Contains Nonbinding Recommendations 
 
 
 
Food Labeling: Serving Sizes of Foods 
That Can Reasonably Be Consumed At 
One Eating Occasion, Reference 
Amounts Customarily Consumed, 
Serving Size-Related Issues, Dual-
Column Labeling, and Miscellaneous 
Topics: Guidance for Industry 
 
 
 
 
 
Additional copies are available from:  
Office of Nutrition and Food Labeling 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740 
240-402-1450 
https://www.fda.gov/FoodGuidances 
 
 
You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to https://www.regulations.gov.  Submit written comments on the guidance to the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.  All comments should be identified with the docket number FDA-2018-D-1459. 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
December 2019  Contains Nonbinding Recommendations 
 
 
Table of Contents 
 
 
 
 
I. Introduction
   
II. Background
   
III. Questions and Answers
   
A. Single-Serving Containers
   
B. Reference Amounts Customarily Consumed (RACCs)
   
C. Dual-Column Labeling
   
D. Miscellaneous Topics
   
 
 
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  Contains Nonbinding Recommendations 
 
Food Labeling: Serving Sizes of Foods 
That Can Reasonably Be Consumed At 
One Eating Occasion, Reference 
Amounts Customarily Consumed, 
Serving Size-Related Issues, Dual-
Column Labeling, and Miscellaneous 
Topics: Guidance for Industry1 
 
 
 
   
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) 
on these topics.  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 or Office 
responsible for this guidance as listed on the title page.  
    
 
 
I.  Introduction 
 
This guidance is intended for conventional food and dietary supplement manufacturers.  It will 
provide questions and answers on topics related primarily to two final rules: (1) 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; and (2) 
Food Labeling: Revision of the Nutrition and Supplement Facts Labels.  This guidance also 
discusses formatting issues for dual-column labeling products that have limited space for 
nutrition labeling, and additional issues dealing with compliance. 
 
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 FDA guidances means that something is suggested or 
recommended, but not required. 
 
                                                           
1 This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and 
Applied Nutrition at the U.S. Food and Drug Administration. 
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  Contains Nonbinding Recommendations 
 
In this guidance, you (or I) refers to a manufacturer of conventional foods or 
dietary supplements. 
 
 
II.  Background
 
In the Federal Register of May 27, 2016, we published two final rules related to the Nutrition 
and Supplement Facts labels, which amended our labeling regulations for foods to provide 
updated nutrition information to help consumers in maintaining healthy dietary practices.  One 
final rule is entitled 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 (81 FR 34000) (the serving size final rule), and the other 
final rule is entitled Food Labeling: Revision of the Nutrition and Supplement Facts Labels 
(81 FR 33742) (the Nutrition Facts label final rule).  The provisions of the final rules are 
codified at Title 21 of the Code of Federal Regulations, part 101 (21 CFR 101.9 101.12, 101.30, 
and 101.36). For purposes of this guidance, the following is a summary of the key changes that 
were codified in 21 CFR part 101: 
 
  Amending the definition of a single-serving container (21 CFR 101.9(b)(6)); 
 
  Requiring that labeling for certain packages bear an additional column of nutrition 
information regarding the contents of the entire package (21 CFR 101.9(b)(12)(i)); 
 
  Requiring that labeling for products in discrete units of certain sizes bear an additional 
column of nutrition information regarding the contents of the entire unit (21 CFR 
101.9(b)(2)(i)(D));  
 
  Allowing manufacturers to provide voluntarily an additional column of nutrition 
information for single-serving containers of certain sizes that reflects the nutrition 
information per common household measurement that most closely approximates the 
reference amount customarily consumed (RACC) (21 CFR 101.9(b)(6)); 
 
  Amending a pre-existing provision to allow manufacturers to provide voluntarily an 
additional column of nutrition information that reflects the nutrition information per unit, 
regardless of whether the product is a single-serving container or contains multiple 
servings (21 CFR 101.9(b)(10)(ii)); and 
 
  Amending the requirements for RACCs that are used by manufacturers to 
determine their label serving size in 101.12(b). 
 
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  Contains Nonbinding Recommendations 
 
 
 
III.  Questions and Answers
 
A. Single-Serving Containers 
 
A.1   How does the serving size final rule define serving or serving size? 
 
A serving or serving size is the amount of food customarily consumed (i.e., typically eaten) in 
one eating occasion (section 403(q)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 343(q)(1)(A)(i)) and 21 CFR 101.9(b)(1))).  Serving sizes are 
determined from the RACCs established in 21 CFR 101.12(b) and the procedures described in 
21 CFR 101.9(b).  A serving size must be written in a common household measure or common 
household unit (e.g., for a 20-fluid-ounce carbonated beverage, Serving size 1 bottle) (21 
CFR 101.9(b)(5)).  
 
