The health claim for soyfoods and heart disease was issued by the U.S. FDA in 1999 and is still in effect.1 In 2007, the FDA announced they were reevaluating the evidence in support of the claim. The FDA has stated publicly that its decision to reevaluate the evidence was not because it is no longer supportive, but rather because so many relevant studies have been published since the claim was initially approved.
The current estimate of the cholesterol-lowering effects of soy protein is about 4%,2 which is lower than initially reported.3 Nevertheless, even a 4% reduction in cholesterol can be expected to lower heart disease risk by as much as 10%.4,5 Furthermore, the cholesterol-lowering effect of soy protein is similar to that of oats (soluble fiber),3,6 which were also awarded a heart disease claim by the FDA.7
No single food will lower elevated cholesterol levels to the optimal goal. However, by using a comprehensive dietary approach that includes soyfoods, foods high in soluble fiber (such as oats, nuts, fruits, and vegetables), phytosterols, and foods low in saturated fat, it is possible to reduce cholesterol levels by 20% to 30%—thereby eliminating the need for medications in many cases.8,9
Featured Expert
Mark Messina
Dr. Messina is the co-owner of Nutrition Matters, Inc., a nutrition consulting company, an adjunct associate professor at Loma Linda University, and the Executive Director of the Soy Nutrition Institute. Full bio >>
References:
1. Food labeling: health claims; soy protein and coronary heart disease. Food and Drug Administration, HHS. Final rule. Fed Regist. 1999;64:57700-33.
2. Zhan S, Ho SC. Meta-analysis of the effects of soy protein containing isoflavones on the lipid profile. Am J Clin Nutr. 2005;81:397-408.
3. Anderson JW, Johnstone BM, Cook-Newell ME. Meta-analysis of the effects of soy protein intake on serum lipids. N Engl J Med. 1995;333:276-82.
4. Law MR, Wald NJ, Thompson SG. By how much and how quickly does reduction in serum cholesterol concentration lower risk of ischaemic heart disease? BMJ. 1994;308:367-72.
5. Law MR, Wald NJ, Wu T, Hackshaw A, Bailey A. Systematic underestimation of association between serum cholesterol concentration and ischaemic heart disease in observational studies: data from the BUPA study. BMJ. 1994;308:363-6.
6. Wolever TM, Tosh SM, Gibbs AL, Brand-Miller J, Duncan AM, Hart V, Lamarche B, Thomson BA, Duss R, et al. Physicochemical properties of oat {beta}-glucan influence its ability to reduce serum LDL cholesterol in humans: a randomized clinical trial. Am J Clin Nutr. 2010.
7. US Food and Drug Administration. Food Labeling:Health Claims: Soluble Fiber From Whole Oats and Risk of Coronary Heart Disease. Washington, DC: U.S. Food and Drug Administration; 2001. p. 15343-4. Docket. 95P-0197.
8. Jenkins DJ, Kendall CW, Faulkner D, Vidgen E, Trautwein EA, Parker TL, Marchie A, Koumbridis G, Lapsley KG, et al. A dietary portfolio approach to cholesterol reduction: combined effects of plant sterols, vegetable proteins, and viscous fibers in hypercholesterolemia. Metabolism. 2002;51:1596-604.
9. Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, et al. Direct comparison of a dietary portfolio of cholesterol-lowering foods with a statin in hypercholesterolemic participants. Am J Clin Nutr. 2005;81:380-7.
ANSWERED QUESTIONS
What is the status of the Food and Drug Administration (FDA) soy heart health claim?
Answered by Mark Messina, PhD, MS - October 1, 2010
The health claim for soyfoods and heart disease was issued by the U.S. FDA in 1999 and is still in effect.1 In 2007, the FDA announced they were reevaluating the evidence in support of the claim. The FDA has stated publicly that its decision to reevaluate the evidence was not because it is no longer supportive, but rather because so many relevant studies have been published since the claim was initially approved.
The current estimate of the cholesterol-lowering effects of soy protein is about 4%,2 which is lower than initially reported.3 Nevertheless, even a 4% reduction in cholesterol can be expected to lower heart disease risk by as much as 10%.4,5 Furthermore, the cholesterol-lowering effect of soy protein is similar to that of oats (soluble fiber),3,6 which were also awarded a heart disease claim by the FDA.7
No single food will lower elevated cholesterol levels to the optimal goal. However, by using a comprehensive dietary approach that includes soyfoods, foods high in soluble fiber (such as oats, nuts, fruits, and vegetables), phytosterols, and foods low in saturated fat, it is possible to reduce cholesterol levels by 20% to 30%—thereby eliminating the need for medications in many cases.8,9
Featured Expert
Dr. Messina is the co-owner of Nutrition Matters, Inc., a nutrition consulting company, an adjunct associate professor at Loma Linda University, and the Executive Director of the Soy Nutrition Institute. Full bio >>
References:
1. Food labeling: health claims; soy protein and coronary heart disease. Food and Drug Administration, HHS. Final rule. Fed Regist. 1999;64:57700-33.
2. Zhan S, Ho SC. Meta-analysis of the effects of soy protein containing isoflavones on the lipid profile. Am J Clin Nutr. 2005;81:397-408.
3. Anderson JW, Johnstone BM, Cook-Newell ME. Meta-analysis of the effects of soy protein intake on serum lipids. N Engl J Med. 1995;333:276-82.
4. Law MR, Wald NJ, Thompson SG. By how much and how quickly does reduction in serum cholesterol concentration lower risk of ischaemic heart disease? BMJ. 1994;308:367-72.
5. Law MR, Wald NJ, Wu T, Hackshaw A, Bailey A. Systematic underestimation of association between serum cholesterol concentration and ischaemic heart disease in observational studies: data from the BUPA study. BMJ. 1994;308:363-6.
6. Wolever TM, Tosh SM, Gibbs AL, Brand-Miller J, Duncan AM, Hart V, Lamarche B, Thomson BA, Duss R, et al. Physicochemical properties of oat {beta}-glucan influence its ability to reduce serum LDL cholesterol in humans: a randomized clinical trial. Am J Clin Nutr. 2010.
7. US Food and Drug Administration. Food Labeling:Health Claims: Soluble Fiber From Whole Oats and Risk of Coronary Heart Disease. Washington, DC: U.S. Food and Drug Administration; 2001. p. 15343-4. Docket. 95P-0197.
8. Jenkins DJ, Kendall CW, Faulkner D, Vidgen E, Trautwein EA, Parker TL, Marchie A, Koumbridis G, Lapsley KG, et al. A dietary portfolio approach to cholesterol reduction: combined effects of plant sterols, vegetable proteins, and viscous fibers in hypercholesterolemia. Metabolism. 2002;51:1596-604.
9. Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, et al. Direct comparison of a dietary portfolio of cholesterol-lowering foods with a statin in hypercholesterolemic participants. Am J Clin Nutr. 2005;81:380-7.