WASHINGTON — Guidance from the Food and Drug Administration issued March 1 included a proposed symbol related to the added sugars line on the new Nutrition Facts Panel of certain products. The F.D.A. also provided additional guidance on what the agency looks for when deciding whether an ingredient meets its dietary fiber definition.
The draft guidance on added sugars related to honey, maple syrup and certain cranberry products.
“While honey and maple syrup meet the definition of added sugars, we heard concerns from industry that declaring added sugars on their single ingredient products may lead consumers to think their pure products — such as a jar of honey or maple syrup — actually contain added table sugar because added sugars are listed on the Nutrition Facts label,” said Scott Gottlieb, M.D., commissioner of the F.D.A. “We also heard from cranberry juice manufacturers that their products need to be sweetened for palatability because cranberries have less natural sugar than other fruits.
“Our draft guidance addresses these concerns by stating our intent to allow manufacturers to use a symbol immediately after the added sugars daily value, directing consumers to language that provides truthful and not misleading contextual information about ‘added sugars’ and what it means for each of these specific products.”
The symbol † would be used immediately after the added sugars per cent Daily Value information on certain foods.
“The draft guidance would explain that we intend to consider exercising our enforcement discretion for the use of this symbol on single ingredient packages and/or containers of pure honey or maple syrup, and 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,” the F.D.A. said.
More on the draft guidance, which was scheduled to be published in the March 2 issue of the Federal Register, may be found here.
The F.D.A. will accept comments on the draft guidance. Electronic comments may be sent at www.regulations.gov. Written comments may be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All submissions should include the Docket No. FDA-2018-D-0075 for “The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products: Guidance for Industry.”
Additional fiber guidance
The F.D.A. for the first time gave its definition of fiber in the May 27, 2016, issue of the Federal Register. Ingredients may qualify as fiber if they are non-digestible carbohydrates (with three or more monomeric units) and lignin that are intrinsic and intact in plants. Isolated and synthetic non-digestible carbohydrates (with three or more monomeric units) also may qualify if they are the subject of an authorized health claim or if the F.D.A. rules in favor of a citizen petition.
Draft guidance for industry on how to make a citizen petition showing that an ingredient meets the fiber definition because of its beneficial physiological effects appeared in the Nov. 23, 2016, issue of the Federal Register. The final guidance, scheduled to be published in the March 2 issue of the Federal Register, contains several additions: the inclusion of studies on diseased populations under certain circumstances as part of the F.D.A.’s evaluation of scientific evidence, more detail and clarity on the physiological endpoints considered by the F.D.A. when reviewing scientific evidence, and more detail regarding factors the F.D.A. considers when evaluating the strength of the scientific evidence.
More on the additional guidance may be found here.
Reducing the rise in blood sugar or glucose levels after people consume a food or beverage would be an example of a physiological effect that is beneficial to human health, according to the F.D.A.’s Center for Food Safety and Applied Nutrition.
“In the final guidance, the F.D.A. clarifies that in order for a study to assess whether an N.D.C. (non-digestible carbohydrate) reduces blood glucose and/or insulin levels, the N.D.C should be added to a food or beverage containing sugar or starch and should not replace any sugars or starches since those refined carbohydrates cause the rise in blood glucose levels,” the C.F.S.A.N. said. “It is also important that the N.D.C. is added to a food or beverage with the same amount of sugar or refined carbohydrate as in the food or beverage that is provided to the study’s control group.”
Electronic comments concerning the additional fiber guidance may be sent to www.regulations.gov. Comments also may be mailed to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All submissions must include the Docket No. FDA-2016-D-3401 for “Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30).”
“The F.D.A. has been evaluating data submitted to us from the food industry in petitions on various non-digestible carbohydrates and will communicate our decisions on these petitions soon,” Dr. Gottlieb said. “Our goal is to provide more detail on our scientific principles for evaluating the fiber products and these petitions. We want to give the food industry clear guidance on how to meet the new standards before we make final decisions on these petitions. We’ll give petitioners who may want to add information to their petition the opportunity to revise those filings based on the more detailed guidance.”
Nutrition Facts Panel dates
The F.D.A. introduced the new Nutrition Facts Panel in the May 27, 2016, issue of the Federal Register. The F.D.A. in September 2017 proposed to extend the compliance dates for the Nutrition Facts and Supplement Facts label final rule. Under the proposal, manufacturers with $10 million or more in annual food sales would have until Jan. 1, 2020, to come into compliance and manufacturers with less than $10 million in annual food sales would have until Jan. 1, 2021. The F.D.A. plans to issue a final rule this spring, Dr. Gottlieb said.“We’re also going to be launching an educational campaign to help Americans use the new version of the Nutrition Facts label and interpret the overall nutritional content of products they find on supermarket shelves,” Dr. Gottlieb said. “This opportunity will allow us to reach consumers directly through educational videos, social media campaigns and user-friendly web sites to help them discern the relationship between the dietary choices they make every day and the impact those choices can have on their own and their family’s health in reducing the risk of chronic diseases like obesity, diabetes, heart disease and a variety of cancers.”