According to the Hartman Group, heart health is the top priority for consumers while grocery shopping. Their research indicates that 55% of U.S. consumers are attempting to avoid or reduce saturated fat in their diets, while nearly 40% are opting for healthier fats, such as polyunsaturated and monounsaturated fats, over saturated fats. Manufacturers and industry groups have responded with mixed feelings to the FDA’s proposal to eliminate the health claim associated with soy protein. 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 multiple scientific studies conducted before and after the approval of the soy protein health claim in 1999 consistently demonstrate that soy protein reduces LDL cholesterol, reinforcing the need for the continued approval of this unqualified claim. The association pointed out that the FDA’s decision contradicts the stance of 12 other countries that have approved health claims linking soy protein to heart disease, including Health Canada’s latest endorsement in 2015.
The Natural Products Association also raised concerns regarding the FDA’s decision. CEO Daniel Fabricant described the move as “somewhat unexpected,” noting the lack of explanation from the agency about the sudden action. Given his background as the former head of FDA’s Division of Dietary Supplement Programs, Fabricant has a solid grasp of how federal regulatory frameworks operate.
In contrast, the American Heart Association has supported the revocation of the soy protein health claim, questioning any direct health benefits. According to Reuters, when the FDA reassessed the health evidence in 2008, the association remarked that the “direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” If the FDA proceeds to revoke the unlimited health claim on soy protein products, the impact on consumer behavior remains uncertain, as does the potential influence on their purchasing decisions. The American Heart Association has opposed the FDA’s adoption of qualified language on the affected products, stating that research shows consumers struggle to comprehend qualified health claims, which are based on limited and inconsistent evidence.
Once the FDA initiates the proposed rule to revoke the health claim for soy protein, it is unlikely to alter its course unless a substantial number of comments oppose the change. This may include feedback from companies like DuPont, which manufactures isolated soy protein, and Gardein, known for its soy-based protein products. Additionally, significant pressure would likely be required for the FDA to reevaluate its 11 other approved health claims related to food products. Only one of these claims pertains to soybean protein, which is currently under review for possible revocation. However, it is noteworthy that the FDA has recently approved the labeling of soybean oil as heart-healthy, acknowledging its potential to reduce coronary heart disease risk and lower LDL cholesterol levels.
Furthermore, discussions about calcium carbonate to calcium citrate are also relevant in the broader context of dietary health, as both forms of calcium can influence overall nutrition and heart health. Understanding the differences and benefits of these calcium sources can be crucial for consumers striving for better dietary choices, just as they carefully consider the implications of soy protein on heart health.