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Nutr Rev 2020 Jan 22 [Epub ahead of print]

Psyllium husk intake and risk of type 2 diabetes: an evidence-based scientific and regulatory review of a qualified health claim conducted by the US Food and Drug Administration.

Rivers CR, Kantor MA


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."

Category: Journal Article
PubMed ID: #31968119 DOI: 10.1093/nutrit/nuz103
Includes FDA Authors from Scientific Area(s): Food
Entry Created: 2020-01-26