Policy Related to Cranberry Products 
with Added Flavorings: 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 
(Tel) 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 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 docket number 
FDA-2018-D-0075 and 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 
 
August 2019 
   
Table of Contents 
I.  Introduction
 
II.  Background
 
III.  The Declaration of Added Sugars on Honey, Maple Syrup, and 
Certain Cranberry Products; Guidance for Industry
 
IV.  Discussion
 
V.  References
 
 
  Contains Nonbinding Recommendations 
Policy Related to Cranberry Products 
with Added Flavorings: Guidance for 
Industry1 
 
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 at the phone number listed on the title page. 
 
I.  Introduction 
The purpose of this guidance is to advise manufacturers of certain dried cranberry products2 with 
added flavorings of our intent to exercise enforcement discretion until July 1, 2020, for their 
compliance with the updated labeling requirements set forth in two final rules published in the 
Federal Register of May 27, 2016 entitled, Food Labeling:  Revision of the Nutrition and 
Supplement Facts Labels (hereafter referred to as Nutrition Facts label final rule (81 FR 
33742)) (see 21 CFR 101) and 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 (hereafter referred to as the Serving Size final rule (81 FR 
34000)) (see 21 CFR 101). 
 
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. 
                                                 
1 This guidance has been prepared by the Office of Nutrition and Food Labeling, Nutrition Programs Staff in the 
Center for Food Safety and Applied Nutrition.  
2 Certain dried cranberry products are identified as dried cranberry products that are sweetened with added sugars 
and that contain total sugars at levels no greater than comparable products with endogenous (inherent) sugars, but no 
added sugars.   
1 
  Contains Nonbinding Recommendations 
II.  Background 
A.  Nutrition Facts Label Final Rule 
In the Federal Register of May 27, 2016, we issued a final rule updating the Nutrition Facts label 
for packaged foods to reflect new scientific information (see 81 FR 33742).  The Nutrition Facts 
label final rule includes changes in the individual nutrients that must be declared and also 
changes some Daily Values (DVs).  The science underlying the Nutrition Facts label final rule is 
also reflected in the 2015-2020 Dietary Guidelines for Americans (Ref. 1). 
 
The Nutrition Facts label final rule requires that added sugars be included in the Nutrition Facts 
label and established a DV for added sugars.  The Nutrition Facts label final rule defines added 
sugars, in part, to include sugars that are either added during the processing of foods or are 
packaged as such (21 CFR 101.9(c)(6)(iii)).  The term includes free sugars (free mono- and 
disaccharides), sugars from syrups and honey, and sugars from concentrated fruit or vegetable 
juices that are in excess of what would be expected from the same volume of 100 percent fruit or 
vegetable juice of the same type.  The Nutrition Facts label final rule requires added sugars to be 
declared on the food label by stating Includes Xg Added Sugars indented directly below Total 
Sugars (see 21 CFR 101.9(c)(6)(ii)). 
 
The Nutrition Facts label final rule requires a declaration for added sugars, in part, because 
excess consumption of added sugars makes it difficult to meet nutrient needs within the calorie 
limits generally needed to maintain a healthy weight and can lead to an increase in overall caloric 
intake.  Further, healthy dietary patterns characterized, in part, by lower amounts of sugar-
sweetened foods and beverages, as compared to less healthy dietary patterns, are associated with 
a reduced risk of cardiovascular disease.  The science underlying the 2015-2020 Dietary 
Guidelines for Americans demonstrates that meeting nutrient needs while staying within calorie 
limits is difficult with more than 10 percent of total daily calories from added sugars (50 grams 
of added sugars based on a 2,000 calorie diet)(Ref. 1).  Based on this science, the Nutrition Facts 
label final rule establishes a DV for added sugars, 50 grams based on a 2,000 calorie diet for 
adults and children 4 years of age and older and 25 grams based on a 1,000 calorie diet for 
children 1 through 3 years of age (21 CFR 101.9(c)(8)(vii)). 
 
