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information on the common doses to which safety conclusions are relevant

 

Consideration of data from non-oral routes of exposure

According to the text, “Information associated with other forms of administration were reviewed but was not considered as a sole basis for classification”

Only oral routes of administration were considered in safety evaluations; evidence of adverse effects related to other routes of exposure may be mentioned

Discussion of biological activity or possible mechanism of action

Not discussed

Biological activity and mechanisms for possible harms are discussed

Discussion of specific groups within the general population, if appropriate

Pregnant and lactating women, as well as children, are discussed; however, only 34 of 600 botanicals are classified as “not for use during lactation”

Age, gender, pregnancy, lactation, and sensitive subpopulations are discussed

Interaction with other interventions

Information on some ingredients includes comments about interactions, but a discussion of possible interactions is not included for each substance

Overall model for review includes section on interaction with other nutrients; some ULs are based on their known interaction with other nutrients (e.g., zinc)

Other comments and considerations for using this resource

Working assumption is that “safety concerns for herbal products need not be extrapolated from constituent profiles with any more alarm than is appropriate for foods”

Botanicals are classified as: Class 1, which can be safely consumed when used appropriately; Class 2, for which certain restrictions apply; Class 3, for which significant data exist to recommend special labeling; and Class 4, for which there is insufficient data

Limited to nutrients

Uses a risk-assessment methodology related to chronic intake; does not give guidance related to acute ingestion

Useful for assessing safety of specific nutrient levels used as supplements

Useful in examining specific subpopulations that may be sensitive or at risk



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