Clarifying eligibility for origin claims in the Complementary Medicines Sector

Ocean Oils Pty Ltd is the only Australian Manufacturer of premium grade Squalene and Shark Liver Oil (SLO). It is amazing to note that NOT ONE Complimentary Medicines (CM) player in Australia chooses to use Australian Squalene or SLO yet there are countless CM players claiming to do so. In order to maximise profit, all are instead using cheaper, inferior imported ingredients and use the ‘Australian Made’ logo and endorsement to legitimise and masquerade their imported materials as being Australian in origin and manufacture.

In addition, all are in various ways falsely claiming and/or inferring their imported ingredients are derived from high quality Australian sources in order to sell to unsuspecting consumers in Australia and internationally their fully imported products.

For many years the Complimentary Medicines (CM) sector has promoted itself as ‘squeaky clean’ when an abundance of evidence shows the opposite to be true. It has enjoyed a dream run in its unethical activities with no accountability or scrutiny by government or relevant authorities or to the consuming public in Australia and overseas or to other sectors of genuine Australian industry upon whose hard won reputation it parasitically relies.

Of the options presented, Option 3c is the only viable option likely to provide consumers with some real indication of the origin of the ingredients in CM products (aka Health Food Supplements) they are buying.

To enable consumers (and we are ALL consumers) to make an informed choice, this 3c option or similar needs to be mandatory and enforceable by the authorities and must clearly show the percentage content and country of origin of ALL ingredients in a CM product on the product labelling and attendant advertisements.

Consumers demand and deserve TRUTH IN LABELLING and genuine Australian producers deserve to be recognised and supported by the implementation of such an instrument.

Were we such a party, we would still insist the need for a system such as that proposed in option 3c; but definitely not 3a.

Options 3a, as promoted by CMA Australia, is an open licence for the sector to continue and increase its preferential use of cheaper, imported ingredients that are then endorsed as ‘Australian Made’ and masqueraded as Australian.

The current rotten practices of using and promoting fake imported products as ‘Australian’ preferentially enriches numerous unscrupulous players in the CM sector now dominated by Chinese interests and is at the great expense of genuine Australian producers and ingredient manufacturers. This extremely unfair situation is in desperate need of review and change.

For more than 20 years, Ocean Oils Pty Ltd has been a trusted ingredient supplier to the complimentary medicines sector internationally and in Australia, with our major partners in Japan, USA and China. Such partners promote our ethically sourced products as Australian in quality, origin and purity.

Formerly, we supplied significant quantities to Australian pharmaceutical companies but, due to the CM sector's increasingly destructive practices enthusiastically supported by the AMCL's endorsement of entirely fake 'Australian' Squalene and SLO products with false content, origin and purity claims overseen and condoned by the Therapeutic Good Administration (TGA), there is much open counterfeiting and misrepresentation in store and online of substitute imported material ingredients by numerous unscrupulous CM players as 'Australian'.

Consequently, since 2012, requirements with Australian pharmaceutical companies for Australian Squalene and SLO have fallen to zero. Without exception, they now use cheap, inferior ingredients of dubious origins and openly cheat and lie to the authorities and market about their quality and origin in order to find favour in the eyes of the unsuspecting consumer who is seeking truly genuine Australian products.

The use by the CM sector of the ‘Australian Made’ logo and endorsement is crucial in this deception.

This unethical and unlawful behaviour within the CM sector occurs without penalty or interference despite all relevant authorities, including the TGA, AMCL and the Department of Industry, Innovation & Science being fully aware of the facts in this sad and disturbing situation.

Any robust and thorough audit of this bizarre situation would prove the above facts to be so.

For numerous reasons as stated above, it is evident to us the current 'Australian Made' endorsement situation for CM products is a farce and the plethora of fake ‘Australian Made’ endorsed Squalene, SLO and other products clearly indicates that proper administration of the logo is hopelessly inept or inadequate.

Regrettably this all occurs at the neglect and great expense of genuine Australian producers and ingredient manufacturers who struggle to compete against the fake competition.

If properly and competently managed and enforced with suitable penalties where applicable, a different, improved AM logo eligibility criteria for the CM sector (that shows the proportion and origin of all ingredient material) would have an extremely positive impact for Australian food producers, ingredient manufacturers and for all consumers.

Given that the CM sector so admires the ‘Made in Australia’ image they promote on their products made entirely from imported materials, it would be a refreshing change for the sector to instead embrace the use of genuine Australian ingredients (rather than the tactic of using cheap imported substitutes and intentionally misleading consumers about their origin). Adherence to improved origin labelling requirements enable the sector to honestly state the Australian content on their labels and advertising.

The current widespread misuse of the AM logo use by the CM sector is entirely biased and extremely unfair. Genuine Australian food producers and ingredient manufacturers have built the hard won reputation for Australian quality upon which the counterfeiters parasitically rely and unfairly benefit.
Australian and international consumers deserve better.

In the CM sector, there is a desperate need for the enforcement of TRUTH IN LABELLING. Regrettably, this is something against which the sector has been desperately and cunningly lobbying for years.

For the sake of all consumers and genuine Australian producers and ingredient manufacturers, the CM (Health Food Supplement) sector needs to be subject to the same labelling requirements as any others in the food sector where the origin and proportion of their ingredients are fully disclosed together with any 'Australian Made' endorsement, either by bar chart or percentage table or some equally clear, transparent and enforceable mechanism.

