Contains Nonbinding Recommendations 
Questions and Answers on FDAs 
Fortification Policy 
Guidance for Industry 
             Additional copies are available from: 
Office of Nutrition, Labeling, and Dietary Supplements 
Division of Nutrition Programs Staff HFS-830 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive
College Park, MD  20740 
(Tel) 240-402-1450 
 http://www.fda.gov/FoodGuidances 
You may submit written comments regarding this guidance at any time.  Submit 
written comments on the guidance to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.  All comments should be identified with the title of the guidance document. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
November 2015 
1  Contains Nonbinding Recommendations 
 
 
 
Table of Contents  
 
 
I.    Introduction  
II.   Background 
III.   Questions & Answers 
A.  Overarching Principles and Applicability of the Fortification 
Policy  
B.  Foods Covered Under the Fortification Policy  
Foods with Standards of Identity Used as Vehicles of Fortification 
C.  Nutrients Covered Under the Fortification Policy  
 
D.  Principles of the Fortification Policy for Specific Purposes 
 
E.  Claims and Other Statements on the Food Label  
 
F.  Enforcement of the Fortification Policy Incorporated into 
Regulations 
 
IV.  References    
  2  Contains Nonbinding Recommendations 
 
 
 
  
Questions and Answers on FDAs 
1
Fortification Policy  
 Guidance for Industry 
 
This guidance represents the current thinking of the Food and Drug Administration 
(FDA or we) on this topic.  It does not establish any rights for any person and is not 
binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative 
approach, contact the FDA staff responsible for this guidance as listed on the title page. 
 
I. Introduction 
The achievement and maintenance of a desirable level of nutritional quality in the 
nations 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 
                                                 
1 This guidance has been prepared by the Nutrition Programs Staff and the Food Labeling and 
Standards Staff in the Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration. 
 
  3  Contains Nonbinding Recommendations 
 
 
 
manufacturer, to follow the principles of the policy if you elect to add nutrients to a 
food for human consumption.   
 
FDAs 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.   
 
II. Background  
 
FDAs fortification policy establishes a uniform set of principles to serve as a model 
for the rational addition of essential nutrients to foods.  The principles of rational 
fortification are to: 
  
  Correct a dietary insufficiency (21 CFR 104.20(b));  
  Restore nutrient levels to those prior to storage, handling, and processing 
(restoration principle) (21 CFR 104.20(c));  
  Provide a balance of vitamins, minerals, and protein in proportion to the total 
caloric content of the food (nutrient-to-calorie balance principle) (21 CFR 
104.20(d)); and 
  Prevent nutrient inferiority in a food that replaces a traditional food in the diet 
(21 CFR 104.20(e)). 
 
For more information about applying these principles, please see the Principles of 
the Fortification Policy for Specific Purposes below.    
 
III. Questions & Answers  
A. Overarching Principles and Applicability of the Fortification 
Policy 
 
A1. What is the general purpose of FDAs fortification policy? 
 
This policy establishes a uniform set of principles concerning the nutrient 
fortification of foods, which manufacturers are urged to follow if they elect to add 
nutrients to a manufactured or processed food.  As stated in the background, the 
principles of rational fortification expressed in the policy are to: correct a dietary 
insufficiency, restore nutrient levels to those prior to storage, handling, and 
processing, provide a balance of vitamins, minerals, and protein in proportion to the 
total caloric content of the food, and prevent nutrient inferiority in a food that 
replaces a traditional food in the diet.  The principles are a model for the rational 
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addition of essential nutrients to conventional foods to preserve a balance of 
nutrients in the diet of consumers in the United States. This policy is based on 
United States dietary practices and nutritional needs and may not be applicable in 
other countries. This policy discourages the indiscriminate addition of nutrients to 
foods.  
 
A2. What is an example of a rational addition?  
Adding calcium to soy beverages is a rational addition because it provides a 
reasonable vehicle for people who do not drink milk, such as those who are lactose 
intolerant, but do want to obtain calcium, an essential mineral. 
 
