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  • The FDA initiative to establish current Good Manufacturing Practices 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.

While the focus of this report is on developing a framework and not on safety issues related to good manufacturing practices, these are inseparable because variability in content hampers the evaluation of safety.

  • Adoption of the labeling changes recommended in the report Inspector General Report: Dietary Supplement Labels: Key Elements is urged.

Required labeling information that would be of use to the consumer in making informed decisions about safety is limited. Current regulations related to source of a product only require the name and place of business of the manufacturer, packer, or distributor to be on the label. There are usually few manufacturers of a product, but many distributors or packers. Thus both sources need to be on the label.

  • Additional Research on the Potential to Cause Harm:

    • The continued development of effective working relationships and partnerships between FDA and the National Institutes of Health is encouraged.

    • FDA should ensure that its own National Center for Toxicological Research and the overall Department of Health and Human Services National Toxicology Program are optimally utilized when research is needed to further evaluate concerns.

    • All federally supported research on dietary supplements conducted to assess efficacy should be required to include the collection and reporting of all data related to safety of the ingredient under study.

There is no legal or regulatory requirement that dietary supplement ingredient manufacturers conduct toxicology or safety pharmacology studies on their products or ingredients. Thus experiments and studies to address safety issues will, in most cases, be initiated by FDA or other federal agencies.

BARRIERS TO EVALUATING THE SAFETY OF DIETARY SUPPLEMENTS

Through the process of developing the Framework to evaluate the safety of dietary supplement ingredients, a number of legal and regulatory barriers were identified that hamper FDA’s ability to protect the public



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