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Dietary Supplements A Framework for Evaluating Safety (2005) / Chapter Skim
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Appendix H: Saw Palmetto: Prototype Monograph Summary
Pages 376-379

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From page 376...
... In addition to lipids, other known chemical components of 1This is a summary of a prototype monograph, prepared for the purpose of illustrating how a safety review of a dietary supplement ingredient might be prepared following the format described in this report. While it was prepared as a prototype using the processes described in the report, it was not conducted under the auspices of the Food and Drug Administration utilizing all the resources available to the agency.
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From page 377...
... Preparations of saw palmetto powdered fruit and saw palmetto extracts are typically analyzed for fatty acid content. Currently, the majority of saw palmetto is obtained from the southern coastal United States.
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From page 378...
... are needed in order to determine the presence of biologically active chemical components. · In vitro reports of cytotoxicity in prostate cancer cell lines have not been extended to other cell types in order to ascertain whether there is broader cytotoxicity.
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From page 379...
... Toxicol Sci 74:393­406. Clark RL, Antonello JM, Grossman SJ, Wise LD, Anderson C, Bagdon WJ, Prahalada S, MacDonald JS, Robertson RT.
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Key Terms

  • biologically active
  • prototype monograph
  • palmetto fruit
  • dietary supplement
  • supplement ingredient

  • clinical trials
  • phytochemical analyses
  • palmetto powdered
  • external genitalia
  • palmetto extracts

  • additional phytochemical
  • blended products
  • active components
  • dietary supplements
  • powdered fruit

  • male rat
  • human clinical
  • drug interactions
  • genitalia induced
  • pertinent information

  • nine randomized
  • powdered dried
  • minor components
  • acid content
  • typically analyzed

  • cancer cell
  • functionally related
  • unreasonable risk
  • following oral
  • contaminated blended


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