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Dietary Supplements: A Framework for Evaluating Safety
Does the review address the possible biological activity or mechanism of action of the ingredient and its implications for human safety? Knowledge of the mechanism of action may be useful in understanding the biological basis for possible harm.
Does the review address whether the ingredient might pose safety problems for specific groups within the general population? Does the review address specific concerns related to pregnant or lactating women, children, the aged, or those with specific diseases or other physiological conditions? A good review will address vulnerable populations and may be helpful in targeting safety concerns that may apply to a subpopulation, but that may not cause a significant safety concern for the general population (see Chapter 9).
Does the review address the potential for interaction with other supplements, drugs, foods, or other medical interventions? A useful review will address potential interactions (see Chapter 8) and explain whether possible interactions have actually been observed from human use, or if interactions described are predicted based on other types of information (e.g., in vitro assays, chemical structure). Inclusion of both demonstrated and theoretical interaction information is important to understanding the safety profile of an ingredient. If considering potential interactions is not within the authors’ expertise or capabilities, then the review should acknowledge that the potential for interactions with other substances was not evaluated.
Strengths and Weaknesses of Available Dietary Supplement Resources
Table 2-1 provides an overview of many of the available resources that address dietary supplements and characterizes each based on the considerations listed in the previous section. The summaries following the table1 provide a general description based on the general information reviewed. As is apparent from the table, the resources vary in their relevance to FDA’s mission of identifying dietary supplements that would present risk of significant or unreasonable harm.
Of the resources that do sufficiently focus on safety, some are not ideally transparent or unbiased. Other resources fall short in other areas. Nevertheless, the different resources are valuable even when their conclusions are less relevant to FDA’s task—they can serve as starting points of information about concerns and as sources of primary literature references.
In preparing Table 2-1, it was difficult to provide descriptions for some
The descriptive summaries and Table 2-1 are largely based on information from the resource itself via websites or books, or descriptions written by others (Barrett, 1998); they are not based on verification of the statements included in those resources.