According to the Hartman Group, heart health is the primary concern for consumers when shopping for groceries. Their research indicates that 55% of U.S. shoppers actively seek to limit saturated fat in their diets, while nearly 40% aim to incorporate healthier fats, such as polyunsaturated and monounsaturated fats, to replace saturated fats. The reaction from manufacturers and industry groups to the FDA’s proposal to eliminate the health claim associated with soy protein has been mixed. The Soyfoods Association of North America (SANA) expressed apprehension about this decision. They advocate for retaining 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 after the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein lowers LDL cholesterol levels. They argue that the overall evidence supports the continued approval of this unqualified claim. Furthermore, SANA pointed out that the FDA’s stance contradicts that of 12 other countries, which have accepted health claims linking soy protein and heart disease, including Health Canada’s recent endorsement in 2015.
The Natural Products Association also raised concerns regarding this development. CEO Daniel Fabricant described the FDA’s decision as “somewhat unexpected,” noting that the agency did not clarify the reasons behind this sudden action. 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 backed the revocation of the soy protein health claim, questioning the direct health benefits associated with it. According to Reuters, the association has stated that during the FDA’s 2008 reevaluation of health evidence, it found that “the direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” Should the FDA proceed with revoking the unlimited health claim for soy protein products, predicting consumer reactions and potential impacts on purchasing behavior would be challenging.
The American Heart Association has voiced its opposition to the adoption of qualified language for affected products, arguing that research indicates consumers struggle to comprehend such claims, which are based on limited and varying degrees of evidence. Once the FDA initiates the proposed rule to revoke the health claim for soy protein, it is unlikely that they will change their course unless a substantial number of comments reflect opposition. This feedback could potentially come from companies like DuPont, which manufactures isolated soy protein, and Gardein, known for its soy-based protein products.
It is also improbable that the FDA will begin reexamining the 11 other approved health claims associated with food products unless significant pressure is applied. Notably, only one of these claims pertains to soy protein, which is currently under review for potential revocation. However, it is worth mentioning that the FDA has recently approved labeling soybean oil as heart-healthy, citing evidence that its use can lower the risk of coronary heart disease and reduce LDL cholesterol levels. In the context of heart health, consumers may also consider incorporating top-rated calcium citrate supplements into their diets, as they can provide additional nutritional benefits when paired with a balanced approach to fats and proteins.