US FDA statement on dietary fibre

Increasingly, Americans are seeking healthy food options, whether they’re eating out or dining at home. Their ability to choose healthy foods starts with their ability to understand what’s in their food in the first place. Public surveys suggest that Americans want food makers to be transparent about what is in a product and how it’s made. The food industry has responded by innovating and reformulating their products. Among other things, they’re boosting fibre content, and curbing the amount of sodium and sugar.

At the same time, we at the U.S. Food and Drug Administration are doing our part to ensure consumers have updated, science-based information to help them make more informed dietary choices.

In March, I announced a comprehensive, multi-year Nutrition Innovation Strategyintended to drive additional actions that the FDA can take to reduce preventable death and disease related to poor nutrition. Part of this effort includes taking final steps on the new Nutrition Facts label.

This is our first overhaul of the food label in more than 20 years. It’s aimed at making sure that consumers have access to an updated label that’s based on updated science and provides more information to empower them to choose healthful diets. I also recognize that it’s crucial for the FDA to provide clear expectations so that industry can meet our new labeling requirements and that we provide the greatest flexibility possible, while still maintaining an approach that is grounded in rigorous science.

As part of those efforts, today the FDA issued decisions on citizen petitions regarding additional dietary fibres. We also issued a guidance that will allow food manufacturers to count these fibres when calculating the total amount of fibre per serving to declare on the Nutrition Facts label. They can also be counted as fibre on the Supplement Facts label. The eight new fibres are: mixed plant cell wall fibres (a broad category that includes fibres like sugar cane fibre and apple fibre, among many others); arabinoxylan; alginate; inulin and inulin-type fructans; high amylose starch (resistant starch 2); galactooligosaccharide; polydextrose; and resistant maltodextrin/dextrin.

Our work is not done. We have received additional petitions asking for additional fibres to be recognized in a similar fashion to the eight dietary fibres we are identifying today. We are actively evaluating these additional requests, working through the petitions and, in some cases, supplementary information provided by the petitioners, in an efficient manner. We recognize the importance of providing timely responses so that food makers have certainty around their manufacturing decisions. We also welcome the submission of additional petitions in the future as science emerges and as new ingredients are identified. Our expectation is that we will continue to evaluate additional dietary fibres on a rolling basis, and we expect that additional fibres may be recognized in the future.

All of these decisions build off of the FDA’s evidence-based definition of dietary fibrepublished in 2016, which stated that dietary fibre declared on the updated Nutrition Facts label can include certain naturally-occurring fibres that are “intrinsic and intact” in plants as well as seven other added isolated or synthetic fibres that are well recognized by the scientific community for having physiological benefits. Before the FDA established this definition, manufacturers could declare synthetic or isolated fibres as fibre on the label without evidence that these fibres had beneficial physiological effects on the body. Consumers can be assured that non-digestible carbohydrates counted as fibre on the new Nutrition Facts label have health benefits grounded in scientific evidence. Eating foods rich in dietary fibre, as recommended by the Dietary Guidelines for Americans, can help cholesterol levels, increase feelings of fullness (satiety) resulting in reduced calorie intake, and increase the frequency of bowel movements.

We are taking a flexible approach to dietary fibre, allowing for the possibility of additional fibres to be added to the list of those meeting our dietary fibre definition if the scientific evidence shows they are physiologically beneficial. In addition to other relevant scientific literature, we carefully reviewed submitted petitions requesting that the FDA allow food manufacturers to count other non-digestible carbohydrates as fibre on the Nutrition Facts label. These included sugar cane fibre, apple fibre, and inulin, among others. We also issued a final guidance in March clarifying the information needed and the approach we planned to use to include additional non-digestible carbohydrates in our fibre definition. Petitioners were given the opportunity to revise their filings based on our more detailed guidance.

The decisions regarding most of the eight additional non-digestible carbohydrates come as a result of such petitions. But it’s important to note that these determinations are based on a careful review of the scientific evidence suggesting that each of these additional fibres has a beneficial physiological effect. The FDA also issued two denials to petitioners because we did not agree that the evidence submitted met the scientific standards, as described in our March scientific guidance. We’re also working expeditiously to complete our review and responses for the other petitions that we haven’t yet responded to.

The FDA is issuing new guidance today to express our intent to exercise enforcement discretion, permitting manufacturers to count these eight additional fibres in the dietary fibre declaration on the Nutrition Facts label pending completion of the agency’s rulemaking regarding adding additional fibres to the dietary fibre definition in FDA regulations.

Food manufacturers now have additional clarity to help them move forward to update their labels as needed ahead of the compliance date for the updated Nutrition Facts label, which is Jan. 1, 2020 for manufacturers with $10 million or more in annual food sales and Jan. 1, 2021 for smaller manufacturers. Our goal is to make sure that consumers can trust that the latest, tasty fibre-rich snack food or cereal that comes on the market can offer them some real health benefits.

We’re committed to ensuring that consumers have updated information so they can be empowered to make positive changes in their diets. Access to reliable, science-based information about food and diets not only helps consumers make healthier choices, but it also inspires food manufacturers to compete to offer products that have the healthy attributes that consumers seek and that food makers can declare on labelling. These efforts can help encourage food patterns that are consistent with the dietary guidelines, can help reduce chronic diseases, and can help ultimately alleviate health disparities through improved nutrition.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.