It is a fact in the marketplace that Australian and international consumers preferentially choose food and food ingredient products that they believe to be of Australian origin.

Showing the actual ingredient content, proportion and origin of ALL ingredients is crucial if the real agenda by the CM sector and relevant authorities is that there be TRUTH IN LABELLING.

Option 1 – decadal average financial impact based on the past and current impact of activities in the CM sector due to on-going substitution and misrepresentation of Australian Squalene and SLO products by imported fakes. Also facilitates on-going confusion for consumers.

Option 2 – decadal financial impact based on past and current impact of activities in the CM sector due to on-going substitution and misrepresentation of Australian Squalene and SLO products by imported fakes. Given the current intentionally misleading and deceptive practices in the CM sector, this option is estimated to have a similar outcome and consequences for Australian ingredient suppliers to scenario 1. Also facilitates on-going confusion for consumers.

Option 3a – decadal on-going and increased financial impact based given the current observed lack of any effective regulation of the CM sector by the TGA for Squalene and SLO products.

It is extremely disturbing to us and to many consumers that the TGA indicates it has NO real specification, formulation or monograph for Squalene or Shark Liver Oil nor does it engage in enforcement of any relevant product quality control. We also witness that it allows numerous entities registered to pack Squalene and SLO to freely engage in intentionally misleading and deceptive product content, purity and origin labelling and advertising.

The effects of the TGA’s apparent apathy and mismanagement of the CM sector on Australian businesses striving to produce quality materials/ingredients are already disastrous and, under Option 3a, would be even more profound to say the least.

The very consideration of this extremely dangerous and naïve option shows a high level of bureaucratic ignorance, apathy and/or misunderstanding of current unscrupulous activities within the CM sector.

Option 3a would provide enhanced licence for unscrupulous CM players to continue and enlarge their intentionally misleading and deceptive activities using fake imported products.

It also facilitates on-going confusion for consumers.

Showing the actual ingredient content and origin of ALL ingredients is crucial if the intent is that there is to be TRUTH IN LABELLING.

Option 3b – based on decadal purchasing and usage trends in the CM sector.

This option may provide encouragement for some CM players to use genuine Australian ingredients rather than fake imported ones.

Consumers would have a vague choice of 'Australian' vs 'Imported' ingredients that may in turn support the use of Australian raw materials and ingredients.

Regrettably, under this option, the origin and proportion remains unknown/unstated and this generates on-going confusion for consumers.

Option 3c - Of the options offered, and if mandated and enforced by government in the CM sector, this would be the best outcome for Australian and international consumers.

Of those presented, we believe Option 3c to be the best option to encourage and promote the use of genuine Australian ingredients/ raw materials by the CM sector seeking to use the AM logo and endorsements and promote their products as Australian in content and manufacture.

This question appears to be a repeat of question 11....????

Under options 1, 2 and 3a, Australian raw material and ingredient manufacturers and their loyal suppliers will continue to be undermined, counterfeited and usurped by imported imitations. It will be increasingly difficult for suppliers of genuine Australian raw materials and ingredients to survive.

In order for players in the CM sector to justifiably access the coveted 'Australian Made’ logo and endorsement, Option 3c engages with the CM sector to seek and preferentially use Australian materials/ingredients over its present widespread practice of packaging imported ingredients that are misleadingly and deceptively promoted as Australian.

Innovative Australian raw material and ingredient start-ups wishing to supply the CM sector would also greatly benefit from better product content and origin labelling requirements because of the mandated recognition of genuine Australian content in a world where genuine Australian content and origin is preferentially sought and desired.

Option 1 - Continuation of the status quo. Our loyal international customers and distributors in China, Japan and USA that are struggling to market and support genuine Australian Squalene and SLO materials in their respective marketplaces against imported ‘Australian Made’ fakes will face continued and unfair competition against such products masquerading in store and online as 'Australian'.

Option 2 - ditto

Option 3a - Our loyal international customers and distributors in China, Japan and USA that are struggling to market and support genuine Australian Squalene and SLO materials in their respective marketplaces against imported ‘Australian Made’ fakes will face continued and unfair competition against such products masquerading as 'Australian'.

To legitimise and advance their current deceitful and dishonest practises, Option 3a will grant CM players and their numerous counterfeit (fake) Australian products even easier and unquestioned access to the 'Australian Made' logo.

Option 3b - Provides some recognition of Australian material/ingredient content in the CM sector.

Option 3c – Of the options offered, Option 3c provides for a real and clear recognition of Australian material/ingredient content and proportion.

In the global marketplace, it is evident that genuine Australian content is seen as an extremely positive feature and the promotion of same is an effective marketing tool.

If mandatory, enforced and properly administered, Option 3c would substantially assist in ending the deception to the consumer and encourage the CM sector to seek and use Australian raw materials and ingredients over inferior imported materials that are currently masqueraded as Australian.

We are keenly aware consumers prefer Australian over inferior, imported and unethically sourced Squalene and Shark Liver Oil and that is why the evidence shows that so many players vending these products go to greatly lengths to intentionally misrepresent the quality, composition and origin of their products as Australian.

Please see the attached two documents in support of this submission:-

1. 2016-10-03 Research Paper and attachments - TGA registered & approved Squalene 'Made in Australia .pdf
2. 2019010-13 A Study of TGA registered Complimentary Medicines - Use and Abuse of the AMCL logo and False claims for Squalene .pdf

Thank you for reading.