Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed Rule on Ephedrine Alkaloids
HEHS/GGD-99-90
Published: Jul 02, 1999. Publicly Released: Aug 04, 1999.
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Highlights
Pursuant to a congressional request, GAO reviewed the analyses underlying the Food and Drug Administration's (FDA) proposed rule on the food supplements, ephedrine alkaloids, focusing on: (1) the scientific basis for FDA's proposed rule; and (2) FDA's adherence to the regulatory analysis requirements for federal rulemaking.
Recommendations
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Department of Health and Human Services | Given the uncertainties in the information upon which FDA based its proposed rule, the Secretary of Health and Human Services should direct the Commissioner of FDA to obtain additional information to support conclusions regarding the specific requirements in the proposed rule for dietary supplements containing ephedrine alkaloids before proceeding to final rulemaking. Specifically, FDA needs to provide stronger evidence on the relationship between the intake of dietary supplements containing ephedrine alkaloids and the occurrence of adverse reactions that support the proposed dosing levels and duration of use limits. |
FDA is continuing to monitor and evaluate reports associated with the use of ephedrine alkaloid-containing dietary supplements and is reviewing new scientific literature. Within a few months, FDA plans to reassess the requirements of its proposed rule on ephedrine alkaloids and the need for alternative regulations. Consistent with one of GAO's recommendations, in 2003 FDA withdrew the provisions of the ephedrine alkaloids proposal relating to the dietary dosing regime and duration limits and reopened the proposed rule for further comment. After obtaining and reviewing further evidence concerning ephedrine alkaloids' safety and effectiveness, FDA issued a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids in February 2004.
|
| Department of Health and Human Services | The Secretary of Health and Human Services should direct the Commissioner of FDA to improve the transparency of FDA's cost-benefit analysis in its final rulemaking. Specifically, FDA should more fully explain the bases of its cost-benefit assumptions, the degree of uncertainty associated with those assumptions, and the implications of plausible alternative assumptions to the proposed action and other regulatory alternatives. |
Before publishing a final rule, FDA will take appropriate steps to correct the deficiencies in its cost-benefit analysis, and more fully explain the rationale for its assumptions, any related uncertainties, and the implications of plausible alternative assumptions.
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