According to the Hartman Group, heart health ranks as the top concern for consumers when shopping for groceries. The research indicates that 55% of U.S. consumers actively seek to limit their intake of saturated fats, while nearly 40% aim to incorporate healthier fats, such as polyunsaturated and monounsaturated fats, into their diets. Reactions from manufacturers and industry groups regarding the FDA’s proposal to eliminate health claims related to soy protein have been mixed. The Soyfoods Association of North America (SANA) expressed apprehension about the proposal, advocating for the retention of the current health claim, which states: “25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.”
SANA emphasized that numerous scientific studies, both prior to and following the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein can lower LDL cholesterol levels. They argued that the overall body of evidence supports the ongoing approval of an unqualified health claim. Furthermore, SANA pointed out that the FDA’s decision conflicts with 12 other countries that have endorsed health claims relating soy protein to heart disease, including a recent approval from Health Canada in 2015.
The Natural Products Association also raised concerns about the FDA’s decision. CEO Daniel Fabricant described the move as “somewhat unexpected,” noting that the agency did not clarify the reasons behind its sudden action. Fabricant’s background as the former head of FDA’s Division of Dietary Supplement Programs gives him insight into how federal regulatory bodies typically operate. Additionally, the American Heart Association has supported the revocation of the soy protein health claim, questioning its direct health benefits. According to Reuters, the association noted that during the FDA’s reevaluation of the health evidence in 2008, the direct cardiovascular health benefits of soy protein or isoflavone supplements were minimal at best.
Should the FDA proceed with the revocation of the unlimited health claim for soy protein products, it is challenging to predict how consumers will react and whether it will affect their purchasing choices. The American Heart Association opposes the FDA’s adoption of qualified language for the affected products, citing research that suggests consumers often do not grasp qualified health claims, which are based on limited and inconsistent evidence.
Once the FDA initiates the proposed rule to revoke the health claim for soy protein, it is unlikely that the agency will alter its stance unless a significant volume of comments opposing the decision emerges. Potential comments could come from companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products. Additionally, it is improbable that the agency will reassess its 11 other approved health claims for food products unless substantial pressure is applied. Only one of these claims pertains to soy protein, which is currently under review. However, the FDA recently approved the labeling of soybean oil as heart-healthy, based on findings that its use can reduce the risk of coronary heart disease and lower LDL cholesterol levels.
In the context of health benefits, it is worth noting the importance of slow release calcium citrate, which can provide essential nutrients that support overall heart health. Incorporating slow release calcium citrate into a balanced diet may enhance the effectiveness of maintaining cardiovascular wellness. As discussions continue regarding the health claims associated with soy protein, the role of slow release calcium citrate in promoting heart health should not be overlooked.