A.2  What are common household measures or common household units? What are 
the rules of increments for household units? 
 
For labeling purposes, the term common household measure or common household unit means 
cup, tablespoon, teaspoon, piece, slice, fraction (e.g., 1/4 pizza), ounce (oz), fluid ounce (fl 
oz), or other common household equipment used to package food products (e.g., jar, tray) (21 
CFR 101.9(b)(5)).  To determine the correct household measure for your product, follow the 
steps listed in 21 CFR 101.9(b)(5), which include, but are not limited to, the following:   
 
1.  For all products, except beverages, whenever possible and appropriate the serving size 
should be expressed as cups, tablespoons, or teaspoons.  For beverages, you may use 
fluid ounces (21 CFR 101.9(b)(5)(i)).   
2.  If cups, tablespoons, or teaspoons are not applicable, units such as piece, slice, tray, jar, 
or fraction must be used, as applicable (21 CFR 101.9(b)(5)(ii)).   
3.  If the above options are not applicable, ounce measurements may be used with the 
applicable visual unit of measure such as a dimension of a piece (e.g., 1 oz (28 g/about 
12 pickle)) (21 CFR 101.9(b)(5)(iii)).  Ounce measurements must be expressed in 0.5 
oz increments that most closely approximate the RACC (21 CFR 101.9(b)(5)(iii)). 
Ounces with an appropriate visual unit, as described in step 3 above, can be used for 
products that naturally vary in size (101.9(b)(5)(vi)). 
 
You must express measurements for cups in 1/4 or 1/3 increments (e.g., 1/4, 1/3, 1/2, 2/3, 3/4, 
1, 1 1/4 cups) (21 CFR 101.9(b)(5)(i)).  Tablespoons must be expressed as 1, 1 1/3, 1 1/2, 1 
2/3, 2, or 3 tablespoons (21 CFR 101.9(b)(5)(i)).  Amounts of less than one tablespoon can be 
expressed as teaspoons.  Teaspoons shall be expressed as 1/8, 1/4, 1/2, 3/4, 1, or 2 teaspoons 
(21 CFR 101.9(b)(5)(i)).  
 
For nutrition labeling purposes, a teaspoon means 5 milliliters (mL), a tablespoon means 15 
mL, a cup means 240 mL, 1 fl oz means 30 mL, and 1 oz in weight means 28 grams (g) (21 
CFR 101.9(b)(5)(viii)).   
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A.3    What is the definition of a single-serving container? 
 
A single-serving container is a product that is packaged and sold individually (i.e., that 
bears a Nutrition Facts panel (also known more commonly as a Nutrition Facts label)) and 
contains less than 200 percent of the applicable RACC for that product (21 CFR 
101.9(b)(6)).  The entire content of a single-serving container must be labeled as one 
serving (21 CFR 101.9(b)(6)).   
 
An example of a single-serving container is a 20-oz bottle of soda.  The RACC for 
carbonated beverages is 12 oz (360 mL); a 20-oz bottle of soda contains approximately 167 
percent of the RACC and meets the definition of a single-serving container.  Therefore, the 
serving size for a 20-oz bottle of soda would be labeled as 1 bottle. 
 
A.4  Are there situations in which FDA would not object if products that contain more 
than 200 percent of the RACC were labeled as a single serving?   
 
Yes.  In the serving size final rule, while we declined to define single-serving container as 
containers with 200 percent or more of the RACC, we recognized that some products containing 
up to and including 300 percent of the RACC could reasonably be consumed by one person in a 
single eating occasion (see 81 FR 34000 at 34005).  Those products are generally required to 
bear dual-column labeling that includes nutrition information for a serving of the product as well 
as for the entire container in accordance with 21 CFR 101.9(b)(12).  There are certain exceptions 
to this requirement, including an exception under 21 CFR 101.9(b)(12)(i)(A) for products that 
meet the requirements to use the tabular format or linear format (see 21 CFR 101.9(j)(13)(ii)(A) 
for further information about when use of the tabular and linear formats is permissible).  Because 
we acknowledge that some products containing at least 200 percent and up to and including 300 
percent of the RACC could reasonably be consumed by one person in a single eating occasion, 
and we generally require such products to bear dual-column labeling, we agree that nutrition 
information for the full container for such products can be helpful to consumers.  Therefore, we 
intend to exercise enforcement discretion to permit products containing at least 200 percent and 
up to and including 300 percent of the applicable RACC to be labeled as a single serving, 
provided that it would not be misleading to do so and that the product meets the requirement to 
use the tabular format or the linear format under 21 CFR 101.9(j)(13)(ii)(A).  This would provide 
flexibility to manufacturers to decide whether to label certain products (e.g., a small brownie) as 
a single serving when the product does not meet the definition of a single-serving container, 
contains at least 200 percent and up to and including 300 percent of the RACC, and there is 
insufficient space to include two columns of information.       
 
