AHPA Urges FDA to Provide Guidance on Pending AER Requirements

14/08/07 With the December effective date drawing closer on a new serious adverse event report (AER) law for dietary supplements and over-the-counter medicines, the American Herbal Products Association (AHPA) has made several suggestions and requests to help industry comply.

AHPA wrote the Food and Drug Administration (FDA) about the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which goes into effect on December 22, 2007. That new law requires that information on serious AERs be submitted to FDA, but the details of the law require FDA guidance.

“AHPA and this industry worked hard for several years with interested Members of Congress to get this law passed,” said AHPA’s General Counsel Tony Young, who is with the law firm of Kleinfeld, Kaplan and Becker LLP. “Now we need FDA to implement the law and provide reasonable guidance so that all the large and small companies in this industry can comply.”

In its letter, AHPA suggests:
♦ That domestic addresses on labels may be a street address, city, State, and ZIP code; except the street address may be omitted if it is shown in a current city directory or telephone directory as provided for by current law.
♦ That companies importing products to the US may provide either a domestic address or a domestic telephone number that can be reached by mailing or by dialing from within the United States, whether or not the mail is responded to or the telephone is answered by someone within the United States.
♦ That “signal” language specifically referring to AER reporting on labels is not required by the law, and may be confusing to consumers.

AHPA requests that FDA:
♦ Revise the MedWatch form to create a form for AERs associated with dietary supplements, based on stakeholder input.
♦ Issue a Small Business Compliance Guide to provide information and examples for small businesses, including a decision tree, for evaluating whether an adverse event associated with a dietary supplement is a serious adverse event that is required to be reported to FDA.
♦ Clearly communicate that the compliance date for any label changes that may be necessary to meet requirements of the new law is December 22, 2008, as stated in the Senate Report accompanying the legislation.