Contains Nonbinding Recommendations 
  
 
 
 
 
 
Use of the Term Healthy in the 
Labeling of Human Food Products: 
Guidance for Industry 
 
 
 
 
 
Additional copies are available from: 
Office of Nutrition and Food Labeling 
Nutrition Program 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 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
September 2016  Contains Nonbinding Recommendations 
 
Table of Contents 
 
 
 
I.  Introduction  
 
II.  Background  
 
III.  Discussion  
 
A. Low Fat 
 
B.  Beneficial Nutrients 
 
IV.  References 
 
  2  Contains Nonbinding Recommendations 
Use of the Term Healthy in the 
Labeling of Human Food Products: 
1
Guidance for Industry  
  
 
 
This guidance represents the current thinking of the Food and Drug Administration's (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 purpose of this guidance is to advise manufacturers who wish to use the implied 
nutrient content claim healthy to label their food products as provided by our regulations.  
More specifically, this guidance is intended to advise food manufacturers of our intent to 
exercise enforcement discretion relative to foods that use the implied nutrient content claim 
healthy on their labels which: (1) Are not low in total fat, but have a fat profile makeup of 
predominantly mono and polyunsaturated fats; or (2) contain at least ten percent of the Daily 
Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.   
 
This guidance is immediately effective because the agency has determined that prior 
public participation is not feasible or appropriate (21 CFR 10.115(g)(2)).  
 
FDA's 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 FDA guidances means that something is suggested or 
recommended, but not required.  
 
II.  Background 
 
Under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 343(r)(1)(A)), a food2 is misbranded if it bears claims, either express or implied, 
that characterize the level of a nutrient which is of a type required to be declared in nutrition 
                                                 
1 This guidance has been prepared by the Office of Nutrition and Food Labeling, Nutrition Program Staff, in the 
Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.    
2 Section 201(f) of the FD&C Act (21 U.S.C. 321(f)) defines the term food to mean articles used for food or drink 
for man or other animals, chewing gum, and articles used for components of any such article.   
  3  Contains Nonbinding Recommendations 
labeling3 unless the claim is made in accordance with a regulatory definition established by FDA 
(see section 403(r)(2) of the FD&C Act, 21 U.S.C. 343(r)(2)).  21 CFR 101.65(d) provides such 
regulatory definition for use of the term healthy or related terms (such as health, healthful, 
healthfully, healthfulness, healthier, healthiest, healthily, and healthiness) as an 
implied nutrient content claim on the label or in labeling of a food.  The healthy nutrient 
content claim can be used if the food meets certain nutrient conditions; and, when used with an 
explicit or implicit claim or statement about a nutrient (e.g. healthy, contains 3 grams of fat), 
suggests that a food, because of its nutrient content, may be useful in creating a diet that is 
consistent with dietary recommendations.  The nutrient conditions for bearing a healthy 
nutrient content claim include specific criteria for nutrients to limit in the diet, such as total fat, 
saturated fat, cholesterol, sodium, as well as requirements for nutrients to encourage in the diet, 
including vitamin A, vitamin C, calcium, iron, protein, and fiber.  The criteria are linked to 
elements in the Nutrition Facts label and serving size regulations (see 21 CFR  101.9 and 
101.12).  The nutrient criteria to use the claim can vary for different food categories (e.g., fruits 
and vegetables, or seafood and game meat) (see 21 CFR 101.65(d)(2)). 
 
In addition, it is also important to note that under section 403(a)(1) of the FD&C Act (21 
U.S.C. 343(a)(1)), a food is misbranded if its labeling is false or misleading in any particular.  
Section 201(n) of the FD&C Act (21 U.S.C. 321(n)) provides that labeling is misleading if, 
among other things, it fails to reveal facts that are material in light of representations made or 
suggested in the labeling, or material with respect to consequences that may result from the use 
of the food to which the labeling relates under the conditions of use prescribed in the labeling, or 
under such conditions of use as are customary or usual.   
 
III.  Discussion   
 
  In the Federal Register of May 27, 2016, we issued final rules updating the Nutrition 
Facts label and serving size information for packaged foods to reflect new scientific information, 
including the link between diet and chronic diseases such as obesity and heart disease (see 81 FR 
33742, Food Labeling: Revision of the Nutrition and Supplement Facts Labels; 81 FR 34000, 
Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating 
Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference 
Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments).  
Updates to the Nutrition Facts label include changes in the individual nutrients that must be 
declared and also changes to the Daily Value (DV) of other individual nutrients, reflecting 
changes in recommended intake levels, based on current science.  The individual nutrients 
included in Nutrition Facts and their DVs significantly influence the regulations on nutrient 
content and health claims.  Because the framework for many of FDAs other nutrition labeling 
regulations is linked to elements in the Nutrition Facts label and serving size regulations, we plan 
to update those other regulations, such as those for health claims and nutrient content claims 
(including the implied nutrient content claim healthy), to align with these most recent updates. 
 
