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Dietary Supplements: A Framework for Evaluating Safety
Focused Versus Broad-Based Evaluation. An integrative evaluation may be reactive to the signal and focused in nature in that it is being conducted to examine a specific moderate or high-level concern about an ingredient, or it may be more proactive and broad-based in that it looks for any risk associated with use of the dietary supplement ingredient. For example, a proactive integrative evaluation might be initiated simply because a large percentage of the population is using the ingredient, rather than as a reaction to a particular safety concern.
Drafting a Safety Monograph. In most cases, the integrative evaluation will be documented in a monograph that summarizes the categories of data available and their use in drawing conclusions about the potential risk associated with use of the ingredient; it should include the conclusions of the expert committee and/or FDA. The science-based guiding principles described in the following section of this summary, and explained in detail in Chapters 4 through 10, should be used to reach a decision regarding whether there is an unreasonable risk of illness or injury.
Integrating the Data to Determine Risk. When evidence on a dietary supplement ingredient presents a moderate or higher level of concern relative to this risk, biological plausibility and consistency should be evaluated, especially when independently convincing data are not available. Such an analysis can be represented by creating a causal model diagram—a tool to visualize how the different types of available data link together to establish risk (described in Chapter 10).
The principles described for considering the various categories of data (Chapters 4 through 8), as well as the principles describing how to integrate among and within categories of data (Chapter 10), are applied in the integrative evaluation.
It is expected that FDA may want further input from an advisory committee on many of the dietary supplement ingredients undergoing an integrative evaluation because only ingredients with significant potential for concern are likely to reach this stage.
Decision to Take Action. The results of the integrative evaluation should play a pivotal role in establishing that a supplement ingredient is unsafe. If an advisory committee is used, its findings and rationale should be posted with the monograph on FDA’s website. One of the important components of DSHEA was that the public should be educated about dietary supplements. FDA thus has a responsibility to educate consumers about the safety of supplement ingredients, and the public availability of the completed monographs can be an important aspect of the educational process.