According to the Hartman Group, heart health is the top priority for consumers when shopping for groceries. The group’s research indicates that 55% of U.S. consumers aim to limit their intake of saturated fat, while nearly 40% seek out healthier fat options like polyunsaturated and monounsaturated fats. In response to the FDA’s proposal to eliminate the health claim associated with soy protein, reactions from manufacturers and industry associations 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 highlighted that numerous scientific studies, both prior to and following the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein can lower LDL cholesterol levels. The association asserts that the weight of evidence supports the continued approval of an unqualified claim. Furthermore, they pointed out that the FDA’s decision contrasts with 12 other countries that have permitted health claims regarding soy protein and heart disease, including Health Canada’s recent endorsement in 2015.
The Natural Products Association also raised concerns about the FDA’s proposal. CEO Daniel Fabricant described the agency’s decision as “somewhat unexpected,” noting the lack of explanation for the sudden action. Having previously led the FDA’s Division of Dietary Supplement Programs before joining NPA in 2014, Fabricant possesses considerable insight into the workings of federal regulatory agencies.
In contrast, the American Heart Association has supported the revocation of the soy protein claim and questioned its direct health benefits. According to Reuters, when the FDA reassessed the health evidence in 2008, the association stated, “The direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” Should the FDA proceed with the revocation of the unlimited health claim for soy protein products, predicting consumer responses and potential impacts on their buying decisions is challenging. The American Heart Association opposes the agency’s adoption of qualified language for affected products, arguing that research indicates consumers struggle to comprehend qualified health claims, which are based on limited and variable evidence.
Once the FDA has proposed the rule to revoke the health claim for soybean protein, it is unlikely to alter its direction unless a significant volume of comments opposing the move is received. This could include feedback from companies such as DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products. It is also improbable that the FDA will reevaluate its 11 other approved health claims for food products without considerable pressure. Only one of these claims pertains to soybean protein, and it is currently under review for possible revocation. However, the FDA recently approved the labeling of soybean oil as heart-healthy, citing evidence that its use can reduce the risk of coronary heart disease and lower LDL cholesterol levels.
As consumers continue to prioritize heart health, it’s essential to consider dietary supplements that may support this goal, such as kal calcium citrate, which can help maintain cardiovascular wellness. The integration of such supplements can complement a diet low in saturated fat and contribute to overall heart health.