A3. Should I follow all of the principles listed in the fortification policy?  
No. You should follow the principles that relate to your nutrient objectives.  For 
example, if a food loses a nutrient during processing, then you should follow the 
restoration principle to restore that nutrient to the original level before loss in 
processing (21 CFR 104.20(c)).  See section on Principles of the Fortification 
Policy for Specific Purposes.  
A4. Does the fortification policy apply to animal foods?  
No. The principles of the fortification policy apply to conventional foods consumed 
by humans.    
A5. Does the fortification policy apply to infant formula and dietary 
supplements?  
No.  The fortification policy does not apply to infant formula or dietary supplements.  
For information about regulations for the addition of nutrients to infant formula, see 
21 CFR 107.100.  For information about the addition of nutrients to dietary 
supplements, see http://www.fda.gov/Food/DietarySupplements.  
A6. Is nutrient fortification of foods mandatory in the United States?                            
With the exception of some standardized foods, fortification is not mandatory in the 
United States.  Foods subject to certain standards of identity may be required to be 
fortified with certain vitamins and minerals.  For example, enriched flour must 
contain particular levels of thiamin, riboflavin, niacin, iron, and folic acid specified 
in 21 CFR 137.165.  However, you are not required to enrich your products.  For 
every standard of identity for an enriched product, we have a corresponding standard 
of identity for the unenriched product.    
A7. What is voluntary nutrient fortification of foods? 
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In general, voluntary fortification refers to adding nutrients to foods that do not have 
a standard of identity for enriched products.  Voluntary fortification would apply to 
the following types of foods:  
  Foods that do not have a standard of identity  If you fortify foods without a 
standard of identity, you should follow the fortification policy in 21 CFR 104.20.  
  Foods that have a standard of identity (for example, orange juice) but whose 
standard does not include the addition of a particular nutrient  If you fortify these 
foods, you must follow   
 The requirements in 21 CFR 130.10 (Requirements for foods named by use of 
o
a nutrient content claim and a standardized term referred to as the generic 
standard) at levels for the additional nutrient consistent with 21 CFR 101.54(e) 
claim (the definition for more). This claim requires adherence to the 
fortification policy (21 CFR 101.54(e)). 
  Foods bearing the term healthy to which a nutrient has been added to meet the 
requirement that the food contain 10 percent or more of the Daily Value per 
reference amount of vitamin A, vitamin C, calcium, iron, protein, or fiber (21 
CFR 101.65(d))  These foods must be fortified under the requirements of the 
fortification policy.   
 
A8. Does the fortification policy apply to both voluntary and mandatory  
fortification? 
  
Yes. We have used the principles in the fortification policy to issue regulations such 
as the standards of identity that require the addition of folic acid to various enriched 
grain products (21 CFR Parts 136, 137. 139).  You should also follow the 
fortification policy described in this guidance for voluntary fortification of foods. 
A9. Can I fortify products in order to make a health claim? 
Under the regulation for health claims (21 CFR 101.14(e)(6)), the food must 
naturally contain 10 percent or more of the Reference Daily Intake (RDI) of the 
Daily Reference Value (DRV) for vitamin A, vitamin C, iron, calcium, protein, or 
fiber per reference amount customarily consumed before any nutrient addition.  This 
does not pertain to dietary supplements or exemptions made for specific health 
claims.  However, if a food meets this requirement, you may add the nutrient or 
substance that is the subject of the health claim to meet the requirements of the 
health claim.  An example would be adding calcium to a conventional food such as 
orange juice when making the calcium and osteoporosis health claim (21 CFR 
101.72).  The conventional food must already meet the general requirements of a 
health claim under 21 CFR 101.14.  In this example, the food (orange juice) would 
be required to contain 10 percent or more of the Daily Reference Value of naturally 
occurring vitamin C.   
 
B.  Foods Covered Under the Fortification Policy 
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B1. What foods are covered under the fortification policy? 
 
The fortification policy applies to certain conventional foods for human 
consumption.  It does not apply to animal foods, infant formulas, or dietary 
supplements (see questions A4 and A5).  The policy applies to certain conventional 
foods with or without an FDA food standard of identity regulation.  
 
