Gummy vitamins that are being marketed to children are unhealthy and exploitative products, and their regulation should be reviewed.
That is the call for action from the authors of the article below: Associate Professor Ken Harvey from the School of Public Health and Preventive Medicine, Monash University, Eliza Li, a biomedical science and business student at Monash University, Dr Rosemary Stanton, a nutritionist and Visiting Fellow at UNSW, and Professor Stuart Dashper, Senior Principal Research Fellow at the University of Melbourne.
Beneath their article, which was first published at The Conversation, is an exchange of correspondence with the TGA.
Ken Harvey, Eliza Li, Rosemary Stanton and Stuart Dashper write:
There are many brands of kids’ “gummies” on the market. They are promoted as deliciously flavoured and a great way for growing bodies (and fussy eaters) to get the nutrients they need.
The “active” ingredients are usually listed as vitamins, minerals and sometimes omega-3 fats and vegetable powders. They may say “contains sugars” or they may not. Rarely, some list an amount of sugar and other ingredients such as food acids like citric acid, lactic acid and ascorbic acid.
In our opinion, these products are unhealthy and exploitative. Their high sugar content may appeal to young children, but they’re not a good introduction to a healthy diet.
The problem of tooth decay
Dental caries are a significant Australian public health problem. In 2014-15, A$9.5 billion was spent on dental services in Australia, up from $6.1 billion in 2007–08. In Australia, around 50% of children start primary school with largely untreated cavities. In Victoria, 7.1% of children aged under 12 have had a general anaesthetic for dental treatment.
Sugars provide food for the bacteria that dissolve tooth enamel. As sugar consumption increases, so do cavities. This damage is irreparable and individuals are left with life-long problems that require fillings, and possibly root canal work or extractions.
In addition, food acid (especially citric acid) causes dental erosion that can lead to the progressive loss of the surface of the tooth. This may require complex and lengthy treatment involving fillings, veneers and crowns. The sticky consistency of “gummies” adds to the problem.
The World Health Organisation (WHO) says higher rates of dental caries occur when the intake of free sugars (added sugar plus honey, syrups and sugars in fruit juices) is more than 10% of total energy intake. This is despite fluoride in drinking water and using toothpaste.
Dental caries rates decline progressively as sugar intake is reduced to less than 5% of total energy intake. Hence, for a range of health reasons, the WHO recommends we get no more than 5 to 10% of our daily energy from free sugars.
So, two- to three-year-olds with a daily energy intake of 4,300 to 5,450 kilojoules (kJ) shouldn’t consume more than a maximum 430 to 545 kJ, or about six to eight teaspoons (25-32g) of free sugar a day, and preferably half that amount. And four- to eight-year-olds, with a daily energy intake of 5,700 to 7,100 kJ, shouldn’t consume more than 570 to 710 kJ, or about eight to ten teaspoons (33-42g) a day, and again, preferably half that.
Contrary to this advice, 50% of Australian children aged two to three, and 67% of four- to eight-year-olds, consumed more than 10% of their total energy from free sugars in 2011-12. The top 10% of two- to three-year-old boys consumed 18 teaspoons (70g), rising to 23 teaspoons (90g) in the top 10% of four- to eight-year-olds.
Knowing how much sugar is in what we eat
Part of the problem is there is currently no clear way of knowing how much sugar has been added to a product (including gummies) by looking at the ingredients listed on the label. Choice (the Australian Consumers’ Association) is campaigning for food and health ministers to act on added sugar labelling so consumers can limit their consumption, as advised by the WHO and other authorities.
“Gummies” also exemplify the problem of regulating products at the food-medicine interface. Some of these products, such as the Kids Smart Vita Gummies above, are listed with the Therapeutic Goods Administration (TGA) as complementary medicines.
For complementary medicines, there is a requirement to declare the presence, but not the quantity, of sugars on the label.
For no apparent reason, other “gummies” such as Bioglan Omega 3 Fish Oil Kids Gummies have not been listed with the TGA and may be classified as foods by their sponsor.
For food, there is a requirement by Food Standards Australia New Zealand (FSANZ) to disclose the total content of sugars on the nutrition information panel on the product label.
The Bioglan website states each bottle of 60 gummies contains 168g of product; an average serving is two gummies (5.6g), which the formulation states have 3g sugar (54% by weight). They also stated there was 3mg of sugar per 100g of product which is clearly mislabelled; 100g of product must contain 54g of sugar, not 3mg.
