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Dietary Supplements: A Framework for Evaluating Safety
reviewed 378 botanicals used in German folk medicine for both safety and effectiveness (Blumenthal, 1997; Personal communication, H. Schilcher, Commission E, March 19, 2002). It was the manufacturer’s responsibility to provide proof of quality (Blumenthal et al., 1998). Safety and effectiveness were assessed using published scientific literature. Approximately 100 to 200 worldwide references were consulted for each botanical (Personal communication, H. Schilcher, Commission E, March 19, 2002).
The Commission considered data on traditional use, chemical composition, pharmacology, and toxicology and used data from clinical studies, in vitro and in vivo studies, field studies, epidemiological studies, case reports, and unpublished proprietary data submitted by manufacturers that included chemical, toxicological, pharmacological, and clinical testing data. The Commission also reviewed summaries produced by Kooperation Phytopharmaka (an umbrella organization of about 120 pharmaceutical manufacturers). According to Blumenthal, these summaries were based on literature reviews and clinical experience, but did not contain any recommendations about the product under review (Blumenthal et al., 1998).
According to the American Botanical Council’s description, controlled clinical studies appear to have been considered the most useful type of data (Blumenthal et al., 1998). If no controlled studies were available, safety was evaluated based on other types of data, such as well-documented review articles, older clinical trials, and well-documented knowledge of traditional usage (Blumenthal et al., 1998). Commission E did not accept long-term therapeutic or traditional use as sufficient evidence of safety without additional data, and field and case studies were used only when they had been evaluated according to scientific standards (Blumenthal et al., 1998).
Once the Commission finished drafting a monograph for a botanical medicine, it was published and comments were solicited from scientists and other experts. The Commission then prepared a final draft of the monograph. The resulting monographs do not include references. Unpublished justifications with relevant references for the monographs are kept; however, these justifications cannot be accessed except in cases of legal disputes (Blumenthal et al., 1998).
Each substance was assigned one of three approval ratings: (1) positive (approved), (2) negative (unapproved), or (3) negative-null (unapproved). Potential therapeutic benefit was taken into account in the assignment of ratings. Positive (approved) substances were considered reasonably safe when used according to the dosage, contraindications, and other warnings specified in the monograph. If safety concerns outweighed the potential benefits of a substance, the monograph was assigned a negative (unapproved) rating. No dosage recommendations were provided for substances assigned a negative rating, and the intent of the Commission was the immediate withdrawal from the market of substances receiving a negative rating.