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Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment (2002)
Food and Nutrition Board (FNB)
Institute of Medicine (IOM)
Board on Life Sciences (BLS)

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. "3 Outline of the Overall Process for 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

Ongoing Review and Reassessment

As new information becomes available to FDA, re-evaluation of internal draft monographs and monographs revised by an external advisory committee may be necessary. Such new information should be considered as described in the priority-setting step to determine if there is sufficient substantive new information to review and possibly revise the monograph.

REFERENCES

Betz JM, White KD, der Marderosian AH. 1995. Gas chromatographic determination of yohimbine in commercial yohimbe products. J AOAC Int 78:1189–1194.


CFSAN (Center for Food Safety and Applied Nutrition). 2000. Dietary Supplement Strategy (Ten Year Plan). Online. Food and Drug Administration. Available at http://vm.cfsan.fda.gov/~dms/ds-strat.html. Accessed March 5, 2002.

Chambliss WG. 2001. Nutraceutical formulations: Impact on bioavailability. In: Examining the Science Behind Nutraceuticals: Proceedings of the AAPS Dietary Supplements Forum. Arlington, VA: AAPS Press. Pp. 367–380.


FDA (Food and Drug Administration). 1997. Current good manufacturing practice in manufacturing, packaging, or holding dietary supplements; Proposed rule. Fed Regis 62:5699–5709.

Foreman J. 2000. St. John’s wort: Less than meets the eye. Online. The Boston Globe. Available at http://www.boston.com/globe/search/stories/health/health_sense/011000.htm. Accessed March 5, 2002.


GAO (General Accounting Office). 1997. Medical Device Reporting: Improvements Needed in FDA’s System for Monitoring Problems with Approved Devices. HEHS-97–21. Washington, DC: U.S. Government Printing Office.

Green GA, Catlin DH, Starcevic B. 2001. Analysis of over-the-counter dietary supplements. Clin J Sport Med 11:254–259.


Hamilton-Miller JM, Shah S, Winkler JT. 1999. Public health issues arising from microbiological and labeling quality of foods and supplements containing probiotic microorganisms. Public Health Nutr 2:223–229.

Howe K. 2000. Herb Remedies: Panacea or Problem? Online. San Francisco Chronicle. Available at http://www.sfgate.com/cgibin/article.cgi?file=/chronicle/archive/2000/06/02/MN75760.DTL. Accessed March 5, 2002.


Kamber M, Baume N, Saugy M, Rivier L. 2001. Nutritional supplements as a source for positive doping cases? Int J Sport Nutr Exer Metab 11:25 8–263.


Marrone CM. 1999. Safety issues with herbal products. Ann Pharmacother 33:1359–1362.

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