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 aim to avoid or decrease saturated fat in their diets, while nearly 40% seek to incorporate healthier fats, such as polyunsaturated and monounsaturated fats. The reaction from manufacturers and industry groups to the FDA’s proposal to eliminate this health claim has 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 lowers LDL cholesterol, supporting the ongoing validity of an unqualified health claim. They also pointed out that the FDA’s decision contradicts those made by 12 other countries that have authorized health claims regarding soy protein and heart disease, including Health Canada’s recent approval in 2015.
The Natural Products Association also voiced 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 its sudden action. Having previously led the FDA’s Division of Dietary Supplement Programs, Fabricant 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, questioning its direct health benefits. According to Reuters, when the FDA was reviewing 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 proceeds to withdraw the unlimited health claim for soy protein products, it is challenging to foresee how consumers will react and whether it will impact their purchasing decisions. The American Heart Association opposes the agency’s adoption of qualified language for affected products, arguing that consumers often do not understand qualified health claims, which are based on limited and varying evidence. Once the FDA initiates the proposed rule to revoke the health claim for soybean protein, it is unlikely to reverse course unless faced with a substantial volume of negative feedback. This could include responses from companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products.
Furthermore, it is improbable that the agency will reevaluate the 11 approved health claims associated with food products unless significant pressure is applied. Only one of these claims pertains to soybean protein, the very one now under consideration for revocation. However, the FDA has recently approved the labeling of soybean oil as heart-healthy, based on findings that its use can reduce the risk of coronary heart disease and lower LDL cholesterol. Meanwhile, consumers looking for supplements that support their heart health, such as Walgreens calcium citrate petites, may find themselves navigating these changes as they make informed decisions about their diets.