FDA "healthy cholesterol" supplement claim raises questions about OTCs -- Soller.
This article was originally published in The Tan Sheet
Executive Summary
FDA-PROPOSED "HEALTHY CHOLESTEROL" CLAIM FOR SUPPLEMENTS RAISES QUESTION about the agency's position on OTC cholesterol-lowering drugs, Nonprescription Drug Manufacturers Association Senior VP and Science & Technology Director William Soller, PhD, told the Drug Information Association annual meeting in Boston June 8. Noting FDA's April 29 proposed rule on structure/function claims would allow the statement "Helps maintain a healthy cholesterol level," Soller reasoned "a healthy cholesterol level, to me, is a lower cholesterol level." In its proposed rule, FDA specifically requested comment on such claims ("The Tan Sheet" May 4, pp. 1-5).