The U.S. FDA has Re-shaped how Dietary Fiber is Regulated

Intertek Regulatory Experts Help Companies Understand the Meaning and Implications of FDA’s New Dietary Fiber Definition

January 24, 2017

Mississauga, Ontario – Intertek, a leading Total Quality Assurance provider to industries worldwide, helps clients stay abreast of the changing regulatory landscape in the U.S. as it applies to dietary fiber.

In 2016, the U.S. FDA defined “dietary fiber”, now requiring evidence that “isolated or synthetic non-digestible carbohydrates” are beneficial to human health. The FDA currently recognizes 7 isolated or synthetic non-digestible carbohydrates as having benefits to human health. If companies want to declare, on Nutrition or Supplement Facts labels, the amount of fiber contributed by an isolated or synthetic non-digestible carbohydrate that is not one of these 7 fibers, they must petition the FDA to have their ingredient approved as a dietary fiber.

On November 22, 2016, the U.S. FDA released a draft guidance document wherein they communicate their current thinking on how the health effects of “isolated or synthetic non-digestible carbohydrate” should be demonstrated. Upon her review of this document, Ms. Lina Paulionis, Senior Manager, Health Claims and Clinical Trials at Intertek states “The health effects currently considered by the FDA as beneficial are very specific and notably do not include fermentation or changes in the microbiota, which are effects traditionally associated with prebiotics. This will have impacts on many ingredient manufacturers interested in having their ingredients approved as “dietary fiber” in the U.S.”

Intertek supports companies in understanding FDA’s current position on dietary fiber and the key considerations regarding processes (i.e., citizen petitions) and evidence requirements for efficacy substantiation. Intertek expert Ms. Lina Paulionis will be offering a complimentary webinar titled, “Does Your Ingredient Still Qualify as a “Dietary Fiber in the United States?” on February 1, 2017 (11:00AM EST). To register, visit:

To learn more about Intertek’s efficacy substantiation services, be it for dietary fiber petitions or health claims, please visit:

To learn more about the services offered by our experts, and within the larger Intertek organisation, please visit:


About Intertek
Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 40,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains.

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For Media Inquiries:

Tracy Veale
Global Marketing Manager
Health, Environmental and Regulatory Services (HERS)
Intertek Life Sciences
Tel.: +1 905 542-2900

For Market Inquiries:

Ms. Lina Paulionis
Senior Manager, Health Claims and Clinical Trials
Food & Nutrition Group
Intertek Scientific & Regulatory Consultancy 
Tel.: +1 905 542-2900