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Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment (2002) / Chapter Skim
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3 Outline of the Overall Process for Evaluation of Dietary Supplement Ingredients
Pages 39-46

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From page 39...
... The prionty-setting system will determine which ingredients require a full safety evaluation first and can be done on an on-going basis once an ingredient is flagged in the screening step. After dividing flagged ingredients into priority categories for further evaluation, the third step—in-depth safety evaluations of highest priority ingredients—can be completed.
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From page 40...
... A combination product containing ingredients that individually are not considered safe is likely to demonstrate some of the same safety concerns as the individual ingredients. Even if no single ingredient raises safety concerns, MedWatch and other information sources should be monitored for clusters of serious adverse events and other possible indicators of problems related to specific combination products.
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From page 41...
... Regular monitoring of MedWatch and other information sources will be necessary to detect indications of serious adverse events possibly related to specific brands of products. Initiation of the Process The three steps of the proposed framework are outlined in Table 3- ~ and Figure 3-~.
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From page 44...
... Information or Factors Used to Identify or Flag Ingredients for Further Evaluation Several types of readily available information, or "factors," are used to identify ingredients warranting further consideration, as outlined in Table 3-l and Figure 3-l, and described in more detail in Chapters 4 and 5. The first factor considered is the ingredient status; ingredients introduced to the market as dietary supplements after ~ 994 are automatically flagged in Step One to be reviewed in Step Two, priority setting.
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From page 45...
... The external advisory committee will review the draft monograph, collect additional information as needed, and provide opportunity for public input on the ingredient's inherent safety. The external advisory committee will review the science base for the monograph and revise it as necessary.
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From page 46...
... ~ 999. Public health issues arising Tom microbiological and labeling quality of foods and supplements containing probiotic microorganisms.
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Key Terms

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  • external advisory
  • adverse events
  • dietary supplements
  • serious adverse

  • safety concerns
  • supplement ingredient
  • individual ingredients
  • draft monograph
  • proposed framework

  • safety evaluation
  • combination product
  • combination products
  • priority setting
  • sales volume

  • animal data
  • third step
  • human data
  • safety profiles
  • information sources

  • flagged ingredients
  • supplement products
  • products containing
  • draft monographs
  • considered unsafe

  • related substances
  • ingredients warrant
  • ingredients based
  • monograph preparation
  • inherent safety


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