B2. Is it appropriate to use any conventional food (with exception of infant 
formula) as a vehicle of fortification for human use? 
Under our fortification policy, it is not appropriate to fortify certain foods, such as 
fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies 
and carbonated beverages.  See also questions B3 and B4.  
Customary dietary practice firmly establishes the use of meat, poultry, or fish 
products and fresh produce, and the public understands the role of these products in 
a balanced diet.  Because this policy is a guideline for the rational addition of 
nutrients to food, we see no reason to add nutrients to these foods.  
In the fortification policy, snack foods refer to foods that are not naturally nutrient 
dense; examples include cookies, candies, cakes, chips, and carbonated beverages 
(both sweetened and unsweetened).  Fortification of these types of snack foods could 
mislead consumers to believe that substitution of naturally nutrient dense foods with 
fortified snack foods would ensure a nutritionally adequate diet.     
 
Moreover, the fortification of such snack foods would disrupt public understanding 
about the nutritional value of individual foods and thereby promote confusion among 
consumers, making it more difficult for them to construct diets that are nutritionally 
adequate. 
 
For further discussion on our policy regarding fortification of snack foods, see the 
preamble of the final rule at 45 FR 6314 at 6315.   
B3. Is it appropriate to fortify unsweetened carbonated beverages and low-
calorie and calorie-free snack foods? 
No.  Under our fortification policy, it is not appropriate to fortify unsweetened 
carbonated beverages and low-calorie and calorie-free snack foods (e.g., low calorie 
or fat free cookies).   
B4. Is it appropriate to add vitamins and minerals to alcoholic beverages?  
 
No.  Under our fortification policy, we do not consider it appropriate to add vitamins 
and minerals to alcoholic beverages.  
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B5.   Why should I follow FDAs fortification policy for meat and poultry that 
are under the U.S. Department of Agricultures (USDA) jurisdiction?   
 
The USDA Food Safety and Inspection Service (FSIS) has requirements on 
labeling meat and poultry products (see 
http://www.fsis.usda.gov/shared/PDF/Nutrients_Meat_&_Poultry.pdf).  FSIS 
cites our fortification policy in its label requirements.  As stated in question B2, 
we do not recommend that you fortify meat and poultry products.  If you need 
more information on fortifying meat and poultry products that FSIS regulates, 
consult with FSIS.   
Foods with Standards of Identity Used as Vehicles of Fortification 
B6.  How do FDAs food standards of identity regulations relate to 
fortification?  
FDAs regulations on food standards of identity in 21 CFR parts 130 through 169 
specify which ingredients a food product must contain and how to make the product 
in order to market it under a specific name, or statement of identity.  On occasion, 
food standards of identity have served as a means to improve the overall nutritional 
quality of the food supply and to meet a demonstrated public health need.  For 
example, adding folic acid to certain standardized foods, such as enriched grain 
products, is required so that the resulting food product may help to reduce the risk of 
neural tube birth defects in infants (21 CFR 172.345).  
  
B7.  What are some examples of standardized foods that are fortified? 
 
  Enriched cereal flours and related products such as enriched flour (21 CFR 
137.165);  
  Enriched bakery products such as enriched bread, rolls, and buns (21 CFR      
136.115);  
  Enriched macaroni products (21 CFR 139.115);  
  Margarine, mandatory addition of vitamin A and optional addition of vitamin 
   D (21 CFR 166. 110); and 
  Milk, optional addition of vitamins A and D (21 CFR 131.110). 
 
