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Dietary Supplements A Framework for Evaluating Safety (2005) / Chapter Skim
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Appendix I: Shark Cartilage: Prototype Monograph Summary
Pages 380-384

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From page 380...
... 1 This 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 381...
... Extracts specifically inhibit the proliferation of endothelial cells in culture media and inhibit the activities of vascular endothelial growth factor and basic fibroblast growth factor in accepted assays for angiogenesis. In vitro studies and other data also demonstrate that shark cartilage powder and extracts possess matrix metalloprotease inhibitors; inhibition of metalloproteinases inhibits angiogenesis.
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From page 382...
... For example, thalidomide, a known teratogen, has antiangiogenic activity. Clinical trials using other antiangiogenic agents have reported a wide variety of adverse effects, including neurotoxic effects.
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From page 383...
... However, both peripheral and central nervous system toxicity have been reported in a review of shortterm clinical studies. Adverse effects included central and peripheral neuropathies (e.g., sustained paralysis, cerebellar ataxia, spastic diplegia, sensory neuropathy, sedation, headache)
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From page 384...
... Clinical trials are under way with various preparations of shark cartilage, including clinical trials supported by the National Cancer Institute. These will provide data relevant to safety, and may provide insight into potential serious adverse effects.
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Key Terms

  • cartilage preparations
  • clinical trials
  • antiangiogenic activity
  • serious adverse
  • dietary supplement

  • prototype monograph
  • supplement ingredient
  • chick embryonic
  • sufficient evidence
  • toxicity studies

  • using various
  • indicate sufficient
  • powdered shark
  • safety evaluation
  • scientific safety

  • specific shark
  • available evidence
  • animal toxicity
  • products labeled
  • vitro studies

  • gastrointestinal disturbances
  • adequately assessed
  • contributing factors
  • multiple species
  • cartilage dietary

  • active ingredient
  • identify antiangiogenic
  • chronic disease
  • metalloprotease inhibitors
  • aqueous extract


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