FDA Questions Whether Soy Milk and Tofu Are Actually Good for Your Heart

This is the first time the FDA has ever tried to revoke a health claim.
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Soy foods—like tofu, soy milk, or even those fancy soy burgers—often come with a claim that they're "heart healthy." Cartons of Silk brand soy milk, for example, proclaim the product is "clinically proven to reduce cholesterol 7 percent," based on research showing soy protein can prevent heart disease. Now, though, the Food and Drug Administration has acknowledged the latest scientific evidence is less certain, and announced Monday that it wants food makers to stop using the heart-healthy claim.


The move would affect 200 to 300 products in the United States, according to industry figures. It would also mark the first time the agency has sought to revoke an authorized health food claim since it began approving such statements in 1990.

In 1999, the FDA approved the "heart healthy" language based on studies suggesting soy protein lowered the risk of heart disease by reducing the amount of heart-damaging cholesterol in the bloodstream.

More recent studies, though, have been less conclusive, or even contradictory—including a 2005 government study that showed soy products had little effect on cholesterol. The next year, the American Heart Association found there wasn't enough evidence that soy can lower cholesterol levels enough to reduce the risk of heart disease.

In 2007, the FDA began re-evaluating the link between eating soy and lowered cholesterol, concluding on Monday that "totality of currently available scientific evidence calls into question the certainty of this relationship." the agency will invite comments on the proposed change for 75 days. If the change goes through, companies may still be allowed to make what's known as a "qualified health claim," saying that there may be some health benefits, but providing a disclaimer or more nuanced description of the evidence. (The Heart Association, according to NBC News, thinks qualified claims confuse consumers.)

After all, soy isn't magic—it's wishful thinking to believe eating it would make up for an otherwise unhealthy diet. The Harvard School of Public Health says soy products have little direct effect on lowering cholesterol, but rather they're good for the heart when they replace less heart-healthy foods like red meat.


"This is a sensible proposal by the FDA," Bonnie Liebman, director of nutrition at the Center for Science in the Public Interest, tells Tonic. She says that better studies have been done since the initial decision, which calls for a more careful description of what we actually know. (She says there are other health claims the FDA should revisit for being out of date, though many of them aren't featured prominently by food manufacturers.)

"That said, there's still plenty of reason to eat more soy in place of red meat," she says. "You're better off with a soy burger than a hamburger." Soy is healthier because it's low in saturated fat and high in unsaturated fat, while red meat is just the opposite. Those at risk of heart disease, especially, should avoid saturated fat.

A spokesperson for WhiteWave Foods, the owners of Silk products, declined to comment on the FDA announcement, and referred Tonic to the Soyfoods Association of North America (SANA), which condemned the move in a statement on its web site saying 12 other countries have authorized health claims for soy protein and heart disease. Pulmuone Foods, the makers of Nasoya brand tofu, did not respond to multiple emailed requests for comment.

But Liebman says if the FDA revokes the health claims, it may not change many people's habits, anyway. More people are eating plant proteins such as soy for more reasons that just the health benefits, she says. They're choosing soy because it's good for animals and good for the environment, and it's better for their bodies.

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