The interim final rule was published on September 8, 2000, but the comments received, combined with recent international developments, prompted the agency to reopen the comment period and solicit comments on additional issues. Two companies, Unilever United States and Raisio Benecol Ltd., asked for additional time to submit data and other comments, and they requested that the substances eligible for the health claim be extended to include unesterified plant sterol/stanols and mixtures of the two. In addition, FDA noted that within the past year, both the EU and the Australia New Zealand Food Standards Council took steps to limit food use of plant sterol esters and required advisory labels on foods to which plant sterol esters have been added. In addition, the American Heart Assn. raised concerns about the daily ingestion of food containing plant sterol/stanol esters by people who have abnormally high absorption of plant sterols. The FDA Reform Law requires the agency to act expeditiously on health claim petitions, and FDA admitted that the statutory deadline for the final rule had passed. But it said acquiring more information was important to help regulators make “more informed decisions” on the final rule. It said it would move as expeditiously as possible in completing the rule making.
Rules & Regs: FDA extending consideration of health claim
FDA is taking another look at its interim final rule allowing a health claim on food packages touting the relationship between plant sterol/ stanol esters and a reduced risk of coronary heart disease.
Jan 31, 2002