Health Industry Washington Watch
OIG Examines Dietary Supplement Claims, Registration with FDA
The OIG has released two reports focusing on dietary supplements, one examining labeling claims and the other reviewing the FDA’s ability to identify and contact manufacturers in a public health emergency. In the first report, “Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements,” the OIG analyzed structure/function claims for a sample of 127 dietary supplements marketed for weight loss or immune system support. The OIG concluded that substantiation documents for the sampled supplements generally were inconsistent with FDA guidance on competent and reliable scientific evidence. Among other findings, 20% of the supplements included prohibited disease claims on their labels and 7% lacked the required disclaimer. The OIG recommends that FDA seek explicit statutory authority to review substantiation for structure/function claims to determine whether they are truthful and not misleading. The OIG also recommend that FDA make improvements to the notification system for these claims and expand market surveillance to enforce the use of disclaimers for structure/function claims and to detect disease claims. In the second report, “Dietary Supplements: Companies May Be Difficult To Locate in an Emergency,” the OIG assessed the FDA’s ability to identify and contact manufacturers in a food emergency, again based on a sample of 127 weight loss and immune support dietary supplements. Out of a subset of 79 companies that the OIG interviewed and were required to register with the FDA, only 72% registered as required, and almost three-quarters of those registrations failed to provide complete and accurate information. In addition, 20% of dietary supplement labels in the sample did not provide the required contact information. The OIG recommends that FDA: (1) improve the accuracy of registry information; (2) seek authority to impose civil monetary penalties on companies that do not comply with registration requirements, and (3) educate industry about registration and labeling requirements.