Chapter 7 - Breaking Down the Barriers to Functional Foods, Nutraceuticals and Claims

Abstract

The pressure on Food and Drug Administration (FDA) and Congress for change is building with increased public clamor for resolution on claims for functional foods. FDA needs to consolidate the claims into three categories—health claims for foods, claims for functional foods and claims for dietary supplements. FDA has the power and the duty to resolve the conflict and relieve the burden that has been created for industry, consumers, and for itself. It can be seen as the champion of consumers and encouraging manufacturers to perform research to come up with new and better solutions for a demanding customer base. FDA needs to consolidate the claims into three categories—health claims for foods, functional foods, and dietary supplements. Health claims should remain the gold standard and require the highest level of proof of a health effect. The new category of functional foods would be those substances falling somewhat short of the threshold of a health claim and be substantiated by criteria such as biomarkers and mechanistic studies, not requiring the evidence of disease incidence reduction.