Are you a manufacturer or importer feeling the heat from increased regulatory scrutiny? You're not alone. The U.S. Consumer Product Safety Commission (CPSC) and Food and Drug Administration (FDA) have ramped up their enforcement activities in 2024, continuing trends from the previous year. Let's dive into what this means for your business.
CPSC: Civil penalties pack a punch
The CPSC isn't pulling any punches when it comes to civil penalties. They're doubling down on enforcing reporting obligations for products that could pose substantial hazards or risks. Here's what you need to know:
- Hefty fines: Penalties can reach up to $120,000 per violation and $17,150,000 for a series of related violations.
- Reporting timeline: You have 24 hours to report clear violations and 10 business days to investigate unclear ones.
- When in doubt, report: The CPSC favours a conservative approach to reporting potential hazards.
FDA: Inspections on the rise
The FDA isn't sitting on the sidelines either. They've increased their inspection game:
- More inspections: A 17.6% increase in facility inspections from 2022 to 2023.
- Focus areas: cGMP regulations, particularly for food, pharmaceuticals, and medical devices.
- Foreign supplier verification: Increased enforcement of the Foreign Supplier Verification Program (FSVP) for food importers.
What this means for you
- Stay vigilant: Keep a close eye on your products and supply chain.
- Robust compliance: Implement strong compliance programs to limit your risk.
- Timely reporting: When in doubt, report potential hazards promptly.
- Prepare for inspections: Both domestic and foreign facilities should be ready for FDA inspections.
Looking ahead
- Cosmetics industry: Expect increased FDA oversight due to the Modernisation of Cosmetics Regulation Act of 2022 (MoCRA).
- E-commerce platforms: The CPSC is eyeing increased accountability for online marketplaces.
- Litigation: Both agencies show a renewed interest in using litigation as an enforcement tool.
Don't let these trends catch you off guard. Stay informed, stay compliant, and don't hesitate to seek expert advice if you're unsure about your obligations.
Have questions about how these enforcement trends might affect your business? We're here to help. Get in touch with our product compliance experts today!
Source: https://www.foley.com/insights/publications/2024/08/2024-cpsc-fda-enforcement-trends/