FDA Provides Another Chance to Comment on Its Proposal to Amend the Phytosterols Health Claim

August 14, 2011

By Riëtte van Laack

FDA is reopening the comment period on the proposed rule it published on December 8, 2010, to amend the regulations on plant sterol/stanol esters and risk of coronary heart disease.  (See our previous post on the proposed rule.)

One of FDA’s proposed modifications is the discontinuation of the health claim for dietary supplements containing free (non-esterified) phytosterols.  Based on review of the literature, the Agency concluded that the evidence to support this claim did not meet the standard of significant scientific agreement.

On February 10, 2011, the Agency received a request to extend the comment period to provide additional time to collect data that support a claim for dietary supplements with free phytosterols.  Recognizing that 75 days may not have been sufficient to collect and assess data and submit comments, the Agency has decided to reopen the comment period.  The new closing date is October 25, 2011.