preparing a monograph is to gather as much information as possible from the published literature and other sources regarding the potential hazards of consuming the supplement. Multiple comprehensive databases, such as MEDLINE (NLM, 2003a), TOXLINE (NLM, 2003b), and EMBASE should be searched (Elsevier, 2003). In addition, NAPRALERT (Farnsworth, 2003) can be searched if the supplement is a natural product or botanical. To search for potential ingredient-drug or ingredient-ingredient interactions, the Metabolism and Transport Drug Interaction Database (UW, 2003) is a useful tool.
Abstracts and titles should be reviewed for relevance to the adverse event or harmful effect of concern. Although review articles may be useful for the purpose of providing literature references and an overview of the data, review of the original articles from the peer-reviewed literature is essential to obviate any bias or unsubstantiated opinion of the authors of the review. Information in other non-peer-reviewed literature that raises concerns about adverse effects should not be ignored. In order to get as much information as possible, FDA should request the voluntary submission of safety data information from industry and other stakeholders. This request may be made through notice in the Federal Register and through the FDA website. FDA should also request information directly from manufacturers and distributors of the ingredient under consideration, if they are known.
Collecting descriptive and safety information and organizing and summarizing the information into a draft safety monograph will require significant expertise and resources. Time and other resources required for completion of the draft monographs are likely to vary, depending on the amount and complexity of safety-related information available for the ingredient under consideration, as well as the focus of the monograph. FDA may choose to prepare monographs internally, or it may choose to contract the work out to organizations, individuals, or both.
The extent of time and effort devoted to preparation of monographs on dietary supplement ingredients will depend on FDA’s prioritization of need. FDA could set priorities and develop a complete list of substances warranting monographs first. Alternatively, it could retain one or more individuals or groups to develop monographs and determine the need for individual monographs on an ongoing basis as priority setting proceeds or as new needs emerge. The former approach may be more cost effective to implement, given that the latter approach might not provide continuity in workload. However, preparing monographs for substances considered of high priority will require more resources up front if given to contractors and will be dependent on information available at the time high-priority substances are identified.
As discussed previously, monographs, whether prepared internally or