Adverse Event Reporting Law Information

The Adverse Event Reporting (AER) law, which became effective in December 2007, amended the federal Food, Drug and Cosmetic Act to require the reporting of "serious" adverse events for both over the counter (OTC) drugs and dietary supplements.

NPA has comprehensively reported on this regulation from before its implementation and has continually provided assistance and guidance to members once the law went into effect. This section provides the latest news and key information regarding the law and NPA actions regarding it.

Key Information

Just Added (9/11): Dietary Supplements - Reporting an Adverse Event

Final AER guidance (pdf) as published in the July 14, 2009 issue of the Federal Register. NPA Comments on FDA's Final AER Guidance

NPA Partnership with SafetyCall® for Member Benefit Responding to AER Law(pdf)

Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the AER Final Rule) as published in December 2006. NPA Comments Regarding AER Final Rule

Additional information from before the law's implementation

Why NPA Supports the AER Bill—Legal Analysis

AER Law FAQ

Beware the AER Scare—Perspective from David Taylor, past president of the Natural Products Association

Member benefit: AER Assistance

NPA is partnering with SafetyCall®, one of the most experienced adverse event reporting (AER) call centers in the country, to offer reduced rates for services to help NPA members manage adverse event reports and report serious incidents to the FDA.

Contact SafetyCall at (866) 327-7282 or click here for more information. Please have your NPA Member Number handy.