Court Decision Could Affect Future of Adverse Event Reporting

September 22, 2010

An unprecedented decision in the U.S. Ninth Circuit Court of Appeals could ramp up demands for adverse event reports (AERs), if not reversed, the Natural Products Association (NPA; Washington, DC) announced last week.

An unprecedented decision in the U.S. Ninth Circuit Court of Appeals could ramp up demands for adverse event reports (AERs), if not reversed, the Natural Products Association (NPA; Washington, DC) announced last week.

In the case of Matrixx Iniatitives Inc. (Scottsdale, AZ) v. Siracusano, the court decided 'yes' in the case of whether or not nondisclosure of AERs warrants liability under federal security laws. The Ninth Circuit...s decision allows for a class action lawsuit to move forward.

Matrixx Initiatives owns Zicam LLC, which sells Zicam and Nasal Comfort branded over-the-counter (OTC) products.

"While the case involves an over-the-counter product, there are clear implications for the supplement industry, especially as the reporting requirements for OTCs and supplements were enacted in the same piece of legislation," said John Gay, Executive Director and CEO of the Natural Products Association.

NPA further reports that 'The practical consequence of the Ninth Circuit's decision, if it is not reversed, is that manufacturers of dietary supplements very likely will be forced to disclose all AERs, however insignificant, in order to avoid meritless'”but expensive'”strike suits against the supplement industry."

The Consumer Healthcare Products Association (Washington, DC) and the Council for Responsible Nutrition (Washington, DC) jointly filed an amicus curiae brief, as well.

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