Several organizations have compiled resources that review the safety, efficacy, and/or quality of dietary supplements. A list of considerations was developed for assessing the relevance of different resources to a safety review, and samples of these resources were reviewed. The considerations are described below, followed by a table indicating how each resource met these considerations and a narrative description of each resource. This discussion focuses on resources that appeared to be the product of organization or government-sponsored committees or a peer-reviewed process. Inclusion does not constitute endorsement of resources, nor should this review be considered inclusive of all efforts to consider safety, efficacy, and/ or quality of dietary supplements. Additional publications, although not reviewed here, may also be informative (Ernst, 2000; Foster and Tyler, 1999; Grieve, 1996).
Eighteen considerations were developed to assess the relevance of various resources to safety/risk evaluation. They address the objectives and focus of the resource, the authors and review process, the literature procurement and type of information considered, and the limitations of product-specific evaluations.
Was review of safety/risk a primary goal of the document? Does the review have a clear focus on safety, rather than a focus on quality or potential therapeutic uses? For example, some resources focus mainly on efficacy, with safety issues seemingly an afterthought. Also, some reviews focus on objectives, such as verifying that the label is accurate and determining whether the substance is contaminated. These are useful approaches because quality and purity issues are important and can impact the safety of dietary supplements to a significant degree, but they are product focused, rather than focused on a particular dietary supplement ingredient’s inherent safety.
Does the review rely on primary sources of information rather than secondary sources? Primary sources are original research articles that generate data, while secondary sources are compilations that may include statements of opinion in addition to facts. A review that summarizes data from primary sources is a more appropriate resource for assessing safety. If a resource’s conclusion about safety is based on scientific evidence from the primary literature, then it is more likely to be factual and less likely to be an opinion. Use of primary literature to support statements is a daunting task, but when it is possible, it minimizes the risk of carrying forward anecdotal