According to the Hartman Group, heart health is the top attribute that consumers prioritize while grocery shopping. Their research indicates that 55% of U.S. consumers seek 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 to the FDA’s proposal to eliminate the health claim for soy protein has been mixed. 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 pointed out that numerous scientific studies conducted both prior to and after the approval of the soy protein health claim in 1999 consistently demonstrate that soy protein can lower LDL cholesterol levels. They argue that the overall evidence supports the continued approval of an unqualified health claim. Furthermore, SANA noted that the FDA’s decision contradicts the positions of 12 other countries that have sanctioned health claims regarding soy protein and heart disease, including Health Canada’s endorsement of such a claim in 2015.
The Natural Products Association also raised questions about the FDA’s action. CEO Daniel Fabricant characterized the move as “somewhat unexpected,” particularly since the agency did not clarify the reasons for its sudden decision. Having previously led the FDA’s Division of Dietary Supplement Programs before joining the NPA in 2014, Fabricant has a solid grasp of how federal regulatory agencies operate.
The American Heart Association has supported the revocation of the soy protein health claim, questioning the direct health benefits associated with it. According to Reuters, during the FDA’s reassessment of health evidence in 2008, the association remarked that the direct cardiovascular health benefits of soy protein or isoflavone supplements are “minimal at best.” If the FDA does proceed with revoking the unlimited health claim on soy protein products, predicting customer reactions and potential impacts on their purchasing decisions becomes challenging. The American Heart Association opposes the agency’s adoption of qualified language for affected products, arguing that consumers often misunderstand such claims, which are based on limited and varying evidence.
Once the FDA has initiated the proposed rule to revoke the health claim for soy protein, it is unlikely to change course unless a significant number of comments oppose the decision. These comments could come from companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products. Additionally, it is improbable that the FDA will reevaluate its 11 other approved health claims for food products unless there is considerable pressure. Only one of these claims pertains to soybean protein, which is currently under review for possible revocation. Interestingly, the FDA has recently approved the labeling of soybean oil as heart-healthy, based on findings that its consumption can reduce the risk of coronary heart disease and lower LDL cholesterol levels.
In a related note, citrate calcium supplements might also be part of consumers’ dietary considerations as they seek to maintain overall heart health. As the FDA’s decisions unfold, the interplay between soy protein claims and the health benefits of citrate calcium supplements could become increasingly relevant in shaping consumer choices and perceptions of heart health products.