mends that vitamins, minerals, and protein be added in proportion to the total caloric content of the food for which the stated caloric reference value is “… per 100 kilocalories based on a 2,000-kilocalorie total intake as a daily standard …” (FDA, 1980). This section includes a listing of the nutrients the policy recommends as appropriate to add as fortificants and cites the US RDAs as the reference standards for amounts of nutrients to be added per 100 kilocalories.3 The FDA fortification policy thus recommends using the same reference standards for fortification that are used for the nutrition labeling of food.

The policy includes statements that nutrients added to food should be stable, physiologically available, present at a level that will not led to excess intake, suitable for fortification purposes, and acceptable in terms of food safety regulations. The policy concludes with links to food labeling in that it specifies that claims and statements on the label cannot be false or misleading. Another point mentioned in the fortification policy is that FDA “does not consider it appropriate to fortify” fresh produce, meat, poultry, or fish products, sugars, or snack foods (e.g., candies and carbonated beverages).

Historically the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has followed an unwritten policy prohibiting indiscriminant fortification of the products it regulates (Post, 2002). In 1980 it adopted FDA’s policy guidelines on the addition of nutrients to food (21 C.F.R.104.20). In 1982 an FSIS review of the policy concluded that the food it regulated would continue to follow FDA policy guidelines (Quick and Murphy, 1982). Meat and poultry regulations do, however, permit some limited addition of nutrients for specific purposes, such as the addition of ascorbic acid (vitamin C) to accelerate the curing process and the addition of thiamin hydrochloride for flavoring. With the exception of margarine, there are no FSIS food standards that permit or require the addition of nutrients (Post, 2002). The diversity of food products in the marketplace that fall under FSIS regulation has grown, and FSIS has found that products may contain label claims for fortification that are not addressed by the 1980 guidelines (Post, 2002). FSIS has made some accommodation for these food products by allowing label statements about nutrients contributed by fortified ingredients approved by FDA (e.g., calcium-enriched egg noodles) (Post, 2002).


The US RDA reference standards were updated on January 6, 1993 (FDA, 1993c) to use FDA’s Recommended Daily Intakes and Daily Reference Values.

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