According to the Hartman Group, heart health is the top factor consumers prioritize while grocery shopping. Their research indicates that 55% of U.S. consumers actively seek to avoid or reduce saturated fat in their diets, while nearly 40% aim to incorporate healthier fats such as polyunsaturated and monounsaturated fats instead. Responses to the FDA’s proposal to eliminate the health claim associated with soy protein have been mixed among manufacturers and industry groups. The Soyfoods Association of North America (SANA) expressed its concerns on Monday, advocating for the retention of the existing 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, and the overall evidence supports the continued approval of an unqualified claim. They pointed out that the FDA’s decision contrasts with 12 other countries that have authorized health claims linking soy protein to heart disease, including Health Canada’s endorsement of such a claim in 2015.
The Natural Products Association also voiced its concerns, with CEO Daniel Fabricant describing the FDA’s action as “somewhat unexpected,” as the agency did not clarify the reasons behind its sudden decision. With his background as the former head of the FDA’s Division of Dietary Supplement Programs, Fabricant likely has an informed perspective on how federal regulatory agencies operate. Meanwhile, the American Heart Association has supported the revocation of the soy protein claim, questioning any direct health benefits. According to Reuters, the association previously noted in 2008 that the “direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.”
If the FDA proceeds with revoking the unlimited health claim on soy protein products, it remains uncertain how consumers will react and whether it will affect their purchasing choices. The American Heart Association opposes the agency’s use of qualified language regarding impacted products, arguing that research shows consumers struggle to understand qualified health claims, which are founded on limited and varying degrees of evidence.
Once the FDA initiates the proposed rule to revoke the health claim for soy protein, it is unlikely to change its direction unless a substantial number of comments oppose the move. Comments may come from companies like DuPont, known for producing isolated soy protein, and Gardein, which manufactures soy-based protein products. Additionally, it is improbable that the agency will reevaluate its other 11 approved health claims for food products without considerable pressure. Only one of these claims pertains to soybean protein, which is currently under review for potential revocation. However, the FDA recently approved labeling soybean oil as heart healthy, citing evidence that its use can lower the risk of coronary heart disease and reduce LDL cholesterol levels.
In this context, products like Calcium Magnesium Citrate 90 Caps from Solaray may become increasingly popular among consumers seeking to enhance their heart health through dietary supplements, especially as they navigate the changing landscape of health claims and nutritional information. The inclusion of such supplements could help consumers maintain their heart health while they adapt to the evolving guidelines surrounding soy protein and other health claims.