The US Food and Drug Administration (FDA) is to reopen for 45 days the comment period for the interim final rule authorising a health claim on the association between plant sterol/stanol esters and reduced risk of coronary heart disease (CHD).
This interim final rule appeared before in the Federal Register of September 8, 2000 (65 FR 54686) and interested persons were given until November 22, 2000, to comment on the health claim.
After the comment period closed, the FDA received two requests from Unilever United States, Inc., and Raisio Benecol Ltd., which included requests for an extension of the comment period.
Both comments requested more time for submission of data comparing the daily intake levels of plant sterol esters and plant stanol esters that are effective in reducing the risk of CHD.
Among the other comments received in response to the interim final rule were requests to expand the types of substances eligible for the health claim to include unesterified plant sterols/stanols and mixtures of plant sterols and plant stanols.
The Fda also received a comment advocating the use of serum apolipoprotein B level as a surrogate measure of CHD risk.
The FDA claimed that another further motivation for reopening the comment period is that in the past year, both the European Commission (EC) and the Australia New Zealand Food Standards Council (ANZFSC) have taken regulatory actions limiting food use of plant sterol esters and requiring advisory labelling statements on foods to which plant sterol esters have been added.
The organisation added that a recent publication from the American Heart Association (AHA) (1. Lichtenstein, A. H. and R. J. Deckelbaum for the American Heart Association Nutrition Committee, ``Stanol/Sterol Ester-Containing Foods and Blood Cholesterol Levels.
A Statement for Healthcare Professionals From the Nutrition Committee of the Council on Nutrition, Physical Activity, and Metabolism of the American Heart Association,'' Circulation, vol. 103, pp. 1177-1179, 2001) raised a concern about daily ingestion of plant sterol/stanol ester-containing foods among certain individuals who have abnormally high absorption of plant sterols.
The FDA Claims that the issues raised by comments and recent events are significant and that thorough evaluation is needed before a final rule is issued.
Written or electronic comments should be submitted by November 19, 2001 to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.fda.gov/dockets/ecomments.