Anyone evaluating the health of a food company would start with its balance sheet and financial statements. But from a legal and risk management perspective, there is much more to determining whether a food company is truly “healthy.”
In counseling food companies, I believe there are seven other signs that a company is healthy. Managing those issues ensures a food company is well-positioned for the long-term.
1. Institute a Robust Food Safety Program. Given the implementation of the Food Safety Modernization Act (FSMA), each food company should maintain a culture of food safety. The company needs to prepare and enforce detailed food safety and sanitation policies for all facilities to ensure FDA compliance.
The company must (a) ensure that employees who handle food are properly trained on safety, sanitation and personal hygiene; (b) hire highly qualified individuals to lead food safety and sanitation; and (c) consider retaining a safety expert or organization to review and potentially enhance its food safety program.
David Rosenfield is counsel at the law firm Herrick, Feinstein LLP, where he concentrates on food safety cases and food and drug industry investigations. He can be reached at [email protected].
Maintaining sanitary facilities helps ensure food is safe to eat. A few activities I recommend include: (a) periodic food testing for pathogens, extraneous material and allergens; and periodic swabbing on surfaces and surrounding areas; (b) implementing an effective allergen control program; (c) ensuring that food storage areas are clean, secure and properly temperature-controlled; (d) ensuring an adequate cleaning schedule using proper sanitizers; and (e) conducting regular food safety audits.
2. Use the Best Suppliers. Problems with ingredients or raw materials trigger many food manufacturers' voluntary recalls. Implementing an approved supplier program — including pre-screening suppliers to confirm they have adequate food safety policies, production standards, allergen controls and safety audits — will ensure suppliers are safety-oriented. When possible, a company should obtain suppliers’ guarantees or certifications, inspect their transportation vehicles and food contents upon receipt and periodically test ingredients and raw materials provided.
3. Check Food Labels. Food companies must ensure their food labels are accurate and not in violation of FDA regulations. When preparing or changing label claims, consider:
- Have all claims been thoroughly vetted and approved?
- Has the company adequately ensured allergens not included on a label do not accidentally contaminate a food product?
- Are all labeling claims about the presence of allergens in a food product or a facility accurate and not misleading?
4. Have the Right Insurance. It is critical to have insurance policies covering general liability, directors and officers liability and food recall and contamination. Consult experienced insurance brokers or attorneys to negotiate policy language and, in light of new FSMA recall regulations, have all insurance policies periodically re-examined.
5. Maintain a Robust Records Retention Policy. The FDA requires companies to maintain complete, well-organized and "reasonably accessible" records concerning the manufacturing, processing, packing, transporting, distribution, receipt, recall, detention and importation of food. FSMA imposes new requirements, including the requirement of a Hazard Analysis and Risk-Based Preventive Control (HARPC) plan. It is also much easier to handle an FDA investigation or civil litigation if a company’s records are appropriately maintained.
6. Prepare for a Surprise FDA Inspection In the event of a surprise FDA inspection, prior checks on sanitary facilities, food safety testing, accurate labels and required records become even more important. I recommend developing a written, internal inspection plan to prepare accordingly.
Once FDA inspectors arrive, it is important that the company has designated an authorized person to accompany the inspectors while on-site, and to answer any questions directed to employees. I suggest:
- When inspectors arrive, ask why they are there and what they intend to review.
- Confirm that the inspectors are only given documents to which they are entitled, and keep copies of everything provided.
- Take notes on the inspection, detailing the specific areas viewed, questions asked, samples, labels, swabs taken and the inspectors’ demeanor, including any conversations or comments made.
- Obtain receipts for any food samples taken.
- If critical questions arise, contact outside legal counsel or your food safety consultant.
- Once the inspectors have left, analyze any labels they have taken, have a food laboratory collect and analyze duplicates of food samples taken and also have the lab duplicate and analyze any swabs taken.
- Prepare a corrective action plan for any significant problems found.
7. Actively Monitor and Respond to Complaints, and Monitor New Regulations and Enforcement Actions: Finally, the company should have a program to carefully monitor and appropriately respond to both customer and employee complaints – as they are the ones most likely to report their concerns to regulatory authorities. Adequately responding to their concerns, if possible, is essential. The company can stay updated on current trends by subscribing to the FDA's free email alerts concerning voluntary recalls, warning letters and regulatory updates.
To conclude, as the regulatory landscape shifts with FSMA’s implementation of various rules and regulations over the next year, it is even more important for food companies to ensure best practices are in place. Companies that implement these tactics will be ready should any inspection or crisis occur.