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Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment (2002) / Chapter Skim
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6 Framework Step 3: Critical Safety Evaluation of Dietary Supplement Ingredients
Pages 91-98

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From page 91...
... (Step 3A) , and then, if appropriate, analysis by an advisory committee (Step 3B)
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From page 92...
... FDA should also directly request information from the manufacturers and distributors of the ingredient under consideration to the extent that manufacturers and distributors are known. The collected information should be collated into a "draft dietary supplement ingredient safety review monograph," or simply "draft monograph." The monograph should be prepared using a standard format to summarize all the data collected on the ingredient (see Box 6-1 for an outline of the monograph structure)
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From page 93...
... Alone, in vitro data should serve only as hypotheses generators and as indicators of possible mechanisms of harm when the totality of the data from the different factors is considered. After considering the draft monograph and the totality of the evidence in the context of the guiding principles outlined above, FDA should either make a decision to take regulatory action, not to take regulatory action, or to refer the dietary supplement ingredient to an advisory committee of multidisciplinary experts for a safety review.
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From page 94...
... The decision to refer a dietary supplement ingredient to an external advisory committee rests with FDA and may be made for any reason that external expert opinion is deemed necessary or cost effective. The external advisory committee opinions or conclusions should be based on the information and data presented, but the decision on the regulatory consequences of the external advisory committee determinations must rest with FDA.
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From page 95...
... . After reviewing the information collected in the draft mono graph and in the public 95 information sessions, the external advisory committee should revise the draft monograph as needed to create as complete a picture of the scientific information available on safety as possible within the resources available to FDA.
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From page 96...
... After the advisory committee's conclusions are shared with FDA, the revised monograph and the advisory committee's conclusions should be posted on FDA's website. One of the important components of the Dietary Supplement Health and Education Act of ~ 994 was that the public should be educated about dietary supplements.
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From page 97...
... Management of the External Advisory Committee As discussed above, FDA should consider each draft monograph developed either internally or by a scientifically based organization and decide if additional expert opinion would be helpful in evaluating the evidence. Therefore, in addition to detennining who will be responsible for preparing draft monographs, FDA will also need to decide whether to establish or contract to have established an external advisory committee to develop conclusions and research needs and provide further input on the draft monograph.
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From page 98...
... One advantage of separating management of the external advisory committee from FDA is that this approach would provide greater assurance to the public of the external advisory committee's independence and objectivity. The proposed process regarding development of the draft monograph and public input does not include consensus conclusions, but if FDA determines that consensus conclusions about the safety of dietary supplement ingredients are necessary, then there are additional advantages to contracting with an outside organization to facilitate the development of them.
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Key Terms

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  • outside organization
  • consensus conclusions
  • revised monograph
  • expert opinion

  • scientific evidence
  • administrative management
  • safety information
  • regulatory action
  • nonprofit organization

  • additional advantages
  • critical evaluation
  • approach include
  • ingredient safety
  • information gathering

  • based organization
  • safety review
  • available safety
  • public assurance
  • external scientifically


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