WASHINGTON—As the adverse event reporting (AER) law was originally designated to be effective in December 2007, FDA issued a guidance for industry, featuring questions and answers on compliance with the law and extended the date of enforcement to accommodate the delayed guidance. Signed into law a year ago, the Dietary Supplement and Nonprescription Drug Consumer Protection Act features labeling requirements prescribed for dietary supplement manufacturers, packers and distributors; the rules went into effect Dec. 22, 2007, but FDA said it will delay enforcement until January 2009. Congress provided the past year for companies to prepare for compliance, but due to competing priorities, FDA was not able to consider and develop guidance on the labeling requirements. Considering this lack of guidance, FDA is giving dietary supplements firms one more year to work on labeling compliance.
The newly issued guidance, which is open for public comment, includes detailed questions and answers on subjects including: what information must be included on the label of a dietary supplement to enable consumers to report serious adverse events associated with the use of the dietary supplement, and whether the label of a dietary supplement should also include language indicating the purpose of the domestic address or phone number is to report serious adverse events associated with use of the dietary supplement.
For more information, visit http://www.cfsan.fda.gov/list.html.
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