Description
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.
Scope & Applicability
Product Classes
9Standard food products subject to nutrition labeling; General food labeling context; Standard food products requiring Nutrition Facts.
Foods with names and compositions prescribed by regulation
The primary product category covered by the guidance; Essential food product that is the sole source of nutrition for many infants.
Category of products covered in the table of contents; Covered by allergen labeling requirements; Guidance on declaring major food allergens for dietary supplements.
Foods subject to certain standards of identity may be required to be fortified
Food marketed for general consumption, distinct from dietary supplements.; Comparison point for intake levels
Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.
Regulations specifying ingredients and manufacturing for specific food names.
Food category required to be fortified with folic acid.
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
4Basis for defining nutrient content claim levels
Condition where a substitute food lacks nutrients compared to a traditional food
UL used to assess safe limits of nutrient addition.
ULs established by the IOM to assess excessive nutrient intake.
Identified Hazards
Hazards
1Random fortification could create nutrient imbalances in the food supply
Related CFR Sections (14)
- 21CFR101.65§ 101.65 Implied nutrient content claims and related label statements.
(a) General requirements. An implied nutrient content claim can only be made on the label and in labeling of the food if:Read full regulation →
- 21CFR101.54§ 101.54 Nutrient content claims for “good source,” “high,” “more,” and “high potency.”
(a) General requirements. Except as provided in paragraph (e) of this section, a claim about the level of a nutrient in a food in relation to the Reference Daily Intake (RDI) established for that nutrient in § 101.9(c)(8)(iv) or Daily Reference Value (DRV) established for that nutrient in § 101.9(c)Read full regulation →
- 21CFR101.3§ 101.3 Identity labeling of food in packaged form.
(a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity.Read full regulation →
- 21CFR131.110§ 131.110 Milk.
(a) Description. Milk is the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows. Milk that is in final package form for beverage use shall have been pasteurized or ultrapasteurized, and shall contain not less than 8 1 ⁄ 4 percent milk solRead full regulation →
- 21CFR136.115§ 136.115 Enriched bread, rolls, and buns.
(a) Each of the foods enriched bread, enriched rolls, and enriched buns conforms to the definition and standard of identity and is subject to the requirements for label statement of ingredients prescribed for bread, rolls or buns by § 136.110 , except that: [TABLE] Vitamin | Reference form Name | EmRead full regulation →
- 21CFR104.20§ 104.20 Statement of purpose.
(a) The fundamental objective of this subpart is to establish a uniform set of principles that will serve as a model for the rational addition of nutrients to foods. The achievement and maintenance of a desirable level of nutritional quality in the nation's food supply is an important public health Read full regulation →
- 21CFR104.47§ 104.47 Frozen “heat and serve” dinner.
(a) A product, for which a common or usual name is established in § 102.26 of this chapter , in order to be eligible to bear the guideline statement set forth at § 104.5(b) , shall contain at least the following three components:Read full regulation →
- 21CFR107.100§ 107.100 Nutrient specifications.
(a) An infant formula shall contain the following nutrients at a level not less than the minimum level specified and not more than the maximum level specified for each 100 kilocalories of the infant formula in the form prepared for consumption as directed on the container: [TABLE] Nutrients | Unit oRead full regulation →
- 21CFR137.165§ 137.165 Enriched flour.
Enriched flour conforms to the definition and standard of identity, and is subject to the requirements for label statement of ingredients, prescribed for flour by § 137.105 , except that:Read full regulation →
- 21CFR130.10§ 130.10 Requirements for foods named by use of a nutrient content claim and a standardized term.
(a) Description. The foods prescribed by this general definition and standard of identity are those foods that substitute (see § 101.13(d) of this chapter ) for a standardized food defined in parts 131 through 169 of this chapter and that use the name of that standardized food in their statement of Read full regulation →
- 21CFR101.14§ 101.14 Health claims: general requirements.
(a) Definitions. For purposes of this section, the following definitions apply:Read full regulation →
- 21CFR172.345§ 172.345 Folic acid (folacin).
Folic acid (CAS Reg. No. 59-30-3), also known as folacin or folate, may be safely used in food as a nutrient in accordance with the following prescribed conditions:Read full regulation →
- 21CFR101.9§ 101.9 Nutrition labeling of food.
(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section.Read full regulation →
- 21CFR100.155§ 100.155 Salt and iodized salt.
(a) For the purposes of this section, the term iodized salt or iodized table salt is designated as the name of salt for human food use to which iodide has been added in the form of cuprous iodide or potassium iodide permitted by §§ 184.1265 and 184.1634 of this chapter . In the labeling of such prodRead full regulation →
Related Warning Letters (7)
- 2025-09-30
CGMP/Dietary Supplement/Adulterated/Misbranded
Time Challenger Labs International, Inc.
- 2022-09-13
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
CR Grupo Comercial Alvacora S.A.
- 2022-07-19
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
H2 Beverages, Inc.
- 2021-07-28
Unapproved New Drugs/Misbranded
Nutrishus Brands, Inc.
- 2020-10-20
New Drug/Misbranded
Before Brands Inc
- 2020-10-20
Unapproved New Drugs/Misbranded
Prollergy Corporation/Ready Set Food
- 2020-06-30
Unapproved New Drugs/Misbranded
Only Natural, Inc. dba Bio Nutrition, Inc.
See Also (8)
- CPG Sec 555.875 Water in Food Products (Ingredient or Adulterant) (Status: Final)
- Guidance for Industry: Dear Manufacturer Letter Regarding Front-of-Package Symbols (Status: Final)
- Guidance for Industry: Food Labeling Guide (Status: Final)
- Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (Status: Final)
- Small Entity Compliance Guide: Health Claims on Calcium and Osteoporosis; and Calcium, Vitamin D, and Osteoporosis (Status: Final)
- Small Entity Compliance Guide: Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids Nutrient Content Claims (Status: Final)
- CPG Sec 540.700 Labeling of Processed and Blended Seafood Products Made Primarily with Fish Protein (Status: Final)
- Guidance for Industry: Proper Labeling of Honey and Honey Products (Status: Final)