According to the Hartman Group, heart health is the top attribute consumers prioritize while grocery shopping. Their research indicates that 55% of U.S. shoppers are actively trying to limit saturated fat in their diets, with nearly 40% opting for healthier fat alternatives such as polyunsaturated and monounsaturated fats. The reaction from manufacturers and industry groups to the FDA’s proposal to eliminate the health claim on soy protein has 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 noted in a statement that numerous scientific studies, both before and after the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein can lower LDL cholesterol, and the collective evidence supports the continued validity of an unqualified health claim. They also pointed out 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, which approved such a claim as recently as 2015.
The Natural Products Association also raised concerns about the FDA’s decision. CEO Daniel Fabricant described the FDA’s move as “somewhat unexpected,” questioning the lack of explanation for the agency’s sudden action. Having previously led the FDA’s Division of Dietary Supplement Programs before joining NPA in 2014, Fabricant likely possesses a solid understanding of how regulatory agencies operate.
The American Heart Association has supported the revocation of the soy protein health claim and has expressed skepticism regarding any direct health benefits. According to Reuters, when the FDA was reassessing the 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 revokes the health claim associated with soy protein products, it is challenging to predict how consumers will react and whether this will influence their purchasing behavior. The American Heart Association opposes the adoption of qualified language on the affected products, highlighting that research suggests consumers do not fully understand qualified health claims, which often rely on limited and varying evidence.
Once the FDA initiates the proposed rule to revoke the soy protein health claim, it is unlikely to reverse its decision unless there is a significant influx of comments opposing the move. This opposition could potentially come from companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products. Additionally, it seems improbable that the agency will begin reevaluating its 11 other approved health claims for food products unless substantial pressure is applied. Notably, only one of these claims pertains to soy protein, the one currently under review for possible revocation. However, it is worth mentioning that the FDA has recently endorsed the labeling of soybean oil as heart-healthy, citing its capacity to reduce the risk of coronary heart disease and lower LDL cholesterol.
In this context, consumers may also wonder about other dietary considerations, such as whether calcium citrate causes gas, as they navigate their health-related choices in the grocery aisles. Understanding how different products affect their health, including the potential digestive side effects of ingredients like calcium citrate, will continue to influence consumer decisions.