 
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  Contains Nonbinding Recommendations 
 
 
A.5  Can I provide a voluntary column of nutrition information per unit when my 
packaged product is a single-serving container (i.e., contains less than 200 percent of 
the RACC) and contains more than one individually wrapped unit? For example, 
would voluntary nutrition information per unit be allowed for a packaged product 
that contains two individually wrapped sandwiches or two individually wrapped ice 
cream novelty items for which the entire container contains 180 percent of the 
RACC? 
 
Yes.  In the serving size final rule, we amended 21 CFR 101.9(b)(10)(ii) to allow manufacturers 
to voluntarily provide an additional column of nutrition information per unit for single-serving 
containers that contain more than one discrete unit.  Before 21 CFR 101.9(b)(10)(ii) was 
amended, the provision applied only to multiserving containers.  This provision of the serving 
size final rule was intended to provide flexibility for manufacturers that sell these types of 
products. 
B. Reference Amounts Customarily Consumed (RACCs)  
 
B.1  What are RACCs and how are they determined? 
 
RACCs are used to determine serving sizes in accordance with section 403(q)(1)(A)(i) of the 
FD&C Act, which states that a serving size is an amount of food customarily consumed.  RACCs 
are based, in part, on food consumption, including data derived from the National Health and 
Nutrition Examination Study (NHANES).  NHANES is a population-based survey and program 
of studies designed to assess the health and nutritional status of adults and children in the United 
States and to track changes over time.  NHANES combines interviews and physical 
examinations and provides consumption data for the food products regulated by FDA.  The list 
of RACCs is found in Tables 1 and 2 in 21 CFR 101.12(b). 
 
B.2  How do I determine the appropriate RACC for my food product?  
 
The list of RACCs established by FDA is found in Tables 1 and 2 in 21 CFR 101.12(b).  Table 1 
is for foods for infants and children one through three years of age.  Table 2 is for foods for the 
general population (i.e., aged four years or older).  We established RACCs for a variety of food 
product categories, and these values represent the amount of food customarily consumed at one 
eating occasion.  Most of the RACCs are for foods in a ready-to-eat form.  
 
To determine the appropriate RACC for your food product, locate the appropriate food product 
category for your product in Table 1 or 2, whichever is applicable. If your product in the form in 
which it is sold (i.e., as packaged) does not have a RACC in either of the tables, you must 
generate an appropriate RACC for your product considering the following: 
 
  If your product requires further preparation such as cooking or the addition of water or 
other ingredients (e.g., brownie mix, dried soup), and if only the RACC for the prepared 
form of the product is listed in 21 CFR 101.12(b), then the RACC for the unprepared 
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  Contains Nonbinding Recommendations 
 
product (i.e., the product as it is packaged and sold) must be the amount of the 
unprepared product required to make the RACC for the prepared product (21 CFR 
101.12(c)).  
  If your product is an imitation or substitute food, or altered food, such a low calorie 
version, the RACC must be the same as for the food for which it is offered as a substitute 
(21 CFR 101.12(d)).  For example, a low-calorie cake frosting should use the same 2 tbsp 
RACC as that for other cake frosting. 
  For products that consist of two or more foods packaged and presented to be consumed 
together (e.g., peanut butter and jelly, cracker and cheese pack, pancakes and syrup), the 
RACC for the combined product is determined by the following rules (see 21 CFR 
101.12(f)): 
  For bulk products (e.g., peanut butter and jelly), the RACC for the combined 
o
product shall be the RACC, as established in Tables 1 or 2, for the ingredient that 
is represented as the main ingredient plus proportioned amounts of all minor 
ingredients. 
  For products where the ingredient represented as the main ingredient is one or 
o
more discrete units (e.g., cracker and cheese pack, pancakes and syrup), the 
RACC for the combined product shall be either the number of small discrete units 
or the fraction of the large discrete unit that is represented as the main ingredient 
that is closest to the RACC for that ingredient as established in Tables 1 or 2 plus 
proportioned amounts of all minor ingredients. 
  If the RACCs are in compatible units, they must be summed.  If the RACCs are in 
o
incompatible units, the weights of the appropriate volumes should be used (e.g., 
110 grams (g) pancakes plus the gram weight of the proportioned amount of 
syrup).  
   If your product is an aerated food, there are several technical points that must be 
considered in determining the appropriate RACC. See 21 CFR 101.12(e) for details. 
 
