According to the Hartman Group, heart health is the primary attribute consumers seek while grocery shopping. Their research indicates that 55% of U.S. shoppers aim to limit or reduce saturated fat in their diets, while nearly 40% prefer healthier fats, such as polyunsaturated and monounsaturated fats, over saturated options. Responses from manufacturers and industry groups regarding the FDA’s proposal to eliminate the health claim for soy protein have been mixed. 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 prior to and following the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein can lower LDL cholesterol levels. They argue that the overall evidence supports the continued endorsement of this unqualified claim. Additionally, SANA pointed out that the FDA’s decision contrasts with the positions of 12 other countries that have approved health claims related to soy protein and heart disease, including a recent endorsement by Health Canada in 2015.
The Natural Products Association also raised concerns about the FDA’s decision. CEO Daniel Fabricant described the agency’s action as “somewhat unexpected,” highlighting the lack of explanation for the sudden change. Having previously led the FDA’s Division of Dietary Supplement Programs, Fabricant likely has insight into the workings of federal regulatory agencies. The American Heart Association has supported the revocation of the soy protein health claim, questioning the direct health benefits associated with it. According to Reuters, during the FDA’s 2008 reevaluation of health evidence, the association noted 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 on soy protein products, predicting consumer reactions and potential impacts on purchasing decisions remains challenging. The American Heart Association opposes the use of qualified language on the affected products, arguing that consumers often misunderstand qualified health claims, which are based on limited and varying evidence. Once the proposed rule to revoke the health claim for soybean protein is initiated, it is unlikely that the FDA will reverse its decision unless a significant number of comments oppose the move. This feedback could come from companies such as DuPont, known for producing isolated soy protein, and Gardein, which specializes in soy-based protein products.
Furthermore, it is unlikely that the FDA will reexamine its other 11 approved health claims for food products unless substantial pressure arises. Among these claims, only one pertains to soybean protein, and that is currently under review for possible revocation. However, the FDA has recently approved labeling soybean oil as heart-healthy, citing its potential to reduce coronary heart disease risk and lower LDL cholesterol levels.
In the context of heart health, consumers may also be interested in calcium citrate gummies as a supplement to support their dietary needs. As awareness of heart health continues to grow, products like calcium citrate gummies might become more popular among those looking for ways to enhance their overall wellness.