Resources for Food and Drug Administration (FDA)

FDA Issues AER Guidance, Extends Enforcement Date

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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.

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