B.3  How do I determine the appropriate serving size for my food product based on the 
RACC?    
  
Once you have determined the appropriate RACC for your product, you must determine the 
correct serving size for your product based on 21 CFR 101.9(b).  The first important step in 
establishing an appropriate serving size is to determine if your product is a single-serving 
container.  If your product is packaged and sold individually and contains less than 200 percent 
of the applicable RACC, the serving size must be the contents of the entire container (21 CFR 
101.9(b)(6)).  
 
For products in discrete units (e.g., muffins, sliced products, such as sliced bread, or individually 
packaged products within a multiserving package) within a multiserving package and for 
products which consist of two or more foods packaged and presented to be consumed together 
where the ingredient represented as the main ingredient is in discrete units (e.g., pancakes and 
syrup), the serving size must be declared as follows (21 CFR 101.9(b)(2)(i)): 
 
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  If a unit weighs 50 percent or less of the RACC, the serving size shall be the number of 
whole units that most closely approximates the RACC for the product category (21 CFR 
101.9(b)(2)(i)(A)); 
  If a unit weighs more than 50 percent, but less than 67 percent of the RACC, the 
manufacturer may declare one unit or two units as the serving size (21 CFR 
101.9(b)(2)(i)(B)); 
  If a unit weighs 67 percent or more, but less than 200 percent of the RACC, the serving 
size shall be one unit (21 CFR 101.9(b)(2)(i)(C)); 
  If a unit weighs at least 200 percent and up to and including 300 percent of the applicable 
RACC, the serving size shall be the amount that most closely approximates the RACC 
(21 CFR 101.9(b)(2)(i)(D)).  Also note that dual-column labeling may be required for 
such products (21 CFR 101.9(b)(12)(i)).  Dual-column labeling as described in 21 CFR 
101.9(b)(12)(i)) is discussed in section C of this document. 
 
The serving size for maraschino cherries must be expressed as 1 cherry with the parenthetical 
metric measure equal to the average weight of a medium size cherry (21 CFR 101.9(b)(2)(i)(E)). 
 
The serving size for products that naturally vary in size (e.g., pickles, shellfish, whole fish, and 
fillet of fish) may be the amount in ounces that most closely approximates the RACC for the 
product category (21 CFR 101.9(b)(2)(i)(F)).  Ounces with an appropriate visual unit of measure 
may be used for products that naturally vary in size as provided for in 21 CFR 101.9(b)(2)(i)(F) 
(see 21 CFR 101.9(b)(5)(iii) and (b)(5)(vi)). 
 
For products which consist of two or more foods packaged and presented to be consumed 
together, where the ingredient represented as the main ingredient is in discrete units (e.g., 
pancakes and syrup), the serving size may be the number of discrete units represented as the 
main ingredient plus proportioned minor ingredients used to make the RACC for the combined 
product determined in 21 CFR 101.12(f) (21 CFR 101.9(b)(2)(i)(G)). 
 
For packages containing several individual single-serving containers, each of which is labeled 
with all required information including nutrition labeling as specified in 101.9 (that is, are 
labeled appropriately for individual sale as single-serving containers), the serving size must be 1 
unit (21 CFR 101.9(b)(2)(H)). 
 
For products in large discrete units that are usually divided for consumption (e.g., cake, pie, 
pizza, melon, cabbage), for unprepared products where the entire contents of the package is used 
to prepare large discrete units that are usually divided for consumption (e.g., cake mix, pizza kit), 
and for products which consist of two or more foods packaged and presented to be consumed 
together where the ingredient represented as the main ingredient is a large discrete unit usually 
divided for consumption (e.g., prepared cake packaged with a can of frosting, a baguette with a 
jar of jam), the serving size must be the fractional slice of the ready-to-eat product (e.g., 1/12 
cake, 1/8 pie, 1/4 pizza, 1/4 melon, 1/6 cabbage) that most closely approximates the RACC for 
the product category, and may be the fraction of the package used to make the RACC for the 
unprepared product or the fraction of the large discrete unit represented as the main ingredient 
plus proportioned minor ingredients used to make the reference amount for the combined 
product determined in 21 CFR 101.12(c).  In expressing the fractional slice, manufacturers must 
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use 1/2, 1/3, 1/4, 1/5, 1/6, or smaller fractions that can be generated by further division by 2 or 3 
(21 CFR 101.9(b)(2)(ii)). 
 
