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Guidance for Industry: Evidence‐Based Review System for the Scientific Evaluation of Health Claims

FDA (Jan. 2009)

… Significant scientific agreement refers to the extent of agreement among qualified experts in the field. On the continuum of scientific evidence that extends from very limited to inconclusive evidence, SSA lies closer to consensus. FDA’s determination of SSA represents the agency’s best judgment as to whether qualified experts would likely agree that the scientific evidence supports the substance/disease relationship that is the subject of a proposed health claim. The SSA standard is intended to be a strong standard that provides a high level of confidence in the validity of the substance/disease relationship. SSA means that the validity of the relationship is not likely to be reversed by new and evolving science, although the exact nature of the relationship may need to be refined. SSA does not require a consensus based on unanimous and incontrovertible scientific opinion. SSA occurs well after the stage of emerging science, where data and information permit an inference, but before the point of unanimous agreement within the relevant scientific community that the inference is valid.

For qualified experts to reach an informed opinion regarding the validity of a claim, the data and information that pertain to the claim must be available to the relevant scientific community. A finding of SSA then derives from the conclusion that there is a sufficient body of relevant, publicly available scientific evidence that shows consistency across different studies and among different researchers. The usual mechanism to show that the evidence is available to qualified experts is that the data and information are published in peer‐reviewed scientific journals. The value of an expert’s opinion will be limited if he or she did not have access to all the evidence.

In determining whether there is significant scientific agreement, FDA takes into account the viewpoints of qualified experts outside the agency, if evaluations by such experts have been conducted and are publicly available. For example, FDA intends to take into account:

 documentation of the opinion of an “expert panel” that is specifically convened for this purpose by a credible, independent body;

 the opinion or recommendation of a federal government scientific body such as the National Institutes of Health (NIH) or the Centers for Disease Control and Prevention (CDC), or the National Academics of Sciences (NAS);

 the opinion of an independent, expert body such as the Committee on Nutrition of the American Academy of Pediatrics (AAP), the American Heart Association (AHA), American Cancer Society (ACS), or task forces or other groups assembled by the National Institutes of Health (NIH);

 review publications that critically summarize data and information in the secondary scientific literature.

FDA accords the greatest weight to the conclusions of federal government scientific bodies, especially when the evidence for the validity of a substance/disease relationship has been judged by such a body to be sufficient to justify dietary recommendations to the public. When the validity of a substance/disease relationship is supported by the conclusions of federal government scientific bodies, FDA typically finds that significant scientific agreement exists. Conclusions of other expert bodies may also be relevant to support a determination of SSA. Although reviews by individual outside experts are considered in assessing SSA, evidence from such reviews alone would not necessarily support a conclusion that the standard has been met, especially if the conclusions of such reviews were not supported by available assessments of the same body of evidence from federal scientific bodies, expert panels, or independent expert bodies. Reviews by outside experts or expert panels are most useful when there is a reasonable basis to conclude that they represent the larger group of qualified experts in the field. Most importantly, the relevance of an outside expert review depends on whether the evidence examined applies to the claim in terms of considerations such as specification and measurement of the substance and the disease.

When conclusions from qualified experts are not available (for instance, if the data supporting a proposed health claim are relatively new and have not yet been reviewed by an independent expert panel or body), a compelling and relevant body of evidence may nonetheless cause the agency to conclude that significant scientific agreement exists. Because each situation may differ with the nature of the claimed substance/disease relationship, it is necessary to consider both the extent of agreement and the nature of the disagreement on a case‐by‐case basis. If scientific agreement were to be assessed under arbitrary quantitative or rigidly defined criteria, the resulting inflexibility could cause some valid claims to be disallowed where the disagreement, while present, is not persuasive.

Application of the significant scientific agreement standard is intended to be objective, in relying upon a body of sound and relevant scientific data; flexible, in recognizing the variability in the amount and type of data needed to support the validity of different substance/disease relationships; and responsive, in recognizing the need to re‐evaluate data over time as research questions and experimental approaches are refined….

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