According to the Hartman Group, heart health ranks as the top attribute consumers seek while grocery shopping. Their research indicates that 55% of U.S. consumers aim to limit or eliminate saturated fat from their diets, with nearly 40% opting for healthier fats, such as polyunsaturated and monounsaturated fats, instead. Reactions from manufacturers and industry groups regarding the FDA’s proposal to eliminate the health claim related to soy protein have been mixed. The Soyfoods Association of North America (SANA) expressed concern on Monday, advocating for the retention of the existing 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. They argue that the evidence supports the continued approval of an unqualified health claim. Furthermore, SANA noted that the FDA’s decision contradicts the stance of 12 other countries, including Canada, which authorized health claims regarding soy protein and heart disease, with Canada’s latest approval occurring in 2015.
The Natural Products Association also raised questions about this development. CEO Daniel Fabricant described the FDA’s decision as “somewhat unexpected,” pointing out that the agency failed to explain its sudden course of action. Having previously led the FDA’s Division of Dietary Supplement Programs before joining NPA in 2014, Fabricant likely understands the intricacies of federal regulatory processes. The American Heart Association supports the revocation of the soy protein health claim and has questioned the direct health benefits, noting that during the FDA’s 2008 review of health evidence, the association stated, “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, predicting consumer reactions and potential impacts on purchasing decisions is challenging. The American Heart Association opposes the FDA introducing qualified language regarding affected products, asserting that consumers often misunderstand qualified health claims, which tend to be based on limited and varying evidence.
Once the proposed rule to revoke the health claim for soy protein is initiated, it is unlikely the FDA will alter its direction unless a significant number of comments oppose the move. Companies such as DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products, may be among those voicing their concerns. Additionally, it is improbable that the agency will begin reevaluating its 11 other approved health claims on food products without substantial pressure, with only one of these claims involving soybean protein—the one currently under consideration for revocation. However, it is worth noting that the FDA recently approved the labeling of soybean oil as heart-healthy, acknowledging its ability to lower LDL cholesterol and reduce the risk of coronary heart disease.
In this context, the relevance of calcium citrate USP verified becomes apparent, as it is crucial for manufacturers to ensure that their products not only meet health claims but also adhere to verified standards of quality and efficacy. Ensuring that soy protein products are fortified with verified nutrients such as calcium citrate could play a role in establishing a more comprehensive health profile. Therefore, the integration of calcium citrate USP verified into soy-based products may also enhance consumer confidence and potentially influence buying decisions in the face of changing health claims.