The FDA has called into question its health claim finding a link between consumption of soy protein and reduced risk of heart disease. Since 1999, the FDA has allowed manufacturers and advertisers to label soy products with an “authorized” claim of soy’s heart-health benefits. However, proposed rulemaking may reduce it to a “qualified” claim of such benefits, which has a lower scientific standard, or rescind the claim altogether. The potential revocation follows numerous studies published since 1999 that present inconsistent findings on the relationship between soy protein and heart disease.

This proposal has been a long time coming. The American Heart Association (AHA) has challenged the FDA’s authorization of the health claim as far back as 2008. The AHA reiterated this position when the FDA announced its decision to review soy’s heart-health benefits last month. The FDA has opened a 75-day public comment period before it will decide whether to proceed with a final rulemaking stripping soy of its authorized health claim or allowing it to remain. It would be the first time the FDA has proposed a rule to revoke a health claim.

Takeaway: Manufacturers and advertisers should be aware they may have to remove or qualify authorized claims of soy’s heart-health benefits from their products pending the FDA’s decision in the coming months.