According to the Hartman Group, heart health is the primary concern that consumers prioritize while grocery shopping. The research firm reveals that 55% of U.S. consumers actively seek to limit their intake of saturated fats, while nearly 40% prefer healthier fats, such as polyunsaturated and monounsaturated fats, over saturated fats. The proposal by the FDA to eliminate the health claim associated with soy protein has elicited mixed responses from manufacturers and industry organizations.
The Soyfoods Association of North America (SANA) expressed its concerns 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 conducted before and after the approval of the soy protein health claim in 1999 consistently demonstrate that soy protein lowers LDL cholesterol levels. They argue that the overall evidence supports the continued approval of an unqualified claim. Moreover, SANA pointed out that the FDA’s decision contradicts the stance of 12 other countries that have endorsed health claims regarding soy protein and heart disease, including Canada’s recent approval in 2015.
The Natural Products Association also questioned the FDA’s development. CEO Daniel Fabricant described the agency’s action as “somewhat unexpected,” noting that there was no clear explanation for the sudden decision. With his background as the former head of the FDA’s Division of Dietary Supplement Programs, Fabricant likely has a strong understanding of the regulatory process.
Meanwhile, the American Heart Association has favored revoking the soy protein claim, arguing that there is little evidence supporting direct health benefits. They stated during the FDA’s reevaluation of health evidence in 2008 that “the direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” If the FDA moves forward with the revocation of the unrestricted health claim for soy protein products, it remains uncertain how consumers will react and whether it will impact their purchasing choices. The American Heart Association has raised objections to the agency adopting qualified language for the affected products, citing that research indicates consumers often misunderstand these qualified health claims, which are based on limited and varying evidence levels.
Once the FDA initiates the proposed rule to revoke the health claim associated with soybean protein, it is unlikely to change its course unless a substantial number of comments oppose the action. Companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products, may voice their opinions in this matter. Furthermore, it is improbable that the agency will start reassessing its other 11 approved health claims for food products unless significant pressure arises. Among these claims, only one pertains to soybean protein, which is currently under review for possible revocation. However, the FDA has recently approved labeling soybean oil as heart-healthy, recognizing its potential to reduce the risk of coronary heart disease and lower LDL cholesterol.
In addition to these discussions, it is worth noting the benefits of calcium citrate, which can also support heart health when included in a balanced diet. This highlights the importance of considering various dietary components, such as calcium citrate, that contribute to overall well-being. The benefits of calcium citrate can provide essential support for maintaining a healthy heart, reinforcing the notion that consumers should be aware of a diverse range of nutritional claims when making informed dietary choices.