According to the Hartman Group, heart health is the top attribute consumers seek while grocery shopping. Research indicates that 55% of U.S. shoppers aim to limit or reduce saturated fat in their diets, with nearly 40% opting for 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 soy protein health claim have been mixed. The Soyfoods Association of North America (SANA) expressed concern on Monday, advocating 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 emphasized that numerous scientific studies, both prior to and since the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein lowers LDL cholesterol, supporting the continued approval of an unqualified claim. They pointed out that the FDA’s decision contradicts the positions of 12 other countries that have allowed health claims related to soy protein and heart disease, including Canada, which approved such a claim most recently in 2015.
The Natural Products Association also questioned the FDA’s actions. CEO Daniel Fabricant described the agency’s decision as “somewhat unexpected,” noting that the FDA did not clarify what prompted this sudden change. Before joining the NPA in 2014, Fabricant was the head of the FDA’s Division of Dietary Supplement Programs, giving him considerable insight into federal regulatory processes. The American Heart Association has supported the revocation of the soy protein health claim, raising doubts about any direct health benefits. In 2008, during a reevaluation of health evidence, they stated, “The direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.”
If the FDA does revoke the unlimited health claim on soy protein products, it is uncertain how consumers will react or if it will affect their purchasing decisions. The American Heart Association opposes the agency’s use of qualified language on these products, asserting that consumers often misunderstand qualified health claims, which are based on limited and inconsistent evidence.
Once the proposed rule to revoke the health claim for soybean protein is initiated, it is unlikely the FDA will change its stance unless a substantial number of comments argue against it. This could include feedback from companies like DuPont, which manufactures isolated soy protein, and Gardein, known for producing soy-based protein items. Furthermore, it is improbable that the agency will reevaluate the 11 other approved health claims on food products unless significant pressure is applied. Only one of these claims pertains to soybean protein, which is currently under review for potential revocation. Nevertheless, the FDA recently approved the labeling of soybean oil as heart-healthy, citing its ability to reduce the risk of coronary heart disease and lower LDL cholesterol.
In the context of dietary health, the inclusion of calcium carbonate citrate as a supplement may also play an essential role, as consumers increasingly seek comprehensive solutions to enhance their heart health while navigating food choices. The emphasis on calcium carbonate citrate, along with other health-focused ingredients, reflects the evolving landscape of consumer expectations regarding nutrition and wellness.