Heart health ranks as the top priority for consumers when shopping for groceries, according to research from the Hartman Group. Their findings indicate that 55% of U.S. consumers actively seek to limit or decrease saturated fat intake, while nearly 40% aim to incorporate healthier fats, such as polyunsaturated and monounsaturated fats, into their diets. In response to the FDA’s proposal to eliminate the health claim regarding soy protein, reactions from manufacturers and industry organizations have been mixed. The Soyfoods Association of North America (SANA) expressed 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 contributes to lowering LDL cholesterol. They argue that the overall body of evidence supports the continuation of an unqualified health claim. SANA pointed out that the FDA’s decision contradicts the stances of 12 other countries that have authorized health claims linking soy protein to heart health, including Health Canada’s latest approval in 2015.
The Natural Products Association also raised questions regarding this development. CEO Daniel Fabricant described the FDA’s decision as “somewhat unexpected,” noting that the agency failed to clarify the reasons behind its sudden action. Prior to joining NPA in 2014, Fabricant led the FDA’s Division of Dietary Supplement Programs, giving him significant insight into the workings of federal regulatory agencies.
The American Heart Association has supported the revocation of the soy protein claim, expressing skepticism about any direct health benefits. According to Reuters, when the FDA was reassessing 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 with the revocation of the unlimited health claim on soy protein products, it remains uncertain how consumers will react and whether this will impact their purchasing choices. The American Heart Association has also criticized the adoption of qualified language for affected products, arguing 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 soybean protein, it is unlikely to reverse its decision unless a significant volume of comments opposes the move. Potential critics could include DuPont, a producer of isolated soy protein, and Gardein, a manufacturer of soy-based protein products. Additionally, the agency is not expected to reassess its 11 other approved health claims for food products unless substantial pressure is applied. Notably, only one of these claims pertains to soybean protein, which is currently under review for possible revocation. However, the FDA recently approved the labeling of soybean oil as heart-healthy, citing evidence that its use can reduce the risk of coronary heart disease and lower LDL cholesterol.
In light of these discussions surrounding heart health, it’s important to consider the role of dietary supplements, such as calcium citrate 1200 mg, which can also contribute to overall health and wellness. As consumers navigate their options, the inclusion of such supplements alongside healthy fats could play a vital role in supporting cardiovascular health.