FDA Moves to Revoke Claim About Soy and Heart Health

3 minute read

United States officials announced on Monday that they are moving to revoke a health claim that soy protein can reduce the risk of coronary heart disease.

In a statement, the U.S. Food and Drug Administration (FDA) says that it is, for the first time, proposing a rule to revoke the health claim that soy protein reduces a person’s risk for heart disease. The agency has currently authorized 12 health claims that are allowed on packaged foods (like the claim that calcium can help lower the risk of osteoporosis, for example).

In 1999, the FDA allowed soy protein products to say that the protein could reduce risk of heart disease, but many studies since then have questioned the link. The FDA says there is some evidence that supports the connection, but that available evidence as a whole raises skepticism.

“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, director of the Center for Food Safety and Applied Nutrition at the FDA, in a statement about the agency’s decision.

The FDA is allowing a 75-day commenting period for the public and stakeholders to weigh in on the new rule. Yet even if the rule becomes finalized, it doesn’t necessarily mean you won’t see any packaging claims linking soy protein to a reduced risk of heart disease. The FDA says that it intends to allow the use of “a qualified health claim” for soy protein. According to the FDA, a qualified health claim requires ” lower scientific standard of evidence than an authorized health claim” and would let producers use language that explains that the evidence on the link is limited.

To use a qualified health claim on any product, manufacturers are asked to petition the FDA about the phrasing they want to use. There are no specific phrases that the FDA says meet the criteria for a qualified health claim. Instead, it’s determined on a case-by-case basis. The FDA will weigh in on what language the agency thinks is in line with available evidence, and any statements must be accompanied by language that makes the level of science behind the claim clear to the consumer, the FDA says.

Until the FDA decides if it is going to finalize its new rule on soy protein and heart health, manufactures can continue using the claim on their products.

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