Kendy “courtesy” letter
This article was originally published in The Tan Sheet
Executive Summary
FDA does not believe that the meaning of the "help maintain normal blood cholesterol levels" structure/function claim "limits the meaning of the claim to only effects on already normal cholesterol levels," the agency tells Kendy USA (Palatine, Ill.) in a recent exchange regarding a structure/function claim submission. Rather, it "includes effects on preventing elevations of cholesterol levels outside of the normal range and reduction of elevated cholesterol into the normal range." Kendy had maintained that since there was no reference to coronary heart disease and that the claim was not specific to reducing high cholesterol levels, the claim was appropriate...