In the Federal Register of May 4, 2018, we issued a final rule extending the compliance date for 
the Nutrition Facts Label final rule for manufacturers with $10 million or more in annual food 
sales from July 26, 2018, to January 1, 2020; for manufacturers with less than $10 million in 
annual food sales, the final rule extends the compliance date from July 26, 2019, to January 1, 
2021. (See 83 FR 19619.) 
 
B.  Serving Size Final Rule 
In the Federal Register of May 27, 2016, we issued a final rule pertaining to serving sizes for 
food (see 81 FR 34000).  The final rule amends the definition of a single-serving container, 
requires dual-column labeling for certain containers, updates the tables of Reference Amounts 
Customarily Consumed (RACCs), and amends the serving size for breath mints. 
 
2 
  Contains Nonbinding Recommendations 
In the Federal Register of May 4, 2018, we issued a final rule extending the compliance date for 
the Serving Size final rule for manufacturers with $10 million or more in annual food sales from 
July 26, 2018, to January 1, 2020; for manufacturers with less than $10 million in annual food 
sales, the final rule extends the compliance date from July 26, 2019, to January 1, 2021. (see 83 
FR 19619). 
III.  The Declaration of Added Sugars on Honey, Maple Syrup, and 
Certain Cranberry Products; Guidance for Industry 
In the Federal Register of March 2, 2018 (83 FR 8953), we announced the availability of a draft 
guidance for industry entitled, The Declaration of Added Sugars on Honey, Maple Syrup, and 
Certain Cranberry Products; Draft Guidance for Industry (hereafter referred to as the draft 
guidance) and asked interested parties to submit comments by May 1, 2018.  In the Federal 
Register of April 25, 2018 (83 FR 17961), we extended the comment period to June 15, 2018. 
 
In the draft guidance, we advised food manufacturers of our intent to exercise enforcement 
discretion related to the use in the Nutrition Facts label of a  symbol immediately after the 
added sugars percent DV information on single ingredient packages and/or containers of pure 
honey or pure maple syrup and on certain dried cranberry and cranberry juice products that are 
sweetened with added sugars and that contain total sugars at levels no greater than comparable 
products3 with endogenous (inherent) sugars, but no added sugars.  The  symbol would direct 
consumers to truthful and non-misleading statements on the package outside the Nutrition Facts 
label that would need to comply with applicable FDA statutory and regulatory requirements.  
The draft guidance would extend enforcement discretion to include certain cranberry products 
with added sugars that contain total sugars at levels no greater than comparable products; such 
cranberry products included dried cranberry products and dried cranberries with added 
flavorings. 
 
In the Federal Register of June 6, 2019 (84 FR 28726), we announced the availability of a final 
guidance for industry entitled, The Declaration of Added Sugars on Honey, Maple Syrup, and 
Certain Cranberry Products; Guidance for Industry (hereafter referred to as the final 
guidance)4. 
 
The final guidance clarifies the labeling requirements for single-ingredient packages and/or 
containers of pure honey, pure maple syrup, and other pure sugars and syrups, which are not 
required to bear the words, Includes Xg Added Sugars but must still include the percent DV 
for added sugars on their labels.  The final guidance also advises food manufacturers of our 
intent to exercise enforcement discretion with respect to the use of truthful and not misleading 
statements on single-ingredient packages and/or containers of pure honey, pure maple syrup, and 
other pure sugars and syrups. 
                                                 
3 For the purposes of this guidance document, we consider a comparable product to be one that is in the same food 
category (e.g., fruit), that is in the same form (e.g., dried), and that has the same usage (e.g., a snack).  For example, 
we consider unsweetened raisins to be comparable to sweetened dried cranberries. 
4 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-declaration-added-
sugars-honey-maple-syrup-other-single-ingredient-sugars-
and?utm_campaign=CFSANCU_Guidance_Added_Sugars_06182019 
3 
  Contains Nonbinding Recommendations 
 
Further, the final guidance states our intent to exercise enforcement discretion with respect to the 
use of a  symbol on single-ingredient packages and/or containers of pure honey, pure maple 
syrup, and other pure sugars and syrups immediately following the percent DV representing the 
contribution of added sugars to the diet obtained from a serving of these products.  We also 
intend to exercise such enforcement discretion when the symbol leads the reader to a truthful and 
not misleading statement within a footnote at the bottom of the Nutrition Facts label that includes 
a description of the gram amount of sugar added to the diet by one serving of the product and its 
contribution to the percent DV for added sugars in the diet. 
 
