The International Food Additives Council (IFAC) represents companies that make high quality substances used worldwide as food ingredients.  Members of IFAC’s Cultures Committee make microbial food cultures used by the dairy, bakery and other segments of the food industry.  Members of the Cultures Committee adhere to FDA regulations and guidelines concerning the use of structure/function claims in food labeling for microbial cultures and encourage their customers (i.e., those making products containing microbial cultures) to do so as well.

Structure/Function Claims are food labeling claims that describe the effect of a substance on the normal structure or function of the body.  Such claims must not be expressed or implied claims to diagnose, cure, mitigate, treat or prevent disease.  If they do, they are considered a disease or drug claim under the US Federal Food, Drug, and Cosmetic Act (the Act).  Furthermore, a structure/function claim may not claim to reduce the risk of a disease or health-related condition or it will be considered a health claim.  Health claims in food labeling that are not authorized by a US Food and Drug Administration (FDA) regulation are not allowed and a product bearing an unauthorized claim will be considered misbranded under the Act.  

Structure/function claims differ from disease and health claims not only because they do not claim that a substance diagnoses, cures, mitigate, treat, prevents or reduces the risk of a disease or health related condition but also because they do not require premarket review or approval by the FDA.  Nonetheless, structure/function claims must be truthful and not misleading and supported by appropriate scientific evidence.