Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment (2002) / Chapter Skim
Currently Skimming:
Appendix B Existing Frameworks of Systems for Evaluating the Safety of Other Substances
Appendix B Existing Frameworks of Systems for Evaluating the Safety of Other Substances
Pages 116-123
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 116... ...
FDA conducts safety assessments of new food additives under the pnnciple of establishing a reasonable certainty of no harm by applying a decision Damework. This framework uses a risk assessment approach that includes the compilation of available data and information, arid the application of toxicological arid other types of decision elements.
|
From page 117... ...
for food additive petitioners to use when assembling the required data in support of their petitioned use. 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 and is not a requirement)
|
From page 118... ...
, the trade organization of the flavor ingredients industry, created its own independent expert panel. The FEMA Expert Panel, which has been reviewing flavoring substances since soon after the passage of the ~ 958 Amendments, includes qualified experts in toxicology, pharmacology, biostatistics, pharmacokinetics, biochemistry, pathology, nutntion, organic chemistry, medicinal chemistry, and metabolism (Woods and Doull, ~ 99 1)
|
From page 119... ...
The CIR Program then grouped the remaining ingredients into chemically-related families and pnontized 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 elderly3, biological activity, frequency of consumer complaints, and skin penetration. Using a ranking methodology, ingredients were given a weighted score based on these factors and were then reviewed in priority order.
|
From page 120... ...
Also included in the IND are data from rodent and nonrodent animal studies, such as phannacokinetic and pharmacodynamic data from animal studies, genotoxicity studies, carcinogenicity studies, reproductive and teratogenic studies, and other toxicological data. When available, the application also includes published or unpublished human data.
|
From page 121... ...
. In the third phase, after considering the public comments received in response to the ANPRs, the agency issued proposed rules designated Tentative Final Monographs (TFMs)
|
From page 122... ...
In this step, a risk assessment is conducted, human health hazard information is evaluated, and the chemical is assigned a qualitative determination of the hazard concern level. Evidence of adverse effects in human populations and conclusive evidence of severe effects in animal studies constitute a high hazard concern level.
|
From page 123... ...
2001. Milestone Status of OTC Drug Review Documents as of March 1, 2001.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.