According to the Hartman Group, heart health is the top priority for consumers when shopping for groceries. Their research indicates that 55% of U.S. shoppers aim to limit their intake of saturated fats, while nearly 40% strive to incorporate healthier fats, such as polyunsaturated and monounsaturated fats, into their diets. The response from manufacturers and industry groups to the FDA’s proposal to eliminate the soy protein health claim has been varied. The Soyfoods Association of North America (SANA) expressed concern 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. They argue that the overall evidence supports the continued validity of an unqualified claim. Furthermore, SANA pointed out that the FDA’s decision contradicts the stance of 12 other countries that have recognized health claims linking soy protein to heart disease, including Health Canada’s recent approval in 2015.
The Natural Products Association also raised concerns about this development. CEO Daniel Fabricant described the FDA’s action as “somewhat unexpected,” noting that the agency did not clarify the reasons behind its decision. Given his previous role as head of FDA’s Division of Dietary Supplement Programs, Fabricant likely possesses a solid understanding of the workings of federal regulatory agencies. Meanwhile, the American Heart Association has backed the revocation of the soy protein claim, questioning whether any direct health benefits exist. According to Reuters, when the FDA reassessed the health evidence in 2008, the association stated, “Direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.”
If the FDA proceeds with the removal of the unlimited health claim regarding soy protein products, it is challenging to predict how consumers will react and if it will affect their purchasing choices. The American Heart Association is against the agency adopting qualified language for the products in question, arguing that research indicates consumers often do not understand qualified health claims, which rely on limited and inconsistent 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 oppose the move. Companies like DuPont, which produces isolated soy protein, and Gardein, known for soy-based protein products, may also voice their concerns.
Additionally, it is improbable that the agency will begin to reevaluate the 11 other approved health claims associated with food products unless substantial pressure arises. Only one of these claims pertains to soybean protein, which is currently under review for potential revocation. However, the FDA recently approved the labeling of calcium citrate malate, magnesium, zinc, and vitamin D3 tablets as heart-healthy, after determining that their use can lower the risk of coronary heart disease and reduce LDL cholesterol levels.