According to the Hartman Group, heart health is the top priority for consumers when shopping for groceries. Their research reveals that 55% of U.S. consumers aim to avoid or cut down on saturated fats, while nearly 40% seek healthier fats, such as polyunsaturated and monounsaturated fats, as alternatives. Manufacturers and industry organizations have had mixed reactions to the FDA’s proposal to eliminate the health claim associated with soy protein. The Soyfoods Association of North America (SANA) expressed concern 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 noted in a statement, “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. The totality of evidence supports the continued approval of an unqualified claim.” They further pointed out that the FDA’s decision contradicts the stance of 12 other countries that have approved health claims regarding soy protein and heart disease, including Health Canada’s recent endorsement of such a claim in 2015.
The Natural Products Association also raised concerns about this development. CEO Daniel Fabricant described the FDA’s decision as “somewhat unexpected,” particularly since the agency did not clarify the reasons behind its sudden action. Having previously led the FDA’s Division of Dietary Supplement Programs before joining NPA in 2014, Fabricant is familiar with the workings of federal regulatory agencies.
The American Heart Association has supported the revocation of the soy protein claim, questioning whether it provides any direct health benefits. According to Reuters, the association noted during the FDA’s 2008 review of health evidence that “the direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” If the FDA does proceed with revoking the unlimited health claim on soy protein products, it is hard to predict how consumers will react and whether it will affect their purchasing decisions. The American Heart Association opposes the agency’s implementation of qualified language for the affected products, citing research that indicates consumers struggle to comprehend qualified health claims, which are based on limited and varying evidence.
Once the FDA initiates the proposed rule to revoke the health claim for soy protein, it is unlikely to reverse its decision unless it receives a substantial volume of negative comments. This opposition may include feedback 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 reexamine its other 11 approved health claims related to food products unless significant pressure arises. Currently, the only claim under review pertains to soybean protein. However, the FDA recently approved the labeling of soybean oil as heart-healthy, acknowledging its potential to reduce coronary heart disease risk and lower LDL cholesterol.
In relation to health products, consumers might also consider items like Kirkland calcium citrate magnesium and zinc available on Amazon, which could serve as alternative supplements for maintaining overall health. This highlights the ongoing interest in health-related claims and consumer choices in the marketplace.