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In First-of-Its-Kind Move, FDA Seeks to Revoke Soy Heart Health Benefit Claim

October 30, 2017, 10:26 PM UTC

Since 1999, food makers have been able to slap a Food and Drug Administration (FDA) cleared claim onto their products that soy protein has proven heart health benefits. But the FDA on Monday moved to revoke that soy heart benefit claim—the first time ever that the agency has attempted to nix a previously authorized health claim.

“Today, we are proposing a rule to revoke a health claim for soy protein and heart disease. For the first time, we have considered it necessary to propose a rule to revoke a health claim because numerous studies published since the claim was authorized in 1999 have presented inconsistent findings on the relationship between soy protein and heart disease,” wrote the agency in a statement.

The FDA has authorized 12 health claims related to packaged foods to date. Other popular ones include those linking calcium and vitamin D consumption to a lower risk of certain bone diseases, or the association of some kinds of fruits and vegetables with a lower risk for cancer.

But the soy protein-heart disease link has proved more tenuous as more data has come in over the years. That’s not to say there isn’t any kind of heart benefit to soy protein—it’s just not as certain as an officially designated claim would suggest. “[S]ome studies, published after the FDA authorized the health claim, show inconsistent findings concerning the ability of soy protein to lower heart-damaging low-density lipoprotein (LDL) cholesterol,” as the FDA notes.

This is currently a proposed rule that hasn’t been finalized, so nothing is set in stone. But if the soy health claim reversal does become an authorized regulation, food companies could still slap a “qualified” health claim on their products. Such claims would have to clarify that there’s limited evidence proving the association between soy and better heart health.

The American Heart Association (AHA) has been one major public health organization that’s pushed back on assertions that soy and other so-called superfoods have truly stellar benefits for your heart.