Medicine products

Food and drug regulations do not protect consumers

There seems to be no end to the chain of producing so-called “therapeutic” products promoted to trusted consumers by companies willing to make untested claims.

The latest is Souvenaid®, a product promoted as a “medical food” for “the treatment of mild Alzheimer’s disease” by its manufacturer, Nutricia Australia Pty Ltd.

Souvenaid spruikers also claim that he is “clinically proven”. He recently featured as a “memory drinkOn Channel 9’s A Current Affair (with medical approval) and has been heavily promoted in pharmaceutical publications.

Ken Harvey, co-author of this article, has filed complaints with the Therapeutic Goods Administration (TGA) and the Therapeutic Goods Complaints Resolution Group (CRP), arguing that the promotion of Souvenaide violates the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code. 2007.

This is because the product appears to be a therapeutic good but is not listed in the Australian Registry of Therapeutic Goods (ARTG) and has not been approved for promotion as therapy for serious illness.

Souvenaid contains a blend of omega-3 fatty acids, vitamins, minerals and other nutrients recommended by Australian Food Guidelines 2013. With one exception (uridine monophosphate), all ingredients are listed as suitable for use in complementary medicine by the TGA.

The claims, ingredients and recommended dose meet the definition of a therapeutic good in the Therapeutic Products Act, 1989. If Souvenaid was classified as a therapeutic good, it should be listed with the TGA on the ARTG and comply with Advertising Code for Therapeutic Products 2007.

The advertising code prohibits the promotion of products for serious illnesses such as Alzheimer’s disease. It is possible to obtain advertising approval from the TGA for a restricted representation but a dossier must be presented, including supporting evidence and an explanation of why approval would be in the public interest.

The Code also prohibits the approval of products by healthcare professionals and requires that advertisements be pre-approved. It is said:

an advertisement for vitamins does not imply that vitamin supplements are a substitute for good nutrition or a balanced diet.

The Code also gives clear advice on the use of the words “clinically proven”. Although the absence of sanctions from the Codes is a constant cause for concern, it Public accountability, otherwise repair.

Souvenaid Manufacturer complaints that the ingredients in a vial (the recommended daily dose):

provide the nutritional benefit equivalent to 1 kg of tomatoes, 1.2 kg of broccoli, 710 g of spinach, 100 g of fresh tuna, 100 g of ground beef, 4 eggs, an orange and a handful of Brazil nuts.

But this “equivalence” of product ingredients with nutritious foods undermines the epidemiologically proven value of a Mediterranean diet and the 2013 Australian Dietary Guidelines. dietary alternatives to “medical foods” have been shown to reduce the risk of developing memory impairment and dementia, as well as the burden of symptoms after diagnosis. Such diets also protect against heart disease.

In addition, the results obtained in the scientific studies cited by the manufacturer are largely lacking in statistical significance, or are of questionable clinical significance and not in accordance with the CRP guidelines on “clinically proven”.

There is a “help sheetAbout the product on the Alzheimer’s Australia website. This claims that Souvenaid® is a “food for special medical purposes” under Standard 2.9.5 of the Food Standards Code of Food Standards Australia New Zealand (FSANZ).

The case raises important questions about the consistency of regulations on medicines and food. The sale and provision of food is governed by the food laws of the states and territories, while the import of food is subject to the laws of the Commonwealth.

The manufacturer’s website places great emphasis on taking Souvenaid under medical supervision, but it (and online pharmacies) promotes sales “for the treatment of mild Alzheimer’s disease” directly to consumers online.

The CRP and TGA have now referred the complaint to the NSW Food Authority. It will be interesting to see what will happen. There is an increasing tendency for manufacturers of products formerly known as “complementary medicines” to redefine them as foods.

Reducta Fat Blaster (ARTG no: 176366), for example, containing the infamous Slimaluma (caralluma adscendens var. fimbriata) was canceled from the ARTG by the TGA but reappeared as Reducta FatBlaster Shake promoted for “appetite control”.

Food advertising standards should be harmonized with the Therapeutic Products Advertising Code. In addition, effective and timely sanctions must be provided for violations of the advertising code, whether related to a food or a therapeutic product.


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