This case is yet another example of a major discrepancy in consumer protection between therapeutic claims made for medicines for which the Therapeutic Goods Advertising Code applies (administered by the TGA), compared to therapeutic claims made for food for which FSANZ standards apply (administered by State & Territory Food Health Departments).
Avemar Australia sells sachets & tablets containing 14.5 grams of powdered fermented wheat germ extract to consumers and practitioners, via the Internet. The price (including delivery) for 1 box (30 sachets, one month’s supply) is $220AUD.
The product is claimed to be a Food for Special Medical Purposes for cancer patients undergoing clinical oncological treatments such as chemotherapy, radiation, and immune therapies.
Food Safety Australia New Zealand (FSANZ) set food standards which are enforced by Australian State and Territory governments. Standard 2.9.5 defines Food for Special Medical Purposes as foods formulated for individuals who have special medically determined nutrient requirements or whose dietary management cannot be completely achieved without the use of the food. They are also intended to be used under medical supervision.
I am unaware of any evidence that supports the first two conditions applying to the product in question. In addition, this product is sold to consumers directly over the internet which contradicts the intended use of being under medical supervision.
A cancer patient found a bundle of Avemar brochures displayed, without permission, on an information table next to the ‘cancer patient only’ entry corridor inside the ICON North Lakes Cancer Centre, Qld.
The above claims are not in accord with the body of clinical evidence applicable to this product. A recent Australian systematic review of the effectiveness of Avemar as adjunct therapy in the treatment of cancer concluded that its clinical effectiveness has yet to be established. The U.S. Memorial Sloan Kettering Cancer Center notes that human studies are limited, and benefits must be confirmed by large-scale well-designed clinical trials.
If this product were classified as a therapeutic good, the above claims could constitute multiple breaches of the Therapeutic Goods Advertising Code. In addition, the product is promoted to cancer patients, a group especially vulnerable to such claims. Promoting a product for cancer is a prohibited representation and a serious breach of the Therapeutic Goods Act 1989, and the Therapeutic Goods Advertising Code (No 2) 2018.
However, food sponsors can self-declare their product a Food for Special Medical Purposes without any pre-market assessment by FSANZ or other authorities and the controls on advertising for therapeutic goods do not apply. In addition, Standard 2.9.5 has contradictory clauses with respect to claims and use under medical supervision.
Clause 2.9.5—4, “A claim in relation to food for special medical purposes must not: (a) refer to the prevention, diagnosis, cure or alleviation of a disease, disorder or condition…”.
Clause 2.9.5—10, says the following statements are required, (c) a statement indicating the medical purpose of the food, which may include a disease, disorder or medical condition for which the food has been formulated; and (d) a statement describing the properties or characteristics which make the food appropriate for the medical purpose indicated in paragraph (c)”.
Clause 2.9.5—5, says, “A food for special medical purposes must not be sold to a consumer, other than from or by: (a) a medical practitioner or dietitian; or (b) a medical practice, pharmacy or responsible institution; or (c) a majority seller of that food for special medical purposes (which is a let-out clause from ensuring medical supervision).
We are left with a major discrepancy in consumer protection between therapeutic claims made for medicines for which the Therapeutic Goods Advertising Code applies (administered by the TGA), compared to therapeutic claims made for food for which FSANZ standards apply (administered by State & Territory Food Health Departments). Previous publicised cases have involved Souvanaid, and Neurofolin, but the underlying problems remain unresolved.
The TGA eventually declared the ingredient of Neurofolin, L-Methylfolate (Levomefolic acid) to be a therapeutic good, see: https://www.legislation.gov.au/Details/F2019C00884.Which solved this case but did nothing about the underlying problem – that food sponsors can self-declare their product a Food for Special Medical Purposes without any pre-market assessment by FSANZ or other authorities and thus avoid advertising controls on therapeutic goods.
