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

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)

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)

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

Literature Search Strategy

Literature Cited

Tables of Key Data Evaluated