What FDA Enforcement Changes Mean for Brands Choosing Manufacturers

What Changed in FDA's Enforcement Capacity

The FDA lost 3,859 employees in 2025 and another 473 in early 2026, according to OPM Federal Workforce Data reported by FoodNavigator-USA. The agency currently employs 16,602 staff. Within those cuts, approximately 170 workers came from the Office of Inspections and Investigations, the division responsible for on-the-ground facility oversight (SupplySide).

To put the inspection math in context: in FY2024, the FDA conducted 600 dietary supplement facility inspections (510 domestic, 90 foreign). That was up from approximately 500 in FY2023. But it still covered only about 5% of the estimated 10,000 to 12,000 registered facilities (SupplySide, citing FDA Director Cara Welch).

How Enforcement Is Changing, Not Just Shrinking

The headline numbers might suggest that fewer inspectors means fewer inspections across the board. The data tells a more nuanced story. In FY2025, the FDA actually conducted 694 more total inspections (across all product categories) than in FY2024 (Reed Smith analysis of FDA data). But food and cosmetics warning letters decreased from 148 in FY2024 to 93 in FY2025.

Two factors explain this apparent contradiction. First, the workforce reduction occurred in April 2025, so FY2025 numbers reflect only a partial year of reduced staffing. The full impact is expected in FY2026 data. Second, the FDA is actively shifting resources from routine surveillance toward risk-based targeting.

Meanwhile, new enforcement priorities are emerging even with fewer staff. Component identity testing violations were cited 66 times in 2024, up from zero in 2023 (cGMP Consulting). This signals that where the FDA does inspect, it is looking more carefully at specific cGMPcGMP (Current Good Manufacturing Practice)FDA's mandatory quality standards for supplement manufacturing facilities. requirements.

What This Means When Choosing a Manufacturer

Enforcement gaps test whether a manufacturer's quality systems are self-sustaining or externally driven. A manufacturer who maintains rigorous testing because it is the right thing to do operates the same way regardless of inspection frequency. A manufacturer who treats 21 CFR Part 11121 CFR Part 111The specific FDA regulation governing dietary supplement manufacturing practices. compliance as something to prepare for when an inspector is expected becomes a higher risk when inspectors visit less often.

These red flags carry more weight when routine oversight is declining:

• •No third-party audit history. If the manufacturer has never been audited by anyone other than the FDA, their external accountability depends entirely on an agency now conducting fewer routine visits.
• •Certifications lapsed or self-reported without renewal evidence. A GMP certificationcGMP (Current Good Manufacturing Practice)FDA's mandatory quality standards for supplement manufacturing facilities. that expired 18 months ago tells you more about a manufacturer than one that was just renewed.
• •No documented quality agreementQuality AgreementA contract defining quality responsibilities between a brand and its contract manufacturer., or a vague one. When external oversight shrinks, the specificity of your contractual quality commitments becomes the primary enforcement mechanism.
• •No prior FDA inspection on record. An estimated 95% of supplement facilities are not inspected in any given year. A manufacturer that has never been inspected has had no external compliance check at all.
• •Poor Form 483FDA Warning LetterA formal FDA communication notifying a company of significant regulatory violations. response history. The FDA's Elsa system uses prior inspection outcomes to target future inspections. A manufacturer with unresolved 483 observations is both a compliance risk and more likely to face focused follow-up.

For a complete evaluation framework, see our guide to evaluating supplement manufacturers.

Verification Signals That Replace Missing Oversight

When government inspection frequency drops, the question becomes: what other external checks can verify that a manufacturer is following Part 11121 CFR Part 111The specific FDA regulation governing dietary supplement manufacturing practices. requirements? These four signals carry the most weight.

The FDA has signaled openness to a formal third-party audit program for supplement facilities but has not made a formal proposal. Until that happens, voluntary third-party audits remain the closest substitute for routine government inspection (SupplySide, citing FDA Director Cara Welch).

Regardless of FDA staffing, the 21 CFR Part 111 requirements remain legally enforceable. Fewer inspectors does not mean fewer legal obligations.

How Inventory Ready's Assessment Accounts for Enforcement Data

Our assessment method cross-references manufacturers against the FDA enforcement database and inspection classification records. When a manufacturer has unresolved warning letters or a pattern of adverse inspection outcomes, that information factors into our assessment. See our full assessment method for details.

Primary Sources Checked

All statistics in this guide were verified on April 4, 2026 against the sources listed below. The FDA staffing numbers originate from OPM Federal Workforce Data as reported by FoodNavigator-USA (a secondary source). Inspection data originates from the FDA as reported by SupplySide. Warning letter data originates from FDA records as analyzed by Reed Smith LLP.

• FoodNavigator-USA, FDA and USDA staff cuts raise food safety risks (February 2026)
• SupplySide, FDA in 2025: navigating changes in food and dietary supplement investigations
• Reed Smith, FDA inspections in 2025: heightened rigor, data-driven targeting
• SupplySide, FDA increases annual domestic, foreign dietary supplement inspections
• SupplySide, FDA cGMP inspections: filling in the gaps with accredited third-party program
• cGMP Consulting, Top FDA observations in dietary supplement manufacturing
• FedScoop, FDA tech officials and DOGE staff reductions

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