Skip to main content

Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment (2002) / Chapter Skim
Currently Skimming:

7 Attributes and Limitations of the Proposed Framework
Pages 99-102

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 99...
... A somewhat distinct aspect of this framework, compared to the approaches taken by other organizations, is that it reflects a public health perspective that a supplement ingredient used by more individuals warrants greater attention, given similar safety concerns. The framework 99
Read the entire page →
From page 100...
... An additional limitation of the framework is the extent to which evaluation of the safety of any combination of dietary supplement ingredients can be conducted when the review is limited to available data. In the absence of having the authority to require manufacturers to present specific evidence of safety, the burden of conducting studies to ascertain adverse effects is
Read the entire page →
From page 101...
... ATTRIBUTESA ND LIMITATIONS 101 placed on FDA, which has limited resources compared to the number of the dietary supplements currently marketed. SUMMARY While the framework approach outlined here is not based entirely on empirical data, it should provide a mechanism for FDA to accomplish its goal of using a science-based approach to set priorities for evaluating the safety of dietary supplement ingredients given its available resources and the legislative authority under which it regulates the industry.
Read the entire page →

Key Terms

  • supplement ingredients
  • dietary supplements
  • supplement ingredient
  • proposed framework
  • safety evaluation

  • health impact
  • human data
  • critical safety
  • relevant industry
  • drugs requiring

  • safety depends
  • regulatory scheme
  • somewhat distinct
  • integrating prevalence
  • similar safety

  • framework focuses
  • increasingly accurate
  • additional limitation
  • available evidence
  • easily updating

  • proactively searching
  • reached step
  • current regulatory
  • concern characterized
  • serious adverse

  • evaluation step
  • additional resources
  • consuming dietary
  • evaluate explicitly
  • flagged ingredients


    • 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.