addition of nutritive ingredients to food. In this policy FDA stated that implicit in fortification is the promise to consumers that the fortified food, through its fortificants, contributes substantially to the nutritional well being of the individual who consumes usual amounts of the food. This aspect of the policy was rejected by the courts in the New Dextra Sugar case and by the 1976 vitamin-mineral amendments to the FD&C Act. The FDA policy also said that the specific nutrient deficiencies in the diet of the general population and population subgroups, the overall place of the food item in the diet of this population, and the effectiveness and suitability of the food vehicle should determine the type and amount of nutrients to be added to food. This policy further affirmed the importance of natural food in the diet, endorsed the restoration of nutrients lost during food processing, and indicated that it was appropriate, in some instances, to fortify processed food above restoration amounts and to fortify unprocessed food in order to correct deficiencies if the food in question is a particularly effective vehicle for fortification (Hutt, 1980, 1984).
In 1974 FDA proposed regulations that moved beyond the standard of identity approach and included a more comprehensive view-point of the addition of nutrients to food (FDA, 1974). In 1980 these views were published not as regulations, but as a policy statement that manufacturers “… are urged to follow if they elect to add nutrients to a manufactured or processed food” (FDA, 1980, p. 6314). The policy was codified in 21 C.F.R. 104.20 (FDA, 1980). This policy is the current statement of the agency regarding fortification. It is important to note that this statement, as a policy, it is not enforceable.
Of key relevance to this report, the codified policy includes situations and conditions in which the fortification of food with the nutrients listed in the policy is considered appropriate:
1) … to correct a dietary insufficiency that is recognized by the scientific community to exist and known to result in nutrient deficiency disease … ; 2) … to restore such nutrient(s) to a level(s) representative of the food prior to storage, handling and processing … ; 3) … in proportion to the total caloric content of the food, to balance the vitamin, mineral, and protein content …; and 4) … that replaces traditional food in the diet to avoid nutritional inferiority … (FDA, 1980, p. 6323)
In the codified policy there are a number of qualifications listed with each condition of fortification. For example, the policy recom-