Ensuring Compliance: What Recent FDA Actions Reveal About Global Food Safety Gaps

Recent enforcement trends from the U.S. Food and Drug Administration continue to send a clear signal to the global food industry: regulatory expectations under the Food Safety Modernization Act (FSMA) are not only firmly established - but they are also being actively enforced.

Across both domestic and international operations, the Agency’s use of Detention Without Physical Examination (DWPE) - as reflected in its Import Alert system and the issuance of Warning Letters, reveal a consistent pattern of non-compliance that extends well beyond isolated cases. These actions are not merely administrative; they directly impact market access, disrupt supply chains, and expose companies to significant financial and reputational risk.

A review of recent cases highlights several recurring deficiencies:

• Foreign Supplier Verification Programs (FSVP) that are incomplete, poorly documented, or entirely absent - undermining importer accountability and failing to meet requirements under 21 CFR Part 1 Subpart L

• Sanitation Preventive controls that are either inadequately designed or not effectively implemented, despite being formally documented

• Food safety systems that exist on paper but fail during execution, particularly in monitoring (§117.145), verification (§117.155), and corrective actions (§117.150), as outlined in FDA guidance

These findings point to a systemic issue: many organizations continue to approach compliance as a documentation exercise, rather than as an operational discipline embedded in daily activities.

Under FSMA, compliance is not satisfied by the existence of a food safety plan alone. The FDA expects evidence of execution - that hazards are properly identified, controls are validated, and procedures are consistently followed in practice, as detailed in its preventive controls’ framework and guidance

This distinction is where many companies fall short. In numerous Warning Letters, the FDA emphasizes that while procedures may be written, firms fail to demonstrate that they are effectively implemented. Missing records, inconsistent monitoring, and inadequate corrective actions remain among the most cited observations. In practical terms, this signals a breakdown not in knowledge, but in governance and oversight.

One of the most overlooked yet decisive factors in compliance is personnel competency. FSMA places explicit responsibility on facilities to ensure that individuals are qualified through education, training, or experience under 21 CFR §117.4 (Qualified Individuals).

However, regulatory actions repeatedly show that:

• Staff lack a practical understanding of FSMA requirements

• Training is conducted as a one-time event rather than a continuous process

• There is limited alignment between written procedures and actual plant-floor practices

Effective compliance requires that training translates into operational behavior - where employees understand not only what to do, but why it matters from a regulatory and food safety perspective.

The FDA’s current enforcement posture reflects a broader shift toward preventive, risk-based oversight, a central principle of FSMA. Companies that succeed in this environment are those that move beyond reactive compliance and adopt a proactive, systems-driven approach.

This includes:

• Integrating food safety into corporate governance and decision-making

• Establishing robust verification and internal audit programs

• Ensuring continuous improvement through data-driven monitoring and corrective actions

For international suppliers and U.S. importers alike, this is particularly critical. Failures in FSVP programs not only expose importers to regulatory action but can also lead to placement on Import Alerts (DWPE), effectively blocking products from entering the U.S. market.

Compliance with FSMA is often viewed through a regulatory lens, but its implications are fundamentally commercial. Market access to the United States depends on the ability to demonstrate control, transparency, and accountability across the supply chain, as reflected in FDA’s import oversight framework.

Companies that invest in robust food safety systems, competent personnel, and effective implementation do more than meet regulatory requirements - they build trust with regulators, customers, and consumers.

Conversely, those that rely on superficial compliance strategies face increasing scrutiny in an environment where enforcement is both data-driven and globally coordinated.

Recent FDA enforcement actions make one point unequivocally clear: compliance is no longer about having the right documents - it is about demonstrating that systems work, consistently and effectively.

Guest Contributor: Dr. Tania Martinez, Demos Global Group