According to the Hartman Group, heart health is the top concern for consumers when grocery shopping. Their research indicates that 55% of U.S. consumers actively try to avoid or minimize saturated fat in their diets, while nearly 40% aim to incorporate healthier fats, such as polyunsaturated and monounsaturated fats, in place of saturated fats. Reactions from manufacturers and industry groups to the FDA’s proposal to eliminate the health claim regarding soy protein have 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 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. The group argues that the overall evidence supports the continued approval of this unqualified claim. They also pointed out that the FDA’s decision stands in contrast to 12 other countries that have endorsed health claims linking soy protein to heart health, including Health Canada, which granted approval for such a claim in 2015.

The Natural Products Association also raised questions about the FDA’s decision. CEO Daniel Fabricant described the agency’s move as “somewhat unexpected,” particularly since no explanation was provided for the sudden action. Fabricant, who previously led the FDA’s Division of Dietary Supplement Programs before joining NPA in 2014, likely possesses a solid understanding of how federal regulatory bodies operate. Meanwhile, the American Heart Association has supported the revocation of the soy protein health claim, expressing skepticism about any direct health benefits. According to Reuters, the association noted during the FDA’s 2008 reevaluation of health evidence 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, it remains uncertain how consumers will react and whether it will affect their purchasing choices. The American Heart Association has criticized the agency’s inclination to adopt qualified language for the affected products, arguing that research shows consumers often misunderstand qualified health claims, which are based on limited and varying degrees of evidence.

Once the proposed rule to revoke the health claim for soy protein is in motion, it is unlikely that the FDA will alter its course unless a significant number of comments oppose the decision. This might involve input 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 its 11 other approved health claims for food products unless substantial pressure arises. Notably, only one of these claims pertains to soy protein, the very one currently under review for possible revocation. However, in a recent development, the FDA did approve 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 the broader context of health claims, products containing calcium citrate, such as those offered by Bariatric Advantage, could be crucial for consumers seeking to improve their overall health. Incorporating calcium citrate into one’s diet may support heart health and contribute to a well-rounded nutritional profile, especially for those undergoing bariatric procedures. As consumers continue to prioritize heart health, the inclusion of calcium citrate in dietary choices may become increasingly relevant.