For non-discrete bulk products (e.g., breakfast cereal, flour, sugar, dry mixes, concentrates, 
pancake mixes, macaroni and cheese kits), and for products which consist of two or more foods 
packaged and presented to be consumed together where the ingredient represented as the main 
ingredient is a bulk product (e.g., peanut butter and jelly), the serving size must be the amount in 
household measure that most closely approximates the RACC for the product category and may 
be the amount of the bulk product represented as the main ingredient plus proportioned minor 
ingredients used to make the reference amount for the combined product determined in 21 CFR 
101.12(f) (21 CFR 101.9(b)(2)(iii)). 
 
The serving size for meal products and main dish products, as defined in 21 CFR 101.13(l) and 
(m), that come in single-serving containers as defined in 21 CFR 101.9(b)(6) must be the entire 
content (edible portion only) of the package (21 CFR 101.9(b)(3)).  Serving size for meal 
products and main dish products in multiserving containers must be based on the RACC 
applicable to the product in 21 CFR 101.12(b) if the product is listed in 101.12(b) (21 CFR 
101.9(b)(3)).  The serving size for meal products and main dish products in multiserving 
containers that are not listed in 21 CFR 101.12(b) must be based on the reference amount 
according to 21 CFR 101.12(f) (21 CFR 101.9(b)(3)). 
 
B.4  How do I determine the number of servings for my food product? 
 
The number of servings in a single-serving container must be one (21 CFR 101.9(b)(6)) (see also 
question A.3).  For products that do not meet the definition of a single-serving container, the 
number of servings per container must be based on the serving size of the product (21 CFR 
101.9(b)(8)), using the following procedures:  
 
  The number of servings must be rounded to the nearest whole number except for the 
number of servings between 2 and 5 servings and random weight products (21 CFR 
101.9(b)(8)(i)).  The number of servings between 2 and 5 servings must be rounded to the 
nearest 0.5 serving (21 CFR 101.9(b)(8)(i)).  Rounding should be indicated by the use of 
the term about (e.g., about 2 servings or about 3.5 servings) (21 CFR 101.9(b)(8)(i)).   
 
  For drained solids for which product size varies naturally (e.g., maraschino cherries, 
pickles), you may state the typical number of servings per container (e.g., usually 5 
servings) (21 CFR 101.9(b)(8)(ii)). 
 
  For random weight products, you may declare varied for the number of servings per 
container provided the nutrition information is based on the RACC expressed in the 
appropriate household measure based on the hierarchy described in 21 CFR 101.9(b)(5) 
(21 CFR 101.9(b)(8)(iii)).  Random weight products are foods such as cheeses that are 
sold as random weights that vary in size, such that the net contents for different 
containers would vary.  You may provide the typical number of servings in parentheses 
following the statement varied (e.g., varied (usually 5 servings) or varied (usually 4 
to 6 servings)) (21 CFR 101.9(b)(8)(iii)). 
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  For packages containing several individual single-serving containers, each of which is 
labeled with all required information including nutrition labeling as specified in 21 CFR 
101.9 (that is, are labeled appropriately for individual sale as single-serving containers), 
the number of servings must be the number of individual single-serving containers within 
the total package (21 CFR 101.9(b)(8)(iv)). 
 
  For packages containing several individually packaged multiserving units, the number of 
servings must be determined by multiplying the number of individual multiserving units 
in the total package by the number of servings in each individual unit (21 CFR 
101.9(b)(8)(v)). 
 
B.5  The RACC for my product is 50 g; however, a single serving of my product 
actually weighs 54 g because 54 g is the weight of the 1-cup household measure 
most closely approximating the RACC.  How should the serving size be 
declared? Is the nutrition information based on the 50-g RACC, or the 1-cup 
serving size (weighing 54 g)?  
 
The serving size and the nutrition information on the label are based on the household unit 
closest to the RACC (i.e., 1 cup).  The RACC is used as the starting point to determine the 
serving size for the foods in each product category (see 21 CFR 101.9(b)(2)), but the actual 
amount of the product per serving (i.e., 54 g) is used to calculate the nutrient amounts for the 
nutrition information in the Nutrition Facts label.  
 
B.6  What is the RACC for partially cooked, packaged pasta products?  Table 2 only 
gives RACCs for prepared pasta and dry pasta. 
 
The RACC for a partially cooked pasta product is the amount of partially cooked pasta that 
makes the RACC for cooked pasta (140 g) (see 21 CFR 101.12(c)). 
 
B.7  What is the label serving size for fruitcake? 
 
The label serving size for fruitcake is 1 12 ounces (see 21 CFR 101.12(b), Table 2, footnote 5). 
 
B.8  What is the label serving size for ice cream cones, eggs, and breath mints of all 
sizes? 
 
The label serving size for ice cream cones, eggs, and breath mints is one unit (see 21 CFR 
101.12(b), Table 2, footnote 8). 
 
