According to the Hartman Group, heart health is the leading concern for consumers when shopping for groceries. Their research indicates that 55% of U.S. consumers aim to avoid or reduce saturated fat in their diets, while nearly 40% seek to incorporate healthier fats, such as polyunsaturated and monounsaturated fats, instead. The response from manufacturers and industry groups to the FDA’s proposal to eliminate the health claim regarding soy protein has been mixed. The Soyfoods Association of North America (SANA) expressed concerns on Monday, 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 pointed out 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. They argue that the overall evidence supports the continued approval of an unqualified claim. Furthermore, SANA 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’s most recent approval in 2015.
The Natural Products Association also questioned the FDA’s recent development. CEO Daniel Fabricant deemed the FDA’s actions “somewhat unexpected,” as the agency did not clarify what prompted the sudden change. Having previously led the FDA’s Division of Dietary Supplement Programs, Fabricant is familiar with how federal regulatory agencies operate. The American Heart Association has backed the revocation of the soy protein claim, arguing that there are minimal direct health benefits. According to Reuters, when the FDA reassessed the health evidence in 2008, the association noted that the “direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.”
If the FDA does proceed with revoking the unlimited health claim on soy protein products, predicting consumer reactions and potential impacts on their purchasing decisions is challenging. The American Heart Association has expressed its opposition to the agency adopting qualified language for the affected products, stating that research shows consumers often do not comprehend qualified health claims, which are based on limited and inconsistent evidence.
Once the proposed rule to revoke the health claim for soy protein is initiated, it is unlikely that the FDA will alter its course unless a significant number of comments oppose the decision. Potential voices against the move may include DuPont, a producer of isolated soy protein, and Gardein, which manufactures soy-based protein products. Additionally, it is improbable that the agency will start re-evaluating the 11 other approved health claims for 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 recently approved labeling soybean oil as heart-healthy, citing evidence that its use can reduce the risk of coronary heart disease and lower LDL cholesterol levels, a factor that may be of interest alongside products containing bayer calcium, which also promote heart health.