Its Panel on Dietetic Products, Nutrition and Allergies NDA concluded, “the claim ‘prevents bad breath by neutralising of volatile sulphur compounds in the mouth and oral cavity’ is related to breath odour rather than to a function of the body as required by Article 13 of Regulation (EC) No 1924/2006.”
It therefore did not, “comply with the criteria laid down in Regulation (EC) No 1924/2006.”
The opinion can be found here.
During its assessment of the dossier related to aproduct called Hali-Z, the NDA said it had asked the Danish applicant, Jemo-Pharm, how its claim fitted within the remit of the NHCR.
“The applicant replied by expressing the view that the production of volatile sulphur compounds and halitosis as part of the bacterial flora of the mouth and oral cavity is related to the function of the mouth and oral cavity, and thus to a function of the body,” the NDA wrote in its opinion.
But unfortunately for Jemo-Pharm the NDA found, “the applicant did not provide any additional evidence that the chemical neutralisation of volatile sulphur compounds in the mouth in order to improve bad breath constitutes a physiological effect in relation to a function of the body.”
Jemo-Pharm markets a range of supplements and pharma products, selling the product in question, Hali-Z, in Denmark for about 15 years, marketed with halitosis improvement claims. It is also sold in Finland and Poland.
The company’s chief executive officer Peter Samulesen said the claims regime in Denmark permitted for such claims on supplement products that draw no opposition from the Danish Veterinary and Food Administration (DVFA).
The Hali-Z dossier contained about 15 studies.
Up to six hours
Product claims for Hali-Zon on the Jemo-Pharm website state:
“Hali-Z is a little tablet you suck on, and it will remove halitosis. The tablet contains zinc, which is a very effective remedy against malodorous sulphur products.
“Hali-Z can be had with a mix of raspberry and peppermint flavour. Each tablet contains 68 mg aminochelerated zinc, corresponding to 6.8mg pure zinc.
“Let the tablet melt on your tongue, then your breath will be freshened and you will have a good taste in your mouth. The effect lasts up to 6 hours.”