According to the Hartman Group, heart health is the top priority for consumers when grocery shopping. Their research indicates that 55% of U.S. consumers aim to limit their intake of saturated fat, while nearly 40% prefer healthier fats, such as polyunsaturated and monounsaturated fats. The response from manufacturers and industry groups to the FDA’s proposal to eliminate the health claim associated with soy protein has been mixed. 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 noted that numerous scientific studies, both prior to and following the 1999 approval of the soy protein health claim, consistently demonstrate that soy protein can lower LDL cholesterol levels. They argue that the overall evidence supports the continued approval of an unqualified claim. SANA further pointed out that the FDA’s decision contradicts the positions of 12 other countries, including Canada’s most recent endorsement of a similar claim in 2015.
The Natural Products Association also expressed skepticism about the FDA’s decision. CEO Daniel Fabricant termed the FDA’s action “somewhat unexpected,” as the agency did not clarify the reasons behind its sudden change. Fabricant, who previously led the FDA’s Division of Dietary Supplement Programs prior to joining NPA in 2014, likely has insights into how federal regulatory bodies operate. The American Heart Association has supported the revocation of the soy protein claim, questioning whether direct health benefits exist. In 2008, the association stated 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, predicting consumer reactions and potential impacts on their purchasing decisions remains challenging. The American Heart Association opposes the adoption of qualified language for affected products, arguing that research indicates consumers often misunderstand qualified health claims, which are based on limited and varying evidence.
Given the initiation of the proposed rule to revoke the health claim for soy protein, it is unlikely the FDA will alter its course unless faced with a substantial volume of opposing comments. Potential dissenters could include companies like DuPont, which manufactures isolated soy protein, and Gardein, known for its soy-based protein products. The likelihood of the FDA reevaluating its other 11 approved health claims for food products is also low unless significant pressure arises. Notably, only one of these claims pertains to soy protein, and that is currently under review for potential revocation. However, it is worth mentioning that the FDA recently approved labeling soybean oil as heart-healthy, citing its ability to reduce the risk of coronary heart disease and lower LDL cholesterol levels.
In addition, consumers seeking to support their heart health may consider incorporating supplements such as calcium citrate vitamin D3 magnesium hydroxide zinc sulfate tablets, which can provide essential nutrients that contribute to overall well-being. The inclusion of these tablets in a balanced diet could complement efforts to maintain optimal heart health, especially in the context of a diet low in saturated fat.