The Department of Health and Human Services Office of Inspector General released two reports (see here and here) critical of dietary supplements in the weight loss and immune support categories. OIG focused on those categories because they were reported by experts to be among the most popular. (Perhaps not coincidentally, products marketed in the weight loss and immune support categories have also been of keen interest to the FTC.)
Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence. FDA could not readily determine whether manufacturers had submitted the required notification for their claims. Seven percent of the supplements lacked the required disclaimer, and 20 percent included prohibited disease claims on their labels. These results raise questions about the extent to which structure/function claims are truthful and not misleading.
Twenty-eight percent of contacted companies had facilities that failed to register with FDA as required. Of the companies with facilities that did register, 72 percent failed to provide the complete and accurate information required in the registry. Finally, 20 percent of dietary supplement labels in our sample did not provide the required telephone numbers or addresses.
Source: Click here
