Contains Nonbinding Recommendations 
FDAs Policy on Declaring Small 
Amounts of Nutrients and Dietary 
Ingredients on Nutrition Labels: 
Guidance for Industry  
    Additional copies are available from:  
Office of Nutrition and Food Labeling, HFS-820 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
      5001 Campus Drive
College Park, MD  20740 
(Tel) 240-402-2371  
http://www.fda.gov/FoodGuidances 
You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to http://www/regulations.gov.  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 docket number FDA-2015-D-1839 listed in the notice of availability 
that publishes in the Federal Register.   
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition  
July 2016  Contains Nonbinding Recommendations 
Table of Contents 
I.    Introduction  
II.    Background  
III.   Discussion  
IV.   FDAs Policy  
  2  Contains Nonbinding Recommendations 
FDAs Policy on Declaring Small 
Amounts of Nutrients and Dietary 
Ingredients on Nutrition Labels:  
1
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  
This guidance addresses how conventional food and dietary supplement manufacturers should 
declare small amounts of nutrients and dietary ingredients on nutrition labels.  It specifically 
explains how FDA intends to consider exercising enforcement discretion when a conflict occurs 
between compliance with Title 21 of the Code of Federal Regulations (21 CFR), section 
101.9(c), and compliance with 21 CFR 101.9(g) such that compliance with both sections is not 
possible.  
 
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  
FDAs regulations in 21 CFR 101.9 and 21 CFR 101.36 describe requirements for nutrition 
labeling in conventional foods and dietary supplements, respectively.  The requirements for 
declaring the nutrient value in a serving of conventional food are in 21 CFR 101.9(c)(1)-(8). 
Certain dietary ingredients in dietary supplements are also required to be declared in accordance 
with these requirements (see 21 CFR 101.36(b)(2)(ii)).  These dietary ingredients are listed in 
                                                 
1This guidance has been prepared by the Office of Nutrition and Food Labeling, Food Labeling and Standards Staff 
in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.  Contains Nonbinding Recommendations 
21 CFR 101.36(b)(2) and are referred to as (b)(2)-dietary ingredients.  Unlike nutrients in 
conventional food, the (b)(2)-dietary ingredients can only be declared when they are present in 
dietary supplements in amounts that exceed the amount that can be declared as zero in nutrition 
labeling according to 21 CFR 101.9(c) (see 21 CFR 101.36(b)(2)(i)). 
 
FDAs regulations under 21 CFR 101.9(g)(4) and (5) describe compliance requirements for 
declaring nutrients and dietary ingredients2 in nutrition labeling.  A conventional food or dietary 
supplement declaring the amount of a nutrient or dietary ingredient in its labeling is misbranded 
under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(a)(1)] if: 
  The nutrient content of the composite of a vitamin, mineral, protein, total carbohydrate, 
polyunsaturated or monounsaturated fat, or dietary fiber is below 80 percent of the value 
for that nutrient declared on the label (21 CFR 101.9(g)(4)(ii)).3  
  The nutrient content of the composite of calories, total sugars, added sugars (when the 
only source of sugars in the food is added sugars), total fat, saturated fat, trans fat, 
cholesterol, or sodium is greater than 20 percent in excess of the value for that nutrient 
declared on the label (21 CFR 101.9(g)(5)).4
For the remainder of this document, we refer to 21 CFR 101.9(g)(4)(ii) and 21 CFR 101.9(g)(5) 
as the compliance requirements.  
III.  Discussion  
In many cases, the amount of a nutrient or (b)(2)-dietary ingredient declared in nutrition labeling 
in accordance with 21 CFR 101.9(c)(1)-(8) will not conflict with the compliance requirements.  
However, certain small amounts of nutrients or (b)(2)-dietary ingredients cannot be declared in 
accordance with both 21 CFR 101.9(c)(1)-(8) and the compliance requirements.  In these cases, 
the amount declared in accordance with 21 CFR 101.9(c)(1)-(8) is below or above the level 
provided by the compliance requirements. 
 
Example 1 shows when a conflict occurs between compliance with 21 CFR 101.9(c) and 21 CFR 
101.9(g)(4)(ii).  Under 21 CFR 101.9(c)(2)(iv), monounsaturated fat content must be expressed 
to the nearest 0.5 gram increment below 5 grams.  Therefore, if the analyzed value of 
monounsaturated fat is 0.75 to 1.00 grams, the amount of monounsaturated fat declared in 
accordance with this requirement is 1.00 gram (or 1 g).  This declared amount complies with 21 
CFR 101.9(g)(4)(ii) if the analyzed value is 0.80 gram or greater.  However, this declared 
amount would not comply with 21 CFR 101.9(g)(4)(ii) if the analyzed value of monounsaturated 
                                                 
2 See 21 CFR 101.36(f)(1).  
3 Provided that no regulatory action will be based on a determination of a nutrient value that falls below 
this level by a factor less than the variability generally recognized for the analytical method used in that 
food at the level involved (21 CFR 101.9(g)(4)(ii)).   
4 Provided that no regulatory action will be based on a determination of a nutrient value that falls above 
this level by a factor less than the variability generally recognized for the analytical method used in that 
food at the level involved (21 CFR 101.9(g)(5)).   
 
