The U.S. Food and Drug Administration (FDA) recently issued its final guidance on the definition and labeling of medical foods, entitled "Frequently Asked Questions About Medical Foods:...10 June 2016
FDA’s Changing Culture: What Food Companies Need to Know
The Food and Drug Administration (FDA) is undergoing a major culture change, and nowhere is that impact being felt more than in the food industry. While visibly preparing new regulations to implement the Food Safety Modernization Act (FSMA), the agency has quietly become much more inspection-oriented and enforcement-minded, even under its historic authorities. Here is what food companies need to know and what to do about it.
The FDA “cop on the beat” is back. The agency is conducting more factory inspections than in recent years, and is being more strategic in its deployment. FDA targets particular industries, and sometimes particular companies. While still nominally based on risk, FDA’s definition of “high risk” has expanded so much that it covers 1/3 of the food industry.
The demeanor of FDA inspections has changed as well. Inspectors are much more assertive, often insisting on access to records and asserting their “right” to take photographs, always sensitive issues. And their inspections are more thorough.
In particular, FDA has switched from collecting just product samples (which rarely test positive) to conducting extensive environmental testing – what some have dubbed a “swab-a-thon” – which is much more likely to find positives. The inspector’s list of observations (Form 483) is consistently longer and more detailed.
With more inspections comes more enforcement. FDA is now routinely issuing Warning Letters based on insanitary conditions and violations of good manufacturing practices (GMPs), something unheard of a decade ago.
Companies which receive Warning Letters will now face steep reinspection fees under FSMA, and companies that fail that reinspection become candidates for an injunction action, twelve of which FDA has brought in the past 15 months.
FDA has also threatened to resurrect usage of the Park doctrine, based on a 1976 Supreme Court case affirming FDA’s right to bring a criminal misdemeanor case against corporate executives based on a strict liability theory.
What does this mean for food companies? Go back to basics:
- Refocus attention in your facilities to basic sanitation and adherence to GMPs.
- Be ready for an FDA (or state) inspection at any time.
- Know your rights and responsibilities during an FDA inspection, including records access and photography.
- Update your internal inspection manual and retrain your staff to address the new generation of FDA inspectors.
- Implement timely corrective actions to all FDA inspectional observations – do not let matters escalate!
As the saying goes, “being forewarned is forearmed.”