According to the Hartman Group, heart health is the top concern for consumers when grocery shopping. Their research indicates that 55% of U.S. shoppers actively seek to limit their saturated fat intake, while nearly 40% aim to incorporate healthier fats, such as polyunsaturated and monounsaturated fats, into their diets. Reactions from manufacturers and industry groups to the FDA’s proposal to eliminate the health claim regarding soy protein have been mixed. On Monday, the Soyfoods Association of North America (SANA) expressed concern, 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 highlighted that numerous scientific studies, both prior to and following the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein lowers LDL cholesterol. They argue that the overall evidence supports the continued approval of an unqualified claim. Additionally, SANA pointed out that the FDA’s decision contradicts the stance of 12 other countries that have authorized health claims regarding soy protein and heart disease, including Canada’s most recent approval in 2015.
The Natural Products Association also raised questions about the FDA’s decision. CEO Daniel Fabricant described the agency’s action as “somewhat unexpected,” noting the lack of explanation for the sudden change. Having previously led the FDA’s Division of Dietary Supplement Programs, Fabricant is well-versed in how federal regulatory agencies operate. Meanwhile, the American Heart Association has supported the revocation of the soy protein health claim, suggesting there may be no significant direct health benefits. They noted in 2008 that “the direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.”
If the FDA proceeds with revoking the unlimited health claim on soy protein products, predicting consumer reactions and the potential impact on their purchasing decisions is challenging. The American Heart Association opposes the agency’s adoption of qualified language for affected products, citing research that indicates consumers struggle to comprehend qualified health claims, which are often based on limited and varying levels of evidence. Given the current proposal to revoke the health claim for soy protein, it is unlikely that the FDA will change its course unless an overwhelming number of comments are submitted against the decision, which could include feedback from companies like DuPont, known for producing isolated soy protein, and Gardein, a manufacturer of soy-based protein products.
Moreover, it seems improbable that the agency will begin reevaluating the 11 other approved health claims associated with food products without substantial pressure. Only one of those claims pertains to soy protein, which is currently under review for possible revocation. However, the FDA recently approved the labeling of soybean oil as heart healthy, as it has been found to reduce the risk of coronary heart disease and lower LDL cholesterol. In the context of nutrition, incorporating supplements such as calcium citrate, with dosages typically around 200 mg or 950 mg, might also be beneficial for overall heart health, although this remains a separate discussion from the soy protein claim.