How to Comment
The comment period opens March 2, 2018. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance within 60 days from when the comment period opens.
Submit electronic comments to https://www.regulations.gov to docket number FDA-2018-D-0075
Submit written comments to:
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-0075.
Contains Nonbinding Recommendations
Draft – Not for Implementation
February 2018
This guidance is being distributed for comment purposes only.
The purpose of this draft guidance is to advise food manufacturers of our intent to exercise enforcement discretion related to the use in the Nutrition Facts label of a symbol “†” immediately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 Daily Value 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 products with endogenous (inherent) sugars, but no added sugars.
With respect to the labeling of single ingredient packages of pure honey or pure maple syrup, we are taking this action in response to concerns from stakeholders that consumers might misinterpret the added sugars declaration to mean that non-endogenous sweeteners, such as corn syrup or cane sugar, have been added to the pure product.
With respect to the labeling of certain cranberry products, cranberries are a naturally tart fruit, and certain dried cranberries and cranberry juice products have added sugars added to them to bring the total sugars per serving up to levels comparable to the levels of non-cranberry competitor products that contain equivalent amounts of total sugars, but whose labels list zero “added sugars” because their fruit products are inherently sweet. Some stakeholders are concerned that consumers may think certain cranberry products are less nutritious than these competitor products because of the added sugars declaration.
FDA’s guidance documents, including this draft guidance, do not establish legally enforceable responsibilities.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.
This draft guidance, when finalized, will represent 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.
