The FDA has released new guidance for dietary supplement labeling pursuant to the Dietary Supplement and Nonprescription Drug Consumer Protection Act passed at the end of 2006.
The Act requires supplement companies to report serious adverse events (adverse event reports or AER) concerning their products to the FDA. The AER reporting requirement went into effect on December 22, 2007.
The draft guidance was just published in the Federal Register on January 2, 2008. The guidance is presented in question and answer format. To read the new guidance, click here.
We will be posting additional information regarding the new AER reporting requirements here so check back soon.
About Joel Rothman
Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.
