According to the Hartman Group, heart health is the top concern for consumers while grocery shopping. Their research indicates that 55% of U.S. shoppers aim to avoid or reduce saturated fat in their diets, while nearly 40% seek to incorporate healthier fats, such as polyunsaturated and monounsaturated fats, in place of saturated fats. The proposal from the FDA to eliminate the heart health claim associated with soy protein has elicited mixed responses from manufacturers and industry groups.
The Soyfoods Association of North America (SANA) expressed concern over the FDA’s proposal, advocating for the retention of the current claim that 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 highlighted that numerous scientific studies, both prior to and after the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein lowers LDL cholesterol. They emphasized that the overall evidence supports the continued approval of an unqualified health claim. Additionally, SANA pointed out that the FDA’s decision contradicts the stance of 12 other countries, including Canada, which authorized health claims regarding soy protein and heart disease.
The Natural Products Association also raised concerns, with CEO Daniel Fabricant describing the FDA’s decision as “somewhat unexpected,” noting the lack of explanation for the agency’s sudden action. Having previously led the FDA’s Division of Dietary Supplement Programs before joining NPA in 2014, Fabricant is likely well-versed in the workings of federal regulatory agencies.
On the other hand, the American Heart Association has backed the revocation of the soy protein health claim and has questioned any direct health benefits associated with it. According to Reuters, the association stated that the “direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best” during the FDA’s reevaluation of health evidence in 2008.
Should the FDA proceed to revoke the unrestricted health claim on soy protein products, it is challenging to predict how consumers will react and whether it will affect their purchasing choices. The American Heart Association has also opposed the use of qualified language on products impacted by this change, arguing that consumers often misunderstand qualified health claims, which are based on limited and varying degrees of evidence.
Once the FDA has initiated the proposed rule to revoke the health claim for soybean protein, it is unlikely to reverse its decision unless there is a significant influx of negative comments. This could potentially include feedback from companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products. Furthermore, it is improbable that the agency will reevaluate its 11 other approved health claims for food products unless considerable pressure mounts. Only one of these claims pertains to soybean protein, which is now under review for possible revocation.
Interestingly, the FDA did recently approve labeling soybean oil as heart healthy, acknowledging its role in reducing the risk of coronary heart disease and lowering LDL cholesterol levels. Meanwhile, for those seeking to enhance their heart health through supplements, products like GNC Calcium Citrate Plus with Vitamin D3 could provide beneficial nutrients, supporting overall wellness. In summary, the ongoing discussions around soy protein health claims highlight the complexities of consumer health information and regulatory practices, with companies and health organizations closely monitoring the developments.