B8.  What are the nutrient requirements for standardized cereal flours and 
other standardized bakery products that are labeled as being enriched?  
Standards for these enriched products require that they contain specified amounts of 
thiamin, riboflavin, niacin, iron, and folic acid.  We also have provisions for the 
optional addition of calcium and vitamin D to some of these products.  Details on 
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specific provisions of each standard of identity are provided in 21 CFR parts 130 
through 169.  
B9.  What is an example of a conventional food that is not a standardized food 
that may be fortified?   
Though not covered under a standard of identity regulation, manufacturers may add 
iodine, in the form of cuprous iodide (21 CFR 184.1265) or potassium iodide 
(21 CFR 184.1634), to salt or table salt for human food use.  The term iodized salt 
or iodized table salt is designated as the name of salt that has added iodine.  The 
statement This salt supplies iodide, a necessary nutrient must also appear on the 
label of packages intended for retail sale (21 CFR 100.155).  However, you are not 
required to add iodine to salt or table salt.  Retail packages of salts without iodine 
must bear the statement This salt does not supply iodide, a necessary nutrient (21 
CFR 100.155). 
 
C.  Nutrients Covered Under the Fortification Policy  
C1. What nutrients are covered under the fortification policy?  
Only essential nutrients are within the scope of our fortification policy.  The term 
essential nutrient under the fortification policy refers to the vitamins and minerals 
assigned Reference Daily Intakes (RDIs) listed in 21 CFR 101.9(c)(8)(iv), as well as 
protein and potassium that have daily reference values (DRVs) (21 CFR 101.9(c)(9) 
or 21 CFR 104.20(d)(3)). 
 
In addition, the source of the essential nutrient must be safe and lawful under the 
applicable food safety provisions of the Federal Food, Drug, and Cosmetic Act.  For 
conventional foods, this evaluation involves considering whether the nutrient added 
to the food is generally recognized as safe (GRAS) under the conditions of its 
intended use, approved as a food additive, or authorized by a prior sanction issued by 
FDA (21 CFR parts 182, 184 and 172).  The food additive regulations or GRAS 
status of some nutrients may also limit which foods may be fortified and at what 
level.  For example, the food additive regulation on folic acid (21 CFR 172.345) and 
vitamin D (21 CFR 172.379; 21 CFR 172.380) stipulates which foods may be 
fortified and at what level.   
C2. Does the fortification policy apply to all of the essential vitamins and 
minerals listed in 21 CFR 101.9(c)(8)(iv)?  If so, why are they not listed under 
21 CFR 104.20(d)(3)?  
The fortification policy applies to all essential vitamins and minerals listed in 21 
CFR 101.9(c)(8)(iv).      
 
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When we established the fortification policy in 1980, we anticipated that additional 
essential nutrients would be added to the list of vitamins and minerals in 21 CFR 
101.9(c)(8)(iv) and would be eligible for the rational fortification of food.  
Therefore, 21 CFR 104.20(a) states, in part, that:  
 
It is reasonable to anticipate that the RDIs as delineated in 21 CFR 101.9 
of this chapter and in paragraph (d) of this section will be amended from 
time to time to list additional nutrients and/or to change the levels of 
specific RDIs as improved knowledge about human nutrient 
requirements and allowances develops.   
 
In 1980, the essential vitamins and minerals listed in 21 CFR 104.20(d)(3) were the 
same as those listed in 21 CFR 101.9(c)(7)(iv) (38 FR 2125; January 19, 1973).  At 
that time, RDIs for several vitamins and minerals that are now considered essential 
had not been established (for example, selenium and chromium).  In 1995, we 
amended the list of essential vitamins and minerals to include vitamin K, manganese, 
selenium, chromium, molybdenum, and chloride and provided RDIs under 21 CFR 
101.9(c)(8)(iv) (60 FR 67164; December 28, 1995).  These nutrients may be 
rationally added to food under the fortification policy.  As we add other essential 
vitamins and minerals to 21 CFR 101.9(c)(8)(iv), they will also be covered under the 
fortification policy unless other regulations prohibit the addition of the nutrients to 
certain foods.   
C3. Are nutrients that do not have an RDI or an established reference value 
(for example, lycopene and lutein) covered under this policy?  
No.  Only essential nutrients with an RDI (21 CFR 101.9(c)(8)(iv)), as well as 
potassium and protein (21 CFR 101.9(c)(9)) are covered under this policy.  
C4. When is it appropriate to add an essential nutrient to a food under the 
fortification policy (21 CFR 104.20(g))?   
In addition to the circumstances permitting fortification discussed throughout this 
document, the general requirements in 21 CFR 104.20(g) applies to all types of 
nutrient additions under the fortification policy.  Before adding a nutrient to a food, 
you should ensure the nutrient meets all of the following conditions:   
  The nutrient is stable in the food under customary conditions of storage, 
distribution, and use.   
  The nutrient is physiologically available from the food. 
  The nutrient is added at an appropriate level to avoid excessive intake of that 
nutrient, considering cumulative amounts from all sources in the diet.  To assess 
excessive total intakes of essential vitamins and minerals and to estimate safe 
limits of addition of essential nutrients, you should use upper levels of intake 
when available, such as the tolerable upper intake level (UL) established by the 
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Institute of Medicine (IOM).  After we established the fortification policy, the 
IOM established ULs for a number of nutrients.  The ULs can be considered in 
assessing excessive intake in different subpopulations (Ref 1).  
  The nutrient is suitable for its intended purpose and complies with the Federal 
Food, Drug, and Cosmetic Act and regulations governing the safety of substances 
in food.  
 
