October 2007

AHPA seeks FDA commitment on AER guidance

The American Herbal Products Association (AHPA) has requested a publication date for an overdue guidance document that was scheduled to be published by Sept. 18.

The request was made to the Food and Drug Administration (FDA) and its parent agency, the U.S. Department of Health and Human Services (HHS), as the dietary supplements and over-the-counter medicine industries prepare to comply with a new law on serious adverse event reports (AERs). The law is scheduled to take effect Dec. 22.

When it goes into effect, the Dietary Supplement and Nonprescription Drug Consumer Protection Act will require information on serious AERs associated with dietary supplements and OTC drugs be submitted to FDA.

When a law is passed, the agencies tasked with enforcement issue guidance documents detailing how the law is to be put into effect.

AHPA also asked HHS and FDA whether, in the absence of clear guidance, FDA would exercise enforcement discretion if companies do not submit AERs as the agency wishes.

Source: American Herbal Products Association, www.ahpa.org

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