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Dietary Supplements: A Framework for Evaluating Safety
voluntary program. While the U.S. Pharmacopeia has developed some standards for content uniformity for dietary supplements (USP, 2004), to date few standards have been published.
Recommendation: The FDA initiative to establish cGMPs for dietary supplement ingredients is supported and additional efforts to develop standards for content uniformity should be undertaken. Sufficient resources to support these efforts should be provided by Congress.
Revision in Requirements for Labeling of Dietary Supplements
Finding: Required label information that would be of use to the consumer in making informed decisions is limited relative to safety of use. Current regulations related to source of a product only require the name and place of business of the manufacturer, packer, or distributor to be provided on the label. In March 2003, the U.S. Department of Health and Human Services Inspector General presented a template for labeling dietary supplements to provide information in a clear and understandable format to help consumers make informed decisions about the safe and appropriate use of dietary supplements (DHHS, 2003b). Several recommendations that relate specifically to the safe use of dietary supplements are provided in a related report, Dietary Supplement Labels: An Assessment (DHHS, 2003a).
Recommendation: Adoption of the labeling changes recommended in the report Dietary Supplement Labels: Key Elements is urged. In addition, the label should contain the name and place of business of both the distributor and manufacturer of the product (e.g., manufactured for Company XX by Company YY) to facilitate tracing the source of the product if adverse events or other problems occur.
Additional Research on the Potential to Cause Harm
Finding: Based on the experience of preparing the prototype monographs for this report, it is evident that as the process for review of ingredients expands, research needs will be identified to address unresolved issues regarding the potential of certain ingredients to cause harm. There is no legal or regulatory requirement that dietary supplement ingredient manufacturers conduct toxicology or safety pharmacology studies on their products or ingredients. Thus the application of any testing of the types described in Chapters 5, 6, and 8 to dietary supplement ingredients will in most cases be initiated by FDA or other federal agencies. A number of collaborative activities between FDA and other governmental bodies have been undertaken and successfully completed.
Recommendation: The continued development of effective working relationships and partnerships between FDA and the National Insti-