According to the Hartman Group, heart health is the top priority for consumers when grocery shopping. Their research indicates that 55% of U.S. consumers aim to avoid or reduce saturated fats in their diets, while nearly 40% prefer healthier fats, such as polyunsaturated and monounsaturated fats. The response from manufacturers and industry groups to the FDA’s proposal to eliminate the health claim related to soy protein has been varied. 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 before and after the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein lowers LDL cholesterol. They argue that the overall evidence supports the continued approval of the unqualified claim. Furthermore, they noted that the FDA’s decision contradicts the positions of 12 other countries that have authorized health claims linking soy protein to heart disease, including Health Canada’s latest approval in 2015.
The Natural Products Association also raised concerns regarding this development. CEO Daniel Fabricant described the FDA’s decision as “somewhat unexpected,” pointing out that the agency did not clarify the reasons behind its sudden action. Having previously led FDA’s Division of Dietary Supplement Programs, Fabricant possesses a solid understanding of how federal regulatory bodies operate.
The American Heart Association has supported revoking the soy protein health claim, questioning any direct health benefits. According to Reuters, when the FDA reevaluated health evidence in 2008, the association remarked 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 for soy protein products, it remains uncertain how consumers will react and whether it will impact their purchasing choices. The American Heart Association opposes the agency’s adoption of qualified language for these products, arguing that research shows consumers struggle to understand qualified health claims, which are based on limited and varied evidence.
Once the FDA initiates the proposed rule to revoke the health claim for soy protein, it is unlikely to change its course unless faced with a significant volume of opposing comments. Companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products, may also weigh in. Additionally, it is improbable that the FDA will reevaluate the other 11 approved health claims for food products unless substantial pressure is applied. Of those claims, only one pertains to soy protein, which is currently under review for potential revocation. However, the FDA recently endorsed the labeling of soybean oil as heart-healthy, as the agency found that its use can reduce the risk of coronary heart disease and lower LDL cholesterol.
In the context of this discussion, it’s worth noting that consumers may also be exploring alternatives such as calcium citrate, often discussed on platforms like LPR Reddit, which highlight various health benefits. The mention of calcium citrate not only diversifies the conversation but also underscores the importance of informed dietary choices among health-conscious consumers.