The FDA has proposed a rule revoking the right of companies to say soy protein protects the heart, while potentially allowing a more circumspect health claim.
The agency, which to date has never revoked a health claim, said studies published since it authorized the soy protein claim in 1999 had shown inconsistent results.
“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,” the agency said in a statement.
The FDA said that if its proposed rule is finalized, it would consider allowing the use of a qualified health claim, which requires a lower scientific standard of evidence than an authorized claim.
The move comes nearly a decade after the FDA announced its intent to re-evaluate the scientific evidence for certain health claims, including the one that soy protein may lower the risk of heart disease.
The American Heart Association (AHA) has long advocated revoking the soy health claim. In a 2008 comment on the FDA’s intent to re-evaluate the evidence, the association said: “Direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” In the same comment, the association urged the FDA not to allow the use of a qualified health claim.
“Consumer research conducted by AHA, the FDA, and others has repeatedly shown that despite the presence of qualifying language, consumers do not understand qualified health claims, and do not understand that they are based on limited and varying degrees of evidence,” the organization said.
In its statement, the FDA invited stakeholders and others interested in the topic to submit comments on the proposed rule. The comment period will be open for 75 days, after which the agency will consider the comments received along with the existing information available to determine whether to proceed with final rulemaking. Manufacturers will be allowed to keep the current authorized claim on their products until the agency makes a final decision.
The FDA advised consumers to follow advice from the 2015–2020 Dietary Guidelines, which state that a healthy eating pattern can include soy beverages and a variety of protein foods, including soy products. The agency noted that the authorized health claim at issue addresses only soy protein and the reduced risk of coronary heart disease. Other purported health benefits of soy or soy-derived food ingredients (such as soybean oil) are not addressed as part of the proposed rule.
American Heart Association officials were not immediately available to comment on the FDA’s announcement.