                                                 
3 Section 201(m) of the FD&C Act (21 U.S.C. 321(m)) defines labeling as all labels and other written, printed, or 
graphic matter upon any article or any of its containers or wrappers or accompanying such article. 
  4  Contains Nonbinding Recommendations 
  The science underlying the final rules, referenced above, is also reflected in the 2015-
2020 Dietary Guidelines for Americans (2015-2020 Dietary Guidelines) (Ref. 1).  The Dietary 
Guidelines is designed for professionals to help all individuals ages 2 years and older and their 
families consume a healthy, nutritionally adequate diet. The Dietary Guidelines is the foundation 
of federal nutrition guidance and is fundamental in shaping federal policies and programs related 
to food, nutrition, and health.  The Dietary Guidelines provides information and perspectives on 
healthy eating patterns and consumption of foods from various food groups, as well as the intake 
of specific macronutrients such as fats, sugars, and micronutrients such as vitamins and minerals.  
Specific recommendations in the Dietary Guidelines have evolved over time, as nutrition science 
has advanced.  For example, scientific understanding and nutrition guidance has shifted from 
recommending diets low in total fat (2005 Dietary Guidelines) (Ref. 2) to no longer 
recommending limiting overall fat intake, and instead prioritizing increasing intakes of 
polyunsaturated and monounsaturated fats and decreasing intakes of saturated fat and trans fat 
(2015-2020 Dietary Guidelines).  The 2015-2020 Dietary Guidelines, also emphasizes the 
importance of dietary patterns as a whole, the combination of foods and drinks that people 
consume over time.  The body of scientific evidence and the recommendations based on that 
science in the Dietary Guidelines will help FDA shape additional updates to regulations on 
nutrition related claims and information that are permitted on the food label. 
 
  We are re-evaluating the regulatory criteria for use of the implied nutrient content claim 
healthy in light of the latest nutrition science and the current dietary recommendations and 
seek input on possible future rulemaking to update the existing regulations for this claim.  
Because the rulemaking process can sometimes be lengthy, we intend to exercise enforcement 
discretion in the interim with respect to some of the existing criteria for the nutrient content 
claim healthy if the alternative nutrient criteria described below are met.  We intend to exercise 
enforcement discretion until we amend 21 CFR 101.65(d)(2). 
  
A.  Low Fat  
 
  As stated above, since we published the final rule defining healthy (58 FR 2302, 
January 6, 1993), the science related to public health recommendations for intake of dietary fats 
has evolved.  The focus of the most recent dietary fat recommendations has shifted away from 
limiting total fat intake to encouraging intakes of mono and polyunsaturated fats.  Foods that use 
the term healthy on their labels that are not low in total fat should have a fat profile makeup of 
predominantly mono and polyunsaturated fats (i.e., sum of monounsaturated fats and 
polyunsaturated fats are greater than the total saturated fat content of food).  Consistent with 
consensus science and public health recommendations for dietary fats which no longer 
recommend low total fat intake, we intend to exercise enforcement discretion with respect to the 
current requirement that any food bearing the nutrient content claim healthy meet the low fat 
requirement (101.65(d)(2)(i)), provided that: (1) The amounts of mono and polyunsaturated fats 
are declared on the label and (2) the amounts declared constitute the majority of the fat content.  
These conditions are necessary so that consumers are made aware that the total fat is mostly 
made up of fats that are encouraged by current dietary recommendations.     
 
  5  Contains Nonbinding Recommendations 
B.  Beneficial Nutrients 
 
  The definition for healthy also includes a nutrient contribution criterion.  Healthy 
dietary patterns not only restrict nutrients that increase risk of chronic disease, but also help 
assure nutrient adequacy to ensure sufficient intake of nutrients that are important in sustaining 
body function and reducing the risk of disease.  The current definition of healthy has focused 
on foods providing a good or excellent source of nutrients for which there had been public health 
concern.  Historically, these nutrients have been vitamin A, vitamin C, iron, calcium, and dietary 
fiber.  Nutrient intakes have shifted over time, however, and vitamins A and C are no longer 
nutrients of public health concern.  The nutrients of public health concern now include potassium 
and vitamin D, in addition to iron and calcium (2015-2020 Dietary Guidelines).  This change in 
nutrients of public health concern has been reflected in the mandatory nutrients to be labeled in 
the Nutrition Facts Label (see 81 FR 33742, May 27, 2016).  In recognition of this change, we 
intend to exercise enforcement discretion with respect to the current requirement that any food 
bearing the nutrient content claim healthy contain at least ten percent of the Daily Value (DV) 
per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, 
protein, or fiber, if the food instead contains at least ten percent of the DV per RACC of 
potassium or vitamin D.  The regulations updating the Nutrition Facts label have provided for 
new DVs for potassium and vitamin D and manufacturers have been given some time to come 
into compliance with these regulations.  If a manufacturer has not yet implemented the updated 
Nutrition Facts label, they may use the old DVs for potassium and vitamin D.  If a manufacturer 
has already implemented the updated Nutrition Facts label, they must use the new, updated DVs 
for potassium and vitamin D.  In either case, if a food is basing its eligibility for bearing a 
healthy claim on potassium or vitamin D, whichever nutrient is being used as the basis for 
eligibility should be declared in the Nutrition Facts label.   
 
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.  
As of June 1, 2016, FDA had verified the Web site address for the references we make available 
as hyperlinks from the Internet copy of this guidance, but we are not responsible for any 
subsequent changes to Non-FDA Web site references after June 1, 2016.  
 
1.  U.S. Department of Health and Human Services and U.S. Department of Agriculture. 2015  
2020 Dietary Guidelines for Americans. 8th Edition. December 2015. Available at 
http://health.gov/dietaryguidelines/2015/guidelines/. 
 
2.  U.S. Department of Health and Human Services and U.S. Department of Agriculture. Dietary 
Guidelines for Americans, 2005. 6th Edition, Washington, DC: U.S. Government Printing 
Office, January 2005.  Available at http://health.gov/dietaryguidelines/dga2005/. 
 
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