Excerpted from Food and Drug Administration, Thursday, 15 August 2002.

For Immediate Release
15 August 2002
(888) INFO-FDA

Statement from FDA Deputy Commissioner Crawford

Statement Regarding Metabolife

Three weeks ago, we asked the Department of Justice to pursue a criminal investigation of Metabolife - whether they made false statements to FDA regarding the existence of adverse event reports.

Since at least 1997, the FDA has tried to get these adverse event reports from industry. We also unsuccessfully sought these reports through litigation. Metabolife has refused and resisted us every step of the way.

Given their long history of being uncooperative, we view their offer to make these reports available now to be disingenuous. We are greatly disturbed that Metabolife has repeatedly refused to cooperate with the FDA, and news that so many reports exist greatly heightens our concern.

Once we get these reports, the FDA will have a special task force review them.

Remember, Congress placed the burden on the Secretary of Health and Human Services to prove that these products are unsafe. Thus, the Secretary called for an extensive scientific review of ephedra in June to establish a scientific base for addressing health concerns around ephedra. The Rand Corporation is conducting a comprehensive review of the existing science on ephedra, and the NIH will use this information to guide an expanded research effort on the safety of the product.

Consumers may wish to consult their physicians before using this product.

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Excerpted from Food and Drug Administration, Thursday, 15 August 2002.