The authority concludes evidence provided is insufficient to establish a relationship between the lozenges containing Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289L and maintenance of normal gum function.
In summing up its final decision, EFSA did acknowledge evidence that linked lozenge consumption and improvements in gingivitis in patients.
“The Panel also took into account evidence for mechanisms by which consumption of lozenges containing L. reuteri twice daily could improve outcomes of gingivitis in patients with chronic periodontitis (i.e. exclusion of pathogenic bacteria from gingival pockets and possibly a reduction in local tissue damage).
“This outcome is particularly associated with professional plaque removal (SRP) in gingival pockets, where the relevance of such mechanisms for the target population of the claim (i.e. subjects without periodontitis) is unclear.”
Biogaia’s application, first submitted in June 2019, refers to the probiotics’ ability to form biofilms and adhere to the oral mucosa.
Both L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 have been shown to reduce pro‐inflammatory cytokines, tumour necrosis factor α (TNF‐α) and interleukin‐8 (IL‐8), in gingival crevicular fluid of patients with gingivitis, while also reducing other visible signs of inflammation such as bleeding on probing (BoP).
L. reuteri is also known for its ability to produce the antimicrobial compound, reuterin, which induces oxidative stress in cells and can inhibit the growth of both Gram‐positive and Gram‐negative bacteria.
Swedish biotechnology firm BioGaia intended to market the product at the general European population with daily consumption of two lozenges (one lozenge taken twice daily).
These lozenges would contain a total minimum amount of 1 × 108 colony forming units (CFU) of L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289, approximately equal amounts of each strain is recommended.
Only last month, the firm made available its randomised, double-blind, placebo-controlled trial in healthy patients that showed supplementation of L. reuteri Prodentis significantly reduced bleeding of the gums compared to placebo.
Recently published online in Journal of Periodontology, the study’s principal investigator, Professor Ulrich Schlagenhauf from the University Hospital Würzburg in Germany says, “Based on our study results, we can conclude that supplementation of L. reuteri-lozenges offers new therapeutic and preventive options in individuals with gingivitis”.
“The result of this study is adding to the impressive volume of positive data with L. reuteri Prodentis – to date 47 scientific publications – and is also coupled with a growing interest in many markets for launching our oral health probiotic”, adds Isabelle Ducellier, president and CEO of BioGaia.
In summing up the data presented, EFSA’s Panel on Nutrition, Novel foods and Food Allergens (NDA) concludes that the orodispersible lozenges contain a combination of L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289, which is the subject of the health claim and is sufficiently characterised.
The Panel also state the claimed effect proposed is ‘support normal gum function’ with the target population proposed is ‘general healthy population’. The Panel add that maintenance of normal gum function is a beneficial physiological effect.
“The evidence provided is insufficient to establish a cause and effect relationship between the consumption of orodispersible lozenges containing a combination of L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 and maintenance of normal gum function,” they conclude.