A press release from the American Herbal Products Association summarizes the guidance:
The Food and Drug Administration (FDA) today issued two Federal Register notices to announce the availability of draft guidance documents on labeling of dietary supplements and nonprescription drugs, respectively, as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. This law, which went into effect on December 22, 2007, requires marketers of dietary supplements and nonprescription drugs to maintain records of received adverse event reports associated with their products and to submit serious adverse event reports to FDA. The law also requires labels to bear “a domestic address or domestic phone number through which the responsible person … may receive a report of a serious adverse event.”
These new guidance documents specifically address three labeling issues:
- That a domestic address included on a label to satisfy the address or phone number requirement of the law must include “a full U.S. mailing address that includes the street address or P.O. box, city, state, and zip code;” or
- That a domestic phone number that serves to satisfy the address or phone number requirement of the law on a label must include the area code; and
- That FDA “recommends that the label also bear a clear, prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of the product.”
In both of the newly issued draft guidance documents, FDA states that it will exercise enforcement discretion for any new labeling requirements associated with this law until January 1, 2009.
For more information see the full release.
