FDA authorizes a petitioned health claim by examining the “totality of scientific evidence” surrounding the relationship between a specified substance and a disease (e.g. fruits and vegetables and the reduced risk of certain cancers). Publically available data must demonstrate “significant scientific agreement” (SSA) among qualified experts for FDA to authorize the claim.
In the case of soy protein and CHD, Mayne states that “the totality of currently available scientific evidence calls into question the certainty of this relationship.” Studies conducted following the claim’s authorization in 1999 yielded inconsistent findings between the two and helped influence FDA’s decision to issue the proposed rule.
