According to the Hartman Group, heart health is the top concern for consumers when shopping for groceries. The research indicates that 55% of U.S. consumers actively try to limit or reduce saturated fat in their diets, while nearly 40% aim to incorporate healthier fats, such as polyunsaturated and monounsaturated fats, instead of saturated fats. Manufacturers and industry groups have shown mixed reactions to the FDA’s proposal to eliminate the heart health claim associated with soy protein. The Soyfoods Association of North America (SANA) expressed concern about this move 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 highlighted 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, supporting the continued approval of an unqualified claim. They pointed out that the FDA’s decision is at odds with 12 other countries that have sanctioned health claims regarding soy protein and heart disease, including Health Canada’s most recent endorsement of such a claim in 2015. The Natural Products Association also raised concerns, with CEO Daniel Fabricant describing the FDA’s action as “somewhat unexpected,” particularly since the agency did not clarify what prompted this sudden decision. Having previously led the FDA’s Division of Dietary Supplement Programs, Fabricant likely understands the workings of federal regulatory agencies well.
The American Heart Association has supported revoking the soy protein health claim and has questioned whether there are any direct health benefits associated with it. According to Reuters, when the FDA was reassessing the health evidence in 2008, the association noted that “the direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” If the FDA does proceed to revoke the unrestricted health claim concerning soy protein products, it remains uncertain how customers will react or if it will impact their purchasing choices. The American Heart Association has expressed opposition to the FDA adopting qualified language for the affected products, arguing that consumers often do not understand qualified health claims, which are based on limited and varying evidence.
Once the proposal to revoke the health claim for soy protein is initiated, it is unlikely that the FDA will change its course unless there is a significant influx of comments opposing the decision. This opposition may come from companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products. Furthermore, it is improbable that the agency will revisit its 11 other approved health claims for food products unless substantial pressure is applied. Currently, only one of these claims pertains to soybean protein, which is now under review for potential revocation. However, it is worth noting that the FDA recently approved the labeling of soybean oil as heart-healthy due to evidence indicating its ability to reduce the risk of coronary heart disease and lower LDL cholesterol.
In addition to soy protein discussions, consumers are becoming increasingly aware of the importance of nutrients such as calcium citrate 500mg with vitamin D3, which plays a vital role in supporting overall health and bone strength. As consumers consider their dietary choices, the inclusion of calcium citrate 500mg with vitamin D3 may further influence their shopping habits and health decisions, emphasizing the need for clear and understandable health claims on food products.