Using the TGA Food-Medicine Interface Guidance Tool, we determined this product was a food, so we sent a complaint about mislabelling to the NSW Food Authority. However, they advised us to send the complaint to the TGA. The TGA response ignored our concern about mislabelling. We also asked why there were different sugar labelling requirements for foods compared to medicine. The TGA stated the warning statement, “contains sugar”, serves as an advisory without unnecessarily deterring general consumers from taking a medicine they may need.
It is our view “gummies” that contain food acids, and have a high sugar content, are not medicines consumers need, and their sale should be prohibited on public health grounds. At the very least, the amount of sugar (and the presence of food acids) should be disclosed.
Health benefits dubious
In addition to the high and damaging sugar content, we argue these are exploitative products that mislead consumers about the benefit of dietary supplements.
Both the website and the label of Kids Smart Vita Gummies Multivitamin for Fussy Eaters say the zinc content will boost the appetite of a “fussy eater”. Zinc is readily available in foods such as meat, fish and poultry while cereals, grains and dairy foods also contribute substantial amounts. We are unaware of any evidence that zinc boosts the appetite of “fussy eaters”.
Kids Smart omega-3 supplementation claims “to help support brain function, growth and development”. The US Food and Drug Administration recommends eating oily fish two to three times a week. They do not recommend taking omega 3 supplements, reflecting findings that randomised controlled trials of fish oil supplementation have generally been disappointing and fish contain many more nutrients than omega-3 supplements.
Gummy vitamins are unhealthy and exploitative products that mislead parents about the benefits of dietary supplements. The TGA and FSANZ should urgently review the regulation of these products.
• This article was first published at The Conversation.
Ken Harvey is Associate Professor, School of Public Health and Preventive Medicine, Monash University. Eliza Li is a biomedical science and business student at Monash University. Dr Rosemary Stanton is a nutritionist and Visiting Fellow at UNSW. Professor Stuart Dashper is a Senior Principal Research Fellow at the University of Melbourne.
Letter to TGA from Eliza Li
I sent a complaint about mislabelling of Bioglan Omega 3 Kids Gummies to the NSW Food Authority because, using your Food-Medicine Interface Guidance Tool (FMIGT), this product appeared to be a food. The product made no therapeutic claims and unlike many other “gummies” was not listed on the Australian Register of Therapeutic Goods (ARTG).
However, the NSW Food Authority said that you, the TGA, is the responsible regulator (see below).
I have been researching the regulation of ‘gummies” and I hope to present my results at the 2017 International Conference of Undergraduate Research (ICUR).
I note that for foods, there is a requirement in the Australia New Zealand Food Standards Code to disclose the sugar content on the nutrition information panel on the product label, which the Bioglan product has done, albeit with errors.
However, for complementary medicines, there appears to be only a requirement in Therapeutic Goods Order 69 and Therapeutic Goods Order 92to declare the presence of sugars (but not the quantity) on the label. For example, Nature’s Way Kids Smart Vita-Gummies range merely say, “Contains sugars”.
You will be aware of concern about excessive sugar consumption in Australia, especially by children, which has been linked to dental caries, childhood obesity and chronic non-communicable disease in later life. Hence the campaign by Choice (Australian Consumers’ Association) for clearer labelling of products containing sugar.
I should be grateful if you could explain the rationale behind the different approaches to sugar labelling of the TGA compared to FSANZ?
In addition, I should appreciate an explanation as to why the NSW Food Authority directed me to send my complaint about the mislabelling of Bioglan Omega 3 Kids Gummies to the TGA, rather than dealing with it themselves?
Letter from TGA
Thank you for your email of 9 May 2017 to the Therapeutic Goods Administration
The requirements for food labelling of sugar is to advise consumers about the nutritional content of their food. The purpose of declaring sugars on a medicine label is to advise particular consumers, such as diabetics, about the potential to impact their health condition.
Overall, the general quantity in which medicines are consumed is far less than for foods. Additionally, the benefits from a person taking a particular medicine may outweigh the risks of sugar consumption. The warning statement serves as an advisory to affected individuals without unnecessarily deterring general consumers from taking a medicine that they may need.
The TGA is responsible for the regulation of therapeutic goods in Australia including labelling, hence the reason for your enquiry being directed to us.
We trust this information is of assistance.
Complementary and OTC Medicines Branch