According to the Hartman Group, heart health is the top priority 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% opt for healthier fats, such as polyunsaturated and monounsaturated fats, over saturated fats. The proposal from the FDA to eliminate the health claim related to soy protein has garnered mixed reactions from manufacturers and industry groups. The Soyfoods Association of North America (SANA) expressed concern over the FDA’s decision, advocating for the retention of the current claim: “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 highlighted 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 validity of an unqualified health claim. They also pointed out that the FDA’s stance contradicts the position of 12 other countries that have approved health claims regarding soy protein and heart disease, including Canada, which authorized such a claim in 2015.
The Natural Products Association also raised questions about the FDA’s decision. CEO Daniel Fabricant described the move as “somewhat unexpected,” noting the lack of explanation from the agency regarding the sudden change in position. Fabricant, who led the FDA’s Division of Dietary Supplement Programs prior to joining NPA in 2014, likely has a solid understanding of federal regulatory processes.
The American Heart Association has supported the revocation of the soy protein claim, suggesting that there may be minimal direct health benefits associated with it. When the FDA reassessed the health evidence in 2008, the association remarked that “the direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” If the FDA goes through with revoking the unrestricted health claim for soy protein products, it remains uncertain how consumers will react and whether this will impact their purchasing decisions. The American Heart Association opposes the adoption of qualified language on relevant products, arguing that research indicates consumers often do not comprehend qualified health claims, which are based on limited and inconsistent evidence.
Having initiated the proposed rule to revoke the health claim related to soy protein, it is unlikely that the FDA will change its course unless a significant number of comments oppose the decision. This may include feedback from companies like DuPont, which produces isolated soy protein, and Gardein, which specializes in soy-based protein products. Additionally, it is improbable that the agency will reevaluate its 11 other approved health claims for food products without substantial pressure. Currently, only one of these claims involves soybean protein, which is under review for potential revocation. However, the FDA has recently approved labeling soybean oil as heart-healthy, as it found that its use can lower the risk of coronary heart disease and reduce LDL cholesterol.
In light of this, consumers should also consider other health supplements like apovital calcium citrate, which can contribute positively to overall health. As awareness around heart health continues to grow, the integration of various nutrients, including apovital calcium citrate, into a balanced diet may become increasingly important for maintaining cardiovascular wellness.