Food for Thought: Compliance with U.S. Food Safety Laws

Food for Thought: Compliance with U.S. Food Safety Laws

In a modern manufacturing enterprise, compliance with U.S. food laws isn’t just about what you make, it’s about how you make it, where, and under what controls. For manufacturing organizations, compliance encompasses technical, legal, and corporate requirements, in other words, the rules and practices you must obey simply to be allowed to operate and market your goods.

These can impact you directly or indirectly through U.S. rules related to:

• Product safety
• Health, safety, and environmental (HSE) impact
• Data protection
• Export controls
• Anti-corruption
• IT safety and security
• Fair competition
• Employment law

In order to be strategic, manufacturers must compete, grow, and innovate, and they must embed compliance into their operations. Failing on that front can be catastrophic.

Risks of Non-Compliance

When compliance is neglected through poor documentation or not enforced, several dangers arise, including:

·      Regulatory penalties: fines, shutdowns, and product recalls

·      Legal liability: lawsuits from harmed customers or workers

·      Reputational damage: loss of brand trust, especially in food and health sectors

·      Operational disruption: production halts, and remediation costs

In a globalized environment, non-compliance in one jurisdiction often ripples across others. Thus, companies increasingly treat compliance as a core capability, not an afterthought. Employees must own their roles in compliance and management must design systems and documentation to prove that compliance is real, consistent, and enforceable.

Let’s drill into key compliance requirements for food and related manufacturers and analyze how recent compliance failures underscore how serious these risks are.

FDA Regulations: 21 CFR Part 11, Part 820, and GMP Controls

Food, dietary supplements, and medical devices often fall under the U.S. Food and Drug Administration (FDA) oversight involving Good Manufacturing Practices (GMPs) and electronic record rules (Part 11). Originally, Part 11 and Part 820 were central prescriptions for software systems, audit trails, validations, and electronic signatures.

Recent regulatory updates include:

The FDA has refined guidance on data integrity and software validation, emphasizing “unintended bypasses, legacy systems, and cybersecurity risks” in more recent years.
Enforcement priorities at the FDA appear to have shifted to stricter scrutiny of audit trails, access control, and system validation.

On the drug side, 21 CFR Part 211 (current GMP for finished pharmaceuticals) was last amended as recently as August 22, 2025, per the eCFR docket.

In practice, manufacturers using MES (Manufacturing Execution Systems), EBR (Electronic Batch Records), or other digital control systems must ensure system validation, consistent audit trails, and locked-down controls; documentation of all changes, testing, and user roles; and traceability and ability for FDA to review both electronic and paper backup records. Any gaps in these areas can lead to non-compliance findings or, in the worst case, product holds or recalls.

HACCP/Preventive Controls (FSMA, SFCA, etc.)

Hazard Analysis and Critical Control Points (HACCP) remains a foundational approach for food safety. In the U.S., HACCP principles are built into the Food Safety Modernization Act (FSMA) preventive controls rules, which require food facilities to develop a written food safety plan that identifies and minimizes hazards through a hazard analysis, implements process, allergen, sanitation, and supply chain controls, conducts monitoring and corrective actions, and includes verification procedures and a recall plan. A qualified individual must oversee the plan, and facilities must also comply with updated GMPs. Manufacturers must analyze biological, chemical, and physical hazards, then put in place preventive controls to reduce or eliminate those risks. Key expectations include:

• Identification of CCPs (Critical Control Points)
• Monitoring and corrective actions
• Verification and oversight
• Recordkeeping and validation
• Failing to enforce HACCP or to document it properly is a recurring cause of FDA or USDA enforcement actions.

Examples of companies cited for failing to enforce HACCP often involve seafood and juice processors, industries where HACCP is federally mandated by the U.S. Food and Drug Administration (FDA). Violations are frequently detailed in FDA Warning Letters, which are publicly available enforcement actions. A prominent example is the seafood processor, which the FDA cited in a December 2024 warning letter following an inspection. The company's products were deemed "adulterated" due to serious violations of seafood HACCP regulations, including:

·      Inadequate hazard analysis - The company failed to properly control for histamine formation in canned tuna and sardines, which can cause scombrotoxin poisoning.

