Safety and efficacy requirements are spelled out in regs. In keeping with its criminal law status, responsibility under the Food and Drug Act for product safety rests with the manufacturer . Pre-market review by HPB is a method to control use and market introduction of foods and ingredients until safety can be scientifically evaluated to be assured. The only published criteria relating to functional foods are found in Guidelines for the Safety and Physiological Effect of Novel Fibre Sources and Food Products Containing Them. Some structure function claims allowed following a simple notification process.
Safety is addressed at other regulatory levels separate from health claim applications.
Efficacy is key consideration for health claims, as assessed through scientific agreement on publicly available data. European Union Health claims are not permitted at the E.U. level although tolerance varies among member states of use of health claims on labels and in advertising. Concerned about inconsistency, the E.U. food sector is conducting a survey of definition, regulation, burden of proof for claims in use for functional foods and related products.