EFSA has recently rejected a health claim, submitted by the Swedish company BioGaia, on orodispersible lozenges containing a combination of Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 and normal gum function.

EFSA considered that normal gum function is a beneficial physiological effect. However, the experts discussed the parameters that may be used to assess gum function. They considered that bleeding on probing is an appropriate measure to assess changes in gum structure, while gingival index can be used for substantiating the maintenance of gum function. Conversely, plaque indices, periodontal pocket depth and clinical attachment levels were not pertinent.

The application contained 8 clinical trials, all conducted with the L. reuteri combination. Five used the proposed dosage, and 2 a half-dose, while the last one examined both the half and normal dosage. However, only two studies assessed the effects of L. reuteri lozenges on pertinent measures of gum structure/function, one provided positive results and one failed to highlight significant effects. Other studies were considered as supportive due to the lack of pertinent measures or the inclusion of subjects with periodontitis.

Despite a potential mechanisms of action, EFSA concluded that data was insufficient to conclude to a cause and effect relationship between the consumption of L. reuteri lozenges and the maintenance of normal gum function.

EFSA NDA Panel (EFSA Panel on Nutrition, Novel foods and Food Allergens), Turck D, Castenmiller J, De Henauw S, Ildico Hirsch-Ernst K, Kearney J, Knutsen HK, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Thies F, Tsabouri S, Vinceti M, Bresson J-L, Sanz Y and Siani A, 2020. Scientific Opinion on the orodispersible lozenges containing a combination of Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 and normal gum function: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2020;18(3):6004.