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BOX 3-1
Safety Monograph

  1. DescriptIon of the Ingredient

    • Constituents as appropriate: chemical classification and structure; for a botanical ingredient, genus, species, part of plant; for an animal ingredient, genus, species, part of body

    • Description of individual components, alternative forms or secondary constituents

    • Descriptions of different dietary supplement preparations, how they may differ in constituents, and amounts ingested in ordinary use

  1. Safety Information (in narrative form, referencing data tables)

    • Human safety data (serious and nonserious adverse effects): historical use, if applicable; adverse effects from clinical trials, clinical case reports, and adverse event reports; interactions (i.e., drug interactions); consequences of unusually large intake and/or chronic cumulative use

    • Animal studies

    • In vitro studies

    • Biological activity of related substances (structurally, taxonomically, and functionally related)

  1. Other Relevant Information (if known and applicable)

    • Sources of ingredient

    • Conditions of use suggested or recommended in labeling or other marketing material

    • Cautions about use from historical use, labeling, or other marketing material

    • Usage patterns (prevalence of use in the general population, use by vulnerable groups)

    • Information on regulatory actions, including those of regulatory agencies in other countries

    • Available information on physiological and biochemical aspects (bioavailability, distribution, metabolism)

  1. Summary and Conclusions

    • Summary

    • Conclusions about the safety of the ingredient, based on the strength of the scientific evidence

    • Unresolved issues and uncertainties in the available data

    • Data gaps and future research recommended

  1. Literature Search Strategy

  2. Literature Cited

  3. Tables of Key Data Evaluated

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