The company’s website made health claims about five dietary supplements suitable for young children, including those addressing conditions such as deficient bone development.
Italy’s Antitrust Authority found the claims - made on supplements Ditrevit Forte, Forte Ditrevit K50, Difensil junior, Colecalcium and Chetonex - went beyond approved EFSA definitions and fined Humana €110,000.
The company was unable to respond to our request for comment in time for publication of this article.
References to disease
Luca Bucchini, managing director of Rome-based law specialists Hylobates Consulting, said that the decision saw Antitrust Authority’s firmly reassert itself as Italy’s health claim regulator after managing to halt an attempt to strip its competence a few months ago.
“Humana made many references to disease, even if indirectly, and this did not sit well with the authority,” he said.
Italy’s stricter approach
The decision came just as the UK’s Advertising Standards Authority (ASA) upheld a complaint against Danone subsidiary Nutricia for Vitamin D claims on its Growing Up Milk.
“Contrary to UK's ASA, the [Italian] Authority will fine companies directly. The decisions can be challenged in court. A 110K euro fine is in line with historical precedents. With new legislation, fines could theoretically go up to €5m,” said Bucchini.
He said that Italian authorities had gone further than the UK’s ASA by stipulating that only few words could differ from EFSA’s approved health claim wording.
“They allow very little flexibility, much less - in my opinion - than EU law.”
For example, any replacing of the term 'normal' with words such as 'indispensable' or 'fundamental' was deemed unacceptable by the Italian Authority, he said.
‘Not in line with the law’
The consultant said that Italy’s antitrust body was particularly critical of Humana’s ads for implying all children needed supplements. The authority said vitamin and mineral food supplements were only needed when there was real risk of insufficiency – a significant difference to the ASA’s ruling that called Vitamin D supplementation necessary.
“I don't think this is in line with the law, and with science,” said Bucchini, “Moreover, they used EFSA opinions - related to vitamins and dietary requirements - to argue that there are no adequate intake levels in children for vitamin D. Again I think they were wrong on this one, and misinterpreted the opinions.”
He said that while Humana’s claims had exceeded what was prescribed by EU Law, he feared some statements in the ruling could erode flexibility in the wording of health claims, thus impeding consumer understanding of a claim.
Ditrevit Strong and Strong Ditrevit K50 (Supplements of vitamins D and K and DHA Docosahexaenoic acid)
“Vitamin K: regulates blood coagulation. A deficiency at birth and in early months of life may cause haemorrhagic problems ... Vitamin D prevents rickets, regulates immune function and muscle function.”
Colecalcium (a supplement of calcium and vitamin D for children)
“Vitamin D and calcium are essential for bone and skeletal growth but also belong to a hormone cycle which is essential for the maintenance of the right calcium / phosphate balance, in turn necessary to protect physiological homeostasis.”
Difensil Junior (a supplement of Vitamin C, Vitamin E, Zinc and Beta-carotene)
The nutrients and vitamins contained therein "[...] reduce the production of free radicals that are formed in our bodies and are the cause of acute (such as that occurring during an illness like flu) or chronic (lifestyle, pollution, etc) oxidative stress, ", including "ROC (Red Orange Complex), Vitamin C and zinc [which] synergistically exert their reactive action supporting immunity and anti-inflammatory activity. "
ChetoNex (product made from glucose and sodium)
Recommended in cases of "[...] and ketosis and vomiting associated with ketonic hypoglycaemia", due to its ability to reduce the '"spastic activity of the stomach."