FDA Delays Issuing Final Rule on Plant Sterol/Stanol Esters Health Claim

WASHINGTON--The Food and Drug Administration (FDA) is pushing back by 50 days its issuance of a final rule on the health claim for plant sterol/stanol esters and coronary heart disease (CHD). According to the agency, the comments received in response to the Sept. 8, 2000, interim final rule raised "numerous complex issues" to be addressed. Also, FDA said it did not have the staff to review the issues before the June 5 scheduled deadline.

The interim final rule noted that plant sterol/stanol esters may reduce the risk of CHD, and specified daily intake levels, categories of food eligible to bear the claim, and analytical methods for assessing compliance. Among the issues FDA said it must consider before issuing the final rule were broadening the categories of food eligible to carry the claim; making the daily intake level equal for plant stanol and plant sterol esters; and allowing foods containing nonesterfied forms of plant sterols/stanols to carry the claim.

According to the agency, it will publish a final rule on or before July 25, 2001. This falls within the 540-day statutory limit, as taken from the Feb. 1, 2000, petition filing by Lipton. The extension notice will be published in the June 6 Federal Register (www.fda.gov/OHRMS/DOCKETS/98fr/cf0135.pdf).

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