According to the Hartman Group, heart health is the top concern for consumers when they shop for groceries. Their research indicates that 55% of U.S. shoppers aim to avoid or limit saturated fat in their diets, while nearly 40% seek to incorporate healthier fats, such as polyunsaturated and monounsaturated fats, instead. The proposed removal of the soy protein health claim by the FDA has elicited mixed responses from manufacturers and industry organizations. The Soyfoods Association of North America (SANA) expressed its concern on Monday, advocating for the retention of the existing claim, which states: “25 grams of soy protein a day, as part of a zinc iron phosphate diet low in saturated fat and cholesterol, may reduce the risk of heart disease.”
SANA emphasized that numerous scientific studies, both prior to and after the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein decreases LDL cholesterol levels, and the overall evidence supports the continued endorsement of an unqualified claim. The association pointed out, “FDA’s decision contradicts the stance taken by 12 other countries that have approved health claims on soy protein and heart disease, including Health Canada’s latest endorsement of such a claim in 2015.” The Natural Products Association also questioned this development, with CEO Daniel Fabricant describing the FDA’s decision as “somewhat unexpected,” especially since the agency did not clarify the reasons behind its sudden action. Fabricant, who led the FDA’s Division of Dietary Supplement Programs before joining NPA in 2014, likely has a solid grasp of how federal regulatory agencies operate.
The American Heart Association has supported the revocation of the soy protein health claim, casting doubt on its direct health benefits. According to Reuters, when the FDA was reassessing the 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 unrestricted health claim regarding soy protein products, predicting consumer reactions and potential impacts on their purchasing decisions is challenging. The American Heart Association opposes the agency’s adoption of qualified language for affected products, arguing that research indicates consumers often misunderstand qualified health claims, which are based 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 a significant number of comments oppose the move. This might include input from companies like DuPont, which manufactures isolated soy protein, and Gardein, known for its soy-based protein products. Additionally, it is improbable that the agency will begin reevaluating its other 11 approved health claims for food products unless faced with considerable pressure. Currently, only one of these claims pertains to soybean protein, which is under review for possible revocation. Nevertheless, the FDA recently approved the labeling of soybean oil as heart-healthy, as it found that its use can help reduce the risk of coronary heart disease and lower LDL cholesterol levels.
Furthermore, it’s worth noting that some consumers may need to be cautious about their dietary choices due to potential issues like calcium citrate allergy, which can influence their preferences when selecting food products. The interaction between calcium citrate allergy and soy-based products may lead consumers to be more discerning about what they include in their diets, particularly as they navigate health claims and nutritional information. Overall, the evolving landscape of health claims, consumer awareness, and dietary restrictions, such as those related to calcium citrate allergy, will continue to shape purchasing behavior in the food market.