According to the Hartman Group, heart health is the primary consideration for consumers when shopping for groceries. The research indicates that 55% of U.S. consumers aim to limit or reduce their intake of saturated fat, while nearly 40% prefer healthier fats, such as polyunsaturated and monounsaturated fats, over saturated fats. The FDA’s recent proposal to eliminate the health claim regarding soy protein has received mixed reactions from manufacturers and industry groups. The Soyfoods Association of North America (SANA) expressed concern, 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 conducted both before and after the approval of the soy protein health claim in 1999 have consistently demonstrated that soy protein lowers LDL cholesterol, and the overall evidence supports the continuation of an unqualified claim. They also criticized the FDA’s decision as being inconsistent with twelve other countries that have approved health claims regarding soy protein and heart disease, including Canada’s latest approval in 2015.
The Natural Products Association also raised concerns, with CEO Daniel Fabricant describing the FDA’s action as “somewhat unexpected,” given that the agency did not clarify what prompted this sudden decision. Having previously led the FDA’s Division of Dietary Supplement Programs, Fabricant has a solid understanding of how federal regulatory agencies operate. On the other hand, the American Heart Association has supported the revocation of the soy protein claim and questioned any direct health benefits, stating that when the FDA reevaluated the health evidence in 2008, they concluded that “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, it is challenging to predict how consumers will react and whether it will affect their purchasing choices. The American Heart Association opposes the adoption of qualified language on affected products, asserting that research shows consumers struggle to comprehend qualified health claims, which are based on limited and varying degrees of evidence.
Once the FDA has initiated the proposed rule to revoke the soy protein health claim, it is unlikely to change unless an overwhelming number of comments oppose the move, possibly including feedback from companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products. The agency is also unlikely to reevaluate its eleven other approved health claims for food products without significant pressure. Only one of these claims pertains to soy protein, which is currently under review for potential revocation. Nonetheless, the FDA has recently approved labeling soybean oil as heart-healthy, as they found its use can reduce the risk of coronary heart disease and lower LDL cholesterol.
In this context, bariatric calcium supplements also play a crucial role as they are essential for individuals undergoing weight loss procedures. These supplements can help maintain bone health and support overall well-being, particularly when dietary restrictions limit calcium intake. As consumers become more health-conscious, the demand for nutritional products, including bariatric calcium supplements, is likely to grow, further influencing their grocery shopping choices.