Current regulatory status of foods for special dietary uses

The Food and Drug Administration has redefined foods for "special dietary use". Such foods must now: (1) Supply a special dietary need that exists by reason of a physical or physiological condition, such as convalescence, a pregnancy, lactation, or by reason of a specific disease or disorder; (2) Supply a vitamin, mineral, or other dietary property to supplement diet by increasing total dietary intake; (3) Meet a special nutritional need as the sole item of the diet. The stricter definition of this category of food means that the conventional foods with added nutrients or food for which nutritional claims are made or nutritional information provided will no longer be considered as foods for special dietary uses, although they must conform to standard nutritional labeling requirements. The new regulation establishes a clearly delineated position within which the consumer, industry, and FDA can deal with special dietary foods without the past confusion as to what belonged in this category.