The agency is concerned that some of these added ingredients are neither approved food as additives nor generally recognized as safe for these purposes. The letter reminded manufacturers of the legal requirements regarding health, nutrient content and structure/function claims for conventional foods, noting that FDA must review health and nutrient content claims prior to marketing unless the claims have been otherwise authorized. The agency encouraged manufacturers to determine the regulatory status of the ingredients and the claims they intend to use. The Center for Science in the Public Interest applauded FDA’s action, calling it a “shot across the bow.” It indicated companies will be sued if they sell products containing unsafe ingredients. CSPI also said manufacturers should be required to notify FDA of all labeling claims that a food can affect the structure or functioning of the body, and that these claims should be based on scientific consensus.
