FDA Fortification Policy and 

Infant Formula Regulation 

Essie Yamini, PhD, RD

Sue Anderson, PhD

Office of Nutrition, Labeling & Dietary Supplement

Center for Food Safety and Applied Nutrition

Food and Drug Administration
Food Fortification Policy (21 CFR 

104.20) 

• FDA published fortification policy guidelines in 

1980 (45 FR 6314, January 25, 1980)

• The objective was to establish a uniform set of 

principles that would serve as a model for the 

rational addition of essential vitamins and 

minerals and protein 
Fortification Policy

• Discourages indiscriminate addition of nutrients 

to foods

• Does not consider it appropriate to fortify fresh 

produce; meat, poultry, or fish products; 

sugars; or snack foods (e.g., candies or 

carbonated beverages) 
Nutrients under the fortification policy

• FDA considers only essential nutrients to be within 

the scope of its fortification policy

• The term essential nutrient under the fortification 

policy refers to the vitamins and minerals that are 

essential for human nutrition (Reference Daily 

Intakes (RDIs) - codified in 21 CFR 101.9(c)(8)(iv)), 

as well as potassium and protein (Daily Reference 

Values (DRVs) (21 CFR 101.9(c)(9)) 
Nutrients...

• This list in 101.9 (c)(8)(iv) has been modified since 

1980 and now includes 6 more vitamins and 

minerals (vitamin K, manganese, selenium, 

chromium, molybdenum and chloride)

• As other essential vitamins and minerals are added 

to 101.9 (c)(8)(iv), they can also be recognized for 

rational addition under the fortification policy
Nutrients... 

 There must be a safe and lawful source of the nutrient 

• The nutrient must be an approved food additive or 

GRAS under the conditions of its intended use

• There should be no determination by the FDA, in a 

regulation or as a matter of policy, that fortification by 

that nutrient is inappropriate 

• In addition, some nutrients are limited by food additive or 

GRAS regulation regarding the foods that may be 

fortified and to what level (e.g., folic acid (21 CFR 

172.345); vitamin D (21 CFR 172.380; 184.1950))
Principles of fortification policy

A nutrient(s) may appropriately be added to a food: 

• to correct a dietary insufficiency and for a public 

health purpose (21 CFR 104.20(b))

• recognized by the scientific community to exist and 

known to result in nutritional deficiency disease;

• to restore nutrients (21 CFR 104.20(c))

• to levels representative of the food prior to storage, 

handling, and processing;
Principles.. (Cont’d)

• to maintain a balanced nutrient profile in proportion to 

the caloric value of a food (21 CFR 104.20(d));

• to improve the quality of a replacement food so as to 

avoid nutritional inferiority relative to the food that it 

replaces (21 CFR 104.20(e));

• as permitted or required by applicable FDA regulations (21 

CFR 104.20(f))
What other regulations are mentioned 

under 104.20 (f)?

• Standards of identity (21 CFR parts 130-169))

• Nutritional quality guidelines (e.g., 21 CFR 

104.47) 

• Common or usual name regulations (21 CFR 

part 102) 
A nutrient added to a food is appropriate 

only when the nutrient is...

• Stable under customary conditions of storage, 

distribution, and use

• Physiologically available from the food

• Present at a level at which there is a reasonable 

assurance that over-consumption will not occur, 

considering cumulative amounts from other sources 

in the diet

• Suitable for its intended purposes and meets 

requirements for the safety of substances in food
Enforcement

• The provisions of the fortification policy have 

been incorporated into two labeling regulations 

which have the force and effect of law: 

• Nutrient content claims for “More” (21 CFR 

101.54(e)) 

• Nutrient content claim for “Healthy” (21 CFR 

101.65(d))
Infant Formula Regulation (21 CFR 

107)

• Not under the scope of fortification policy

• Specific statutory requirements pertaining to the 

required nutrients and nutrient levels (under 

section 412 of the FD&C Act and regulatory 

requirements in 21 CFR 107)
Nutrient requirements for infant 

formula 

• Provides sole source of nutrition during a 

vulnerable period 

• Must contain appropriate amounts of all essential 

nutrients 

• Minimum levels for 29 nutrients and maximums for 

9 of the 29 under 21 CFR 107.100

• Adulterated if it does not provide all nutrients as 

required under 21 CFR 107.100
Premarket notification requirements 

for infant formula manufacturers

• Must provide a 90-day notification before marketing a 

new infant formula or formula with a major change

• Premarket notification must contain: 

• Quantitative formulation

• Description of the changes made

• Assurances that the formula will not be marketed unless 

it meets nutrient requirements and quality factors and is 

manufactured with good manufacturing practices and 

quality control procedures
FDA compliance tools for infant 

formulas

• FDA plant inspections

• Yearly inspections at all infant formula facilities

– Good manufacturing practices

– Quality control procedures

– Records and reports

• Mandatory recalls of adulterated products