FDA warning letters are on the rise

Food Safety News reported on May 22 that FDA warning letters to food manufacturers, sellers and importers are rising, describing the shift as part of a more mature enforcement phase under the Food Safety Modernization Act. The article was published as an opinion piece by a guest contributor, not as an FDA announcement. FDA’s own warning-letter page says the letters identify concerns and may be followed by later interactions that change the regulatory status of the issues described. ### What is a warning letter in FDA practice? FDA says a warning letter is a formal notice that identifies violations or other concerns and gives a company or individual a chance to address them. The agency says the response can include correction plans, after which FDA may check whether the corrections are adequate. FDA also notes that the public posting of a warning letter does not necessarily reflect the current status of a case because subsequent interactions may have occurred. (foodsafetynews.com) A 2024 FDA warning letter to Mena Food Group, for example, told the company to notify the agency in writing within 15 working days of the specific steps taken to address the cited violations. Food Safety News has also reported in recent warning-letter coverage that business owners have 15 days to respond. (fda.gov) ### Why are preventive controls showing up so often in this discussion? FDA’s preventive-controls framework is built into 21 CFR Part 117, the rule covering current good manufacturing practice, hazard analysis and risk-based preventive controls for human food. FDA says Part 117 establishes requirements for CGMPs and for hazard analysis and risk-based preventive controls for human food. The agency’s draft guidance says the rule implements the Food Safety Modernization Act provisions in section 418 of the Federal Food, Drug, and Cosmetic Act. (fda.gov) Food Safety News argued that preventive controls are now “baseline requirements,” along with supplier verification and traceability, after years of phased FSMA implementation. That framing is the publication’s characterization, but it aligns with FDA’s long-established rule structure requiring documented hazard analysis, preventive controls and related records for covered facilities. (fda.gov) ### How does supplier verification fit into the rise in letters? FDA’s Foreign Supplier Verification Programs rule requires importers to perform risk-based verification activities for food imported into the United States. FDA says importers must verify that the food is produced in a manner that provides the same level of public health protection as applicable U.S. requirements and is not adulterated or misbranded with respect to allergen labeling. (foodsafetynews.com) Food Safety News said foreign suppliers and importers face particular exposure because a warning letter to one facility can force U.S. importers to reassess supplier risk, documentation and verification activities. Recent Food Safety News items on FDA warning letters have focused heavily on FSVP failures, including April and February reports about importers that allegedly failed to verify supplier compliance. (fda.gov) ### Where does traceability enter the picture? FDA published new traceability-related actions on February 19, 2026, including guidance on implementation of the Food Traceability Rule and a notice exempting certain cottage cheese products. The agency said the rule establishes added recordkeeping requirements for companies that manufacture, process, pack or hold foods on the Food Traceability List, including records on shipping, receiving, initial packing and transformation. (foodsafetynews.com) FDA said those records are intended to help it identify recipients of designated foods more rapidly during foodborne illness outbreaks or other serious threats. Food Safety News cited traceability as one of the areas where companies should no longer expect extended learning periods before enforcement escalates. (fda.gov) ### What happens after a warning letter lands? FDA says a warning letter is an opportunity to correct problems, not the last step in an enforcement matter. Food Safety News wrote that unresolved violations can lead to further actions including import alerts and suspension of facility registration. FDA’s warning-letter materials similarly say the letters are part of a broader compliance and enforcement process, with later agency action possible if corrections are not satisfactory. (fda.gov) FDA’s warning-letter database was showing 3,495 entries on the page snapshot available as of May 20, 2026. Companies tracking food enforcement can monitor new postings there, while food businesses subject to the traceability rule can also follow the docket FDA-2025-D-2837 referenced in FDA’s February 19 guidance. (fda.gov) (foodsafetynews.com)