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 proposed claim states: "Zinc prevents bad breath by the neutralising of volatile sulfur compounds (VSC) in the mouth and oral cavity."
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).
But Samuelsen admitted having a claim OK’d by local authorities and gaining a positive opinion from the European Food Safety Authority (EFSA) were too separate things altogether.
“I think we have a 75 per cent chance the claim will win a positive opinion from EFSA but it is unpredictable,” Samuelson told NutraIngredients.com. “We are expecting feedback from EFSA soon.”
The Hali-Z dossier contains about 15 studies on the breath improving potential of zinc iron dating back “15-20 years” but no product-specific data on Hali-Z itself. Samuelsen said this was the case because up until now, there had been no requirement for such data.
“I don’t think it’s a problem but EFSA might,” he said, noting EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) stated preference for formulation-specific data, especially under the proprietary and emerging science article 13.5 route.
Samuelsen said despite the possibility of a negative NDA opinion and a situation where Hali-Z and other products may no longer be permitted to make any claims, his company supported the EU 2206 nutrition and health claims regulation.
“There are a lot of claims out there that can’t be proven so we fully support the aims of the regulation although the pharma-like nature of the scientific process is challenging.”
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.”