FDA issued guidance explaining how it evaluates whether an ingredient meets its regulatory definition of dietary fiber; a draft guidance on added sugars in honey, maple syrup and certain cranberry products; a final guidance on labeling of honey and honey products; a final guidance on reference amounts customarily consumed (RACCs); and a small entity compliance guide for the Serving Size final rule.
Defining Dietary Fiber
On May 27, 2016, FDA published its first evidence-based definition of dietary fiber. Prior to that date, food and beverage manufacturers could declare synthetic or isolated fibers as dietary fiber on the label, even if they did not have a physiological effect that is beneficial to human health.
The 2016 evidence-based definition allows naturally occurring fibers in fruit, vegetables and whole grains to be considered fiber, as well as seven other isolated (i.e., extracted from plant sources) or synthetic non-digestible carbohydrates (NDCs) or synthetic fibers that are well-recognized by the scientific community for having physiological benefits.
“We’re also aware of evidence that other isolated or synthetic fibers could also benefit 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 now will consider evidence from studies with subjects who have a disease associated with the beneficial physiological effect of interest (e.g., lowering blood sugar and/or insulin) in considering whether the research supports a finding that an NDC may have a beneficial 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 beneficial to human health.
In the final guidance, published March 2 in the Federal Register, FDA clarified 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 refined 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 refined 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 the FDA’s regulatory definition of “dietary fiber.” The petition should provide scientific evidence that shows the NDC has a beneficial physiological effect on human health.
“Our goal is to provide more detail on our scientific principles for evaluating the fiber 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 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.”
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.
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 definition of added sugars, there were concerns from industry 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 specific 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 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 final rule, regardless of the size of the RACC, all products that are packaged and sold individually and contain less than 200% of the applicable reference amount for that product must be labeled as a single-serving container. However, if the product is more than 150% and less than 200% 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.