New Law Requires Adverse Event Reporting for Dietary Supplements and OTC Drugs

Kelley Drye Client Advisory

On December 22, 2006, President Bush signed into law the Dietary Supplement and Non-Prescription Drug Consumer Protection Act.” The Act requires manufacturers, packers, and distributors of dietary supplements and certain over-the-counter drugs to notify the Food and Drug Administration of all serious adverse events reported by consumers. The effective date for the Act is December 22, 2007.

This Client Advisory provides more information about reporting requirements and companies that are regulated by the Act.