Fiberall cholesterol label claims changes under way in response to FDA "courtesy" letter.
This article was originally published in The Tan Sheet
Executive Summary
FIBERALL CHOLESTEROL LABELING CLAIMS MODIFICATION under way at Heritage Consumer Products in response to a June 17 "courtesy" letter from FDA. The letter designated as unapproved new drug claims the product's label statements: "Helps lower cholesterol when used as part of a low fat diet" and "...When used as part of a low fat diet, gives your body more of what it needs to lower cholesterol." The agency letter followed a June 10 company notification describing the statements as dietary supplement structure/function claims allowable under the Dietary Supplement Health & Education Act.