New dietary supplement requirements went into effect December 22, 2007, requiring new reporting and recordkeeping for adverse events associated with dietary supplements. You may read more about the requirements in the FDA draft publication:
Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act Draft Guidance (Oct. 2007) available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0388-gdl0001.pdf.
