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Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment (2002) / Chapter Skim
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Appendix D Table of Food and Drug Administration Actions on Dietary Supplements
Pages 138-139

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From page 138...
... about the safety concerns of these products FDA requested voluntary recall by manufacturers and distributors; several issued a recall FDA reco~ended that manufacturers remove product from the market and alert customers to immediately stop use FDA requested HCPs to review liver toxicity cases and to report possible kava-related cases to MedWatch FDA warned consumers to stop use immediately FDA alerted HCPs that Lipokinetix may be a serious health risk and asked HCPs to review and report cases of possible Lipokinetix-related hepatitis FDA recommended to distributor that it remove product from market and alert customers FDA informed manufacturer of possible contamination of the product and manufacturer issued recall FDA notified HCP of the risk of drug interactions FDA warned consumers to stop use immediately 138 continues
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From page 139...
... FDA notified HCPs and continues to warn public that these substances are unapproved new drugs that may cause harm FDA conducted seizures of product FDA warned the public that these are unapproved new drugs that may cause harm FDA conducted seizures of product FDA warned consumers not to use product because it contains an unlabeled prescription drug ingredient FDA noted the presence of impurities in some products FDA determined product was an unapproved drug (later upheld by court rulinga) FDA warned consumers not to consume product FDA proposed limits to epedrine alkaloids allowed in products.
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