Dietary Supplements A Framework for Evaluating Safety (2005) / Chapter Skim
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Appendix A: Existing Frameworks or Systems for Evaluating the Safety of Other Substances
Appendix A: Existing Frameworks or Systems for Evaluating the Safety of Other Substances
Pages 307-315
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From page 307... ...
PREMARKET APPROVAL OF FOOD ADDITIVES "Food additives" include an array of substances that accomplish a variety of technical effects in food. Included are direct food additives (e.g., artificial sweeteners)
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The Redbook outlines the types of toxicological testing FDA normally expects to be provided in support of the food additive's safety, based initially on the additive's chemical structure and probable human exposure. (The Redbook provides guidance; it does not include requirements.)
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of the Federation of American Societies for Experimental Biology for assistance with a comprehensive review of GRAS substances. LSRO established a Select Committee on GRAS Substances that examined monographs that provided all known data on physical and chemical properties of a substance, human exposure data, animal and human toxicity data, and reports of special studies on mutagenicity, carcinogenicity, and teratogenicity of each substance.
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To determine GRAS status for flavoring substances, the Flavor and Extract Manufacturers Association (FEMA) , the trade organization of the flavor ingredients industry, created its own independent expert panel.
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drug ingredients. The CIR Program then grouped the remaining ingredients into chemically related families and prioritized based on the following factors: frequency of use, ingredient concentration in cosmetic products, area of human exposure, number of products containing the ingredient used by sensitive population subgroups (such as infants and the elderly)
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NEW DRUGS Unlike dietary supplements, premarket approval of new drugs places the burden of proof regarding safety on the manufacturer rather than on FDA. The evaluation of new drugs, new uses for approved drugs, and classification of OTC drugs is an intensive interactive process that evaluates both safety and efficacy.
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The data collected in all of the clinical studies enable FDA to approve or disapprove a drug based on a risk-benefit analysis. Once a drug is approved and marketed, additional safety information continues to be collected through mandatory submission of adverse event information from the manufacturer to FDA via MedWatch and other reporting mechanisms.
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. In the third phase, after considering the public comments received in response to ANPRs, the agency issued proposed rules designated Tentative Final Monographs.
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Evidence of adverse effects in human populations and conclusive evidence of severe effects in animal studies constitute a high hazard concern level. A moderate level of concern results from suggestive animal studies and analog data and knowledge that the chemical class has produced toxicity.
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