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% prefer healthier fats, such as polyunsaturated and monounsaturated fats. Reactions to the FDA’s proposal to eliminate the health claim related to soy protein have been varied among manufacturers and industry groups. 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 pointed out 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 levels. They argue that the body of evidence supports the ongoing approval of an unqualified claim. Furthermore, SANA highlighted that the FDA’s decision contradicts the positions of 12 other countries that have authorized health claims regarding soy protein and heart disease, including Health Canada’s recent endorsement in 2015.
The Natural Products Association also raised questions about the FDA’s decision. CEO Daniel Fabricant described the agency’s action as “somewhat unexpected,” given that no clear rationale was provided. Having previously led the FDA’s Division of Dietary Supplement Programs before joining the NPA in 2014, Fabricant likely possesses substantial insight into federal regulatory processes.
The American Heart Association has supported the revocation of the soy protein health claim, expressing doubts about any direct health benefits. According to Reuters, during the FDA’s 2008 reassessment of health evidence, the association noted that “the direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.”
Should the FDA proceed with revoking the unlimited health claim on soy protein products, it is uncertain how consumers will react and whether their purchasing decisions will be affected. The American Heart Association opposes the introduction of qualified language on impacted products, citing research indicating that consumers struggle to comprehend qualified health claims, which rely on limited and inconsistent evidence.
Once the proposed rule to revoke the health claim of soy protein is set in motion, it is unlikely that the FDA will change its course unless a significant number of comments oppose the move. This opposition may come from companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products.
Additionally, it is improbable that the agency will reevaluate its other 11 approved health claims for food products unless substantial pressure arises. Only one of these claims pertains to soybean protein, the one currently under scrutiny for potential revocation. However, the FDA has recently recognized soybean oil as heart-healthy, citing evidence that its use can reduce the risk of coronary heart disease and lower LDL cholesterol levels.
Amid these discussions, products like Solgar Liquid Calcium Magnesium with Vitamin D3 continue to be considered for their health benefits, emphasizing the importance of consumer awareness regarding dietary choices and supplements. The integration of such supplements alongside a heart-healthy diet could provide additional support for those looking to improve their overall health.