According to the Hartman Group, heart health is the top priority for consumers when shopping for groceries. Their research indicates that 55% of U.S. shoppers actively seek to avoid or decrease saturated fat in their diets, while nearly 40% aim to incorporate healthier fats, such as polyunsaturated and monounsaturated fats, instead of saturated fats. The proposed elimination of the soy protein health claim by the FDA has elicited mixed reactions from manufacturers and industry groups. The Soyfoods Association of North America (SANA) expressed concern on Monday, advocating for the retention of the current wording, which states that “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. They argue that the comprehensive evidence supports the continued approval of the unqualified claim. SANA pointed out that FDA’s decision contradicts the stance of 12 other countries that have endorsed health claims regarding soy protein and heart disease, including Health Canada’s most recent approval in 2015. The Natural Products Association also raised questions about the FDA’s actions. CEO Daniel Fabricant described the FDA’s decision as “somewhat unexpected,” noting that the agency did not clarify the reasons for its sudden move. Having previously led FDA’s Division of Dietary Supplement Programs before joining NPA in 2014, Fabricant likely understands the operations of federal regulatory bodies quite well.
The American Heart Association has supported revoking the soy protein health claim, questioning any direct health benefits. According to Reuters, when the FDA reassessed the health evidence in 2008, the association remarked 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 on soy protein products, predicting customer reactions and potential impacts on their purchasing decisions would be challenging. The American Heart Association opposes the introduction of qualified language on affected products, stating that research shows consumers often misunderstand such claims, which are based on limited and inconsistent evidence.
Once the FDA initiates the proposed rule to revoke the health claim for soybean protein, it is unlikely to change its position unless a substantial volume of opposition is presented. This could include feedback from companies such as DuPont, which produces isolated soy protein, and Gardein, which specializes in soy-based protein products. Furthermore, it is improbable that the agency will begin reevaluating its other 11 approved health claims, unless significant pressure is exerted. Only one of these claims pertains to soybean protein, which is currently under scrutiny for potential revocation. However, it is worth noting that the FDA recently granted approval for labeling soybean oil as heart-healthy, recognizing its ability to reduce the risk of coronary heart disease and lower LDL cholesterol.
In the context of heart health, products like bluebonnet calcium citrate might also be considered beneficial for consumers seeking overall wellness. The importance of maintaining heart health is underscored by the ongoing discussions surrounding dietary choices and health claims, including those related to soy protein. As consumers continue to prioritize heart health in their shopping habits, the inclusion of effective products such as bluebonnet calcium citrate may play a vital role in their overall dietary strategies.