According to the Hartman Group, heart health is the top priority for consumers when they shop for groceries. Their research indicates that 55% of U.S. consumers aim to avoid or decrease saturated fat in their diets, while nearly 40% prefer healthier fats, such as polyunsaturated and monounsaturated fats, over saturated fats. Manufacturers and industry organizations reacted differently 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 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, both prior to and following the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein can lower LDL cholesterol levels, reinforcing the need for the claim to remain unqualified. The organization highlighted that the FDA’s decision contradicts the stance of 12 other countries that have authorized health claims regarding soy protein and heart disease, including Health Canada, which approved such a claim in 2015. The Natural Products Association also raised concerns, with CEO Daniel Fabricant describing the FDA’s action as “somewhat unexpected,” particularly since the agency did not clarify the reasons behind its sudden decision. Having previously led the FDA’s Division of Dietary Supplement Programs, Fabricant likely has a good grasp of how federal regulatory agencies operate.
The American Heart Association has backed the revocation of the soy protein health claim, questioning its direct health benefits. According to a Reuters report, when the FDA reviewed health evidence in 2008, the association pointed out that “the direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” Should the FDA proceed with revoking the unrestricted health claim on soy protein products, predicting consumer reactions and potential effects on buying behaviors becomes challenging. The American Heart Association opposes the adoption of qualified language on affected products, arguing that research indicates consumers struggle to understand qualified health claims, which are often based on limited and inconsistent evidence.
Once the FDA initiates the proposed rule to revoke the health claim for soy protein, it’s unlikely that the agency will reverse its decision unless there is a substantial outcry against it. Companies such as DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products, may contribute to this opposition. Additionally, the agency is not expected to reevaluate the 11 other approved health claims related to food products unless significant pressure is applied. Only one of these claims pertains to soy protein, and that is the subject of the current review for potential revocation. However, it is worth noting that the FDA has recently approved soybean oil labeling as heart-healthy, concluding that its use can reduce the risk of coronary heart disease and lower LDL cholesterol.
In this context, it is essential to consider products like Caltrate Petites, which may offer additional health benefits. With a focus on heart health, consumers might find that incorporating Caltrate Petites into their diets helps support overall wellness, particularly in conjunction with healthy fats and proteins. As the conversation around health claims continues to evolve, the potential impact on consumer choices remains significant.