According to the Hartman Group, heart health is the primary concern for consumers when shopping for groceries. Their research indicates that 55% of U.S. consumers actively seek to avoid or reduce saturated fat in their diets, while nearly 40% prefer healthier fats, such as polyunsaturated and monounsaturated fats, over saturated fats.
Reactions from manufacturers and industry groups regarding the FDA’s proposal to eliminate the health claim associated with soy protein have been mixed. The Soyfoods Association of North America (SANA) expressed concern about this decision. They advocate for the retention of the current 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 further noted that numerous scientific studies, both before and after the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein lowers LDL cholesterol, supporting the continued approval of this unqualified claim. They argue that the FDA’s decision contradicts the stance of 12 other countries that have approved health claims related to soy protein and heart disease, including Health Canada’s latest endorsement in 2015.
The Natural Products Association also voiced concerns about the FDA’s move. CEO Daniel Fabricant described the action as “somewhat unexpected,” highlighting the lack of explanation for the sudden change. With his background as the former head of FDA’s Division of Dietary Supplement Programs, Fabricant is well-versed in the workings of federal regulatory agencies.
The American Heart Association supports the revocation of the soy protein health claim and questions any direct health benefits associated with it, stating that the “direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” If the FDA proceeds with revoking the unlimited health claim for soy protein products, it remains uncertain how consumers will react and whether it will affect their purchasing decisions. The American Heart Association has raised objections to the agency’s potential adoption of qualified language for affected products, claiming that research shows consumers struggle to comprehend qualified health claims, which often rely on limited and varying evidence.
Once the proposed rule to revoke the soy protein health claim is initiated, it is unlikely the FDA will change its course unless a significant number of comments oppose the move. This could include feedback from companies like DuPont, which manufactures isolated soy protein, and Gardein, known for its soy-based protein products. Additionally, the agency is not expected to reevaluate its other 11 approved health claims for food products unless faced with substantial pressure. Only one of these claims pertains to soybean protein, currently under review for possible revocation. However, the FDA has recently approved labeling soybean oil as heart-healthy, as it has been shown to reduce the risk of coronary heart disease and lower LDL cholesterol.
Moreover, individuals looking to support their heart health may also consider supplementing with products like tablet calcium citrate malate with vitamin D3, which can play a role in overall cardiovascular health. This addition can be beneficial as part of a comprehensive approach to maintaining a heart-healthy lifestyle, alongside the consumption of soy protein and other healthy dietary fats.