D.  Principles of the Fortification Policy for Specific Purposes 
 
D1. What is meant by the principle that permits the addition of nutrients to a 
food to correct a dietary insufficiency (21 CFR 104.20(b))?   
 
This principle means that you can add essential nutrients (see question C1 for 
definition of essential nutrients) to a food to correct a dietary insufficiency or meet a 
demonstrated public health need if the scientific community recognizes the dietary 
insufficiency and knows the deficiency results in a nutritional deficiency disease.  
 
D2. Who should identify nutritional problems, the population groups affected 
by these problems, and the identity of suitable foods that may act as vehicles for 
adding appropriate nutrients to address these problems?  
 
Identifying nutritional problems and implementing measures to correct these 
problems involve the combined efforts of many participants.  FDA serves as a focal 
point for identifying public health problems with respect to fortifying and labeling 
foods that it regulates.  In conjunction with other government agencies, research 
groups, educational institutions, and informed consumer groups, FDA participates in 
the collection and exchange of information relating to nutritional problems.  We urge 
you to consult us if you are considering adding nutrients to food based on this 
principle.  (For contact information, see the information on the title page of this 
guidance document.)  
D3. What is an example of a nutrient addition to the U.S. food supply for public 
health purpose? 
Requiring folic acid in standardized enriched grain products is an example of a 
nutrient addition for a public health purpose.  In September 1992, the United States 
Public Health Service (PHS) recommended that all women who are capable to 
become pregnant consume 400 micrograms of folic acid daily to reduce their risk of 
having a newborn affected by neural tube defects.  Since 1998, in keeping with the 
recommendations of PHS, FDA has required that folic acid be added to standardized 
enriched grain products (21 CFR Parts 136, 137 and 139).  The rationale for 
fortifying standardized enriched cereal grain products as a vehicle of fortification 
was that most women consume these products.  Thus, fortification of these products 
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would lead to increased folic acid intake of most women without requiring a change 
in their dietary patterns.   
 
In general, before FDA requires fortification of the food supply with a nutrient (for 
example, folic acid), we perform a dietary modeling exercise of current dietary 
intakes to evaluate possible fortification levels for the target population (women of 
childbearing age).  The intake levels must be effective for the target population and 
safe for the overall population.   
 
Before requiring fortification of enriched cereal grains with folic acid, FDA 
estimated the effects of fortification on the target population and the general 
population.  Estimated distributions of current total daily folate intake (conventional 
foods plus supplements) and projected intakes with folic acid fortification from a 
national food consumption survey were created for eight age groups for males and 
females.2  
 
