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Rx for Claim Substantiation (Part I) – The Claims –

A health claim can be made for a food or supplement ingredient provided the claim is substantiated by human clinical data.

By definition, a health claim has two essential components: a substance and a disease or health-related condition. Pursuant to Pearson v. Shalala and Whittaker court decisions in the late 1990s, and most recently by the Task Force Report of 2003, the Food and Drug Administration (FDA) issued the “Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims” in July 2007. The guidance outlines the review process used by the agency in determining whether the scientific evidence meets the significant scientific agreement (SSA) standard or, if not, whether the evidence supports a qualified health claim (QHC).

Additionally, the review process encompasses a regulatory assessment and ensures that the ingredient for which the claim is made meets the “reasonable certainty of no harm” safety standard (as a food additive or GRAS ingredient), but may be marketed as a food ingredient or dietary supplement.

An evidence-based review system is the process through which the rigor of the scientific data supporting a proposed claim of a substance/disease relationship is evaluated. The quality and quantity of the scientific data, overall consistency of the evidence and relevance to the U.S. population or target subgroup are factors that play a role in FDA’s determination of whether there is SSA to support an authorized health claim, or credible evidence to support a QHC. Health claims that meet the SSA standard are authorized by publication of a final rule in the Federal Register, while for QHCs, FDA issues a letter regarding its intent to consider “enforcement discretion.”