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 aim to limit or reduce saturated fat in their diets, while nearly 40% prefer healthier fats, such as polyunsaturated and monounsaturated fats, over saturated options. Manufacturers and industry associations have had varied responses to the FDA’s proposal to eliminate the health claim associated with soy protein. The Soyfoods Association of North America (SANA) expressed concern on Monday, advocating for the retention of the existing 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 pointed out that numerous scientific studies, both prior to and following the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein reduces LDL cholesterol levels. The organization believes that the evidence overwhelmingly supports maintaining the unqualified health claim. They also highlighted that the FDA’s stance is inconsistent with the policies of 12 other countries that have endorsed health claims related to soy protein and heart disease, including Health Canada’s recent approval of such a claim in 2015.
The Natural Products Association also raised concerns about the FDA’s decision. CEO Daniel Fabricant described the agency’s move as “somewhat unexpected,” as it did not clarify the reasons behind its sudden action. Having previously led the FDA’s Division of Dietary Supplement Programs before joining the NPA in 2014, Fabricant likely possesses a strong understanding of federal regulatory processes. Meanwhile, the American Heart Association has supported the revocation of the soy protein health claim, questioning whether there are any direct health benefits. According to Reuters, when the FDA was reassessing health evidence in 2008, the association noted that “the direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.”
If the FDA proceeds with the revocation of the unrestricted health claim regarding soy protein products, it is difficult to predict how consumers will react and whether it will affect their purchasing behavior. The American Heart Association has expressed opposition to the adoption of qualified language on the affected products, stating that research shows consumers often misunderstand these claims, which are based on limited and varying levels of evidence. Given that the proposed rule to revoke the health claim for soybean protein is already underway, it is unlikely the FDA will reverse its course unless there is a significant outcry against the decision. This could potentially include feedback from companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products.
Furthermore, it is unlikely that the FDA will begin reevaluating the 11 other approved health claims on food products unless substantial pressure arises. Only one of these claims pertains to soybean protein, which is currently under review for possible revocation. However, the FDA recently approved labeling soybean oil as heart-healthy, as the agency concluded that its use can lower the risk of coronary heart disease and reduce LDL cholesterol levels. In the broader context of health and nutrition, products like Garden of Life calcium citrate can play a vital role in maintaining overall health, alongside considerations for dietary fats and proteins.