B.9  Table 1 in 21 CFR 101.12(b) that provides RACCs for infants and young children 
one through three years of age lists a RACC of 120 mL (4 fl oz) for Juices all 
varieties.  What RACC should I use for beverages that are not juice in this age 
group? 
 
Table 1 of 21 CFR 101.12(b) does not establish a RACC for beverages that are not juices.  
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However, we recommend that manufacturers of beverages that are not juices, such as milk or 
water, use a RACC of 120 mL for this age group (4 fl oz).   
 
As discussed in the serving size final rule, we acknowledge that more products for infants and 
children 1 through 3 years of age are currently on the market than were available in 1993 (81 FR 
34000 at 34031-34032).  While we have yet to establish RACCs for many such products, we 
intend to review available information, including information submitted to FDA via comments, 
and consider next steps. 
 
C. Dual-Column Labeling 
 
C.1  What are the requirements for mandatory dual-column labeling? 
 
The serving size final rule requires that products that are packaged and sold individually and that 
contain at least 200 percent and up to and including 300 percent of the applicable RACC (e.g., a 
75-g bag of chips that is 250 percent of the RACC of 30 grams for chips) must provide an 
additional column within the Nutrition Facts label that lists the quantitative amounts and percent 
DVs for the entire package, as well as a column listing the quantitative amounts and percent DVs 
for a serving that is less than the entire package (i.e., the serving size derived from the RACC), 
unless an exception applies (21 CFR 101.9(b)(12)(i)).  
 
The first column must list nutrition information based on the serving size for the product, and the 
second column must list the nutrition information based on the entire contents of the package.  
See Figure 1 (21 CFR 101.9(b)(12)(i)). 
 
The dual-column labeling requirements also apply to products in discrete units.  If a discrete unit 
weighs at least 200 percent and up to and including 300 percent of the applicable RACC, the 
serving size will be the amount that approximates the RACC, and the product label must provide 
dual-column labeling for the discrete unit, unless an exemption applies (21 CFR 
101.9(b)(2)(i)(D)).  The first column would list the nutrition information based on the serving 
size, while the second column would list the nutrition information for the individual unit (21 
CFR 101.9(b)(2)(i)(D)).  
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  Contains Nonbinding Recommendations 
 
Figure 1. Example of a Dual-Column label per serving and per container 
 
C.2  What is a discrete unit? 
 
Examples of what constitutes a discrete unit are provided in 21 CFR 101.9(b)(2)(i).  The 
examples include muffins, sliced products (such as sliced bread), or individually packaged 
products within a multiserving package. 
 
C.3  Are products that have limited space for labeling exempt from the dual-
column labeling requirement? 
 
Yes.  An exemption from the dual-column labeling requirements under 21 CFR 101.9(b)(12)(i) 
and 21 CFR 101.9(b)(2)(i)(D) is available for products that have: (1) a total surface area 
available to bear labeling of less than 12 square inches; or (2) a total surface area available to 
bear labeling of 40 or less square inches and the package shape or size cannot accommodate a 
standard vertical column or tabular display on any label panel (21 CFR 101.9(b)(12)(i)(A)).  For 
the exemption to apply, the product must meet the requirements to use the tabular format for 
small or intermediate-sized packages (see 21 CFR 101.9(j)(13)(ii)(A)(1) and Figure 2, below) or 
meet the requirements to use the linear format (see 21 CFR 101.9(j)(13)(ii)(A)(2) and Figure 3, 
below) (21 CFR 101.9(b)(12)(i)(A)).  All products that are eligible for the exemption described 
in this paragraph are eligible to use the tabular display format (21 CFR 101.9(j)(13)(ii)(A)).  
Nutrition information can only be given in the linear format if the label cannot accommodate the 
tabular display as shown in 21 CFR 101.9(j)(13)(ii)(A)(1).  
 
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Figure 2. Example of a tabular format for packages with 40 or less square inches  
 
Figure 3. Example of a linear format for packages with 40 or less square inches  
 
       
C.4  Are there other types of products that are exempt from the dual-column 
labeling requirements? 
 
