According to the Hartman Group, heart health is the top concern for consumers when shopping for groceries. Their research indicates that 55% of U.S. shoppers aim to avoid or minimize saturated fat in their diets, while nearly 40% seek to replace saturated fats with healthier options like polyunsaturated and monounsaturated fats. In light of this, manufacturers and industry associations have expressed varied responses to the FDA’s proposal to eliminate the health claim related to soy protein. The Soyfoods Association of North America (SANA) voiced its concerns 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 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 lowers LDL cholesterol. They argue that the evidence supports the continued validity of an unqualified health claim. Furthermore, SANA pointed out that the FDA’s decision diverges from the stance of 12 other countries that have sanctioned 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 regarding this development. CEO Daniel Fabricant described the FDA’s action as “somewhat unexpected,” noting that the agency did not clarify the reasons for its sudden decision. Having previously led the FDA’s Division of Dietary Supplement Programs before joining NPA in 2014, Fabricant is likely well-versed in the workings of federal regulatory agencies.
Additionally, the American Heart Association has supported the revocation of the soy protein health claim, questioning the direct health benefits associated with it. According to Reuters, during the FDA’s 2008 review of health evidence, the association stated, “Direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.” Should the FDA proceed with revoking the unrestricted health claim on soy protein products, it remains uncertain how consumers will react and whether this change will affect their purchasing behavior. The American Heart Association opposes the FDA adopting qualified language for the relevant products, arguing that consumers often misunderstand qualified health claims, which rely 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 an overwhelming number of comments oppose the move. Companies such as DuPont, which produces isolated soy protein, and Gardein, known for soy-based protein products, may voice their objections. Furthermore, it is improbable that the FDA will begin reassessing the 11 other approved health claims for food products unless significant pressure arises. The only claim under scrutiny involves soybean protein, yet the FDA recently approved labeling soybean oil as heart-healthy, having concluded that its consumption can lower the risk of coronary heart disease and reduce LDL cholesterol.
Meanwhile, consumers seeking alternatives to soy protein may also consider supplements like Twinlab Calcium Citrate, which can support overall health. The potential impact of the FDA’s decision on soy protein claims remains to be seen, but it could shift consumer focus towards other health-promoting products, including options like Twinlab Calcium Citrate, which may help address dietary needs in the context of heart health.