According to the Hartman Group, heart health remains the top priority for consumers when shopping for groceries. Research from the firm indicates that 55% of U.S. consumers actively seek to avoid or limit saturated fat in their diets, while nearly 40% aim to incorporate healthier fats, such as polyunsaturated and monounsaturated fats, instead of saturated fats. Responses from manufacturers and industry organizations regarding the FDA’s proposal to eliminate the health claim related to soy protein have been mixed. The Soyfoods Association of North America (SANA) expressed concern on Monday, 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 emphasized that numerous scientific studies published before and after the approval of the soy protein health claim in 1999 consistently demonstrate that soy protein lowers LDL cholesterol, thus supporting the continuation of an unqualified health claim. They noted that the FDA’s decision contradicts the stance of 12 other countries that have authorized health claims linking soy protein to heart health, including Health Canada’s recent approval in 2015.
The Natural Products Association also raised concerns about the FDA’s decision. CEO Daniel Fabricant described the agency’s move as “somewhat unexpected,” given that no explanation was provided for the sudden action. With his prior experience as the head of the FDA’s Division of Dietary Supplement Programs, Fabricant likely has insight into the workings of federal regulatory agencies.
The American Heart Association has supported the revocation of the soy protein health claim, questioning its direct health benefits, as reported by Reuters. During the FDA’s reevaluation of health evidence in 2008, the association stated that the “direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” If the FDA follows through with revoking the unlimited health claim on soy protein products, it is challenging to predict consumer reactions and whether it might affect their purchasing choices. The American Heart Association has also opposed the agency’s adoption of qualified language for affected products, arguing that research shows 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 associated with soy protein, it is unlikely that they will change their course unless a significant number of comments oppose the move. Potential dissent may come from companies like DuPont, which produces isolated soy protein, and Gardein, known for its soy-based protein products. Additionally, the agency is not expected to reevaluate the 11 other approved health claims related to food products unless substantial pressure arises. Of these claims, only one pertains to soybean protein, which is now under review for potential revocation. Nevertheless, the FDA recently approved labeling soybean oil as heart-healthy, as it has been found to reduce the risk of coronary heart disease and lower LDL cholesterol.
In the context of heart health, it’s also worth noting the importance of nutrients like calcium magnesium citrate with vitamin D3. These nutrients play a crucial role in overall cardiovascular health and should be considered alongside dietary choices. The integration of calcium magnesium citrate with vitamin D3 into a balanced diet can further support heart health, highlighting the multifaceted approach that consumers may take to make informed decisions. The emphasis on calcium magnesium citrate with vitamin D3 underscores the importance of understanding how various nutrients contribute to a heart-healthy lifestyle.