Nutrition Scientists Present Data Challenging FDA Proposal to Revoke Heart-Health Benefit of Soy Protein

A team of nutrition experts led by Professor David J.A. Jenkins at the University of Toronto (U of T) in Canada, gathered data from clinical trials from the past 2 decades, and found consistent information attesting to the cholesterol-lowering effect of soy protein. The primary purpose of their study is to contend the US FDA’s plans of revoking the health benefits linked to soy protein in addressing heart diseases.

The UK-born professor of U of T’s Department of Nutritional Sciences is renowned in his field for having developed the concept of the glycemic index, as a means of explaining how dietary carbohydrate affects blood sugar. In their most recent study, Professor Jenkins and his colleagues developed a dietary portfolio consisting of plant-based protein, plant sterols, nuts, and viscous fibre, which combined together can reduce risk factors for heart disease by as much as 30 per cent.

Nutrition researchers performed a cumulative meta-analysis, which allowed them to look at the effect of soy in all the trials combined, at different points in time but with the addition of data from each new trial. The analysis showed that soy helped in lowering both total cholesterol and low-density lipoprotein cholesterol, substances that can damage the heart. The effect remained consistent in all 46 trials cited by the Food and Drug Administration, when it first announced in 2017, the proposal to revoke heart-health claim attributed to soy based foods.

Professor Jenkins asserts that

“At no time since, when the original claim for soy as a reducer of serum cholesterol was introduced, had the ability of soy been questioned.” “Data has not changed and remained consistent since 1999.”

Canadian nutrition scientist John Sievenpiper,also of Nutritional Sciences at the U of T and a clinician-scientist at St. Michael’s Hospital, who co-authored the study added,

There are times a regression to the mean is seen; as where analyses with small scale studies produce big effects, which diminish over time when sample sizes increase and results become more precise “”We saw that happen with fish oil; but in the soy protein study, nothing has changed.”

Why the US FDA Proposed a Reversal of Soy Protein Health Claim in 2017

According to Susan Mayne, Director of the US FDA Center for Food Safety and Applied Nutrition,, it became necessary for them to propose a rule revoking a health claim for soy protein because numerous studies made since the claim was authorized in 1999, presented findings that were inconsistent with the supposed relationship between soy protein and heart disease.

Dr. Karol Watson, Director of the UCLA Women’s Cardiovascular Health Center and a cardiologist supported the FDA’s proposal saying that there has never been any clinical trials that prove eating more soy can improve heart health. She added that not every method of lowering cholesterol yields benefits; asserting that some things that lower cholesterol have actually shown harm.