The makers of Nutella have proposed a settlement of $3 million (US) for claims that they mislead consumers with regard to the “healthiness” of the product. Setting aside my biases as the child of immigrants who grew up with Nutella as a reasonably regular part of my breakfast (although, heaven forbid – I had to walk or bike to school and participate in sports), firms must take note of this suit and settlement. The Nutella case comes on the heels of $45 million settlement in the Dannon Activia suit in 2010 (“helps to naturally regulate your slow intestinal tract”) – a much more significant figure.
The cost of defending a multidistrict class action such as this would quickly exceed the proposed settlement of $3 million, and settling avoids the uncertainties of a jury. The plaintiff’s lawyers will likely walk away with at least $1 million of that settlement, for about a years work. That is enough incentive to keep these suits coming, and food companies need to consider their claims and advertising campaigns carefully, as the FDA and FTC may no longer be the most expensive sheriffs in town.
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