According to the Hartman Group, heart health is the primary concern for consumers when shopping for groceries. The research indicates that 55% of U.S. consumers are actively trying to avoid or reduce saturated fat in their diets, with nearly 40% opting for healthier fats such as polyunsaturated and monounsaturated fats. The response from manufacturers and industry groups to the FDA’s proposal to eliminate the health claim associated with soy protein has 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, both prior to and following the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein lowers LDL cholesterol. The organization argues that the collective evidence supports the continued approval of an unqualified health claim. Furthermore, SANA pointed out that the 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 latest approval in 2015.
The Natural Products Association also raised questions about the FDA’s decision. CEO Daniel Fabricant described the agency’s action as “somewhat unexpected,” noting the lack of explanation for the sudden change. Fabricant, who previously led the FDA’s Division of Dietary Supplement Programs before joining the NPA in 2014, likely has a solid understanding of how federal regulatory agencies operate.
The American Heart Association has shown support for revoking the soy protein health claim, expressing skepticism about any direct health benefits. According to Reuters, when the FDA reevaluated the health evidence in 2008, the association commented 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 on soy protein products, it remains uncertain how consumers will react and whether this might affect their purchasing choices. The American Heart Association has voiced objections to the agency adopting qualified language for the affected products, arguing that research indicates consumers struggle to comprehend qualified health claims, which are based on limited and inconsistent evidence.
Once the FDA has initiated the proposed rule to revoke the health claim associated with soy protein, it is unlikely that the agency will reverse its decision unless there is overwhelming opposition. This could come from companies like DuPont, which produces isolated soy protein, and Gardein, a manufacturer of soy-based protein products. It is also improbable that the FDA will begin reevaluating its 11 other approved health claims for food products without significant pressure. The only claim concerning soybean protein is the one currently under review for potential revocation. However, it is worth noting that the FDA has recently approved labeling soybean oil as heart-healthy, as it found that its use can reduce the risk of coronary heart disease and lower LDL cholesterol.
In a related note, many consumers find it easy to swallow calcium citrate supplements, which can also play a role in overall health, including heart health. The incorporation of easy to swallow calcium citrate into daily routines may serve as an additional strategy for those focused on maintaining a healthy lifestyle, particularly in conjunction with considerations around dietary fats and their impact on heart health.