The FDA is proposing to revoke its regulation authorizing health claims on the relationship between soy protein and coronary heart disease on the label or in the labeling of foods, but has failed to perform its own meta-analysis. In an officialcomment letterto the FDA, the association provided the details of its new analysis.
“The FDA has failed to offer any compelling evidence in its proposal to eliminate the soy heart health claim,” said Daniel Fabricant, Ph.D., president and CEO of NPA. “We are strongly urging the FDA to take into account the overwhelming amount of evidence included in NPA’s meta-analysis indicating a clear benefit in soy protein consumption and lower cholesterol. The FDA’s proposal to revoke its health claim for soy protein is not only bad public health policy but it will harm small business manufacturers, distributors, re-packers, and retailers who would be affected by this proposal. We are hopeful the FDA will take into account our new meta-analysis and conduct its own economic analysis on this proposal.”
Key details of the study include the following:
- The totality of evidence indicates a clear benefit in heart health as a result of the positive association between soy protein consumption and LDL cholesterol reduction.
- FDA should not eliminate the soy protein heart health claim or convert it to a qualified health claim.
- FDA does not have any material fact to compel industry to change labeling by eliminating the soy protein heart health claim or converting it to a qualified health claim.
- All material facts support keeping the heart health claim and lowering the threshold to 15 g soy protein.
- NPA encourages FDA to replace 25 g in the current heart health claim with 15 g as the new threshold in soy protein.
- A newer meta-analysis from 2011 supports this serving level to consistently lower LDL cholesterol and therefore benefit heart health.
- Soy protein lowers LDL cholesterol through an intrinsic or direct effect and an extrinsic effect by consumers replacing animal protein sources with plant-based soy protein sources.