Soy has been widely accepted as a heart-healthy food for nearly two decades. Manufacturers of packaged food products have claimed that soy protein reduces the risk of coronary heart disease, and labeled their products thusly.
Now, the U.S. Food and Drug Administration isn’t so sure and is seeking an unprecedented revocation of the authorized claim. With an authorized claim, manufacturers get a stamp of approval from the FDA to directly state a health benefit — calcium, for instant, helps stymie osteoporosis.
The agency said a review of evidence linking soy protein to improved heart health wasn’t conclusive enough to warrant an authorized claim.
Douglas Balentine, director of the Office of Nutrition and Food Labeling, said studies have evolved since the authorized claim for soy's heart benefits was approved in 1999.
"The majority of newer studies did not support that there was a strong relationship between the protein component of soy and the reduction of LDL cholesterol, which is a risk factor for heart disease," he said.
The agency's decision was unwelcome news for Ron Moore, president of the American Soybean Association. He said after nearly two decades of well-established and well-regarded evidence for soy’s heart-healthy benefits, the FDA’s decision may confuse consumers.
“Not only is soy protein a benefit for a healthy heart, it’s also an advantage for a healthy diet,” he said.
Moore said most soybean farmers are wrapping up the harvest and have not yet had time to react to the FDA’s decision, but that it won’t sit well with the soybean farming industry.
“It’s really disappointing that the FDA has done this,” Moore said, and questioned why the move is being made if the studies were inconclusive.
Soy would still be eligible for a qualified claim, which is a less-direct statement about a potential health benefit. In July, the FDA approved a qualified claim which allowed manufacturers to state that “supportive but not conclusive evidence suggests” that macadamia nuts are part of an overall diet low in saturated fat and cholesterol, and may reduce the risk of heart disease. Soy manufacturers would be able to make a similar statement.
“This is basically just saying you can add more words to the package,” said Sally Fallon Morell with the Walter A. Price Foundation, which advocates for nutrient-dense foods and supports the demotion of soy.
Morell said the change from an authorized claim to a qualified claim is a good start, but should be weakened further. In 2006, her group unsuccessfully filed a petition with the agency to try to get soy’s authorized claim revoked. A similar petition was made by the American Heart Association in 2008. In 2017, the association said its position has not changed since then.
Pam Towery, director of the Coordinated Program in Dietetics at Arkansas State University, said she interpreted the FDA’s decision as meaning that the evidence may lean towards soy being heart-healthy but is not overwhelmingly positive enough to justify the authorized claim. Still, she said the move may be unsettling for people on special diets because of cardiac conditions, vegetarians and vegans who get their protein from soy and people who have assumed that soy is a healthy diet choice.
“I think this idea will have a difficult time being accepted by the general public,” she said, especially since 18 years have passed since the authorized claim was first approved.
Balentine said the agency will work to ensure that any future health claims authorized through the regulatory process are made clear and transparent to consumers.
"What we'll really be trying to do is make sure that we communicate to consumers what the claim is, and what the strength of the evidence supporting that claim is," he said.
Balentine confirmed that the step down for soy does not mean the agency thinks people should stop consuming soy.
"The dietary guidelines clearly continue to advise the use of plant-based foods like soy as a replacement for foods higher in saturated fat, [and that is] one technique that would reduce the risk of heart disease," he said.
The Food and Drug Administration will accept public comment on the proposed revocation through Jan. 16 here. Manufacturers may continue to use the current labels while the decision is pending.
This story is produced by Arkansas Public Media, a statewide journalism collaboration among public media organizations. Arkansas Public Media reporting is funded in part through a grant from the Corporation for Public Broadcasting, with the support of partner stations KUAR, KUAF, KASU and KTXK and from members of the public. You can learn more and support Arkansas Public Media’s reporting at arkansaspublicmedia.org. Arkansas Public Media is Natural State news with context.