FDA-Regulated Goods Face CPSC Jurisdiction Over Packaging
Mechanical hazards in the packaging of otherwise-exempt food, drugs, and cosmetics can trigger a 24-hour reporting duty to the Consumer Product Safety Commission.
Although food, drugs, and cosmetics are generally excluded from the Consumer Product Safety Act's definition of a 'consumer product,' their packaging is not. This distinction creates a significant compliance trap for companies focused solely on FDA regulations. A mechanical hazard posed by packaging—such as a detachable cap creating a choking risk or a glass container prone to breaking and causing lacerations—can trigger a duty to report to the Consumer Product Safety Commission (CPSC). Sophisticated counsel must be aware that this reporting obligation under Section 15(b) of the CPSA arises within 24 hours of the company learning of information that reasonably supports the conclusion of a reportable issue. Failure to make a timely report can result in significant civil penalties. Companies in this space should proactively establish compliance programs to identify, investigate, and evaluate potential packaging hazards to determine whether a CPSC report is warranted, even before any injuries have been reported.