The Food and Drug Administration has advised infant formula manufacturers and distributors to substantiate structure/function claims based on the results of infant feeding intervention studies that are randomized, double-blind, and parallel-controlled.   The agency issued draft guidance this month to provide recommendations for the “type and quality of scientific evidence” suitable for substantiating structure/function health claims on infant formula labels.
Structure/function claims for conventional foods are labeling statements pertaining to the nutritive effects of a product or its ingredients upon the structure or function of the human body.    
The FDA does not pre-approve structure/function health claims.  The draft guidance marks the first time the agency has issued guidance for substantiating structure/function health claims for a conventional food.

The draft guidance advises infant formula manufacturers and distributors to conduct a “systematic, evidence-based review”.  Based on the results, firms should then determine if the labeling claims satisfy the standard for “competent and reliable” scientific evidence. Infant formula firms are advised to retain all documentation regarding the substantiation of every labeling claim.

Get in touch with our Labeling Dept to ask for support.

Source: Food and Drug Administration