According to the Hartman Group, heart health is the primary concern that consumers have when shopping for groceries. Their research indicates that 55% of U.S. consumers aim to limit or reduce saturated fat in their diets, while nearly 40% opt for healthier fats, such as polyunsaturated and monounsaturated fats, over saturated fats. The reaction from manufacturers and industry groups regarding the FDA’s proposal to eliminate the health claim related to 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, 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 emphasized that the totality of evidence supports the continued approval of an unqualified health claim. Furthermore, they noted 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 recent approval in 2015.
The Natural Products Association also raised questions about the FDA’s decision. CEO Daniel Fabricant described the move as “somewhat unexpected,” noting that the agency did not clarify the reasons behind its sudden action. With his background as the former head of the FDA’s Division of Dietary Supplement Programs, Fabricant likely has a solid understanding of how federal regulatory agencies operate.
The American Heart Association has supported the revocation of the soy protein health claim and has questioned the direct health benefits associated with it, according to reports from Reuters. They 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.” If the FDA proceeds with revoking the unlimited health claim on soy protein products, it is difficult to predict how consumers will react and whether it will affect their purchasing choices. The American Heart Association has expressed concerns about the FDA adopting qualified language for affected products, arguing that research shows consumers often do not understand qualified health claims, which are based on limited and varying degrees of evidence.
Once the FDA sets the proposed rule to revoke the health claim for soybean protein in motion, it is unlikely to change its course unless a significant number of comments oppose the decision, potentially including 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 reevaluate the 11 other approved health claims associated with food products unless substantial pressure is applied. Notably, the only other claim related to soybean protein is the one currently under review for possible revocation. However, the FDA has recently approved labeling soybean oil as heart healthy, citing its ability to reduce the risk of coronary heart disease and lower LDL cholesterol levels.
In discussions about dietary health, it’s also essential to consider the roles of levothyroxine and calcium citrate. These supplements can influence heart health and overall well-being, particularly for those who may need to manage cholesterol levels or support thyroid function. Integrating knowledge of how these supplements interact with dietary choices, like soy protein, can help consumers make more informed decisions regarding their heart health.