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intake increases above the UL, the potential risk of adverse effects may increase.

While not recommended intakes, the ULs are based on published data on adverse effects of consuming excess levels of nutrients, usually demonstrated in humans, on a chronic basis over time. Using a risk assessment methodology (IOM, 1998a), uncertainty factors are applied to develop the UL, and depend on the availability of a dataset with dose-response information. In some cases, ULs have not been set where information on chronic ingestion was not available. The reviews are under the direction of an oversight committee of experts, as well as a subcommittee of experts in toxicology and risk assessment. To date, all essential vitamins, minerals, trace elements, macronutrients, and electrolytes have been reviewed (IOM, 1997, 1998b, 2000, 2001, 2002, 2004).

Commission E2

In 1978 the Second Medicines Act in the Republic of Germany went into effect, requiring a scientific review of all medicines in the pharmaceutical market, including conventional drugs, medicinal plants, and phytomedicines. This resulted in the formation of a series of scientific commissions. Commission E was established by the German Minister of Health to review botanical drugs and preparations from medicinal plants. This 24-member committee was made up of physicians, pharmacists, nonmedical practitioners, pharmacologists, toxicologists, and biostatisticians (Blumenthal et al., 1998). According to a Commission E member consulted, at least 60 percent of the commission members had practical experience with phytomedicines (Personal communication, H. Schilcher, Commission E, March 19, 2002). The Commission completed its monograph work in 1994; however, it has met since 1994 to review drug registrations (Blumenthal, 1997; Blumenthal et al., 2000). The monographs produced by Commission E were compiled and published in English in 1998 by the American Botanical Council (Blumenthal et al., 1998). A subsequent publication by the American Botanical Council, Herbal Medicine: Expanded Commission E Monographs, was published in 2000 (Blumenthal et al., 2000).

The stated objective of Commission E was to ensure that approved botanicals were reasonably safe when used according to the product label instructions and to remove unapproved botanicals from the market even if they only posed minor safety risks (Blumenthal et al., 1998). Commission E

2  

Translation of the German Commission E (1998) is a translation of German documents and describes the process used by Commission E. In addition to input from a member of the Commission E, it serves as the basis for this summary.



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