New FDA Draft Guidance: “Evidence-Based Review System for the ScientificEvaluation of Health Claims”

New FDA Draft Guidance: “Evidence-Based Review System for the Scientific Evaluation of Health Claims” - http://www.cfsan.fda.gov/~dms/hclmgui5.html

Following closely after the FDA draft anti-CAM guidance, this new draft guidance, just published, continues the FDA’s policy of more closely regulating the natural products industry. There is a 60 day comment period that should run until the end of August. Says the introduction:

“This draft guidance document represents the agency's current thinking on 1) the process for evaluating the scientific evidence for a health claim, 2) the meaning of the significant scientific agreement (SSA) standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act …and 3) credible scientific evidence to support a qualified health claim. …

"This guidance document describes the evidence-based review system that FDA intends to use to evaluate the publicly available scientific evidence for SSA health claims or qualified health claims on the relationship between a substance and a disease or health-related condition… This guidance document explains the agency's current thinking on the scientific review approach FDA should use and is intended to provide guidance to health claim petitioners …

"The specific topics addressed in this guidance document are: (1) identify ingstudies that evaluate the substance/disease relationship, (2) identifying surrogate endpoints for disease risk, (3) evaluating the human studies to determine whether scientific conclusions can be drawn from them about the substance/disease relationship, (4) assessing the methodological quality of each human study from which scientific conclusions about the substance/disease relationship can be drawn, and (5) evaluating the totality of scientific evidence.”

This guidance attempts to impose a high standard on Health Claims.

Dr. Ron Paul’s pending bill, the Health Freedom Protection Act - HR.2117 - addresses this further FDA power grab by imposing the standard commercial substantiation requirement instead.

Essentially Dr. Paul's bill shifts the burden of proof onto the FDA whenever the agency wants to deny the public the benefit of health claims information about Dietary Supplements. It provides that reasonable health claims, with proper disclosure language, shall be allowed "unless the Secretary determines that -- `(i) there is no scientific evidence that supports the claim; and `(ii) the claim is inherently misleading and incapable of being rendered nonmisleading through the addition of a disclaimer."

Thus, even "a scintilla" of scientific evidence would allow the making of nonfraudulant claims that Dietary Supplements may be of benefit to individuals. The requirements of the bill are consistent with the law that already governs the agency's position, announced in 2004, "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'.''

The text of the bill, reintroduced on May 7, 2007, can be found at: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117

This latest FDA Guidance needs further analysis and comments will need be addressed to the FDA recommending that Dr. Paul’s approach be substituted for the overly bureaucratic approach favored by the Agency. If not, Congress needs to act fast to protect our alternatives!