Guidance for Industry: Questions and Answers on FDA’s Fortification Policy November 2015
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 (we) 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.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in our guidances means that something is suggested or recommended, but not required.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.