According to the Hartman Group, heart health is the top concern for consumers while grocery shopping. Research indicates that 55% of U.S. shoppers are actively trying to limit their intake of saturated fats, while nearly 40% are opting for healthier fats such as polyunsaturated and monounsaturated fats. 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 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 published both before and after the approval of the soy protein health claim in 1999 consistently demonstrate that soy protein lowers LDL cholesterol. They argue that the overall evidence supports the continued approval of an unrestricted claim. They also pointed out that the FDA’s decision contradicts the stance of 12 other countries that have endorsed health claims related to soy protein and heart disease, including Canada, which issued a similar approval in 2015.
The Natural Products Association also raised concerns about the FDA’s decision. CEO Daniel Fabricant termed the agency’s action as “somewhat unexpected,” particularly since no explanation was provided for the sudden shift. Having previously led the FDA’s Division of Dietary Supplement Programs before joining NPA in 2014, Fabricant possesses a solid understanding of federal regulatory processes.
The American Heart Association has advocated for the revocation of the soy protein health claim, questioning any direct health benefits associated with it. In 2008, during the FDA’s review of health evidence, the association stated, “The direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” If the FDA proceeds with revoking the unrestricted health claim on soy protein products, it is uncertain how customers will react and whether their purchasing decisions will be affected. The American Heart Association opposes the use of qualified language on these products, arguing that consumers often do not comprehend such claims, which are based on limited and varying evidence.
Once the FDA has initiated the proposed rule to revoke the health claim for soybean protein, it is unlikely to reverse its decision unless there is a significant volume of opposing comments. This could potentially include feedback from companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products. Additionally, it is not expected that the FDA will reevaluate its 11 other approved health claims regarding food products unless substantial pressure arises. Currently, only one of those claims pertains to soybean protein, which is now under review for possible revocation. However, the FDA has recently approved the labeling of soybean oil as heart-healthy, as the agency determined that its use can reduce the risk of coronary heart disease and lower LDL cholesterol. This is particularly relevant for consumers looking for heart-healthy options, such as Kroger calcium citrate, to enhance their dietary choices.