FDA FSVP Warning Letters Have Nearly Tripled in 2026: What Importers Need to Know
September 22, 2026 · FSVP Associates
Foreign Supplier Verification Program (FSVP) enforcement has picked up sharply this year. FSVP Associates’ review of FDA’s public warning letter records found 52 FSVP-specific warning letters issued between January 1 and August 31, 2026, compared to 19 over the same period in 2025, an increase of about 174%.
Why FSVP exists, and why enforcement is catching up now
FSVP isn’t a new rule, but the way FDA is enforcing it has clearly shifted, and understanding the timeline explains why.
The Food Safety Modernization Act (FSMA), signed into law in January 2011, was a sweeping overhaul of the U.S. food safety system, shifting the emphasis from reacting to contamination toward preventing it in the first place. FSVP was one of the specific programs created under FSMA, with a more targeted purpose: imported food should meet the same safety standards as food made in the United States, and someone on the U.S. side of the transaction needs to be responsible for verifying that. FDA spent years working out the details, and the actual FSVP rule wasn’t finalized until November 2015.
Even then, importers weren’t expected to comply overnight. The first compliance date didn’t arrive until May 2017, and depending on the size of the importer and the type of supplier involved, some businesses had until as late as 2019 or 2020 before the rule applied to them. FDA’s first-ever FSVP warning letter wasn’t issued until 2019, years after the law existed, following a Salmonella outbreak traced to an importer with no FSVP in place.
In other words, there was a long runway. Importers had years to build a program before FDA started actively checking for one. That runway is effectively over. The years of phased-in compliance dates and light early enforcement have given way to a period where FDA is actively verifying that the programs it required years ago actually exist. The 2026 numbers reflect an older law finally being enforced at scale.
FDA is operating with fewer resources
At the same time, FDA’s own staffing has shrunk. FSVP Associates’ review of U.S. Office of Personnel Management federal workforce data found that FDA’s staff count fell by 3,880 in FY2025, followed by another 744 employees so far in FY2026.
FDA has also faced significant constraints in its food inspection capacity. The U.S. Government Accountability Office has reported that FDA has consistently fallen far short of its foreign food facility inspection targets, with FDA officials identifying limited workforce capacity as the agency’s primary challenge to meeting those targets.
Against that backdrop, the nearly threefold increase in FSVP warning letters in 2026 is particularly significant.
One possible explanation is that FSVP is receiving greater enforcement attention, with FDA placing increased emphasis on importer accountability and compliance with Foreign Supplier Verification Program requirements. If so, the increase in warning letters may reflect a broader shift toward stronger FSVP enforcement, even as FDA operates with fewer overall resources.
Another possibility is more operational: with fewer personnel and limited inspection capacity, FDA may be relying more heavily on formal enforcement once FSVP deficiencies are identified, rather than using resources for repeated follow-up before escalating a case. The available data does not establish what is driving the increase, and both factors may be contributing.
Whichever explanation is behind the trend, the 2026 data points in the same direction for importers: FSVP compliance remains an active area of FDA enforcement. With warning letters increasing despite broader resource constraints, importers should ensure that their FSVP requirements are being addressed and that the required documentation is in place before FDA requests it.
The pattern behind most letters
The substance of the 2026 FSVP warning letters is also notably consistent. A recurring issue is one of the most basic requirements of the rule: importers have failed to develop, maintain, and follow an FSVP for the foods they bring into the United States.
The individual circumstances vary, and some letters cite additional deficiencies involving supplier evaluation, verification activities, or required documentation. But the underlying issue often starts in the same place: when FDA asks for the importer’s FSVP records, an adequate program is not there to support the imported food and foreign supplier.
That pattern is important in the context of the broader increase in enforcement. Many of these cases are not centered on obscure technical violations. They involve foundational FSVP requirements that have been in effect for years.
Why this matters more than a raw count of letters
A warning letter isn’t the end of the process, and warning letters are only one part of FDA’s FSVP enforcement activity. FDA maintains Import Alert 99-41 specifically for FSVP noncompliance, allowing food associated with listed importers to be detained without physical examination (DWPE). The current Red List contains thousands of individual importer-product listings, although a single importer may appear across multiple products or product categories. In some cases, FDA may place a broad range of an importer’s foods under DWPE when the apparent FSVP violations extend across its imports.
In practical terms, FSVP deficiencies can move beyond an inspection finding or warning letter and directly affect an importer’s ability to bring food into the United States. Warning letters are also publicly available on FDA’s website, meaning FSVP compliance issues can become visible to customers, distributors, business partners, and others.
What this means for Importers
The 2026 trend does not point to a new FSVP requirement. It points to increased enforcement activity around requirements that have already been in place for years.
For importers, the practical takeaway is straightforward. The FSVP should be developed before importing covered food into the United States and maintained as those imports continue. The program should reflect the foods being imported, the foreign suppliers producing them, the applicable hazards, and the verification activities required to support those supplier relationships.
The data we are seeing in 2026 suggests greater FDA enforcement activity around FSVP compliance. Whether that trend continues at the same pace remains to be seen, but the direction this year is clear: importers should not wait for an FDA records request or inspection to determine whether their FSVP documentation is in order.
FSVP Associates’ review of FDA’s public warning letter records found 52 FSVP-specific warning letters issued between January 1 and August 31, 2026, compared to 19 over the same period in 2025, an increase of about 174%.
A recurring issue in FDA’s 2026 FSVP warning letters is the failure to develop, maintain, and follow an FSVP for the foods being imported. Some warning letters also identify additional deficiencies involving supplier verification, required documentation, or compliance with modified FSVP requirements.
FDA may take action beyond issuing a warning letter. Import Alert 99-41 allows FDA to detain without physical examination (DWPE) specified foods offered for import by FSVP importers identified on the Red List. In some cases, an importer may be subject to DWPE for all foods it imports when FDA determines that the apparent FSVP violations extend across those foods.
The FSVP importer is responsible for compliance with the applicable FSVP requirements. One or more Qualified Individuals must develop the FSVP and perform the activities required under the FSVP regulation. A Qualified Individual must have the education, training, or experience necessary to perform the applicable activity and must be able to read and understand the records being reviewed.
For food subject to FSVP, the required program should be developed before the food is offered for import into the United States and maintained as imports continue. Importing or offering food for import without an FSVP that meets the applicable requirements is prohibited under the FD&C Act.
Not sure whether your FSVP program would hold up to an FDA inspection? FSVP Associates helps importers build, document, and maintain FSVP programs that are ready before FDA ever comes asking. Get a Quote