Natural Products Insider

MAY-JUN 2018

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6 INSIDER May/June 2018 In the News On March 1, 2018, FDA released several guidance documents in relation to the updated Nutrition Facts label proposed to take effect on Jan. 1, 2020. Of importance is the agency's fi nal guidance explaining how it evaluates whether an ingredient meets its regulatory defi nition of dietary fiber. The latest guidance follows the May 27, 2016 release of FDA's fi rst evidence-based defi nition of dietary fi ber. Prior to 2016, food and beverage manufacturers could declare synthetic or isolated fi bers as dietary fi ber on the label, even if they did not have a physiological effect benefi cial to human health. The 2016 evidence-based defi nition allows naturally occurring fi bers in fruit, vegetables and whole grains to be considered fi ber, as well as seven other isolated (i.e., extracted from plant sources) or synthetic nondigestible carbohydrates (NDCs) or synthetic fi bers that are well-recognized by the scientifi c community for having physiological benefi ts. "We're also aware of evidence that other isolated or synthetic fi bers could also benefi t human health, such as improving glucose and cholesterol levels, increasing frequency of bowel movements and increasing satiety, which can lead to a reduced calorie intake," said FDA Commissioner Scott Gottlieb, M.D. In a change from the draft science review guidance, FDA will consider evidence from studies with subjects who have a disease associated with the benefi cial physiological effect of interest (e.g., lowering blood sugar and/or insulin) in considering whether the research supports a fi nding that an NDC may have a benefi cial effect in "healthy" individuals who do not have the disease. 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 benefi cial to human health. In the fi nal guidance, published March 2 in the Federal Register, FDA clarifi ed that for a study to assess whether an NDC reduces blood glucose and/or insulin levels, the NDC should be added to a food or beverage containing sugar or starch, and should not replace any sugars or starches since those refi ned carbohydrates cause the rise in blood glucose levels. It is also important that the NDC is added to a food or beverage with the same amount of sugar or refi ned carbohydrate as in the food or beverage that is provided to the study's control group. A manufacturer may submit a citizen petition for FDA's consideration to add a given isolated or synthetic NDC to FDA's regulatory defi nition of "dietary fi ber." The petition should provide scientifi c evidence that shows the NDC has a benefi cial physiological effect on human health. "Our goal is to provide more detail on our scientifi c principles for evaluating the fi ber products and these petitions," Gottlieb said. "We want to give the food industry clear guidance on how to meet the new standards before we make fi nal decisions on these petitions. We'll give petitioners who may want to add information to their petition the opportunity to revise those fi lings based on the more detailed guidance." Gottlieb said FDA has been evaluating data submitted from the food industry in petitions on various NDCs and will communicate its decisions on these petitions soon. Clarifying Added Sugars FDA also issued draft guidance to help industry declare added sugars on the label of honey, maple syrup and certain cranberry products. While honey and maple syrup meet the defi nition of "added sugars," industry had concerns that declaring added sugars on the single-ingredient products may lead consumers to think pure products, such as a jar of honey or maple syrup, contain added table sugar because added sugars are listed on the Nutrition Facts label. FDA 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 specifi c products," Gottlieb said. The symbol † would be used immediately after the added sugars percent Daily Value (DV) 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," Gottlieb added. Serving Sizes and RACCs FDA also provided guidance on appropriate reference amounts customarily consumed (RACCs) for a variety of products to aid manufacturers in determining the appropriate serving sizes to include on the labels of their products. Under the fi nal rule, regardless of the size of the RACC, all products packaged and sold individually, and containing less than 200 percent of the applicable reference amount for that product, must be labeled as a single-serving container. However, if the product is more than 150 percent and less than 200 percent of the applicable RACC, the manufacturer may voluntarily provide an addition on the Nutrition Facts label, to the left of the column that provides nutrition information per container (i.e., per serving). The voluntary column would list the quantitative amounts and the percent DV per common household measure that most closely approximates the RACC. FDA Issues Guidance on Fiber Claims, Added Sugars by Judie Bizzozero

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