The Council for Responsible Nutrition (CRN), Washington, D.C., recently submitted comments to FDA regarding the agency’s proposed rule for the health claim on phytosterols and risk of coronary heart disease. Douglas MacKay, ND, vice president, Scientific & Regulatory Affairs, said CRN has concerns that FDA’s proposed action to exclude all dietary supplement products that contain free phytosterols from bearing the approved health claim does not reflect full consideration of the impact of all delivery matrices on the efficacy of dietary supplements containing free phytosterols.

“In addition to tablets, soft gels and capsules, dietary supplements can be formulated as dry powders that are intended to be blended into a food or beverage prior to consumption,” he noted. “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. Spilburg, et al., 2003, demonstrated that 4‐weeks’ supplementation with a powdered phytosterol that was mechanically blended into a lemonade-flavored beverage prior to consumption significantly reduced LDL‐cholesterol as compared to placebo.

“Furthermore, Kassis, et al., 2008, demonstrated that supplementation with a free phytosterol powder that was mixed into margarine and served as a single dose with breakfast significantly lowered plasma total cholesterol and LDL‐cholesterol. These data suggest that the delivery matrix used for free phytosterol‐containing dietary supplements influences the efficacy of the formulation and that some dietary supplements should be able to bear the health claim relating phytosterols and risk of coronary heart disease.”

A closer look at disintegration time and efficacy data reveals that disintegration of the specific dietary supplement delivery matrix is an important variable that needs consideration when evaluating the effect of free phytosterols, he added, noting that disintegration time has been an important variable for other FDA approved nutrition‐related health claims.