Food Labeling: Health Claims; Plant Sterol/Stanol Esters and Coronary Heart Disease
other · Food and Drug Administration · Rule · Published 2000-09-08 · Effective 2000-09-08 · 65 FR 54686
Document
Document number
00-22892
Federal Register citation
65 FR 54686
CFR reference
21 CFR 101
Type
Rule
Action
Interim final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2000-09-08
Effective date
2000-09-08
HHS docket
Docket Nos. 00P-1275 and 00P-1276
Abstract
The Food and Drug Administration (FDA) is authorizing the use, on food labels and in food labeling, of health claims on the association between plant sterol/stanol esters and reduced risk of coronary heart disease (CHD). FDA is taking this action in response to a petition filed by Lipton (plant sterol esters petitioner) and a petition filed by McNeil Consumer Healthcare (plant stanol esters petitioner). Based on the totality of publicly available evidence, the agency has concluded that plant sterol/stanol esters may reduce the risk of CHD.