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ASA Urges FDA to Reconsider Soy Protein Health Claim

Mar 22, 2018

The American Soybean Association (ASA) submitted comments to the Food and Drug Administration (FDA) earlier this week, underscoring soy protein’s contribution to heart health and asking the agency to withdraw its proposed rule.

The FDA recently proposed revoking the unqualified health claim regarding soy protein and coronary heart disease (CHD) and changing it to a qualified claim.

“Numerous scientific studies published before and after the soy protein health claim was approved in 1999 show that soy protein lowers LDL-cholesterol and the totality of the evidence supports continued approval of an unqualified health claim,” ASA states in the letter. “We do not support revoking the authorized claim and do not believe the studies cited by the FDA validate a conclusion to do so.”

ASA urged the FDA to withdraw its proposed rule and develop a process for revoking claims.

“We believe that overwhelming data must be present to revoke a claim, which is not the case with the soy protein claim,” ASA states. “We appreciate the Agency’s clear statement in the record that soy protein has been demonstrated to be safe and lawful. Unfortunately, this proposed rule has unfairly contributed to negative perceptions surrounding soy protein. As part of the final rule, we respectfully ask that the FDA make a public statement to correct any negative impression that has been created due to this rulemaking.”

Click here to read the letter.