1. A specific and measurable health benefit is demonstrated in humans.
The term “prebiotic(s)” and similar representations should be used only when accompanied by a statement of the specific and measurable health benefit2,3 conferred by the prebiotic substance, as demonstrated in good quality human clinical trials. “Prebiotic X increases calcium absorption” is an example4 of a function claim while “prebiotic X reduces the risk of diarrhea” is an example of a disease risk reduction claim.
2. A change in gut bacterial composition or activities is demonstrated in humans.
Scientifically acceptable methodology should be used to demonstrate a change in gut bacterial composition or activities.
3. The human health benefit demonstrated for criterion 1 is attributed to the change in gut bacterial composition or activities demonstrated for criterion 2. Human or animal studies can be used to support a biologically plausible mechanism of action.
Showing a change in gut bacterial composition or activities, without demonstrating a health benefit, is insufficient, in itself, to support a prebiotic claim. Sufficient evidence is required to demonstrate a biologically plausible mechanism through which the change in gut bacterial composition or activities referred to in criterion 2 is responsible for the human health benefit referred to in criterion 1.
Comments are due no later than May 16, 2012. The draft guidance may be downloaded here: DRAFT – Prebiotic Guidance for consultation
I’ll be speaking at the IFT Wellness 12 in Chicago next week. Kathy Musa-Veloso, Ph.D., Intertek Cantox and I will be discussing the future of functional foods and claims substantiation in the US and EU. More info here.
Hope to see you in the Windy City!