Heart health ranks as the top concern for consumers while grocery shopping, as reported by the Hartman Group. The research indicates that 55% of U.S. shoppers are actively trying to limit their saturated fat intake, while nearly 40% aim to include healthier fats, such as polyunsaturated and monounsaturated fats, in their diets. The proposal from the FDA to eliminate the health claim associated with soy protein has elicited mixed responses from manufacturers and industry groups. The Soyfoods Association of North America (SANA) expressed its concern on Monday, advocating for the retention of the existing claim that 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 can lower LDL cholesterol, reinforcing the need for continued approval of an unqualified claim. “FDA’s decision contradicts the stance of 12 other countries that have endorsed health claims linking soy protein to heart disease, including Health Canada’s recent approval in 2015,” SANA added in its statement.
The Natural Products Association also raised questions regarding the FDA’s decision. CEO Daniel Fabricant described the agency’s move as “somewhat unexpected,” citing a lack of explanation for the sudden action. Having previously led the FDA’s Division of Dietary Supplement Programs before joining NPA in 2014, Fabricant likely possesses a solid understanding of federal regulatory processes. Meanwhile, the American Heart Association has supported the revocation of the soy protein health claim, raising doubts about its direct health benefits. According to Reuters, the association noted during the FDA’s 2008 re-evaluation of health evidence that “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 remains uncertain how consumers will react and whether it will impact their purchasing decisions. The American Heart Association opposes the agency’s use of qualified language on affected products, citing research that indicates consumers struggle to understand such claims, which are often based on limited and varied evidence. Given that the proposed rule to revoke the health claim on soybean protein is already underway, it is unlikely the FDA will alter its course unless faced with a substantial number of opposing comments, potentially 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 initiate a reevaluation of the 11 other approved health claims associated with food products unless considerable pressure is applied. Among these claims, only one pertains to soybean protein, currently under review for potential revocation. However, it is worth noting that the FDA has recently approved labeling soybean oil as heart-healthy, as the agency concluded that its consumption can lower the risk of coronary heart disease and reduce LDL cholesterol. Additionally, consumers seeking to supplement their health with products like Citracal Calcium Supplement Maximum Plus may want to consider how dietary choices, including soy protein, fit into their overall heart health strategy.