Health Canada has released a draft guidance regarding the use of “prebiotics” claims.  The guidance outlines the following three criteria for prebiotic claims:

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  The draft guidance may be downloaded here: DRAFT – Prebiotic Guidance for consultation