TSCL Comments on FDA Draft Guidance for Industry on Evidence-Based Review System for the Scientific Evaluation of Health Claims

Michael Harless Administrative Law, Health Law

On behalf of TREA Senior Citizens League (“TSCL”), we filed comments with the Food and Drug Administration (“FDA”) in opposition to the FDA’s  “Draft Guidance for Industry on Evidence-Based Review System for the Scientific Evaluation of Health Claims”.

The FDA Draft Guidance asserts that the FDA is authorized by the NLEA to treat health claims for both conventional food and health claims for dietary supplements in virtually the same manner.  In 1990, Congress adopted a “significant scientific agreement” standard applicable to “conventional food health claims” and the FDA subsequently purported, by regulation, to extend that same standard to “dietary supplements health claims,” even though the statute provided that this standard did not apply to dietary supplements.

Moreover, the Draft Guidance would adopt an evidence-based scientific model more suitable to tracing the cause and effect between a single, potentially-toxic pharmaceutical and a disease, rather than to the identification of the complex manner in which foods and dietary supplements are used by the body in achieving overall health wellness.  Instead of submitting such claims to a review process that would assess the series of interconnections, cross-connections, and recombinations of nutrition in order to assess the effectiveness of appropriate combinations to achieve health wellness, health claims for foods and dietary supplements are assessed by studies that evaluate “the relationship between a substance and a disease.”

If the Draft Guidance were adopted, TSCL submits that the FDA will have exceeded its statutory authority, and violated senior citizens’ constitutional right to have important information about dietary supplements on the label of the product.  While appearing to comply with the instructions given in a 1999 D.C. Circuit decision (Pearson v. Shalala), designed to make it easier to obtain health claim approval, the FDA instead is attempting to tighten its grasp on health claims.

Our comments urged the FDA to withdraw its Draft Guidance on the grounds that its proposal to regulate dietary supplement health claims as food health claims not only has not been authorized by Congress, but also appears to contradict the legislative authorization for an FDA standard in this area.

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