FDA Proposes Rule Change on Plant Sterol Esters

December 9/Washington/U.S. Fed News -- The Food and Drug Administration has issued a proposed rule called "Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease."

The proposed rule, published in the Federal Register on December 8 by Leslie Kux, acting assistant commissioner for Policy, states, "The Food and DrugAdministration (FDA) is proposing to amend the regulation authorizing a health claim on the relationship between plant sterol esters and plant stanol esters and reduced risk of coronary heart disease (CHD) for use on food labels and in food labeling. The agency is taking this action based on evidence previously considered by the agency, and FDA's own review of data on esterified and nonesterified plant sterols and stanols (collectively, phytosterols) published since the agency first authorized the health claim by regulation. FDA is also taking these actions, in part, in response to a health claim petition submitted by Unilever United States Inc. The proposal would amend the authorized use of the claim by modifying the nature of the substances that may be the subject of the claim for conventional foods to include nonesterified, or free, phytosterols, by expanding the types of foods that may bear the claim to include a broader range of foods, by modifying the daily dietary intake of the substance specified in the claim as necessary for the claimed benefit, by adjusting the minimum amount of the substance required for a food to bear the claim, and by making other minor changes."

For more information, contact Blakeley Denkinger, Center for Food Safety and Applied Nutrition (HFS-830), 5100 Paint Branch Pkwy., College Park, MD 20740, 301/436-1450.

The full text of the notice can be found at: http://edocket.access.gpo.gov/2010/2010-30386.htm.

From the December 20, 2010, Prepared Foods E-dition