September 20, 2016  -  The September 2016 Draft Guidance for Industry – Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling - represents USFDA’s first definitive guidance on the required Substantiation Standard for Structure / Function Claims for a Conventional Food. Industry observers, including myself, believe that FDA is sending a strong signal that it intends to apply this Substantiation Standard (consistent with the position of the FTC) to all Structure / Function Claims for Conventional Foods. (See discussion in FDA Law Blog September 19, 2016).

Thus, all marketers of Conventional Foods are advised to pay careful attention to this document. Furthermore, the new Draft Guidance: (1) narrows the scope of Structure / Function Claims for Conventional Foods; (2) aligns FDA thinking on Structure / Function Claims with that of the FTC; and (3) defines the Substantiation Standard as “competent and reliable scientific evidence.” It further clarifies that multiple studies (at least two) must achieve “adequate statistical power.”

With respect to Substantiation Standards, the Draft Guidance: (1) recommends the process for evaluating Scientific Evidence for a Structure/Function Claim; (2) discusses the relationship between the Product or Substance and the Claimed Effect; (3) defines Critical Elements and Quality Considerations for Intervention Studies; and (4) provides guidelines for evaluating the Strength of the “Totality of the Evidence” and Applying “competent and reliable evidence” Substantiation Standard.

We post the Draft Guidance below: