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

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

WASHINGTON--The Food and Drug Administration (FDA) noted June 6 that it waspushing back by 50 days its issuance of a final rule on the health claim forplant sterol/stanol esters and coronary heart disease (CHD). According to theagency, the comments received in response to the Sept. 8, 2000, interim finalrule raised "numerous complex issues" to be addressed. Also, it statedthat it did not have the staff to review the issues before the scheduled June 5deadline.

The interim final rule noted that plant sterol/stanol esters may reduce therisk of CHD, and specified daily intake levels, categories of food eligible tobear the claim, and analytical methods for assessing compliance. Among theissues FDA said it must consider before issuing the final rule were broadeningthe categories of food eligible to carry the claim; making the daily intakelevel equal for plant stanol and plant sterol esters; and allowing foodscontaining non-esterfied 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 filed by Lipton, prior to the filing by McNeil ConsumerHealthcare. The extension notice was published in the June 6 Federal Register(www.fda.gov/OHRMS/DOCKETS/98fr/cf0135.pdf).