Vitabiotics presented a range of science for the product – Diabetone – that included references to the individual vitamins and minerals and a randomised, double-blinded clinical study on the product itself.
But the ASA ruled the studies did not substantiate the claim that Diabetone could help maintain wellbeing among those with diabetes.
Specifically it said the individual nutrient studies did not sufficiently detail their methodologies or demonstrate that the participants were healthy, and did not substantiate the collective effect of the formulation.
Statistical significance
Of the product-specific trial the ASA concluded that blood glucose and lipid profile improvements could not be substantiated because a, “prior estimation of the number of volunteers needed in order to establish statistical significance” had not been conducted.
The trial involved 29 subjects with type two diabetes with the control group reporting lower levels of depression and anxiety, but the ASA noted the researchers themselves reported glycaemic and lipaemic profiles were not significantly improved.
“We considered that the trial was, by its own admission a pilot and was therefore not sufficiently comprehensive to establish if the product could maintain the emotional or physical well-being of people with type 2 diabetes,” the ASA ruled.
It therefore concluded: “We considered that Vitabiotics had not substantiated that the product could maintain either physiological or psychological well-being and furthermore could discourage essential treatment. We concluded that the ad was likely to mislead.”
The ASA also expressed concern that the name of the product could be interpreted as an implied health claim, but advised no action on this point.
Regulatory gap
Vitabiotics complied with the ruling but promotional materials remain on its website which is not covered by the ASA although a working group is investigating whether it should be. ASA rulings relate to newspapers, magazines, billboards, television and radio.
ASA spokesperson, Matt Wilson, said local trading standards authorities often reviewed ASA rulings and could take action if they determined website marketing contravened rulings from agencies like the ASA.
“There is a regulatory gap and efforts are being made to close that gap,” he said.
Vitabiotics makes it clear on the web pages devoted to Diabetone, as it does in its defence of its marketing to the ASA, that the product is not designed to replace medicine, but rather is a sugar-free multivitamin that diabetics can use.
It states: “Diabetone is a vitamin and mineral supplement for those who wish to safeguard their daily diet with key vitamins and minerals. It is not a treatment for diabetes or metabolic control, but intended to help maintain overall health and wellbeing. Diabetone should be used under the guidance of your pharmacist, physician or healthcare professional.”
Vitabiotics was unavailable for comment.
Diabetone contains B vitamins, vitamin C, chromium, L-carnitine, biotin, magnesium and zinc and is available from major UK pharmacy chain, Boots.
Wilson said while most of its activity was driven by complaints from members of the public or industry, it did its own monitoring of sectors “behind the scenes” to identify potential breaches of the advertising code.