Based on the modeling exercise and rulemaking procedures, we approved 
fortification of enriched grains with folic acid at specified levels (21 CFR parts 136, 
137, and 139), as well as under the food additive regulation (21 CFR 172.345).  
Under the food additive regulation, you can add folic acid to enriched grain 
products, breakfast cereals, corn grits, meal replacement products, infant formula, 
and foods for special dietary use.  The addition of folic acid to standardized enriched 
grains has led to increased folic acid intake, improved levels in serum and red blood 
cells, and decreased prevalence of neural tube birth defects in the United States 
(Refs.2 and 3).  
D4.  What does the restoration principle in 21 CFR 104.20(c) mean? 
The restoration principle means you can add nutrients to a food to restore such 
nutrients to levels representative of the food prior to storage, handling, and 
processing, when adequate scientific documentation shows the nutrient to have been 
lost in a measurable amount (that is, at least 2 percent of the RDI or Daily Reference 
Value (DRV) per serving) in storage, handling, and processing.  You should use this 
principle when: 
  Good manufacturing practices and normal storage and handling procedures 
cannot prevent the loss of the nutrients; 
  All nutrients that are lost in measurable amounts are restored and all ingredients 
of the food product that contribute nutrients are considered in determining 
restoration levels;   
  No other Federal regulation requires or prohibits nutrient additions to the food;  
                                                 
2 See the final rule of March 5, 1996, for more information on fortification with folic acid (61 FR 
87818807). 
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  The food has not been fortified in accordance with a Federal regulation that 
permits voluntary nutrient additions.  
D5. Should I restore only one or all nutrients that were lost during storage, 
processing, and handling?  
If you use the restoration principle, then you should restore all essential nutrients 
(see question C1 for definition of essential nutrients) lost at measurable amounts (at 
least 2 percent of the RDI or DRV per serving) during storage, processing, and 
handling.  Partial restoration may result in restoring only those nutrients that are least 
expensive, technologically easiest to add, or required to be listed in nutrition 
labeling.  Therefore, partial restoration may contribute to nutrient imbalance in the 
food supply.  
D6. What is the nutrient-to-calorie balance principle in 21 CFR 104.20(d)? 
This principle means you may add nutrients listed in 21 CFR 101.9(c)(8)(iv) as well 
as protein and potassium under 21 CFR 101.9(c)(9) to a food in proportion to the 
foods total caloric content, to balance the vitamin, mineral, and protein content if 
the following apply: 
 
  A normal serving of the food contains at least 40 calories, (that is, 2 percent of 
2,000 calories as a daily reference amount); 
  Based on the 2,000 calorie daily reference amount, the food contains each of the 
listed nutrients in 21 CFR 101.9(c)(8)(iv), as well as protein and potassium under 
21 CFR 101.9(c)(9), at a level equal to at least 1/20th of the RDI per 100 calories 
of food; and 
  No other Federal regulation for the food or class of food requires, permits, or 
prohibits nutrient additions. 
D7. Why did FDA establish the nutrient-to-calorie balance principle?  
 
We established this principle to provide a general basis for fortifying foods when no 
specific regulation exists, such as a food standard of identity or nutritional quality 
guideline under 21 CFR 104.47.  In the absence of a specific regulation governing 
the enrichment of a food, the nutrient-to-calorie balance principle provides a suitable 
basis for adding nutrients to fabricated foods that may replace large portions of the 
total diet.   
 
In general, when the specific use of new or unique products cannot be predicted, it is 
not possible to anticipate a specific and limited nutrient content or profile.  
Therefore, when products cannot be categorized as substitutes or replacements for a 
particular food and you elect to add nutrients to such products, the nutrient additions 
should conform to a profile reflecting all the foods that the product might substitute 
for or replace in the diet.  Because it is impractical to develop a profile for each food, 
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a logical alternative is a profile that would sustain a balance in the average persons 
overall nutrient intake by relating nutrient content to caloric content. 
 
For further discussion on the nutrient-to-calorie balance principle, see the final rule 
preamble at 45 FR 6314 at 6317.     
 
D8. When is the use of the nutrient-to-calorie balance principle not 
appropriate? 
 
