In a recent guidance document, the U.S. Food and Drug Administration (FDA) announced the intention to permit eight isolated or synthetic non-digestible carbohydrates to be declared as dietary fiber on the nutrition facts label. Pending rulemaking, FDA intends to exercise enforcement discretion when the following are included in a label’s dietary fiber declaration:
- Mixed plant cell wall fibers
- Inulin and inulin-type fructans
- High amylose starch (resistant starch 2)
- Resistant maltodextrin/dextrin
Why Is FDA Permitting These Fibers?
Prior to publication of the 2016 Revision of the Nutrition and Supplement Facts Label Final Rule, existing FDA regulations did not define “dietary fiber.” Under the revised rule, isolated or synthetic non-digestible carbohydrates may only be included in dietary fiber declarations if FDA determines them to have “physiological benefits.” The final rule named seven isolated or synthetic fibers that met this requirement:
- Beta-glucan soluble fiber
- Psyllium husk
- Guar gum
- Locust bean gum
After reviewing petitions and scientific literature surrounding twenty-six isolated or synthetic non-digestible carbohydrates, FDA determined that the eight additional fibers demonstrate the required physiological benefits.
How Does This Affect My Label?
Industry previously expressed concern that FDA’s new definition for dietary fiber would exclude fibers they were already declaring on their labels, limiting their ability to make certain nutrient content or health claims. For example, in order for many foods to say they are a “good source of fiber,” “contain fiber,” or “provide fiber,” their fiber content must be between 10 and 19 percent (2.8 g – 5.32 g) of the daily reference value (28 g) per reference amount customarily consumed (RACC). FDA’s inclusion of the above fibers will allow more manufacturers to continue to make fiber claims under updated label requirements.
When Do I Need To Comply?
Changes to the dietary fiber declaration take effect following the compliance deadline for FDA’s new label rules. Food manufacturers grossing $10 million or more in annual food sales have until January 1, 2020 to update their label for compliance with FDA’s new regulations. Businesses grossing less than $10 million are provided an additional year.
Start compliance now for a smooth transition. Registrar Corp can review your food labeling for compliance with new U.S. FDA regulations. In addition to a report of recommended changes, you will receive a print-ready graphic file of your revised label. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.