March 6, 2008 — The American Herbal Products Association (AHPA) has submitted comments to the Food and Drug Administration (FDA) requesting the agency to withdraw the guidance it issued concerning the labeling of dietary supplements in regard to the reporting of adverse events.
The FDA published two draft guidance documents that were described as intending to assist industry in complying with the labeling requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
AHPA asserts that the draft documents are both unnecessary and contrary to the clear language of the statute. AHPA’s comments express particular concern with the agency’s recommendation that labels have a prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of the product.
Source: American Herbal Products Association, www.ahpa.org