Law Helping FDA Regulate Dietary Supplements, OTC Drugs Takes Effect

The Dietary Supplement and Nonprescription Drug Consumer Protection Act has gone into effect a year after it was signed by President Bush.

The law requires manufacturers and distributors of dietary supplements and OTC drugs to report all serious adverse events associated with the use of their products to the FDA. It also requires them to keep records of other adverse events.

The FDA released two draft guidances in October 2007, instructing manufacturers how to submit reports of serious adverse events for dietary supplements and unapproved nonprescription medications as required under the law.

More information on the law is available at www.govtrack.us/congress/bill.xpd?bill=s109-3546. The nonprescription drugs guidance can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/07d-0386-gdl0001.pdf, and the dietary supplements guidance is available at www.fda.gov/OHRMS/DOCKETS/98fr/07d-0388-gdl0001.pdf.