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Scientific Concepts

The comments received suggested that some scientific concepts in the framework report should be addressed or addressed in more detail, as described below.

Dose-Response Relationship

Several comments mentioned that more consideration should be given to the relationship between the dose consumed of a dietary supplement ingredient and adverse effects.

Historical Use Information

Comments suggested that guiding principles on human data outlined in the framework should give more consideration to historical use. However, industry stakeholders and a consumer interest group agreed that historical data are not prima facie evidence that a supplement is harmless.

Adverse Event Reports

A consumer interest group commented that priority should be given to credible adverse event reports but that an absence of these reports should not be an assurance of safety. In addition, a consumer interest group suggested that there should be further investigation and evaluation of adverse events that are reported. Some industry stakeholders expressed that adverse event reports should not be used to reach conclusions about causality. Other comments were received suggesting that the benefits of dietary supplement ingredients should also be taken into account when evaluating the incidence and severity of adverse events. 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.

Prevalence of Use in the Population

Several of the comments received mentioned that more attention needs to be focused on dietary supplements that are widely used among the



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