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ingredient is critical to providing a well-documented review of the literature where the data are equivocal.

To ensure that the critical evaluation of the information contained in the monograph and related information is as free of conflict of interest and as objective as possible, the external advisory committee should be composed of expert scientists who have appropriate training, education, and experience. Whether as a result of the appointment of a committee by FDA or by contract with a scientifically based, nonprofit organization, examples of expertise to be included are toxicology, preferably with expertise in safety evaluation; pharmacognosy; clinical pharmacology; nutritional science; epidemiology; biostatistics; clinical trials; medicinal chemistry and structure–activity relationships; pharmacokinetics; consumer behavior related to dietary supplement use; and public health, as well as ad hoc consultants with expertise in specific fields on an as-needed basis (e.g., specialists needed to evaluate particular ingredients, such as experts on oriental medicine, herbalists, veterinary toxicologists, or clinicians with relevant experience). Advisory committee members should be selected based on their disciplinary expertise rather than as representatives of stakeholder viewpoints, and they should not have a financial stake in the outcome of the process or otherwise have a real or perceived conflict of interest.

After the external advisory committee is assembled, a draft monograph should be released, and the public should be provided with an opportunity to comment on the completeness of the data included, as well as on the strength and relevance to humans of the different types of evidence. Industry and other stakeholders should be given time during meetings of the external advisory committee to provide input into the process. The external advisory committee should provide advice on the further refinement of the draft monograph as it reviews all the data and summarizes its conclusions.

REFERENCES

Elsevier. 2003. EMBASE (Excerpta Medica Database). Online. Available at http://www.elsevier.nl/homepage/sah/spd/site/locate_embase.html. Accessed March 13, 2004.


Farnsworth NR. 2003. NAPRALERT (Natural Products ALERT) Database. Chicago: University of Illinois at Chicago.


Gillette JR. 1976. Application of pharmacokinetic principles in the extrapolation of animal data to humans. Clin Toxicol 9:709–722.


IOM (Institute of Medicine). 1994. How Should the Recommended Dietary Allowances be Revised? Washington, DC: National Academy Press.

IOM. 1997. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. Washington, DC: National Academy Press.

IOM. 1998a. Dietary Reference Intakes: A Risk Assessment Model for Establishing Upper Intake Levels for Nutrients. Washington, DC: National Academy Press.



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