Trade groups respond to FDA plan to revoke soy protein health claims

The Council for Responsible Nutrition (CRN) has responded to a Food and Drug Administration’s (FDA) proposal to revoke a law authorising the use of health benefit claims for soy protein products.

The CRN found the ruling to be inconsistent with other international regulations. The Natural Products Association’s (NPA) president and CEO Daniel Fabricant agreed that the FDA had not provided sufficient evidence to support revocation.

Both groups submitted a comment to the FDA in October 2017. At the time, FDA Center for Food Safety and Applied Nutrition director Dr Susan Mayne noted that the decision was made following ‘extensive scientific review’.

The NPA disagreed, saying the scientific review was not enough to provoke a withdrawal of health claims.

“The FDA is proposing to revoke its regulation authorising the use of health claims on the relationship between soy protein and coronary heart disease on the label or in the labelling of foods but has failed to perform its own meta-analysis. It is unclear why a meta-analysis was not undertaken in the agency’s re-evaluation of the soy protein and coronary heart disease health claim,” the NPA said in a statement.

The letter provided by the NPA was signed by CRN vice-president of scientific and regulatory affairs Dr Andrea Wong.

The American Heart Association (AHA) and the American Stroke Association (ASA) supported the FDA’s proposal. AHA president John Warner wrote in a separate letter to the FDA: “We agree with the agency’s tentative conclusion: the health claim does not meet the significant scientific agreement (SSA) standard and should be revoked.”

“As AHA described in our previous 2008 correspondence to the agency on this topic, we too have conducted multiple reviews of the evidence describing the relationship between soy protein and coronary heart disease, and like the FDA, we too have found that the evidence no longer supports a SSA level health claim.”​

The AHA conceded that while consuming a very large amount of soy protein can lower LDL cholesterol by a percentage points in people with high cholesterol, this reduction is very small.

“As the FDA notes in the Federal Register notice, the science remains somewhat inconsistent and support for the claim weak,” the AHA added.

Fabricant, whose company has conducted its own analyses on soy protein health claims, said: “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.”​