CRN Sends FDA Comments on Proposed Phytosterol Rule

April 25, 2011

CRN’s says that phytosterol-powdered dietary supplements should be exempt from FDA's December 2010 ruling.

FDA’s December 2010 proposed rule for products containing phytosterols states that dietary supplements using free-form phytosterols will not warrant health claims for cholesterol-lowing effects. But the Council for Responsible Nutrition (CRN; Washington, DC) has since responded to FDA, urging that the agency reconsider data used to make its conclusion on free-form phytosterol dietary supplements.

CRN’s belief is that phytosterol-powdered dietary supplements should be exempt from this ruling.

“A free phytosterol powdered dietary supplement that is reconstituted into a food or liquid beverage will overcome dissolution and distribution limitations that may occur with the tablet or capsule form of free phytosterols,” said CRN in a recent press statement.

In reviewing data that FDA originally reviewed to make its claim, CRN observed that studies with free phytosterol powders meeting United States Pharmacopeia (USP) disintegration standards produced cholesterol-lowering results while studies that did not meet the standards did not provide an effect.

CRN is now calling for free-form phytosterol dietary supplements to be allowed a cholesterol health claim assuming the active ingredient meets USP standards for disintegration.