FDA Considering to Revoke the Heart-Healthy Claim for Soy

Almost everyone is well aware of the heart-healthy benefits of soy for the heart. Researchers from the University of Toronto with the help of a number of clinical trials from the last two decades supports that soy has the potential to show the consistent lowering effect of cholesterol.

The study asks the U.S. Food and Drug Administration to consider again the health claim made for soy and its beneficial impact on heart disease.

David Jenkins, lecturer of nutritional sciences and of medicine at the University of Toronto says, “At no time since the original claim for soy as a reducer of serum cholesterol has its ability been in question. It’s been consistent since 1999. The data have not changed.”

Low-density lipoprotein and cholesterol are the main two contributing factors for heart disease. Researchers previously showed how soy helps in protecting the heart by reducing both to a great extent. Same results were observed in all the 46 trails in 2017 except the recent one which shows slight variations.

Today the findings of the research paper “Cumulative Meta‐Analysis of the Soy Effect Over Time” are published in the journal of the American Heart Association.

John Sievenpiper, coauthor of the study, lecturer of nutritional sciences at the University of Toronto and a clinical researcher says, “Sometimes you see a regression to the mean, where analyses with small studies produce big effects that diminish over time as sample sizes increase and results get more precise. We saw that with fish oil, for example. But in this case, nothing has changed.”

Researchers performed a cumulative meta-analysis in which they compared all the trials altogether. They also compared the trials individually with the data of the new trials. It is expected that FDA will soon (in summer) take a decision over this health claim of soy. They will either abjure the health claim or will continue it.

Jenkins, a scientist in the Joannah & Brian Lawson Centre for Child Nutrition at the University of Toronto and a clinician-scientist at St. Michael’s Hospital says, “These data strongly support the rationale behind the original FDA heart health claim for soy. And it’s important to note that while the reduction in cholesterol was less than five percent if you put that together with other plant-based foods in a portfolio you get a much stronger effect.”

Jenkin with his team members in the 1980s made a glycemic index showing the content of sugar in various foods. Recently he with his team came up with a dietary portfolio which can decrease the risk for heart diseases by approximately 30%. This dietary portfolio includes nuts, plant sterols, plant-based protein, and viscous fiber.

This dietary portfolio has been accepted by Heart UK and the European Atherosclerosis Society. While FDA is focusing on health claims made for other plant foods mentioned in the portfolio.

Jenkins Explains “It’s disheartening that the FDA has focused on soy. We see similar data for other foods in the portfolio. If you knock out one leg of that stool then the others could be up for grabs, right when concerns about health and the environment are bringing plant-based eating into the mainstream.”

Currently, government, several non-profit and funding institutions are supporting the cause of Professor Jenkins and Sievenpiper. These institutions also include the ones who promote soy and plant-based foods in the diet.

Jenkins further asks for support by saying, “We’re moving into an age of plant-based protein, and it would be a shame to see that shift undermined. Plant-based food producers, industry and retailers need all the help they can get, to make their products accessible.”

Emma Colleen

Emma’s professional life has been mostly in hospital management, while studying international business in college. Of course, she now covers topics for us in health.

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