Yes.  The following products are exempt from the dual-column labeling requirements:  (1) raw 
fruits, vegetables, and seafood for which you provide nutrition labeling voluntarily on the 
product or in advertising, or are required to provide nutrition labeling when claims are made 
about the product (see 21 CFR 101.9(b)(12)(i)(B)); (2) products that require further preparation 
(e.g., pancake mix) and for which you voluntarily provide an additional column of nutrition 
information for the as prepared form of the food (see 21 CFR 101.9(b)(12)(i)(C) and 21 CFR 
101.9(e)); (3) products that are commonly consumed in combination with another food (e.g., 
cereal and milk) and for which you voluntarily provide an additional column of nutrition 
information for the combination (see 21 CFR 101.9(b)(12)(i)(C) and 21 CFR 101.9(e)); (4) 
products for which you provide an additional column of nutrition information for two or more 
groups for which Reference Daily Intakes are established (e.g., both infants and children less 
than 4 years of age) (see 21 CFR 101.9(b)(12)(i)(C) and 21 CFR 101.9(e)); (5) popcorn products 
for which you provide an additional column of information per 1 cup popped popcorn (see 21 
CFR 101.9(b)(12)(i)(C)); and (6) varied-weight products (see 21 CFR 101.9(b)(12)(i)(C) and 21 
CFR 101.9(b)(8)(iii)).   
 
C.5  Can I use voluntary dual-column labeling for products that contain more than 150 
percent and less than 200 percent of the RACC to provide consumers with nutrition 
information per common household measure closest to the RACC to facilitate more 
direct comparisons of nutrition information between similar products in similar-
sized containers? 
 
Yes.  If a container or package contains more than 150 percent and less than 200 percent of the 
applicable RACC, you may voluntarily provide on the Nutrition Facts label a second column of 
nutrition information, to the left of the column that provides nutrition information per container 
(i.e., per serving) (21 CFR 101.9(b)(6)).  The voluntary column would list the quantitative 
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amounts and the percent Daily Values (percent DVs) per common household measure that most 
closely approximates the RACC.   
 
This provision allows the nutrition information on products such as a container of ice cream that 
contains 195 percent of the RACC for ice cream (i.e., a single-serving container) to be compared 
to an ice cream product that must provide nutrition information per serving and per container, 
such as a container of ice cream that contains 200 percent of the RACC.  In this example, if the 
container with 195 percent of the RACC voluntarily provides nutrition information for the 
common household measure closest to the RACC, consumers would be able to compare the 
nutritional information for the column on each product that provides nutrition information for the 
common household measure closest to the RACC (i.e., per 2/3 cup).  
 
Note that providing a second column of nutrition information voluntarily under 21 CFR 
101.9(b)(6) does not change the serving size of the product.  As explained previously in this 
guidance document, the serving size of a product that is packaged and sold individually that 
contains less than 200 percent of the applicable RACC must be labeled as one serving.  Products 
that voluntarily provide a second column of nutrition information under 21 CFR 101.9(b)(6) are 
single-serving containers; however, for such products the amount most closely approximating the 
RACC is not the serving size.   
 
The following graphic provides an example for a single-serving container that weighs more than 
150 percent and less than 200 percent of the RACC that voluntarily adds a second column of 
nutrition information per household measure that is closest to the RACC (i.e., per 12 cup).  The 
serving size for the product is 1 can (i.e., the full container).    
 
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Figure 4. Example of voluntary dual-column labeling for a package containing more than 
150 percent and less than 200 percent of the RACC2
 
 
D. Miscellaneous Topics  
 
D.1  What is the label serving size for pieces of chewing gum that weigh more than the 
RACC and can reasonably be consumed at a single-eating occasion? 
 
The label serving size is one unit (see 21 CFR 101.12(b), Table 2, footnote 8). 
 
D.2  Can products for which a Nutrition Facts label is required that meet the 
requirements to use the simplified format (e.g., certain sugar-free chewing gums) 
bear the truncated Not a significant source of other nutrients statement? 
                                                           
2 This example presumes that the product is a can of vegetables with liquid, with an applicable RACC of 130 g.  The 
can contains 191% of the RACC, meaning that the package must be labeled as a single-serving container; however, 
a second column of nutrition information may be provided under 21 CFR 101.9(b)(6).  The 12 cup is the common 
household measure that most closely approximates the RACC of 130 g.  Therefore, the nutrition value in the dual 
columns show as 1/2 cup (i.e., the household measure most closely approximating the RACC) and 1 can (i.e., 
the serving).  However, situations may vary depending on the actual products.  
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Products in the general food supply that contain insignificant amounts of eight or more of 
calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, 
total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium are eligible to 
provide a simplified declaration of nutrition information (21 CFR 101.9(f)).  Products that 
qualify for the simplified declaration that bear nutrition claims are required to bear the statement 
Not a significant source of _____ (with the blank filled in with the name(s) of any nutrient(s) 
identified in 21 CFR 101.9(f) that are present in insignificant amounts) and included at the 
bottom of the nutrition label).  However, some products are sold in small packages (e.g., certain 
sugar-free chewing gums) for which the package size may render it impracticable for the label to 
display a substantial amount of information.  Under 21 CFR 101.9(g)(9), when circumstance[s] 
make it impracticable for firms to comply with Nutrition Facts labeling requirements, FDA 
may permit alternative means of compliance or additional exemptions to deal with the situation. 
 