·      Inadequate critical limits - Issues were identified with temperature monitoring and time controls at multiple processing points.

·      Deficient corrective actions - The company's corrective action plans for addressing histamine issues were inadequate.

U.S. OSHA (Occupational Safety & Health Administration)

In the U.S., OSHA enforces worker health and safety. For manufacturing, compliance often requires regular hazard identification (machinery, chemicals, ergonomics), training workers on safe practices, keeping records of injuries or illnesses (OSHA logs), and providing appropriate PPE, ventilation, machine guards, etc. Violations can lead to fines, citations, or enforced shutdowns.

In July 2025, U.S. Department of Labor safety inspectors cited Keystone Foods, a distributor for Tyson Foods, for allegedly failing to protect employees against fire and explosion hazards at its Camilla, Georgia, poultry plant. OSHA determined that on Dec. 26, 2024, two workers at the plant, which is a wholly owned subsidiary of Tyson Foods Inc., were seriously burned when a hose filled with oil ruptured, igniting the oil mist and causing a fire and explosion in the boiler room. Inspectors concluded Keystone Foods did not ensure workers followed proper internal procedures nor the manufacturer’s guidelines when conducting maintenance on its boiler pump.

OSHA issued a citation to Keystone Foods for a serious violation under the OSH Act’s general duty clause and proposed penalties of $16,550.

U.S. EPA (Environmental Protection Agency)

Food manufacturers also must be concerned about environmental compliance with standards related to emissions, waste, chemical storage, pollutant discharge, and more. The U.S. EPA expects manufacturers to monitor pollutant levels, including in water or air. They must properly store, label, and dispose of chemicals, and report spills or environmental releases. In addition, food manufacturers must follow U.S. energy and emissions standards.

Failure to comply can lead to substantial fines, remediation orders, or injunctions. HP Hood LLC, a national ice cream manufacturer, agreed to pay a penalty of $115,849 in November 2023 to settle claims by the U.S. EPA that it violated federal laws regulating the handling and storage of ammonia at its facility in Suffield, Conn. As part of the settlement, the company agreed to complete system safety audits of its six facilities nationwide that have requirements under the risk management program (RMP) regulation.

At the time, the EPA commented, “When a company falls short in meeting its safety obligations, it puts workers, local communities, and the environment at risk. With the company operating facilities across the country, we have a duty to call out a lack of accountability when we see it.”

International Standards (ISO, IEC, etc.)

To sell globally, manufacturers adopt standards such as ISO 9001 (quality management), ISO 13485 (for medical devices), IEC 61215 / 61646 (photovoltaic module standards), and Conformity to EMC (electromagnetic compatibility) or CE directives (in Europe). These standards impose requirements for consistency, documentation, risk management, and continuous improvement.

Lessons Learned & Best Practices

These recent examples highlight the real consequences of non-compliance. To protect operations, reputation, and public health, manufacturers should:

Embed compliance culture: Not as a checkbox exercise, but as a daily mindset shared by workers and managers.

Document rigorously: Audit trails, change controls, software validation, and inspection logs must be accessible and defendable.

Automate and digitize: Use tools that enforce validation, traceability, and accountability.

Use a workflow platform: Tools like Weever Process enable you to configure regulatory workflows while ensuring traceability, data integrity, and oversight.

Audit and review frequently: Internal audits, mock inspections, and continuous review of compliance metrics prevent surprises.

Stay current on guidance: Monitor regulatory changes, such as evolving FDA data integrity expectations or environmental rules.

In an era where a single food illness-related outbreak can shutter a plant or decimate consumer trust, compliance is not optional. Compliance with the many laws related to food and drug manufacturing is your responsibility. By understanding each compliance domain, learning from recent failures, and deploying modern tools to enforce controls, manufacturers can their people, their customers, and their business.