FDA Seeks Comments on Phytosterol Health Claim

ROCKVILLE, Md.The U.S. Food and Drug Administration (FDA) is seeking public comments beginning Dec. 8, 2010, on its proposal to amend its labeling regulation authorizing a health claim on the relationship between plant sterol esters and plant stanol esters and reduced risk of coronary heart disease (CHD).

FDA 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. The amendment also is in response to a petition filed by Unilever United States Inc. dating back to the year 2000.

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.

Comments are due on or before Feb. 20, 2011. Electronic comments can be submitted at www.regulations.gov. Written comments can be sent to Division of Dockets Management (HFA305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.