Given the small package size of certain products and the potentially long statement that would be 
required if the label had to identify each nutrient that is present in insignificant amounts (see 21 
CFR 101.9(f)), we consider 21 CFR 101.9(g)(9) to permit an alternative means of compliance 
with respect to the nutrition labeling for certain products sold in small packages for which the 
addition of such statement would be impracticable.  In lieu of providing the Not a significant 
source of _____ statement as required in 21 CFR 101.9(f)(4), we recommend that the label for 
such packages bear a statement such as Not a significant source of other nutrients at the bottom 
of the simplified Nutrition Facts label on such products sold in small packages. 
 
D. 3  What are the requirements relating to multiunit retail food packages?  
 
We recognize that many retail food products contain multiple, individually packaged items 
within the larger container (i.e., multiunit retail food packages).  FDAs labeling requirements 
provide flexibility for such products, and manufacturers of such products generally have two 
options.  The individual units within the multiunit retail food packages may be packaged and 
sold individually, meaning that each individually packaged item bears a Nutrition Facts label 
(81 FR 34000 at 34005).  Note that, when individual units are packaged and sold individually, 
the Nutrition Facts label must still be visible at point of sale (see 21 CFR 101.9(h)).  FDA 
regulations provide different requirements for unit containers in a multiunit retail food package 
when the individual unit containers are securely enclosed within and not intended to be separated 
from the retail package under conditions of retail sale and each unit container is labeled with the 
statement This Unit Not Labeled For Retail Sale or This Unit Not Labeled for Individual 
Sale in type size not less than 1/16-inch in height, except that this statement shall not be 
required when the inner unit containers bear no labeling at all (see 21 CFR 101.9(j)(15)(iii)).  
When this option is used, the multiunit retail food package must bear nutrition information in 
accordance with 21 CFR 101.9.   
 
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D.4  Can Nutrition Facts or Supplement Facts labels be placed on the bottom of a food 
package? 
 
Generally not.  The bottom of the package (such as the bottom of boxes, cans, and bottles, which 
generally cannot be viewed by the consumer at the point of sale) is not a permissible location for 
a Nutrition Facts or Supplement Facts labels, unless it is visible during normal retail display and 
consumer handling (as with some frozen food packages or containers of mints and gum).  The 
Nutrition Facts or Supplement Facts labels must be placed either on the principal display panel 
or on the information panel (21 CFR 101.2(b)).  The principal display panel means the part of 
a label that is most likely to be displayed, presented, shown, or examined under customary 
conditions of display for retail sale (21 CFR 101.1).  The information panel means the part of 
the label immediately contiguous and to the right of the principal display panel as observed by an 
individual facing the principal display panel, subject to a few exceptions (see 21 CFR 101.2(a)).   
 
D.5  Will the increase in RACCs for certain beverages, combined with recent 
changes to daily values (DVs) and the mandatory declaration of potassiumas 
updated in the Nutrition Facts label final rulerequire products such as 
coffee, tea, and bottled water to bear mandatory nutrition labeling when such 
products were previously exempt under 21 CFR 101.9(j)(4)?  
 
No.  As explained in the serving size final rule, we intend to exercise enforcement discretion 
with respect to mandatory nutrition labeling on any products currently on the market, or that 
come on the market in the future, that would have been exempt under 21 CFR 101.9(j)(4) before 
the effective date of the serving size final rule, until such time as we have the opportunity to 
consider this issue in a future rulemaking (81 FR 34000 at 34026-34027).  Examples of such 
products include coffee beans (whole or ground), tea leaves, condiment-type dehydrated 
vegetables, flavor extracts, food colors, and certain bottled water products. 
 
D.6  Does FDA have recommendations or requirements relating to how nutrition 
information should be formatted if I use the tabular display for small packages as 
provided in 21 CFR 101.9(j)(13)(ii)?  Specifically, are there limitations on the 
number of columns I can use in the tabular display?    
 
Manufacturers using the tabular display must comply with all applicable requirements in 21 CFR 
101.9.  With respect to specific requirements that could impact the display of nutrition 
information using the tabular format, we note that 21 CFR 101.9 includes requirements for which 
nutrients must be indented under other nutrients (e.g., under 21 CFR 101.9(c)(6)(i)(A), Soluble 
fiber content shall be indented under dietary fiber).  Attempting to divide the required nutrition 
information into more than two columns could result in a violation of such formatting 
requirements.  We recommend that manufacturers follow the sample tabular display for small 
packages provided in 21 CFR 101.9(j)(13)(ii), which uses two columns of nutrition information.   
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