Adding nutrients to foods based on the nutrient-to-calorie balance principle is not 
appropriate under any of the following conditions: 
 
  The nutrient addition or composition of a food or class of foods has already been 
established by an applicable Federal regulation, such as a standard of identity.   
  A formulated meal replacement product for use in weight reduction replaces a 
traditional, higher calorie meal.  If a manufacturer fortifies the meal replacement 
based on its caloric contribution, the meal replacement would not always provide 
the appropriate amounts of necessary vitamins and minerals that a traditional, 
higher calorie meal normally provides.   
  The food substitutes for and resembles a traditional food.  It may be more 
appropriate to fortify a food under the imitation principle described in 
question D9.  
D9. What does 21 CFR 104.20(e) mean when it states, a nutrient(s) may 
appropriately be added to a food that replaces traditional food in the diet to 
avoid nutritional inferiority in accordance with  101.3(e)(2) of this chapter? 
Some foods are designed to replace traditional foods, such as an almond spread for 
an almond butter.  Absent a specific regulation, such as a common or usual name 
regulation (21 CFR part 102), a food that substitutes for and resembles another food 
must provide essential nutrients at levels nutritionally equivalent to the food it 
resembles or must bear an imitation label in accordance with 21 CFR 101.3(e).  
To avoid labeling the substitute food as imitation based on nutritional inferiority, 
you must fortify the substitute food with the same amount of any nutrients, other 
than fat or calories that are present in the traditional food in a measurable amount 
(21 CFR 101.3 (e)).  A measurable amount of an essential nutrient is as follows:  
  2 percent or more of the DRV of protein (101.9(c)(7)(iii)) and of potassium 
(21 CFR 101.9(c)(9)) per reference amount customarily consumed (RACC); 
  
  2 percent or more of the RDI of any vitamin or mineral listed under 21 CFR 
101.9(c)(8)(iv) per RACC, except for selenium, molybdenum, chromium, and 
chloride.  
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Alternatively, you must label the food by a different name, such as almond spread 
rather than almond butter.  See 21 CFR 101.3(e) for details on the provisions for 
imitation labeling. 
D10.  What does the statement Nutrient(s) may be added to foods as permitted 
or required by applicable regulation established elsewhere in this chapter in 
21 CFR 104.20(f) mean?  
This statement means you can add essential nutrients to foods according to existing 
regulations.  We based the regulations on adding nutrients to foods on the best 
available scientific data on food consumption patterns, nutritional needs, and dietary 
habits of the general population.  The applicable regulations are those pertaining to a 
common or usual name for specific nonstandardized foods (21 CFR part 102), food 
standards of identity (21 CFR parts 130 through 169), and specific nutritional quality 
guidelines (21 CFR 104.47).   
 
E.  Claims and Other Statements on the Food Label  
 
E1. What requirements pertain to claims and other statements on the food 
label of fortified foods (21 CFR 104.20(h))?  
 
As explained in 21 CFR 104.20(h), any labeling claims or statements about the 
addition of a vitamin, mineral, or protein to a food shall be made only if the 
following apply:  
 
  The claim or statement is not false or misleading in accordance with the 
provisions in section 403 of the Federal Food, Drug, and Cosmetic Act; and 
  The claim or statement complies with any applicable regulations such as those in 
the food labeling regulations (21 CFR part 101). 
 
E2. How does FDA regard the terms fortified and enriched on the food 
labels (21 CFR 104.20(h))? 
The terms enriched, fortified, or similar terms may be used interchangeably to 
indicate that one or more essential nutrients were added to a food unless an 
applicable Federal regulation requires the use of specific words or statements.  
Since FDA issued regulations under the Nutrition Labeling and Education Act of 
1990, enriched and fortified as well as added, plus, extra, and more are 
defined nutrient content claims.  In general, labeling bearing these terms must 
comply with the definition for more (21 CFR 101.54(e)).  However, if a food 
standard of identity exists for a particular food and the claim is part of the foods 
name, you must use the term identified in the regulation.  Examples of a name 
required by a standard of identity include enriched bread, rolls, and buns (21 CFR 
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136.115) and enriched flour (21 CFR 137.165).  An example of a standardized food 
that must use a particular claim is milk vitamins A and D added (21 CFR 
131.110).  See also questions E4 and E5.   
E3. Can I use alternate terms, such as fortified, interchangeably for 
standardized foods?   
No.  You must use the name prescribed in the regulations for the standardized food 
(Section 403 (g) of the Federal Food, Drug, and Cosmetic Act).  For example, you 
cannot substitute the term fortified flour for enriched flour.   
 
