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Appendix B: Scope of Work and Comments to Initial July 2002 Framework
Pages 316-321

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From page 316...
... · The contractor shall describe a process for developing a monograph system with specifications for evaluating the safety of dietary supplement ingredients and shall develop at least six prototype monographs as examples. · The contractor shall solicit public input on the proposed framework and relative to their plans for monograph development.
From page 317...
... COMMENTS RECEIVED ON THE PHASE I FRAMEWORK As part of the requirements noted in the scope of work for this project, a proposed framework was released for comment. The committee received more than 20 oral or written comments from various stakeholders related to the proposed framework.
From page 318...
... In addition, comments were made recommending that if clinical data indicate conditions of safe use, then the dose-response relationship needs to be considered when evaluating adverse event reports. Vulnerable Subpopulations Some of the comments indicated that more attention needs to be focused on the use of dietary supplement ingredients among subgroups of the population that may be more susceptible to serious adverse effects.
From page 319...
... Some stakeholders interpreted the report as indicating that human data are to be relied on, which caused a concern because of the opinion that adequate human data may not be available. Comments were also received expressing that the weight placed on animal data, in vitro data, and the biological activity of structurally related or taxonomically related substances needs to be reconsidered in the screening process.
From page 320...
... A few stakeholders expressed concerns that the quantitative nature of the scoring system may give the false impression of numerical precision. Furthermore, several industry stakeholders were concerned that the numerical scoring system for prioritization may be misused in legal cases against manufacturers.
From page 321...
... One comment was also received suggesting that the description for the 75-day advanced notice for new dietary supplements should be compared with the self-declaration of "generally recognized as safe" used for conventional food ingredients. Testing the Framework A few comments called for a description on how the six supplements chosen for monograph development as part of this report came through each of the steps of the proposed framework.


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