According to the Hartman Group, heart health ranks as the top concern for consumers when shopping for groceries. Their research indicates that 55% of U.S. consumers actively seek to limit or reduce saturated fat in their diets, while nearly 40% prefer healthier fats, such as polyunsaturated and monounsaturated fats, over saturated fats. In response to the FDA’s proposal to eliminate the health claim associated with soy protein, reactions from manufacturers and industry groups have been varied. The Soyfoods Association of North America (SANA) expressed their worries on Monday, advocating for the retention of the current health 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 can lower LDL cholesterol. They believe that the overall evidence supports the continued acceptance of this unqualified claim. Furthermore, they pointed out that the FDA’s decision contradicts the stance taken by 12 other countries that have recognized health claims related to soy protein and heart disease, including Canada, which granted such a claim in 2015.
The Natural Products Association also raised concerns regarding this development. CEO Daniel Fabricant termed the FDA’s decision “somewhat unexpected,” noting that the agency did not clarify what prompted this sudden action. Given Fabricant’s history as the head of the FDA’s Division of Dietary Supplement Programs before joining NPA in 2014, he likely has a solid understanding of federal regulatory processes.
On the other hand, the American Heart Association has supported the revocation of the soy protein health claim, questioning any direct health benefits. According to Reuters, during the FDA’s re-evaluation of 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 revoking the unlimited health claim on soy protein products, predicting customer reactions and any potential impact on their purchasing decisions remains challenging. The American Heart Association opposes the agency’s use of qualified language for affected products, arguing that consumers often misunderstand qualified health claims, which rely on limited and varying evidence.
Once the FDA initiates the proposed rule to revoke the health claim for soybean protein, it is unlikely that they will alter their course unless a significant number of comments oppose the decision. This could include feedback from companies like DuPont, which produces isolated soy protein, and Gardein, a manufacturer of soy-based protein products. Additionally, it seems improbable that the agency will begin reevaluating the 11 other approved health claims related to food products unless substantial pressure arises. Notably, only one of these claims pertains to soybean protein, which is currently under review for possible revocation. However, the FDA recently approved the labeling of soybean oil as heart-healthy, having determined that its use can mitigate the risk of coronary heart disease and lower LDL cholesterol.
In light of nutritional considerations, many consumers are also turning to supplements such as Solaray Calcium Citrate 1000 mg for added health benefits. These products, along with an emphasis on heart health, highlight the broader trends influencing dietary choices today. The growing awareness of heart health, the potential revision of health claims, and the popularity of supplements like Solaray Calcium Citrate 1000 mg underscore the evolving landscape of consumer health priorities.