  Contains Nonbinding Recommendations 
fat is 0.75 to 0.79 gram because values in this range are not at least equal to 80 percent of 1.00 
gram.  
 
Example 1 pertains to the analyzed nutrient values that are below 80 percent of the nutrient value 
declared on the label for the 21 CFR 101.9(g)(4)(ii) nutrients.  Regarding analyzed nutrient 
values that are greater than the amount declared on the label, the regulations allow for reasonable 
excesses of nutrients, such as monounsaturated fat, within current good manufacturing practices 
in accordance with 21 CFR 101.9(g)(6).  
Example 1: Monounsaturated fat (amount in grams) 
Analyzed  Declared  Declared  Declared amount is 
value of a  amount  amount is in  not in compliance 
nutrient is   according to   compliance  with 21 
21 CFR    with 21 CFR  CFR 101.9(g)(4)(ii) 
101.9(c)(2)(iv)    101.9(g)(4)(ii)  for analyzed values 
for analyzed 
values 
0.751.00  1.00    0.80  0.750.79  
Example 2 shows when a conflict occurs between compliance with 21 CFR 101.9(c) and 21 CFR 
101.9(g)(5).  Under 21 CFR 101.9(c)(2)(i), saturated fat must be expressed to the nearest 
0.5 gram increment below 5 grams, unless the amount is less than 0.5 gram.  Therefore, if the 
analyzed value of saturated fat is 0.50 to 0.74 gram, the amount of saturated fat declared in 
accordance with this requirement is 0.50 gram (0.5g).  This declared amount complies with 
21 CFR 101.9(g)(5) if the analyzed value is 0.50 to 0.60 gram.  However, this declared amount 
would not comply with 21 CFR 101.9(g)(5) if the analyzed value of saturated fat is 0.61 to 0.74 
gram because values in this range are greater than 20 percent in excess of 0.50 gram.  
 
Furthermore, if the analyzed value of saturated fat is 1.00 to 1.24 grams, the amount of saturated 
fat declared in accordance with 21 CFR 101.9(c)(2)(i) is 1.00 gram (1 g).  This declared amount 
complies with 21 CFR 101.9(g)(5) if the analyzed value is 1.20 grams or less.  However, this 
declared amount would not comply with 21 CFR 101.9(g)(5) if the analyzed value is 1.21 to 
1.24 grams because values in this range are greater than 20 percent in excess of 1.00 gram.  
 
Example 2 pertains to the analyzed nutrient values that are above 20 percent of the nutrient value 
declared on the label for the 21 CFR 101.9(g)(5) nutrients.  Regarding analyzed nutrient values 
that are less than the amount declared on the label, the regulations allow for reasonable 
deficiencies of nutrients, such as saturated fat, within current good manufacturing practices in 
accordance with 21 CFR 101.9(g)(6).   
 
  Contains Nonbinding Recommendations 
Example 2: Saturated fat (amount in grams) 
Analyzed  Declared  Declared  Declared amount  is 
value of a  amount  amount is in  not in compliance 
nutrient is   according to   compliance  with 21 
21 CFR  with 21 CFR  CFR 101.9(g)(5) for 
101.9(c)(2)(i)     101.9(g)(5)  analyzed values 
for analyzed 
values 
0.500.74   0.50    0.60   0.610.74  
1.00-1.24   1.00    1.20   1.211.24 
For certain nutrients, such as total fat and its components (including monounsaturated fat and 
saturated fat), if the serving contains less than 0.5 gram, the amount must be expressed as zero in 
nutrition labeling (21 CFR 101.9(c)).  Unlike nutrients in conventional food, (b)(2)-dietary 
ingredients in dietary supplements must not be declared in nutrition labeling when the amount is 
zero (21 CFR 101.36(b)(2)(i)).   
IV.  FDAs Policy  
As discussed, when the analyzed value of nutrients or (b)(2)-dietary ingredients present in small 
amounts is declared in nutrition labeling in accordance with 21 CFR 101.9(c)(1)-(8), the declared 
amount may conflict with the compliance requirements.  In such cases, we intend to consider the 
use of our enforcement discretion with respect to the compliance requirements and recommend 
that manufacturers declare nutrients and (b)(2)-dietary ingredients in accordance with 21 CFR 
101.9(c)(1)-(8).   
 
FDAs nutrition labeling requirements in 21 CFR 101.9(c)(1)-(8) specify the increments and 
units of measure for declaring nutrient values.  However, 21 CFR 101.9(g)(4)(ii) and (5) do not 
specify the increments and units of measure required for declaring nutrient values.  Instead these 
provisions provide acceptable levels of variance for declared values.  FDA considers it more 
practical and consistent for manufacturers to follow paragraph (c)(1)-(8) when a conflict occurs 
between 21 CFR 101.9(c)(1)-(8) and FDAs compliance requirements.  This policy applies the 
same requirements to all products in a consistent way. 
 
We will continue to consider the variability generally recognized for the analytical method used 
in the compliance requirements.  We will also continue to consider the reasonable excesses and 
deficiencies of declared amounts acceptable within current good manufacturing practice (21 CFR 
101.9(g)(6)).