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FDA Proposes Unprecedented Revocation of Soy Health Claim

Nov 01, 2017

The Food and Drug Administration this week proposed a rule to revoke a health claim for soy protein and the risk of coronary heart disease. This is the first time that the agency has proposed to revoke a health claim that was originally put into place under its "significant scientific agreement" criteria. In the announcement, FDA said a volume of studies have presented inconsistent findings on the relationship between soy protein and heart disease since it adopted the health claim in 1999.

FDA authorizes the use of 12 significant scientific agreement health claims based on strong scientific evidence, connecting consumption with health results, for companies to use on food labels. One example of a health claim available for use on eligible dairy products is a label statement that connects the intake of calcium and vitamin D to lower risk of osteoporosis. Other health claims that FDA allows the food industry to make include linking diets low in fat and high in fruits and vegetables to reduced cancer risk, as well associating diets low in sodium with a low prevalence of hypertension. The list of the 12 claims is available here.

The FDA proposal, if finalized, would move soy protein and heart health claims from this authorized list of health claims to its qualified health claim list, which means companies wanting to make the claim would have to use language that demonstrates there is limited scientific evidence for it.

 “While this proposed revocation could indicate that FDA is reconsidering the scientific evidence supporting various health claims, FDA has asked for updated data only on the health claim regarding soy protein and heart disease,” said Cary Frye, IDFA senior vice president of regulatory affairs. “These significant scientific agreement claims are based on a longstanding consensus in the scientific community, so we don’t expect to see any other immediate changes from the agency.”

IDFA is engaging with its Nutrition Working Group to consider submitting comments to FDA on the proposal.

For more information, see FDA’s “Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims” or contact Frye at

Members may also visit the IDFA bookstore to purchase IDFA’s labeling manuals, which offer comprehensive advice to dairy companies that want to make claims on their products.

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