The guidance also states our intent to exercise enforcement discretion with respect to the use in 
the Nutrition Facts label of the  symbol immediately after the added sugars percent DV 
information that leads consumers to a statement outside of the Nutrition Facts label on certain 
dried cranberry and cranberry beverage products that are made up of cranberry juice that is 
sweetened with added sugars and that contain total sugars at levels no greater than comparable 
products with endogenous (inherent) sugars, but no added sugars. 
 
The final guidance advises manufacturers of single-ingredient packages and/or containers of pure 
honey, pure maple syrup, and other pure sugars and syrups, as well as certain dried cranberry and 
cranberry beverage products of our intent to exercise enforcement discretion until July 1, 2021, 
for complying with the updated labeling requirements in the Nutrition Facts label final rule and 
the Serving Size final rule. 
IV.  Discussion 
When we published the draft guidance, we extended our enforcement discretion to include 
certain cranberry products with added sugars that contain total sugars at levels no greater than 
comparable products.  The draft guidance did not expressly discuss cranberry products with 
added flavorings.  However, in the final guidance, we did not extend enforcement discretion to 
dried cranberries with added flavorings.  After we announced the availability of the final 
guidance, we received correspondence from certain cranberry manufacturers (Ref. 2).  The 
cranberry industry presented us with concerns that manufacturers of dried cranberries with added 
flavorings have regarding their ability to comply with the Nutrition Facts label final rule and 
Serving Size final rule by January 1, 2020 and requested that we extend the compliance date for 
the final rules for dried cranberries with added flavorings.  The cranberry industry explained that 
it had anticipated that the final guidance would extend to dried cranberries with added flavorings 
the same enforcement discretion as the other certain cranberry products covered under the draft 
guidance.  Consequently, when the final guidance did not indicate an intent to extend 
enforcement discretion to dried cranberries with added flavorings, the cranberry industry sought 
additional time to comply with the Nutrition Facts final rule and Serving Size final rule. 
 
We understand the change to exclude dried cranberries with added flavorings in the final 
guidance may have been unexpected for manufacturers of dried cranberries with added 
flavorings.  We also understand that manufacturers of these dried cranberry products face 
operational constraints with respect to changing their labels by the compliance date for the final 
rules.  To address these issues, through this guidance document, we are announcing our intent to 
4 
  Contains Nonbinding Recommendations 
exercise enforcement discretion with regard to compliance with the Nutrition Facts label final 
rule and the Serving Size final rule for certain dried cranberry products5 with added flavorings 
until July 1, 2020.  We are taking this position because we recognize the importance of giving 
manufacturers of dried cranberries with added flavorings additional time to comply with the 
Nutrition Facts label final rule and Serving Size final rule. 
V.  References 
The following references are on display at the Dockets Management Staff, Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  You may see them in 
person at this location between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov as these references are not copyright 
protected.  Some may be available at the website address if listed.  FDA has verified the website 
addresses, as of August 22, 2019, but websites are subject change over time. 
 
1.  U.S. Department of Health and Human Services and U.S. Department of Agriculture.  
2015-2020 Dietary Guidelines for Americans. 8th Edition, p. 28. December 2015. 
Available at http://health.gov/dietaryguidelines/2015/guidelines/. 
2.  Letter from Richard A. Stamm, Vice President, General Counsel, Ocean Spray 
Cranberries, Inc., submitted to Dr. Susan Mayne, Director, Center for Food Safety & 
Applied Nutrition, dated July 2, 2019. 
                                                 
5 See Footnote 2. 
5