- Docket Number:
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Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition
The purpose of this guidance is to provide clarification on 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 Daily Value (DV) for added sugars on their labels. This 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. We intend to exercise our 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 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.
We also intend to exercise our 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 statement would provide flexibility to address concerns raised by stakeholders regarding the declaration of added sugars on certain cranberry products. We have information demonstrating that cranberries are a naturally tart fruit to which manufacturers sometimes add sugar in order to increase palatability. Therefore, certain dried cranberries and cranberry juice products have amounts of total sugars per serving up to levels comparable to the levels of non-cranberry comparable products. The comparable products contain equivalent amounts of total sugars, but their 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 comparable products because of the added sugars declaration.
Finally, as discussed in section III, we are advising 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 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”) 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 33742 and 81 FR 34000).
We are issuing this guidance consistent with our good guidance practices (GGP) regulation (21 CFR 10.115). With respect to our enforcement discretion policy pertaining to compliance with updated Nutrition Facts final rule and Serving Size final rule requirements on the particular products outlined above, this part of the guidance is being implemented without prior public comment because we have 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-0075.