FDA’s Fortification Policy is set forth at 21 C.F.R. § 104.20. It essentially sets forth principles for the rational addition of nutrients to foods. It provides:
[FDA] does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages.
It recommends fortification in only four circumstances:
- “[T]o correct a dietary insufficiency recognized by the scientific community. . .”
- “[T]o restore such nutrient(s) to a level(s) representative of the food prior to storage, handling and processing. . .”
- “[I]n proportion to the total caloric content. . . to balance the vitamin, mineral, and protein content . . . ” and
- “[T]o avoid nutritional inferiority” when replacing a traditional food.
21 C.F.R. § 104.20 (b)-(e). FDA’s Fortification Policy itself, albeit codified in the C.F.R., generally is simply nonbinding guidance, having no legal force or effect. However, when it is cross-referenced in another FDA regulation, it is made law with respect to complying with that regulation.
FDA now has published a guidance document about its Fortification Policy: Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Nov. 6, 2015). While it conveys a wealth of information, the questions and answers clarify the following matters in particular:
- The Fortification Policy is made law by the following regulations: 21 C.F.R. §§ 54(e) (“more” claims and synonyms), 101.54(f) (“high potency” claims), and 101.65(d) (“healthy” claims and related terms). Any nutrient addition to a food to make it eligible for one of these claims must comply with the Fortification Policy.
- The Fortification Policy applies informally to the addition to a food of any of the essential vitamins and minerals listed in 21 C.F.R. § 9(c)(8)(iv), not just the ones listed in § 104.20(d)(3). This includes vitamin K, manganese, selenium, chromium, molybdenum, and chloride. The Fortification Policy also applies to the addition to a food of protein and potassium.
- The guidance document explains how the four circumstances permitting fortification should be construed.
- The Fortification Policy does not apply to infant formula, dietary supplements, or food for animals.
- The Fortification Policy is applicable to foods marketed domestically, but not to foods for export.
Comments on a guidance document may be submitted to FDA at any time.