Scientific Documents

Gum Periobalance(TM) tablets and chewing gum and oral health - Scientific substantiation of a health claim related to Gum Periobalance™ tablets and chewing gum and oral health pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Summary (26 KB)

Opinion (70 KB)

Summary

Following an application from Sunstar Suisse, S.A. submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Italy, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to Gum Periobalance™ tablets and chewing gum and oral health.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and /or claim including a request for the protection of proprietary data.

The foods that are the subject of the health claim are Gum Periobalance™ lozenge and chewing gum with the active ingredient Lactobacilllus reuteri (L. reuteri) strains DSM 17938 and ATCC PTA 5289. The Panel considers that, on the basis of the information provided by the applicant, the L. reuteri strains DSM 17938 and ATCC PTA 5289 included in the Gum Periobalance™ lozenge and chewing gum as active ingredients are not sufficiently characterised (i.e., the information provided does not allow identification/characterisation of the species and strains used).

The claimed effect is “rebalancing the oral microflora and improving oral health”. The target population is adults, both men and women. The Panel considers that decreasing the levels of mutans streptococci in the oral cavity and reducing the amount of dental plaque may be beneficial to health.
Two published human intervention studies and one unpublished in vitro study were presented by the applicant as being pertinent to the substantiation of the claimed effect.

A randomised, placebo-controlled intervention investigated the effects of L. reuteri ATCC 55730 on the amount of mutans streptococci in the oral cavity. The Panel notes that the strain of L. reuteri used in this study (L. reuteri ATCC 55730) is not the same which is contained in Gum Periobalance™ products (L. reuteri strains DSM 17938 and ATCC PTA 5289), and no data have been provided by the applicant to substantiate a functional equivalence of these two strains and the strain tested in relation to the claimed effect.

A randomised, double-blind, placebo controlled study included 59 patients with moderate to severe gingivitis who were allocated to three experimental parallel arms receiving daily during two weeks; i) LR-1 formulation containing 108 CFU of a L. reuteri strain, ii) LR-2 formulation containing 108 CFU of another L. reuteri strain, or iii) placebo. The Panel notes that it is not possible to establish whether the strains used in the study correspond to the strains included in the food for which the claim is made (Gum Periobalance™ products). Further, L. reuteri strains were not administered in any of the forms for which the claim was proposed (i.e., either tablets or chewing gum).

One unpublished study reports on the capacity of two L. reuteri strains (ATCC PTA 5289 and ATCC 55730) to inhibit the growth of periodontitis-associated bacteria. The Panel notes that only one of the strains in Gum Periobalance™ was tested (ATCC PTA 5289) besides the L. reuteri wild strain ATCC 55730, and that the results do not predict the in vivo effects of the L. reuteri strains contained in Gum Periobalance™ products with regard to the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between consumption of Gum Periobalance™ tablets and chewing gum and “rebalancing the oral microflora or improving oral health” in the general population.