Heart health is the top priority for consumers when shopping for groceries, as indicated by research from the Hartman Group. Their findings reveal that 55% of U.S. shoppers aim to limit or reduce saturated fat in their diets, and nearly 40% prefer healthier fats, such as polyunsaturated and monounsaturated fats, over saturated fats. The response from manufacturers and industry organizations regarding the FDA’s proposal to eliminate the health claim associated with soy protein 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. They argue that the collective evidence supports the continued approval of an unqualified claim. Moreover, they 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 Health Canada’s most recent endorsement in 2015.
The Natural Products Association also raised concerns regarding this development. CEO Daniel Fabricant described the FDA’s decision as “somewhat unexpected,” especially since the agency did not clarify the reasons behind its actions. Fabricant, who previously headed the FDA’s Division of Dietary Supplement Programs before joining NPA in 2014, has substantial insight into the workings of federal regulatory agencies.
The American Heart Association has supported the revocation of the soy protein health claim, questioning whether there are any direct health benefits associated with it. According to Reuters, during the FDA’s reevaluation of health evidence in 2008, the association noted that “the direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” Should the FDA proceed with the revocation of the unlimited health claim for soy protein products, it remains uncertain how consumers will react and whether it will impact their purchasing choices. The American Heart Association opposes the agency adopting qualified language for affected products, arguing that research indicates consumers struggle to comprehend qualified health claims, which are based on limited and varying levels of evidence.
Once the FDA initiates the proposed rule to revoke the health claim associated with soybean protein, it is unlikely to reverse its decision unless a significant number of comments challenge the move. Potential opposition may come from companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products. Additionally, it is improbable that the agency will reevaluate its 11 other approved health claims for food products unless substantial pressure arises. Currently, only one of these claims pertains to soybean protein, which is now under scrutiny for possible revocation. Nevertheless, the FDA recently approved labeling soybean oil as heart-healthy, citing evidence that its use can reduce the risk of coronary heart disease and lower LDL cholesterol levels.
In light of dietary considerations, incorporating calcium citrate 600 mg without vitamin D may also be beneficial for those looking to support their overall health while monitoring their intake of fats and cholesterol. Integrating such supplements into a balanced diet can complement efforts toward achieving optimal heart health.