FDA’s release of two Guidance documents in 2018 on dietary fiber, as well as prior publication of a science review of non-digestible carbohydrates being evaluated for physiological benefit, have led to many industry questions and a need for clarification. Many of the fiber ingredients currently used by industry and declared as fibers have been acknowledged as dietary fiber either by regulation or by enforcement discretion, but what next? Members of CFSAN’s Office of Nutrition and Food Labeling and Independent Consultants from EAS Consulting Group will discuss the policy on dietary fiber and unravel challenges facing the food industry as it considers a path forward.
This webinar will provide further clarification to industry on the declaration of dietary fiber on the Nutrition and Supplement Facts labels. The webinar will address the scientific evaluation undertaken by FDA; review the recently released documents by FDA related to fiber, including enforcement discretion guidance and responses to citizen petitions; and provide clarity on next steps and frequently asked questions.
Learning Objectives:
1. Understand the background on the FDA regulatory definition of dietary fiber, as well as how the agency intends to evaluate the scientific evidence to determine whether a non-digestible carbohydrates has a physiological effect beneficial to human health.
2. Gain clarity on particularly confusing areas such as mixed plant cell wall fibers and other non-digestible fibers to understand label declaration as well as what happens in those areas where there isn’t guidance.
3. Learn practical steps forward for the evaluation of whether substances would be considered dietary fiber, including petitions for specific substances and more.
Speakers:
James Hoadley, Ph.D.
Independent Consultant, EAS Consulting Group, LLC
James Hoadley, Ph.D. is an independent consultant at EAS Consulting Group and one of the developers of the Food Labeling Compliance Seminar and Dietary Supplement Labeling Compliance Seminar. During Dr. Hoadley’s 20-year FDA career, he participated in the development of NLEA-implementing nutrition labeling and health claim regulations. As a Senior Regulatory Scientist in the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) Dr. Hoadley’s primary responsibilities were in food label claim regulations. In this role, he conducted scientific and regulatory reviews of petitions for new health claims and nutrient content claims
Sarah Gebauer, Ph.D.
Nutrition Science Review Team, ONFL, FDA
Sarah Gebauer is a Nutritionist at the FDA Center for Food Safety and Applied Nutrition in College Park, MD. She works in the Office of Nutrition and Food Labeling on the Nutrition Science Review Team, where she reviews the scientific evidence related to nutrition labeling and labeling claims, including the scientific evidence related to dietary fiber. Prior to joining the FDA, Dr. Gebauer worked at the USDA Beltsville Human Nutrition Research...
FDA’s release of two Guidance documents in 2018 on dietary fiber, as well as prior publication of a science review of non-digestible carbohydrates being evaluated for physiological benefit, have led to many industry questions and a need for clarification. Many of the fiber ingredients currently used by industry and declared as fibers have been acknowledged as dietary fiber either by regulation or by enforcement discretion, but what next? Members of CFSAN’s Office of Nutrition and Food Labeling and Independent Consultants from EAS Consulting Group will discuss the policy on dietary fiber and unravel challenges facing the food industry as it considers a path forward.
This webinar will provide further clarification to industry on the declaration of dietary fiber on the Nutrition and Supplement Facts labels. The webinar will address the scientific evaluation undertaken by FDA; review the recently released documents by FDA related to fiber, including enforcement discretion guidance and responses to citizen petitions; and provide clarity on next steps and frequently asked questions.
Learning Objectives:
1. Understand the background on the FDA regulatory definition of dietary fiber, as well as how the agency intends to evaluate the scientific evidence to determine whether a non-digestible carbohydrates has a physiological effect beneficial to human health.
2. Gain clarity on particularly confusing areas such as mixed plant cell wall fibers and other non-digestible fibers to understand label declaration as well as what happens in those areas where there isn’t guidance.
3. Learn practical steps forward for the evaluation of whether substances would be considered dietary fiber, including petitions for specific substances and more.
Speakers:
James Hoadley, Ph.D.
Independent Consultant, EAS Consulting Group, LLC
James Hoadley, Ph.D. is an independent consultant at EAS Consulting Group and one of the developers of the Food Labeling Compliance Seminar and Dietary Supplement Labeling Compliance Seminar. During Dr. Hoadley’s 20-year FDA career, he participated in the development of NLEA-implementing nutrition labeling and health claim regulations. As a Senior Regulatory Scientist in the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) Dr. Hoadley’s primary responsibilities were in food label claim regulations. In this role, he conducted scientific and regulatory reviews of petitions for new health claims and nutrient content claims
Sarah Gebauer, Ph.D.
Nutrition Science Review Team, ONFL, FDA
Sarah Gebauer is a Nutritionist at the FDA Center for Food Safety and Applied Nutrition in College Park, MD. She works in the Office of Nutrition and Food Labeling on the Nutrition Science Review Team, where she reviews the scientific evidence related to nutrition labeling and labeling claims, including the scientific evidence related to dietary fiber. Prior to joining the FDA, Dr. Gebauer worked at the USDA Beltsville Human Nutrition Research Center in Beltsville, MD, where she conducted highly-controlled dietary interventions aimed to investigate the relationship between diet and risk of chronic diseases, such as cardiovascular disease and diabetes. She earned her bachelor’s degree in Biology from Penn State University and her Ph.D. in Molecular Medicine, also from Penn State. She has been an invited speaker at conferences nationally and internationally and has authored numerous book chapters and scientific publications.
Douglas A. Balentine, Ph.D.
Director, Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition, FDA
As the Director of the Office of Nutrition and Food Labeling at CFSAN, Dr. Douglas Balentine provides leadership and scientific direction to a multidisciplinary staff and manages the regulatory programs relating to food labeling, nutrition, infant formula, and medical foods. Prior to assuming this role, he was Director of Nutrition and Health for Unilever North America and was a member of Unilever’s Global Nutrition Leadership Team. He has worked closely with many organizations and served on a number of committees with goals of improving public health. Dr. Balentine holds 9 U.S. patents and has over 40 publications in scientific literature. Dr. Balentine has a Ph.D. in food science and nutrition from Rutgers University.
Length: 54 minutes
Contact Hours: 1.0
Date Recorded: December 6, 2018
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