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 or reduce saturated fat in their diets, while nearly 40% focus on incorporating healthier fats, such as polyunsaturated and monounsaturated fats, instead of saturated fats. The response from manufacturers and industry organizations 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 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 following the approval of the soy protein health claim in 1999, consistently demonstrate that soy protein can lower LDL cholesterol levels. The association argues that the overall body of evidence supports the ongoing approval of this unqualified claim. Furthermore, SANA noted that the FDA’s decision diverges from the stance of 12 other countries that have sanctioned health claims related to soy protein and heart disease, including Health Canada, which approved such a claim as recently as 2015.
The Natural Products Association also raised concerns regarding this development. CEO Daniel Fabricant described the FDA’s actions as “somewhat unexpected,” as the agency did not clarify the reasons behind its sudden decision. Having previously led the FDA’s Division of Dietary Supplement Programs, Fabricant likely possesses a solid understanding of the federal regulatory landscape. In contrast, the American Heart Association has voiced support for revoking the soy protein health claim, questioning whether there are any direct health benefits associated with it. According to Reuters, the association noted during the FDA’s 2008 reevaluation of health evidence, “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, predicting consumer reactions and potential influences on their purchasing behaviors becomes challenging. The American Heart Association opposes the adoption of qualified language regarding affected products, asserting that research shows consumers do not comprehend qualified health claims, which are based on limited and varying evidence.
Once the FDA initiates the proposed rule to revoke the health claim related to soy protein, it is unlikely to reverse its decision unless a significant number of comments oppose the move. This could include feedback 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 on food products unless substantial pressure arises. Notably, only one of these claims pertains to soybean protein, which is currently under review for potential revocation. However, the FDA has recently approved labeling soybean oil as heart-healthy, as it found that its use can lower LDL cholesterol and reduce the risk of coronary heart disease.
In relation to dietary supplements, it’s interesting to note that some consumers might consider products such as Citracal Calcium Citrate, which can play a role in overall health, including heart health, when incorporated into a balanced diet. This highlights the importance of understanding various health claims and their implications for consumer choices.