Pick up a package of soy milk, edamame, tofu, or soy burgers at any American grocery store and you’ll likely see a little red heart on its label. The friendly symbol is the result of the US Food and Drug Association concluding 20 years ago that soy can lower the risk of heart disease. But the little red heart may not be around for long.
The FDA has proposed revoking the conclusion that soy is heart healthy, after a review in 2017 of “the totality of publicly available scientific evidence currently available.”
Here’s the pertinent part of the FDA’s suggestion the soy-is-healthy thing might be overblown:
…such evidence does not support our previous determination that there is significant scientific agreement (SSA) among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease.
However, the lead author of a new meta-analysis of 46 studies criticized by the FDA isn’t so sure. And his disagreement with the FDA’s proposal is representative of a larger fight between the plant-food business and the cattle and dairy business. Plant-based options are proving increasingly popular as the public weighs not just their own health, but the health of the environment, when they choose what to eat.
A new wave of soy-based products that includes the Impossible Burger, which restaurants have found to be a hit, is taking market share from the cattle industry. And Americans are drinking less milk, as more plant-based options, of which soy has long been a go-to, appear on shelves.
A Doctor Who Says There’s a “Soy Effect”
Dr. David Jenkins, MD, Ph.D. the author of that meta analysis, came to a very different conclusion than the FDA: Jenkins says the studies, when looked at together, show a clear “soy effect.” (The FDA reviewed each study individually.) Essentially, soy is just as heart healthy as it’s always been, Jenkins tells Inverse.
Jenkins is the the Canada Research Chair in Nutrition and Metabolism at the University of Toronto and St. Michael’s Hospital. His work was published in the Journal of the American Heart Association in late June, and the finding has him worried about the bigger picture: If soy is being discounted, what does that mean for other ingredients?
“I’m very worried that other foods that have cholesterol-lowering abilities, because they’re only small, and because they have variation, will be taken off the list, and so the public will be left without information,” Jenkins tells Inverse.
Why the FDA Might Revoke Its Endorsement of Soy
The claim that the FDA allowed in 1999 make it clear that soy can decrease the risk of heart disease, noting that 25 grams of soy a day if part of a diet low in saturated fats and cholesterol, might reduce the risk of heart disease.
But in the FDA’s announcement in October 2017, Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, said it was time to rethink that claim:
While some evidence continues to suggest a relationship between soy protein and a reduced risk of heart disease … the totality of currently available scientific evidence calls into question the certainty of this relationship.
The FDA’s decision was based on its assessment that only 19 of the 46 studies showed a significant decrease in so-called “bad cholesterol” (LDL-C), which the agency says isn’t a high enough proportion to justify an unqualified health claim.
In other words, the FDA believes the “soy effect” in these studies is too small or too varied to be worthy of the “heart healthy” claim.
An FDA spokesperson tells Inverse that it’s “currently reviewing comments submitted to the agency on the FDA’s proposed rule to revoke the authorized health claim on the relationship between soy protein and reduced risk of coronary heart disease.”
The Soy Effect Is Under Debate
Jenkins is concerned that the FDA is looking for a big heart health effect from soy, like you would expect from a heart drug, instead of treating food and drugs like separate categories.
“Unlike drugs, where you may take just one drug, with food you take a diet which has got many foods in it,” he explains. “So it’s appropriate to have many small changes with food, whereas with a drug you expect one large difference.”
By using a meta-analysis, which the FDA did not use, Jenkins and his team showed that soy has consistently been able to lower LDL cholesterol between −4.2 and −6.7 mg/dL (P<0.006), with “no loss of significance at any time point.”
“This is not theoretical,” he says. “If you put many small differences together, you get a big difference.”
Asked to comment on Jenkins’ article, the FDA said: “In general, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”
What’s Really at Stake in This Soy Clash?
The FDA spokesperson explained to Inverse what will happen if soy’s heart health claim is revoked.
However, should the FDA finalize this rule, the agency intends to allow the use of a qualified health claim as long as there is sufficient evidence to support a link between eating soy protein and a reduced risk of heart disease. A qualified health claim, which requires a lower scientific standard of evidence than an authorized health claim, would allow industry to use qualifying language that explains the limited evidence linking consumption of soy protein with heart disease risk reduction.
It may seem like a lot of squabbling over minutiae, but the change has the potential for big ripple effects on American diets.
