Dietary Supplements A Framework for Evaluating Safety (2005) / Chapter Skim
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13 Findings and Recommendations
13 Findings and Recommendations
Pages 297-306
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From page 297... ...
This chapter identifies legal and regulatory barriers and provides recommendations for improvement to enhance the evaluation of the safety of dietary supplement ingredients. ABILITY TO DETERMINE UNREASONABLE RISK Judgment of Unsafe Versus Unreasonable Risk For many dietary supplement ingredients, there is little available information about their safety compared with what is available for new drugs or 1DSHEA also gives authority the secretary of the U.S.
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From page 298... ...
However, the standard for demonstrating that a significant or unreasonable risk exists with use of a dietary supplement ingredient does not require the same level of information as is needed to conclusively demonstrate or prove that a substance is unsafe for human consumption. The principles used by the scientific community to determine the risk associated with consumption of various substances should also apply to dietary supplement ingredients, bearing in mind that dietary supplements, by virtue of DSHEA, have been assumed to be safe, but have not been required to be proven safe.
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From page 299... ...
LEGAL AND REGULATORY BARRIERS TO EVALUATION OF 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's health. The following findings are designed to enhance the utility of the Framework and enhance the ability of FDA to protect consumers from unreasonable risk of illness or injury.
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SPECIFIC FINDINGS AND RECOMMENDATIONS Prospective Systematic Monitoring and Tracking Mechanism for Dietary Supplement Ingredients Finding: A prospective, systematic method for recording and monitoring the history of safety issues with specific dietary supplements is necessary to implement a framework for FDA to evaluate the safety of dietary supplement ingredients. During the period of this study, FDA developed a new method of monitoring and tracking adverse event reports -- the Special Nutrition/Adverse Event Monitoring System (FDA, 2002)
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From page 301... ...
Adverse Event Reporting Finding: Reports of adverse events are an important source of information by which FDA becomes aware of potential risks to public health from exposure to dietary supplement ingredients. It has been estimated that FDA receives reports of less than 1 percent of all adverse events associated with dietary supplements, according to the Inspector General's Report, Adverse Event Reporting for Dietary Supplements: An Inadequate Safety Valve, which also documented the limitations in the reports that are received (OIG, 2001)
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From page 302... ...
Recommendation: FDA should increase efforts to inform health care professionals and consumers that they should use the MedWatch ad verse event reporting program to report adverse events associated with the use of dietary supplements. Additional outreach efforts should in clude: · Distribution of MedWatch forms with instructions for use for reporting adverse events relating to use of dietary supplements, · Education of health care professionals to include questions about dietary supplement use when taking diet and drug histories, and · Education of consumers that dietary supplements are not necessarily safe and adverse events should be reported to their healthcare professional or directly to FDA.
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From page 303... ...
FDA Proposed Good Manufacturing Practice Guidelines Finding: While the focus of this report is on developing a framework to evaluate the safety of dietary supplement ingredients per se, and not on safety issues related to good manufacturing practice, these are inseparable because variability in content hampers the evaluation of safety. FDA recently proposed current good manufacturing practices (cGMPs)
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From page 304... ...
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)
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From page 305... ...
In addition, FDA and the National Institutes of Health should establish clear guide lines for cooperative efforts on high-priority safety issues related to the use of dietary supplements. Recommendation: All federally supported research on dietary supple ments conducted to assess efficacy should be required to include the collection and reporting of all data related to safety of the ingredient under study.
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2003. Adverse events associated with dietary supplements: An observational study.
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