FDA To Publish Draft Guidance on Serious Adverse Event Reporting

(October 11, 2007) —The Food and Drug Administration (FDA) has announced that it will publish on Monday, October 15, draft guidance to describe the minimum data elements for serious adverse event reports for dietary supplements. A pre-publication copy of the draft guidance can be accessed at http://www.cfsan.fda.gov/~dms/dsaergui.html.

The publication of this guidance fulfills a portion of FDA’s requirement under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which goes into effect on December 22, 2007. The agency stated that this document will also provide guidance on how, when, and where to submit a serious adverse event report for a dietary supplement, as well as on records maintenance and access for serious and non-serious adverse event reports and related documents. The agency also disclosed that it is preparing a separate guidance on the reporting of serious adverse events associated with nonprescription human drug products that were also affected by the legislation passed by the U.S. Congress last year. As is standard for the issuance of such guidance, there will be a 60-day period during which comments may be submitted.

The American Herbal Products Association (AHPA) had previously scheduled an educational tele-seminar for Tuesday, October 16 (1:00-3:00 pm Eastern), titled Adverse Event Reporting: Strategies for Compliance. This educational event will now incorporate the newly released FDA guidance. For further information, see http://www.ahpa.org/Default.aspx?tabid=69&aId=425&zId=1.


The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade—comprised of the finest growers, processors, manufacturers and marketers of herbal products—our mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbal products are manufactured, labeled, and sold. Celebrating our 25th anniversary in 2007! Website: www.ahpa.org.

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.