This case is more serious as it involves claims for cancer. I argue that FSANZ is responsible for this ongoing lamentable situation. FSANZ have failed to urge the government to apply pre-market evaluation to Food for Special Medical Purposes, failed to resolve contradictions in the Standard and failed to effectively liaise with the TGA to harmonise advertising standards across the food-medicine interface.
A complaint about the promotion of Avemar has been submitted to Food Safety Standards and Regulation Queensland and copied to FSANZ, TGA and ACCC (20 August 2021).
Mark Booth (past CEO of FSANZ) responded to my concerns about these problems in 2019. He left FSANZ on 6 August 2021 to take up a role in the private sector.
As you are aware, FSANZ’s role is the development and amendment of the food standards that comprise the Code. It does not enforce the Code or provide advice on compliance issues.
Premarket approval for Foods for Special Medical Purposes (FSMP) was not considered warranted when Standard 2.9.5 was developed by FSANZ and approved by the Ministerial Forum on Food Regulation in 2012.
Like other Standards in the Code, Standard 2.9.5 sets standards which various food laws require industry to comply with. It is for industry to determine whether or not their products comply with those laws and standards. If their products do not, they face the prospect of compliance action and sanction under the food laws.
This approach, together with the composition, labelling and other restrictions placed on FSMP by Standard 2.9.5, was considered appropriate given FSMPs’ purpose and role and their importance to those who must rely on them for their nutrition.
Update 30 August 2021
Still no acknowledgement of complaint sent on 20 August 2021, however, after many phone calls I found it has ended up at the Qld Gold Coast Public Health Unit. They told me they have started to assess the product (and its promotion) against FSANZ Standard 2.9.5.
They have now learnt that the TGA has contacted the Qld Government Food Safety Standards and Regulation (FSSR) advising that the TGA will be submitting the product to the Food Medicine Interface Working Group for assessment to determine if it should be regulated as a food or as a therapeutic good. If the latter, it will not be followed up by the Qld Gold Coast Public Health Unit.
Update 31 August 2021
From email@example.com. “Please be advised that Avemar Granulate and Avemar Tablets from Avemar Australia (Medimpex Pty Ltd) have been assessed by Queensland Health and are of the view that Avemar Granulate and Avemar Tablets are likely therapeutic goods. As such the matter will be referred to the Therapeutic Goods Administration for their appropriate action.”
“I should be grateful if you could explain the reasoning behind your conclusion that Avemar Granulate and Avemar Tablets are therapeutic goods?
Avemar is derived from wheat germ that is traditionally included in health foods. It is produced by fermenting wheat germ with Saccharomyces cerevisiae (Baker’s yeast), followed by separation of the fermentation liquid, drying, and granulation. Aglycone-type 2-methoxy benzoquinone and 2,6-dimethoxybenzoquinone have been recognised as the most important bioactive compounds of this preparation. Sourdough, fermented with Lactobacillus plantarum LB1 and Lactobacillus rossiae LB5, produces similar quinones.
I used the TGA’s Food-Medicine Interface Guidance Tool (FMIGT), attached, which said the product is not a therapeutic good because there is a ‘standard’ in the Food Standards Code.
I did argue that this product did not fulfill the requirements of Standard 2.9.5, but the TGA’s FMIGT says, “Even if: there are therapeutic claims made about the product, it contains undisclosed Schedule 4 substances (such as sildenafil), or the product fails to comply with the requirements of the standard, it will not be a therapeutic good if it is a good to which that standard applies.”
From firstname.lastname@example.org. “You are correct to examine the requirements of standard 2.9.5 Food for special medical purposes as this is how the product has been marketed. However, the products do not fit within that standard. You might refer to the definition within 2.9.5-2.
The products in their present formulation, containing negligible nutrients in a dosage size with dosage directions and claims made, do not fit within standard 2.9.5. In their current form they are likely therapeutic goods. As such, the matter is referred to the Therapeutic Goods Administration.
You will need to direct any queries regarding the Food-Medicine Interface Guidance Tool to the Therapeutic Goods Administration as this is not a Queensland Health site.”
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