. Probiotics

Researchers have found that both Lactobacilli and Bifidobacteria spp helped to ease hay fever symptoms and improved quality of life during allergy season[v].

Other research has shown taking L. acidophilus for four months reduced nasal swelling and other symptoms in children with perennial allergic rhinitis[vi].

4. Turmeric

Cooking or seasoning foods or drinks with turmeric may also be effective. Turmeric contains anti-allergic and natural decongestant properties and this popular and traditionally used spice suppresses allergic reactions[vii].

As with any supplement, consult your healthcare provider before taking.

[i] https://www.aihw.gov.au/reports/chronic-respiratory-conditions/allergic-rhinitis-hay-fever/data

[ii] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5214562/ [iii] https://pubchem.ncbi.nlm.nih.gov/compound/Quercetin [iv] http://www.foodandnutritionjournal.org/vol04nospl-issue-conf-october-2016/bioavailability-of-quercetin/ [v] https://www.sciencedaily.com/releases/2017/03/170301142203.htm

[vi] (https://www.ncbi.nlm.nih.gov/pubmed/15653517

[vii] https://www.omicsonline.org/open-access/pharmacological-activities-of-tur

16 September 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.

Read the full report about our Australian success story here.

For more information, contact:

Ravinder Lilly corporate marketing communications manager
E-mail: Ravinder.lilly@cmaustralia.org.au

A study published in the Journal of Pharmaceutical and Biomedical Analysis, highlights that inappropriate substances were found in several herbal medicines purchased from Australian pharmacies and other outlets. Again, Complementary Medicines Australia (CMA) wishes to share the facts about this world-leading complementary medicines industry in Australia. And why Australians can be confident in the Therapeutics Goods Administration (TGA) listed and registered products which have been subjected to the highest standards of quality control and testing in the world.

Australian manufacturing
“The Complementary Medicine (CM) industry expected to be worth an estimated US$180 billion by 2020,” say the authors and this is an Australian success story. An increasing number of jobs in Australia rely on this exemplary industry. And, worldwide, discerning companies and consumers have done their research and want to purchase complementary medicines from our highly regulated industry.

“It is of zero benefit for the industry to intentionally adulterate products and damage this important and blossoming industry in this country. Our quality control is world-class. Our reputation relies on it,” says Carl Gibson CEO of Complementary Medicines Australia (CMA).
 
Australian standards = the global benchmark
Australia has the most highly regulated environment in the world for complementary medicines. These are manufactured to a pharmaceutical standard under principles of Good Manufacturing Practice (GMP). Products meet strict guidelines set by the TGA. For Australian products, what you read on the label is what you get inside.
 
Widely, vociferously and repeatedly stated
Products in the study were purchased in Australian capital cities; pharmacies, health food stores, traditional herbal retailers and online. It has been widely, vociferously and repeatedly stated that the CMA does not recommend products from overseas be purchased online or in person. 
 
Regulation and testing
Stringent regulations are applied when Australian products are manufactured and distributed. And, the TGA also conducts post-market control to monitor the continuing quality, safety and efficacy of CMs via:
·        Auditing good manufacturing practices
·        Selected and random audits of Listed products, laboratory testing of products and surveillance in the marketplace
·        A strong pharmacovigilance program, which involves the assessment of adverse events that are reported to the TGA by consumers
·        Implementation of an effective, responsive and timely recalls procedure
·        The placement of controls for the advertising of therapeutic goods.
·        Batch testing of finished products (tablets /capsules) that verifies the consistency and quality of the active ingredients within the label claim. To enhance consumer safety and confidence in Australian products and ensure compliance post-market and prevent potentially dangerous products from being sold in the first place.

To be a listed medicine on the Australian Register of Therapeutic Goods (ARTG) a product:
•    can only contain certain low risk ingredients in acceptable amounts that are permitted for use in listed medicines by the TGA
•    must be manufactured in accordance with the principles of Good Manufacturing Practice (GMP)
•    can only make indications (for therapeutic use) for health maintenance and health enhancement or certain indications for non-serious, self-limiting conditions.
 
Along with the requirement to comply with the TGA’s mandated standards, Carl Gibson stresses that many factors determine the overall quality of ingredients in complementary medicine including their design, development, in-process controls, GMP controls, and process validation plus by specifications applied to them throughout development and manufacture.

“The compositional guidelines, specifications, and monographs are an important component of quality assurance, but these aren’t the only important factors. All of these considerations are necessary to ensure consistent production of high-quality complementary medicines,” says Carl Gibson.

He adds: “Be assured, where complementary medicine products, including herbal medicines are concerned if you see a product in your pharmacy which is registered on the Australian Register of Therapeutic Goods (ARTG) the accurate identification of medicinal herbs is a legal requirement. It would not be possible to meet consumer expectations without it.”
 
Complementary medicines in Australia are more strictly regulated than products from the USA and even the UK, complementary medicines, including finished product herbal medicines. DNA barcoding is not considered to be the most appropriate testing method for authenticating products, especially those that contain herbal medicines and botanical extracts.
 
Those complementary medicines sold legally in Australia must be entered on the ARTG. They are subject to assessments and requirements related to quality and safety, including:
•         Verification and identification testing methods include botanical taxonomy, macroscopic and microscopic examination, and chemical methods.
•         The utilisation of ingredients assessed as safe and allowed at safe levels by the TGA.
•         Stability studies to ensure that the product remains effective and safe throughout its shelf life.
•         Product quality reviews to ensure that quality data is aggregated and tracked over time, allowing the industry to identify and act on any emerging trends.
•         The rigorous capturing and monitoring of adverse events by the TGA so that any emerging issues can be identified and addressed promptly. Labels of Australian products state that consumers should seek the advice of their healthcare practitioner.
 
The anti-natural medicine lobby
The minority group, Friends of Science in Medicine (FSM) is an anti-natural medicine lobby group. One of the researchers of this study, Dr Ian Musgrave, is an active member of this anti-complementary medicines group. Among many activities, they attempt to sully the term traditional medicine. But research is increasingly showing the reason why certain traditional medicines have stood the test of time and has even saved millions of lives. (reference http://www.cmaustralia.org.au/Media-Releases/7860867)
 
Look at the Australian label
“Just look at the label,” Says Carl Gibson. The Department of Health’s Therapeutic Goods Administration requires that several compulsory statements are made on Australian complementary medicines labels.
 
Combatting intentional and unintentional adulteration
Regarding the suggestion that Australian products are contaminated, Carl Gibson points to the GMP followed by Australian manufacturers. “And to help ensure that the Australian complementary medicines industry is informed and forewarned about any possible quality issues with raw materials. CMA and the Australian complementary medicines industry support the work of the American Botanical Council (ABC)” says Carl Gibson.
 
ABC Founder and Executive Director, Mark Blumenthal said: “The Botanical Adulterants Program informs the industry worldwide about the most common causes of both intentional and unintentional adulteration. It provides the tools for product sponsors to combat those causes of unintentional adulteration when developing or reviewing strategies for minimising risk.”
 
Consumers of Australian made CM products can be confident that they are manufactured according to the highest standards. However, this confidence does not extend to products that are not regulated as medicines or bought online or from overseas.
 
Last word
Products from overseas or purchased online outside of Australian domain sites are not subject to such tight controls including those to ingredients, warnings, recommendations, contraindications and therapeutic claims. “The stringent regulations enforced in Australia don’t apply to these products,” says Carl Gibson.
 
Online purchases should only be made on the recommendation of a qualified healthcare professional or bought from a known and reputable source.
 

For more information, please contact Ravinder Lilly on Ravinder.lilly@cma.org.au