F.D.A. seeks more comments on phytosterols

by Jeff Gelski
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WASHINGTON — The Food and Drug Administration has reopened the comment period for a proposed rule to amend regulations on plant sterol/stanol esters and risk of coronary heart disease, according to the Aug. 11 Federal Register. Electronic or written comments should be submitted by Oct. 25.

The Federal Register of Dec. 8, 2010, originally proposed to amend its regulations. Some of the revisions included adopting the term “phytosterols” as inclusive of both plant sterols and stanols; permitting claims on product with phytosterols, derived from either vegetable oils or tall oils, containing at least 80% of beta-sitosterol, campesterol, stigmasterol, sistostanol, and/or campestanol (combined weight); and revising the daily dietary intake of phytosterols necessary to justify the coronary heart disease risk reduction claim of 2 grams per day and the minimum amount of phytosterols (non-esterified weight) required to be in a serving of the food at 0.5 grams per reference amount customarily consumed (RACC).

The F.D.A. originally took comments until Feb. 22, 2011, and now has reopened the comment period. Electronic comments may be sent by visiting www.regulations.gov. Written comments may be sent to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville MD 20852.

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