On October 31, 2017, the U.S. Food and Drug Administration (FDA or the Agency) announced a proposal to revoke the regulation authorizing the use of a health claim characterizing the relationship between soy protein and coronary heart disease. The proposed rule signifies the first time that the FDA has proposed to rescind a health claim regulation. The FDA explained that the proposal is based on the results of recent studies which call into question its previous determination that there is significant scientific agreement among qualified experts that consumption of soy can reduce the risk of coronary heart disease.
The FDA promulgated a final rule authorizing the health claim in 1999 (21 C.F.R. § 101.82). In 2007, the Agency announced its intention to reevaluate the scientific evidence for the claim and provided an opportunity for public comment. This proposed rule is the next step in its reevaluation.
The FDA's determination about whether to authorize a health claim hinges on whether there is "significant scientific agreement" (SSA) among qualified experts that publicly available scientific evidence supports the relationship between the substance and the disease. While the Agency believed that the scientific evidence available in 1999 met that standard, more recent studies have caused it to reconsider.
In its reevaluation, the FDA considered 709 publications, including studies considered in the 1999 final rule, comments submitted to the 2007 notice of reevaluation, a 2008 citizen petition (requesting that FDA revoke 21 C.F.R. § 101.82), and searches of more recent literature. In an October 30 statement explaining the proposed rule, Dr. Susan Mayne, Director of the FDA's Center for Food Safety and Applied Nutrition, explained how the current scientific evidence does not meet the SSA standard: "Some 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. 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."
If, when the rule is finalized, the Agency concludes that there is some credible evidence for the use of a qualified health claim about the relationship between soy protein and a reduced risk of coronary heart disease, the Agency intends to issue a statement of enforcement discretion for the use of a qualified health claim at that time. A qualified health claim requires a lower scientific standard of evidence than an authorized health claim and is permitted so long as the labeling also includes qualifying language explaining the limited nature of the supporting evidence. Qualifying statements are considered on a case-by-case basis, with the FDA considering the particular language in light of available scientific evidence and consumer expectations.