However, some claims will fall outside of the purview of the FDA and be accompanied by the disclaimer: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

Such a disclaimer typically accompanies supplements rather than foods, but since the definition of functional food is still evolving and somewhat amorphous, a functional food may find itself bearing the warning.

Canada, Sweden   United States     European Union  

Labeling    Food and Drug Administration