. "6 Framework Step 3: Critical Safety Evaluation of Dietary Supplement Ingredients." Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment. Washington, DC: The National Academies Press, 2002.
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For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements
BOX 6–1
Safety Review: Monograph Format
INGREDIENT NAME
DESCRIPTION OF THE INGREDIENT, which includes the following:
Constituents as appropriate: chemical structure; for a botanical ingredient, genus, species, part of plant
Examples of products known to contain the ingredient
Descriptions of different preparations (include U.S. Pharmacopeia process if available; country of origin, if known)
Range of typical intake levels (where known, this will include recommended intake levels and data on actual intake)
Description of active components, if known
Traditional indications, if applicable
Claim (label or other marketing information)
Usage patterns (prevalence of use in the general population, use by vulnerable groups, use in combination with other ingredients)
AVAILABLE SAFETY INFORMATION AND EVALUATION
Human data (serious and nonserious adverse effects)
Animal studies
Biological activity of structurally related and taxonomically related substances
In vitro studies
RESEARCH NEEDS
CONCLUSIONS
Unresolved issues and uncertainties in the available data
Recommendations and conclusions about the safety of the ingredient, based on the strength of the scientific evidence
CITATIONS (including citations and hard copies of references used)
public. FDA should also directly request information from the manufacturers and distributors of the ingredient under consideration to the extent that manufacturers and distributors are known.
The collected information should be collated into a “draft dietary supplement ingredient safety review monograph,” or simply “draft monograph.” The monograph should be prepared using a standard format to summarize all the data collected on the ingredient (see Box 6-1 for an outline of the monograph structure).
After the draft monograph is prepared, FDA should consider the totality of the scientific evidence obtained. FDA should decide, based on the weight of the evidence, if the evidence is sufficiently clear to allow the product to remain on the market or if it is sufficiently clear to take action to limit marketing the ingredient. The guiding principles in Box 6-2, summarized from Chapter 4, should be followed for assessing and weighting the different types of evidence that enter into the decision.
