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FDA Ephedra Proposal "Sound Science" Requirement Added To House Budget

This article was originally published in The Tan Sheet

Executive Summary

FDA "shall not proceed" with its ephedra rulemaking "without using sound science to assure strict compliance with the Dietary Supplement Health & Education Act" and without using adverse events reports in a "manner consistent with previous rulemakings and agency policy," a House budget bill amendment states. The amendment was offered by Rep. Sam Farr (D-Calif.) at the House Appropriations/ Agriculture Subcommittee's May 13 mark-up of the Agriculture appropriations bill. The full committee is tentatively scheduled to mark up the bill May 19.

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FDA Ephedrine Adverse Event Data Questioned By GAO

FDA's scientific justification for its proposed rule restricting the use of ephedrine alkaloids in dietary supplements is "open to question," GAO says in a report on the ephedrine proposed rule issued Aug. 4.

FDA Ephedrine Adverse Event Data Questioned By GAO

FDA's scientific justification for its proposed rule restricting the use of ephedrine alkaloids in dietary supplements is "open to question," GAO says in a report on the ephedrine proposed rule issued Aug. 4.

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