According to the Hartman Group, heart health is the top concern for consumers while grocery shopping. Their research indicates that 55% of U.S. consumers are actively trying to avoid or decrease their saturated fat intake, with nearly 40% opting for healthier fats such as polyunsaturated and monounsaturated fats instead. Reactions from manufacturers and industry groups regarding the FDA’s proposal to eliminate the health claim related to soy protein have been varied. The Soyfoods Association of North America (SANA) expressed concern on Monday, advocating for the retention of the current claim that 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 pointed out, “Numerous scientific studies published before and after the approval of the soy protein health claim in 1999 consistently demonstrate that soy protein reduces LDL cholesterol, and the overall evidence supports the continued endorsement of an unqualified claim.” They also highlighted that the FDA’s decision contradicts the stance of 12 other countries that have allowed health claims regarding soy protein and heart disease, including Health Canada’s most recent approval in 2015.
The Natural Products Association also raised concerns over the development, with CEO Daniel Fabricant describing the FDA’s action as “somewhat unexpected,” given the lack of explanation for the sudden decision. Previously, Fabricant led the FDA’s Division of Dietary Supplement Programs, giving him significant insight into federal regulatory processes. The American Heart Association has supported the revocation of the soy protein health claim and has questioned the direct health benefits associated with it. According to Reuters, the association remarked during the FDA’s 2008 reevaluation of health evidence, “The direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.”
If the FDA does proceed with revoking the unlimited health claim on soy protein, it remains uncertain how consumers will react and whether it will affect their purchasing choices. The American Heart Association opposes the agency’s decision to adopt qualified language for affected products, citing that research indicates consumers often misunderstand qualified health claims, which are based on limited and varying evidence. Once the FDA has initiated the proposed rule to revoke the soybean protein health claim, it is unlikely to change course unless a significant number of comments oppose the action. Notable companies such as DuPont, which produces isolated soy protein, and Gardein, which manufactures soy-based protein products, may be among those voicing their concerns.
Furthermore, it is improbable that the agency will start reevaluating the other 11 approved health claims related to food products unless substantial pressure arises. Only one of those claims pertains to soybean protein, which is currently under review for potential revocation. However, the FDA recently endorsed the labeling of soybean oil as heart-healthy, as it found that its consumption can lower the risk of coronary heart disease and reduce LDL cholesterol levels. Amid these discussions, the role of supplements like Pure Encapsulations Calcium Magnesium Citrate could also be relevant, as maintaining proper nutrient balance is essential for overall heart health. The potential impact of the FDA’s actions on consumer behavior and the market for these supplements, including those that incorporate calcium and magnesium, remains to be seen.