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FDA Estimates Substantiation Burden for Dietary Supplements

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By: Sean Moloughney

Editor, Nutraceuticals World

In late January, FDA published a notice in the Federal Register regarding the research burden behind claims for dietary supplements. It points out that the evidence standard is broad enough that some dietary supplement manufacturers may only need to collect peer-reviewed scientific journal articles to sub­stantiate their claims; other companies whose products are less well documented may have to conduct studies to build a body of evidence to support their claims. FDA assumes that it will take 44 hours to assemble information needed to substantiate a claim on a particular dietary supplement when the claim is widely known and established. FDA increased this burden from one hour per claim to 44 hours per claim based on information received from industry last June. FDA believes it will take closer to 120 hours to assemble supporting scientific information when the claim is novel or when the claim is pre-existing but the scientific underpinnings of the claim are not widely established.

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