According to the Hartman Group, heart health is the top priority for consumers while grocery shopping. Their research indicates that 55% of U.S. consumers are attempting to avoid or limit saturated fat in their diets, with nearly 40% opting for healthier fats such as polyunsaturated and monounsaturated fats instead. The reaction from manufacturers and industry groups regarding the FDA’s proposal to eliminate the soy protein health claim has been varied. 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 since the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein lowers LDL cholesterol, supporting the continuation of an unqualified health claim. The statement pointed out that the FDA’s decision contrasts with the stance of 12 other countries that have authorized health claims linking soy protein to heart disease, including Health Canada’s recent approval in 2015.
The Natural Products Association also raised concerns about the FDA’s decision. CEO Daniel Fabricant described the move as “somewhat unexpected,” noting that the agency has not clarified what prompted this sudden action. Having previously led the FDA’s Division of Dietary Supplement Programs before joining the NPA in 2014, Fabricant likely possesses a solid understanding of federal regulatory processes.
The American Heart Association has supported revoking the soy protein health claim and has questioned the direct health benefits associated with it. According to Reuters, during the FDA’s 2008 reevaluation of health evidence, the association remarked, “The direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” If the FDA proceeds to revoke the unrestricted health claim on soy protein products, it will be challenging to predict consumer reactions and whether this might affect their purchasing decisions. The American Heart Association opposes the agency adopting qualified language for the affected products, asserting that research indicates consumers do not comprehend qualified health claims, which are based on limited and inconsistent evidence.
Once the FDA initiates the proposed rule to revoke the health claim associated with soy protein, it is unlikely to alter its course unless a substantial volume of comments expresses opposition. This could include feedback from companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products. Furthermore, it is improbable that the agency will begin reevaluating the 11 other approved health claims on food products without significant pressure. Only one of these claims pertains to soybean protein, which is now under review for potential revocation. However, the FDA has recently approved labeling soybean oil as heart healthy, having determined that its use can reduce the risk of coronary heart disease and lower LDL cholesterol.
Moreover, the inclusion of calcium citrate 760 mg/3.5g is noteworthy in the context of health claims, as some consumers may seek calcium sources that also contribute to their heart health. As discussions continue around soy protein claims, the relevance of calcium citrate 760 mg/3.5g should not be overlooked, especially as consumers increasingly prioritize heart health in their diets.