Heart Health

Soy Protein and the Heart Health Claim


In 1999, the Food and Drug Administration (FDA) approved a health claim for soy protein. The claim states:

“25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of (name of food) provides ____ grams of soy protein.”

The FDA health claim for soy protein recommends that consumers incorporate four servings of at least 6.25 grams of soy protein into their daily diet, for a total of at least 25 grams of soy protein each day.

FDA extensively reviewed research to support this health claim and found that soy protein, when included in a low-fat and low-cholesterol diet, could lower blood total cholesterol and low-density lipoprotein (LDL) or “bad” cholesterol levels, without adversely effecting high-density lipoprotein or “good” cholesterol levels. High total blood cholesterol levels and LDL are proven risk factors for coronary heart disease.

Since the FDA approved the soy protein health claim, numerous scientific studies have continued to support the soy protein health claim. The American Heart Association recognizes that eating soy protein can help decrease LDL cholesterol levels by two to seven percent.(1,2,3) The Federal Agency for Healthcare Research Quality also found a three percent reduction in LDL cholesterol from soy protein consumption.(4) In 2006, Dr. Reynolds et al from Tulane University Medical School performed a meta-analysis that found significant reduction in total cholesterol, LDL cholesterol and triglycerides as well as an increase in the HDL cholesterol levels.(5) Likewise, Dr. James Anderson, from the Virginia Medical Center and University of Kentucky, recently reported that soy protein decreased LDL cholesterol levels five to six percent.(6)

While soy protein may not reduce blood cholesterol levels as significantly as medications, these studies continue to confirm the significant scientific consensus that formed the basis for the FDA Health Claim on Soy Protein and Coronary Heart Disease. Twelve other countries have similar health claims on soy protein.(7) Soyfoods are one of the few foods that can lower cholesterol and should be an important part of an overall heart healthy diet and lifestyle.


  1. Sacks F, Lichtenstein A, VanHorn L, et al. Soy protein, isoflavones, and cardiovascular health. Circulation. 2006:113:1-12.
  2. Hoie LH, et al. Lipid-lowering effect of 2 dosages of a soy protein supplement in hypercholesterolemia. Adv Ther. 2005; 22:175-86.
  3. Stephenson, TJ, et al. Effect of soy protein-rich diet on renal function in young adults with insulin-dependent diabetes mellitus. Clin Nephrol. 2005; 64:1-11.
  4. Balk E, Chung M, Chew P, et al. Effects of soy on Health Outcomes. Summary, Evidence Report/Technology Assessment 126. Rockville, MD: AHRQ. July 2005
  5. Reynolds K, Chin A, Lees K, et al. A Meta-Analysis of the Effect of Soy Protein Supplementation on Serum Lipids, Am J Cardiol 2006; 98:633-640.
  6. Anderson JW. Soyfoods effects on serum lipoproteins in humans: updated meta-analysis. Oral presentation at 6th International Symposium on the Role of Soy in Preventing and Treating Chronic Disease, Chicago, 2005.
  7. Japan (1996), United States (1999), South Africa (2002), The Philippines (2004), Brazil (2005), Indonesia (2005), Korea (2005), Turkey (2006), Malaysia (2006), Chile (2006), Colombia (2008), India (2013) and Canada (2015)