E4. What are examples of acceptable labeling claims I may use in relation to 
the fortification policy (21 CFR 104.20(h))?  
 
In addition to the nutrient content claims added, enriched, extra, fortified, 
more, and plus, you may use the following labeling claims:  
 
  Fully restored with vitamins and minerals or fully restored with vitamins and 
minerals to the level of unprocessed ___ (fill the blank in with the common or 
usual name of the food) to describe foods fortified in accordance with the 
restoration principles in 21 CFR 104.20(c); and  
  Vitamins and minerals (and protein when appropriate) added are in 
proportion to caloric content to describe foods fortified in accordance with the 
nutrient-to-calorie balance principles in 21 CFR 104.20(d). 
 
As discussed in questions E2 and E3, you can use the term enriched, fortified, 
added, or similar terms interchangeably, when labeling claims are allowed, to 
indicate the addition of one or more vitamins, minerals, or protein to a food, unless 
an applicable Federal regulation requires the use of specific words or statements.  
For example, 21 CFR 131.110(e)(1) for milk states:  
 
The following terms shall accompany the name of the food...(i) if vitamins are 
added, the phrase vitamin A or vitamin A added, or vitamin D or vitamin  
D added, or vitamin A and D or vitamins A and D added.... 
 
In this case and in similar cases, you must use only the terms specified in the 
regulation. 
 
E5. Is it appropriate to make a claim or statement about a food that is fortified 
to prevent nutritional inferiority (21 CFR 104.20(i))?  
 
No.  According to 21 CFR 104.20(i), it is inappropriate to make any claim or 
statement (other than in the ingredient list) concerning nutrients that are added to 
foods to prevent nutritional inferiority (see 21 CFR 101.3(e)).  Doing so may result 
in a substitute food appearing to be superior to the food that it resembles because a 
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claim or statement suggests that the food contains additional nutrients compared to 
the traditional food.  See question D10.   
 
F.  Enforcement of the Fortification Policy Incorporated into 
Regulations 
F1. How does FDA enforce the fortification policy that has been incorporated 
into regulations? 
Although this policy is primarily used as guidance, we have incorporated the 
provisions of the fortification policy into the following two nutrient content claim 
regulations that have the force and effect of law:  
  More and its synonyms fortified, enriched, added, extra, and plus 
(21 CFR 101.54(e)); and  
  Healthy and related terms such as healthful and healthier (21 CFR 
101.65(d)(iv)).   
Consequently, FDA may issue a warning letter and take enforcement action if a 
marketed food bearing one or more of these nutrient content claims contains a 
nutrient addition that is inconsistent with the fortification policy as incorporated into 
the regulations noted above.  Nevertheless, FDA strongly encourages you to follow 
these fortification guidelines regardless of whether any claims appear on the label or 
in labeling.  
 
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IV. References 
We have placed the following references on display in the Division of Dockets 
Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.  You may see them at that location between 9 a.m. and 4 
p.m., Monday through Friday.   
1. Institute of Medicine, Dietary Reference Intakes- A risk assessment model for 
establishing upper intake levels for nutrients. National Academy Press. 1998. 
Washington D.C. 
  
2. Pfeiffer CM, Johnson CL, Jain RB, Yetley EA, Picciano MF, Rader JI, Fisher 
KD, Mulinare J, Osterloh JD.  Trends in blood folate and vitamin B-12 
concentrations in the United States, 19882004.  Am J Clin Nutr. 2007. 86:718-
727. 
 
3. Centers for Disease Control and Prevention.  Spina bifida and anencephaly before 
and after folic acid mandateUnited States, 19951996 and 19992000. 2004.  
Report No 53. 
 
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