Fortification of foods (USA)

The U.S. Food and Drug Administration (“FDA”) policy on the fortification of conventional food products can be found at 21 CFR 104.20. This policy establishes a uniform set of principles that is intended to provide a framework to guide manufacturers in deciding whether and how to add essential nutrients to fortify conventional foods intended for sale in the United States. The principles of rational fortification expressed in the policy are to: (1) correct a dietary insuffi-ciency, (2) restore nutrient levels to those prior to storage, handling, and processing, (3) provide a balance of vita-mins, minerals, and protein in proportion to the total caloric content of the food, and (4) prevent nutrient inferiority in a food that replaces a traditional food in the diet. Under the FDA’s fortification policy, the indiscriminate addition of nutrients to food is discouraged, and the FDA considers it inappropriate to fortify certain foods, including fresh pro-duce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages. FDA con-tinues to actively monitor and enforce its fortification policy against foods that are fortified inappropriately and those making inappropriate nutrient content claims that imply fortification. Additional information on FDA’s fortification policy can be found in an FDA Guidance called, Questions and Answers Regarding Fortification Policy (2015). The FDA Guidance is not binding but provides useful information as to FDA’s current thinking.

This is general information rather than legal advice and is current as of 30 May 2024. We recommend you contact a specialised food lawyer for legal advice for your particular circumstances to support commercial decisions which could impact your product or business.

Suzan Onel