CARE Pharmaceuticals is being ordered to cease distribution of its Little Coughs Ivy Leaf (Hedera helix) products bearing labels representing that they can be given to children aged six months to two years, over a "severe breach" of Consumer Healthcare Product Australia (CHPA) Code of Practice.
The CHPA Complaints Panel found that Care failed to comply with a iNova Pharmaceutical's request to provide it with evidence to substantiate the use of Hedera helix in the quantities and extract ratios used in the Little Coughs formulations for dosing in the six months to two years range.
The panel noted that the front labels on the products included statements that they were suitable for infants aged six months and older, "for the soothing relief of coughs and chesty congestion", while warnings on the rear were in fine print advising users to "consult your healthcare professional: before using in children under two years of age".
Care submitted a list of 47 references to support its safety claims, however, the panel found four articles did not support the use of Hedera helix for infants.
"The panel then went on to conclude that in promoting the products for use in children in that age group, Care had engaged in unconscionable commercial practice in breach of section 4.1 of the Code," the CHPA said.
Care has been ordered to pay a $50,000 fine to CHPA, to "immediately discontinue making the claims" about the products' safety for infants, and to stop distributing products bearing labels making the safety claims.
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