Affiliation:
1. Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, Maryland, USA
Abstract
Abstract
The US Food and Drug Administration (FDA) received a petition from a company requesting that FDA issue an authorized health claim for the relationship between psyllium husk and a reduced risk of type 2 diabetes. After an initial assessment of the available scientific evidence, FDA determined that significant scientific agreement was lacking for this substance-disease relationship, whereupon the company agreed to have its petition reviewed as a qualified health claim. This article describes the process FDA used in conducting an evidence-based review of the science underpinning the proposed claim and addresses certain safety issues associated with psyllium husk that FDA considered in its review of the petition. Of the 6 studies from which scientific conclusions could be drawn, as identified through FDA’s review, psyllium husk significantly improved plasma glucose levels and insulin sensitivity in only 1 study. Therefore, FDA’s enforcement discretion letter for this qualified health claim stated: “Psyllium husk may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very little scientific evidence for this claim.”
Publisher
Oxford University Press (OUP)
Subject
Nutrition and Dietetics,Medicine (miscellaneous)
Reference89 articles.
1. How the US Food and Drug Administration evaluates the scientific evidence for health claims;Ellwood;Nutr Rev,2010
2. Food labeling: health claims: soluble fiber from certain foods and coronary heart disease. Final rule;Fed Regist,1998
3. The water-soluble gums-their botany, sources and utilization;Mantell;Econ Bot.,1949
4. Anaphylactic reactions to a psyllium-containing cereal;James;J Allergy Clin Immunol,1991
Cited by
2 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献