FDA Guidance for Industry: Questions and Answers on FDA’s Fortification Policy
The achievement and maintenance of a desirable level of nutritional quality in the nation’s food supply is an important public health objective. Adding nutrients to specific foods is an effective way of maintaining and improving the overall nutritional quality of the food supply. However, random fortification of foods could result in over- or underfortification in consumer diets and create nutrient imbalances in the food supply. It could also result in deceptive or misleading claims on certain foods.
On January 25, 1980, FDA published our fortification policy entitled “Nutritional Quality of Foods; Addition of Nutrients” in the Federal Register (45 FR 6314) and included the policy in the Code of Federal Regulations (21 CFR 104.20). The fortification policy discourages indiscriminate addition of nutrients to foods.
Since the publication of the policy, we have received numerous questions on using the principles within this policy from the food industry, other federal agencies, academia, and others. This guidance is intended to clarify the existing policy, especially those matters we received questions on, and to remind manufacturers of this policy. This policy addresses when foods may be fortified, and it urges you, the manufacturer, to follow the principles of the policy if you elect to add nutrients to a food for human consumption.
Posted on the FDA website on 6 November 2015