FDA Issues Final Guidance for the Scientific Evaluation of Health Claims

By Riëtte van Laack –

On January 16, 2009, FDA announced the availability of its final guidance for industry, titled “Evidence-Based Review System for the Scientific Evaluation of Health Claims” (“2009 guidance”).  At the same time, the Agency withdrew the 2003 “Guidance for Industry and FDA: Interim Evidence-based Ranking System for Scientific Data” and its 1999 “Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements.”  FDA’s new guidance includes the Agency’s 1999 interpretation of “significant scientific agreement,” but omits the ranking of claims from the 2003 guidance.  The Agency “intends to reexamine [this] ranking systems and issue appropriate guidance once [its] studies are completed.”

The 2009 guidance is substantially similar to the draft guidance which was issued in June  2007.  The evaluation criteria and approach described in the guidance are not new and have been used in the evaluation of more recent qualified health claim petitions. 

Since FDA started evaluating health claim petitions, its approach has evolved with the two primary results being that approval has been harder to achieve and, given the expense and low probability of success, that industry is submitting very few petitions.  The most significant development appears to be FDA’s requirement for an intervention study to support a health claim.  Referencing examples of situations in which results from intervention studies contradict results of observational studies, such as the finding of a positive association between beta-carotene and reduced risk of lung cancer in observational studies and a negative association in later intervention studies, FDA has taken the position that observational studies alone are insufficient to support a health claim.  In addition, as has become evident in the evaluation of qualified health claim petitions concerning the effect of a food or substance on cancer, FDA will evaluate the evidence to support a substance disease relationship for each form of cancer individually, rather than cancer generally.  FDA’s approach recognizes that cancer is a “constellation of more than 100 different diseases” each with a unique mechanism, “risk factors, treatment options, and mortality risk.”

Compared to the 2007 draft guidance, the 2009 final guidance includes a new paragraph in which FDA further explains its requirement that the specific disease that is the subject of the claim be measured as a primary endpoint in supporting intervention studies.  In addition, the final guidance includes more examples of the type of factors that FDA will consider when evaluating the methodological quality of studies to support the proposed claim.  FDA’s position regarding validated biomarkers or surrogate endpoints had not changed.