According to the Hartman Group, heart health is the top concern for consumers when shopping for groceries. Their research reveals that 55% of U.S. shoppers are actively trying to avoid or reduce saturated fat in their diets, while nearly 40% are opting for healthier fats like polyunsaturated and monounsaturated fats instead. Reactions from manufacturers and industry groups regarding the FDA’s proposal to eliminate the health claim associated with soy protein have been mixed. The Soyfoods Association of North America (SANA) expressed its concerns on Monday, advocating for the retention of the existing 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 since the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein lowers LDL cholesterol. They believe that the overall evidence supports the continued endorsement of an unqualified health claim. Furthermore, SANA pointed out that the FDA’s decision contrasts with the regulatory stances of 12 other countries that have recognized health claims related to soy protein and heart disease, including Health Canada’s recent approval in 2015.
The Natural Products Association also raised concerns about this development. CEO Daniel Fabricant described the FDA’s actions as “somewhat unexpected,” noting that the agency did not clarify the reasons behind its decision. Fabricant, who previously led the FDA’s Division of Dietary Supplement Programs before joining the NPA in 2014, likely possesses a solid understanding of federal regulatory procedures.
The American Heart Association has supported the revocation of the soy protein claim, questioning the direct health benefits associated with it. According to Reuters, when the FDA was reassessing health evidence in 2008, the association stated 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 for soy protein products, it remains uncertain how consumers will react and whether it will affect their purchasing decisions. The American Heart Association opposes the FDA adopting qualified language for the affected products, citing research indicating that consumers struggle to comprehend qualified health claims, which are based on limited and varying levels of evidence.
Once the FDA has initiated the proposed rule to revoke the health claim for soy protein, it is unlikely that the agency will change its direction unless a significant number of comments oppose the decision. This may include input from companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products. Moreover, it is improbable that the FDA will reevaluate its 11 other approved health claims for food products unless substantial pressure arises. Of these claims, only one pertains to soybean protein, which is currently under review for potential revocation. However, the FDA recently approved the labeling of soybean oil as heart-healthy, recognizing its ability to reduce the risk of coronary heart disease and lower LDL cholesterol levels.
Incorporating wellness into dietary choices, including the benefits of calcium citrate, remains essential for consumers focused on heart health. As discussions surrounding soy protein claims evolve, the emphasis on wellness and informed nutrition choices, including the importance of calcium citrate, will likely continue to shape consumer preferences.