Heart health is the top priority for consumers when shopping for groceries, as reported by the Hartman Group. Their research indicates that 55% of U.S. shoppers attempt to limit their intake of saturated fats, while nearly 40% aim to include healthier fats, such as polyunsaturated and monounsaturated fats, in their diets instead. The response from manufacturers and industry organizations to the FDA’s proposal to revoke the health claim surrounding soy protein has been mixed. The Soyfoods Association of North America (SANA) expressed concern on Monday, advocating for the preservation of the current health 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 following the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein lowers LDL cholesterol levels, bolstering the case for maintaining an unqualified health claim. The organization pointed out that the FDA’s decision diverges from the stance of 12 other countries that support health claims regarding soy protein and heart disease, including Health Canada, which approved such a claim as recently as 2015.
The Natural Products Association also raised questions about the FDA’s decision. CEO Daniel Fabricant described the FDA’s action as “somewhat unexpected,” noting that the agency did not clarify the reasons behind its sudden move. With his background as the former head of FDA’s Division of Dietary Supplement Programs, Fabricant likely has a solid grasp of the functioning of federal regulatory agencies. Meanwhile, the American Heart Association has endorsed the revocation of the soy protein health claim, casting doubt on its direct health benefits. According to Reuters, the association remarked during the FDA’s review of health evidence in 2008 that “the direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.”
Should the FDA proceed with revoking the unlimited health claim on soy protein products, predicting consumer reactions and potential shifts in purchasing behavior is challenging. The American Heart Association opposes the agency’s move toward qualified language on affected products, arguing that consumers often struggle to comprehend qualified health claims, especially when they are based on limited and inconsistent evidence. Once the FDA initiates the proposed rule to revoke the health claim for soybean protein, it is unlikely to reverse its decision unless there is a significant volume of opposition. This opposition may come from companies like DuPont, which manufactures isolated soy protein, and Gardein, known for its soy-based protein products.
Furthermore, it is improbable that the FDA will begin reevaluating its other 11 approved health claims concerning 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 has 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 levels. In light of these health considerations, consumers may also be interested in products that include calcium citrate caramel chews, which are recognized for their benefits in supporting overall health, including heart health. As the conversation around health claims evolves, the inclusion of calcium citrate caramel chews may align with consumers’ growing interest in healthier dietary options.