The U.S. Food and Drug Administration (FDA) has requested public comments on the time burdens associated with the submission of information that would substantiate the claims that dietary-supplement manufacturers place on product labels.

FDA has estimated 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. We believe 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.” According to the agency, this information is needed only when manufacturers choose to place a “nutritional deficiency, structure/function, or general well-being” claim on the product’s label. The substantiation required “is consistent with the standards set by the Federal Trade Commission for dietary supplements and other health-related products that the claim be based on competent and reliable scientific evidence.” The deadline for submission of comments is January 5, 2015.