Docket Management
Docket: 00P-1276 - Food Labeling: Health Claims; Plant Sterol/Stanol Esters & Coronary Heart Disease
Comment Number: EC -1

Accepted - Volume 18

Comment Record
Commentor Dr. Mary Winston Date/Time 2001-11-20 12:42:37
Organization American Heart Association
Category Association

Comments for FDA General
1. General Comments The Nutrition Committee of the American Heart Association is pleased to have the opportunity to respond to the request for comments on “Health Claims ;Plant Sterol/Stanol Esters and Coronary Heart Disease.” - The Nutrition Committee’s suggestions will be found below. If you have any questions or if we can be of any assistance to you, we will be please to respond. 2. Daily Intake Levels Necessary to Reduce the Risk of CHD Reviewing the literature it appears that 1.6 g of sterols or stanol esters a day results in near maximal cholesterol lowering. No clear benefit of consuming additional compound appears warranted at this time. 1. Miettinen TA, Puska P, Gylling H, et al. Reduction of serum cholesterol with sitostanol-ester margarine in a mildly hypercholesterolemic population. New Engl J Med 1995; 333:1308-1312. 2. Hendriks HF, Weststrate JA, van Vliet T, Meijer GW. Spreads enriched with three different levels of vegetable oil sterols and the degree of cholesterol lowering in normocholesterolaemic and mildly hypercholesterolaemic subjects. Euro J Clin Nutr 1999; 53:319﷓327. 3. Hallikainen MA, Sarkkinen ES, Uusitupa MI. Plant stanol esters affect serum cholesterol concentrations of hypercholesterolemic men and women in a dose﷓dependent manner. J Nutr 2000; 130:767﷓776. 4. Christiansen LI, Lahteenmaki PL, Mannelin MR, Seppanen﷓Laakso TE, Hiltunen RV, Yliruusi JK. Cholesterol﷓lowering effect of spreads enriched with microcrystalline plant sterols in hypercholesterolemic subjects. Euro J Nutr 2001; 40:66﷓73. 5. Volpe R, Niittynen L, Korpela R, Sirtori C, Bucci A, Fraone N, Pazzucconi F. Effects of yoghurt enriched with plant sterols on serum lipids in patients with moderate hypercholesterolaemia.. Brit J Nutr 2001; 86:233﷓239. 6. Maki KC, Davidson MH, Umporowicz DM, Schaefer EJ, Dicklin MR, Ingram KA, Chen S, McNamara JR, Gebhart BW, Ribaya﷓Mercado JD, Perrone G, Robins SJ, Franke WC. Lipid responses to plant﷓sterol﷓enriched reduced﷓fat spreads incorporated into a National Cholesterol Education Program Step I diet. Am J Clin Nutr 2001; 74:33﷓43. 7. Davidson MH, Maki KC, Umporowicz MS, Ingram KA, Dicklin MR, Schaefer EJ, Lane RW, McNamara JR, Ribaya-Mercado JD, Perrone G, Robins SJ, Franke WC. Safety and tolerability of esterified phytosterols administered in reduced-fat spread and salad dressing to healthy adult men and women. J Am Col Nutr 2001; 20:307-319. D. Significance of Apolipoprotein B Concentration as a Surrogate Marker for CHD Risk AHA recommends basing the evaluation of plant sterols/stanols on LDL cholesterol rather than apo B for the following reasons; 1. In contrast to cholesterol, there is no standard nor standardization program for apo B. 2. The vast majority of epidemiological data linking lower LDL levels with reduced risk of CHD is based on cholesterol, not apo B. E. Issues Regarding Safe use of Plant Sterol/Stanol Esters in Foods and Advisory Label Statements. For the most part, the AHA supports the use of mandatory statements on labels of sterol/stanol containing foods such as; 1. Products are intended for people who want/need to lower their blood cholesterol levels. 2. Patients on cholesterol lowering medication should use sterol/stanol ester containing foods in consultation with their health care provider. 3. The product may not be appropriate for pregnant and breast-feeding women, and children. 4. The product should be used as part of a healthy (balanced) diet.

EC -1