A number of other foods have been labeled heart-healthy, including nuts, oats, and barley. Jenkins worries they’re next.
"The only thing that they will be left with is drugs.
“If they start taking away the health claim status for soy, they’ll have to do the same thing for nuts. They’ll have to do the same thing for oats and barley. In the end, people will be left with nothing that they can rely on,” he says. “The only thing that they will be left with is drugs.”
Anti-soy advocates think that pressure — and the anti-soy tweets — paid off:
“In response to our 2008 petition, the FDA has proposed to revoke the heart health claim for soy protein!” wrote Sally Fallon Morell, president of the Weston A. Price Foundation, a nonprofit devoted to encouraging Americans to eat more “nutrient-dense” foods, including meat and raw dairy, in a December 2017 blog post. (The FDA’s 2017 statement did not mention the Weston A. Price Foundation.
Asked whether she thought the FDA’s move to revoke soy’s heart-healthy claim was a response to the her group’s petition, Morell tells Inverse: “I certainly think we [did have an effect] because [the FDA] would never have done anything or said anything if we hadn’t filed this petition and then got a lawyer involved.”
"Especially for the elderly and for women, the higher your cholesterol the longer you live. You do not want to be lowering your cholesterol
Morell contests Jenkins’ study because she believes it incorrectly uses high cholesterol as a “surrogate marker” for heart disease. “Especially for the elderly and for women, the higher your cholesterol the longer you live. You do not want to be lowering your cholesterol,” she says.
In case you might think she’s onto something, let the Centers for Disease Control and Prevention remind you: “Too much cholesterol puts you at risk for heart disease and stroke, two leading causes of death in the United States.”
“We are the number one foundation beating this drum,” Morell insists to me. “And of course it’s an uphill battle. Soy is an extremely powerful industry.”
The anti-soy Price Foundation states on its website that it isn’t funded by “any government agency or food processing corporation,” but that many of its members are farmers.
So far, only soy is in the crosshairs of the FDA, but scientists interviewed by Inverse who wouldn’t go on the record because it would harm their future work, say it’s indicative of a larger anti-soy movement, driven by the meat and dairy industries.
John Erdman, Ph.D., nutritional sciences professor emeritus at the University of Illinois and scientific adviser to the Soy Nutrition Institute, explained to CNN in 2017 that the FDA is “under tremendous pressure” to revoke the claim.
In 2018, in the trade journal Today’s Dietitian, registered dietician Matthew Ruscigno, MPH, the Chief Nutrition Officer of the plant-based diet clinic Nutrinic, also pointed out the Price Foundation’s role in the “anti-soy crusade.”
In an editorial published in JAHA along with Jenkins’ article, Kristina S. Petersen, Ph.D., a Penn State University assistant research professor of nutrition sciences, called the controversy a “dilemma.”
While Jenkins’ analysis of the 46 soy studies shows that the plant is good for the heart, the labels that consumers end up seeing in the grocery store can still be misused. Unhealthy, highly processed foods can qualify for the health claim if they include enough soy protein, and this, Petersen argues, also must be addressed.
"I have to say I’m trying not to offend the FDA. But I do want them to reconsider.
Despite the greater powers at play, Jenkins says that at the end of the day, the soy debate is supposed to be about helping people make healthier food choices.
“I have to say I’m trying not to offend the FDA,” he says, “But I do want them to reconsider.” Regarding the FDA being the first institution to build a comprehensive set of plant-based health claims, Jenkins says this:
“They are trailblazers, and to see them going backward is not good!”
The rising popularity of plant-based meats suggest that Americans are poised to accept more soy into their diets. A spokesperson from the Missouri Farm Bureau gave this warning about the soy-based Impossible Burger this earlier this year: “If farmers and ranchers think we can mock and dismiss these products as a passing fad, we’re kidding ourselves.”
The other major player in this new fake-meat market is Beyond Meat, which doesn’t include soy in its burgers. It’s currently being questioned for how it makes them, though. Whether the FDA will move to support the trend, which has been praised for its health benefits and climate impact, remains to be seen.
When Will the FDA Decide on Soy?
It’s expected to make its decision about soy this summer.
Jenkins, for his part, won’t let the FDA’s ruling change what he eats. He lives in Canada, whose national food board supports soy’s heart health claim, and he’s already made his diet choices.
“My family are vegan,” Jenkins says. “We have a conflict of interest, if you like.”