BOX 6–1
Safety Review: Monograph Format

  1. INGREDIENT NAME

  2. 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)

  1. 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

  1. RESEARCH NEEDS

  2. 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

  1. 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.



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