FDA's Expanding Postmarket Authority to Monitor and Publicize Food and Consumer Health Product Risks: The Need For Procedural Safeguards to Reduce "Transparency" Policy Harms in the Post-9/11 Regulatory Environment
Food and Drug Law Journal, Vol. 64, No. 3
September 14, 2009
The article provides a summary of the expansion in FDA’s discretionary authority in the post-9/11 period, particularly with respect to FDA’s postmarket authority to monitor and publicize potential health risks linked to food, dietary supplements, nonprescription drugs, and other consumer health products. In addition, the article evaluates the need for FDA to establish procedural safeguards to reduce the significant risks of unintended and undue harm to people and regulated companies that can result from adverse publicity in the more “transparent” post-9/11 FDA regulatory environment.

With permission from FDLI.