The FDA, looking at recent research, may limit food producers' claims connecting soy protein with heart health. But if you enjoy eating soy foods, don’t stop. Other benefits are not being questioned.

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On Nutrition

If you make a point of eating healthfully, it’s likely out of a desire to reduce your risk for future health problems. That can make health claims awfully appealing. Some claims on foods are little more than marketing spin, but the Food and Drug Administration (FDA) does allow some science-based “authorized health claims,” which state that a specific food or nutrient plays a role in the prevention of a specific disease.

Currently, the FDA only allows food manufacturers to make health claims regarding 12 diet-disease relationships. These include calcium and osteoporosis; fiber-containing grains, fruits and vegetables and cancer; fiber-containing grains, fruits and vegetables and heart disease; fruits and vegetables and cancer; folic acid and neural-tube defects; sugar-free sweeteners and dental cavities; and soy protein and heart disease.

About that last one: In 1999, the FDA approved two versions of an authorized health claim about soy protein and heart-disease risk. If you eat soy products like tofu, tempeh, soy milk, edamame or miso, you may have seen these words: “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] supplies __ grams of soy protein.”

There was a bit of a shake-up last fall when the FDA considered revoking the authorized claim because newer evidence suggests the relationship between soy and reduced risk of heart disease is less of a sure thing. Some studies published in the nearly 20 years since the claim was approved show inconsistent findings about soy protein’s ability to lower levels of “bad” (LDL) cholesterol, a risk factor for heart disease.

“Our review of that evidence has led us to conclude that the relationship between soy protein and heart disease does not meet the rigorous standard for an FDA-authorized health claim,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, in a statement released in October 2017.

The agency is still considering the matter, and may downgrade the claim to a “qualified” health claim, which requires a lower scientific standard of evidence. Manufacturers of foods containing soy protein could still make claims about heart-disease risk reduction, but they would have to be accompanied by qualifying language — a disclaimer explaining the limited current evidence.

So what does this mean for you if you enjoy eating soy? Don’t stop. The 2015-2020 Dietary Guidelines for Americans point out that a healthy eating pattern can include soy beverages and a variety of protein-containing foods, including soy products. The only issue at stake is whether the specific claim for soy protein and reduced risk of coronary heart disease is still supported by scientific evidence. Whole soy foods contain other compounds, like fiber and phytochemicals, that have their own health benefits, and those aren’t being debated. Your best bets are to stick to traditional, less-processed soy foods, such as tofu, tempeh, soy milk, miso and edamame. A nice stir-fry, anyone?