The agency’s Panel on Dietetic Products, Nutrition and Allergies (NDA) agreed with DuPont Nutrition BioSciences proposition that its lactitol sweetener could, in the general population, promote “normal bowel function by increasing stool frequency, increasing stool bulk and moisture, softening stool consistency and reducing transit time”.
It proposed the claim:“lactitol contributes to normal bowel function”.
Dossier drill down
DuPont’s 5-year protected, article 13.5 proprietary science dossier submitted under the EU nutrition and health claims regulation (NHCR) referenced 15 clinical trials, which measured variously stool frequency (12 studies), stool consistency (12), bulk (2) and transit time (3) against placebo or another non-digestible sweetener, lactulose.
The NDA did not agree with all of the data in arriving at its ultimately positive conclusion. It said the studies employing lactulose as point of comparison were “not designed as equivalence studies” and so did not back the submitted claim.
It said transit time was “not necessarily related to normal defecation” and so dismissed it as a valid endpoint for the claim.
But 12 studies utilising at least 10 g / day of lactitol showed significantly increased stool frequency.
Five out of six other studies showed lactitol softened stool consistency and two studies recorded significant increases in stool bulk. All of this was achieved without the provocation of diarrhoea at 10 g /day.
It therefore backed a claim stating “lactitol can contribute to normal defecation”.
The panel added that it “acknowledges the plausible mechanisms of action by which lactitol could exert the claimed effect.”
Of the mechanism of action it noted “that lactitol is a non-digestible carbohydrate that could exert an effect on stool frequency and stool consistency by osmotic effect, by stimulating fermentation in the colon and by increasing faecal bulk.”
DuPont said the effect should be observed within “3-4 days” and lactitol consumption regulated after that.
The NDA opinion is here.
DuPont, along with Purac, are the major suppliers of lactitol which is about 40% as sweet as sugar and typically used in sugar-reduced bakery and confectionery products and dairy products like ice cream.
Earlier this year European giant Beneo won a similar defecation claim for its inulin ingredients.
“Six studies involving 86 subjects consistently showed that consumption of ‘native chicory inulin’ at an amount of at least 12 g/day increases stool frequency,” the NDA wrote at the time.
That opinion is here.