1. What action is FDA taking today on dietary fiber?
Draft Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as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)
FDA is publishing a request for scientific data, information, and comments and a draft guidance to help us to determine whether certain fibers (certain isolated or synthetic non-digestible carbohydrates) should be added to our definition of “dietary fiber” that is found in the Nutrition and Supplement Facts label final rule, which appeared in the Federal Register of May 27, 2016. We are also making available a scientific literature review document about these fibers. The request for information, along with an accompanying draft guidance, also will help industry to understand how FDA reviews scientific evidence to determine whether an isolated or synthetic non-digestible carbohydrate that is added to food is a “dietary fiber” because it provides a beneficial physiological effect to human health. Only fibers that meet the definition can be declared as a dietary fiber on the Nutrition Facts label. Before we published our new definition of “dietary fiber,” manufacturers could declare any fiber as a dietary fiber on Nutrition Facts labels, even those non-digestible carbohydrates that might not have a beneficial physiological effect.
Our scientific literature review document provides summaries of published studies that we have identified and reviewed for 26 types of added isolated or synthetic non-digestible carbohydrate, beyond the seven that FDA has already determined meet the dietary fiber definition. We are asking interested parties to submit to us additional scientific data and information regarding the 26 fibers to include in our evaluation of each of them to determine if they provide a beneficial physiological effect to human health.
We note that manufacturers may submit a citizen petition for FDA’s consideration that provides scientific evidence of a beneficial physiological effect of the fiber to human health. Our draft guidance addresses the type of evidence that should be provided as part of a citizen petition and the approach we plan to use to evaluate the evidence. Alternatively, if an isolated or synthetic non-digestible carbohydrate is the subject of an authorized health claim that FDA has previously evaluated using the health claim petition process in 21 CFR 101.70, FDA would consider the carbohydrate to meet the definition of dietary fiber and would amend the definition accordingly.
2. What is FDA’s definition for dietary fiber that can be declared on the Nutrition Facts label?
Dietary fiber that can be declared on the Nutrition Facts label includes certain naturally occurring fibers that are “intrinsic and intact” in plants, and added isolated or synthetic non-digestible soluble and insoluble carbohydrates that FDA has determined have beneficial physiological effects to human health, such as lowering blood glucose and cholesterol levels, increasing feelings of fullness (satiety) resulting in reduced calorie intake, and improving bowel function.
The Nutrition Facts Label final rule defines “dietary fiber,” in relevant part, as “non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.”
3. What was FDA’s definition of dietary fiber prior to the current definition?
The FDA regulations did not contain a definition of dietary fiber but rather relied on analytical methods for measuring levels of dietary fiber present in food. Therefore, an isolated or synthetic non-digestible carbohydrate could be added to foods and quantified as a dietary fiber even if it did not necessarily provide a beneficial physiological effect to human health.
4. What are the 26 isolated and synthetic non-digestible carbohydrates FDA included in its scientific literature review?
- Gum Acacia
- Apple Fiber
- Bamboo Fiber
- Corn Hull Fiber
- Cottonseed Fiber
- Inulin/Oligofructose/Synthetic Short Chain Fructooligosaccharides
- Karaya Gum
- Oat Hull Fiber
- Pea Fiber
- Potato Fibers
- Rice Bran Fiber
- High Amylose Corn/Maize Starch (Resistant Starch 2)
- Retrograded Corn Starch (Resistant Starch 3)
- Resistant Wheat and Maize Starch (Resistant Starch 4)
- Soluble Corn Fiber
- Soy Fiber
- Sugar Beet Fiber
- Sugar Cane Fiber
- Wheat Fiber
- Xanthan Gum
5. How did FDA select these 26 fibers?
These fibers were the most common ones being added to food and declared on the Nutrition Facts label as dietary fiber.
6. What are the beneficial physiological effects to human health that have to be demonstrated before the added isolated or synthetic carbohydrate in a food product can be declared on the label as a dietary fiber?
The following are examples. At least one, if demonstrated in humans, would make the carbohydrate eligible for listing as a “dietary fiber:”
- Lowering blood glucose and cholesterol levels
- Lowering blood pressure
- Improved laxation and bowel function
- Increased mineral absorption in the intestinal tract
- Reduced energy intake (for example, due to the fiber promoting a feeling of fullness).
