Clarification of FDA’s Fortification Policy

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:

1. “[T]o correct a dietary insufficiency recognized by the scientific community. . .”
2. “[T]o restore such nutrient(s) to a level(s) representative of the food prior to storage, handling and processing. . .”
3. “[I]n proportion to the total caloric content. . . to balance the vitamin, mineral, and protein content . . . ” and
4. “[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.