Other physiological endpoints could be added to the complete list if scientific evidence exists to support their inclusion.
7. What are examples of naturally occurring fibers?
Naturally occurring fiber (often referred to as “intrinsic”) occurs in foods such as vegetables, whole grains, fruits, cereal bran, flaked cereal and flours. The fibers are also considered to be “intact” because they have not been removed from the food. Foods containing these fibers have been shown to be beneficial, and manufacturers do not need to demonstrate that they provide beneficial physiological effects to human health. Manufacturers using fibers that are added to foods—either by isolating them from other foods or synthesizing them—need to demonstrate one beneficial physiological effect to human health to meet the definition of “dietary fiber.”
8. Are all naturally occurring fibers considered to have a beneficial physiological effect to human health?
Yes, as long as they are contained in food and not removed.
9. What fibers that are not naturally occurring in a food has FDA determined meet its dietary fiber definition?
In addition to naturally occurring fibers, the FDA has identified the following added non-digestible carbohydrates as meeting the dietary fiber definition:
- Beta-glucan soluble fiber
- Psyllium husk
- Guar gum
- Locust bean gum
10. What if a manufacturer wants to declare a fiber on the Nutrition Facts label that is not naturally occurring and that is not one of the fibers listed above?
The manufacturer may submit a citizen petition for FDA’s consideration that provides scientific evidence of a beneficial physiological effect to human health. We also plan to use our scientific literature review document and the input we receive from our request for additional scientific data, information, and comments to determine if any of the 26 isolated or synthetic non-digestible carbohydrates we have identified can be added to the list of those fibers that meet the dietary fiber definition. Also, if an added isolated or synthetic non-digestible carbohydrate is the subject of an authorized health claim that FDA has previously evaluated using the health claim petition process in 21 CFR 101.70, FDA would consider the carbohydrate to meet the definition of “dietary fiber” and would amend the definition accordingly.
11. How will additional fibers, other than the seven currently in the regulations, be officially recognized by FDA?
FDA has already reviewed the literature regarding the additional 26 fibers and will review expeditiously any additional data it receives with respect to the additional fibers. If FDA determines that one or more of the fibers reviewed are dietary fibers and eligible to be added to the list of dietary fibers in the definition of “dietary fiber,” FDA will update its regulations. If the Agency is unable to update the list of dietary fibers in time for companies to either relabel or reformulate in advance of the first compliance date, we are committed to exploring options to address the timing issue.
12. How do manufacturers know how much dietary fiber to declare on the Nutrition Facts label?
Analytical methods cannot distinguish between non-digestible carbohydrates that do and do not meet the dietary fiber definition. Therefore, firms must keep records for those foods that contain both dietary fibers that do meet the regulatory definition of dietary fiber along with added non-digestible carbohydrates that do not meet the definition of dietary fiber. The amount of dietary fibers declared should represent the total fiber that is quantified by analytical methods minus the amount that does not meet the dietary fiber definition.
13. If my product currently contains added isolated or synthetic non-digestible carbohydrates that do not meet the definition of dietary fiber, what is the deadline for modifying my product’s labeling?
Manufacturers with $10 million or more in annual food sales must comply with the new dietary fiber declaration requirements by July 26, 2018 and manufacturers with less than $10 million in annual food sales must comply by July 26, 2019.
14. If a manufacturer has submitted a citizen petition, but FDA has not yet responded, can the manufacturer include the amount of the added isolated or synthetic carbohydrate that is the subject of the petition in the “dietary fiber” declaration in the meantime?
No. If an added isolated or synthetic non-digestible carbohydrate is not included in the definition of “dietary fiber,” but is included in the declaration of dietary fiber, the product would be misbranded. However, the added carbohydrate must be included in the declaration for total carbohydrate. If FDA determines an added isolated or synthetic non-digestible carbohydrate meets the definition of “dietary fiber,” FDA would amend the definition of “dietary fiber” and, when the fiber is present as an ingredient in food, such fiber must be included in the declaration for dietary fiber, in addition to the declaration for total carbohydrate.