FDA Enforcement Review: Looking Back at 2025 and Bracing for Continued Unpredictability in 2026

In 2025, the U.S. Food and Drug Administration (“FDA”) and U.S. Department of Justice (“DOJ”) pursued significant criminal, civil, and regulatory enforcement actions grounded in longstanding enforcement priorities across FDA-regulated product areas, including drugs, medical devices, and food. At the same time, FDA and DOJ enforcement activity increasingly reflected the current administration’s stated policy objectives. This review describes evolving enforcement priorities and recent developments relevant to medical products companies and other FDA-regulated entities, as well as the potential impact of a recent DOJ reorganization and workforce reductions at both FDA and DOJ. The review also highlights notable 2025 criminal, civil, and regulatory enforcement matters that involved alleged violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”) and FDA regulations and provides key takeaways for 2026.

Evolving Priorities and Recent Developments

New and Reframed Priorities

Over the past year, FDA and DOJ announced enforcement actions related to longstanding priority areas, including product quality and safety, unapproved products that pose patient risk, and clinical research fraud. However, enforcement initiatives launched in 2025 have been increasingly framed to align with the goals of the Make America Healthy Again (“MAHA”) movement¹ and other administration priorities. For example, U.S. Department of Health and Human Services (“HHS”) Secretary Robert F. Kennedy Jr. described the administration’s “crackdown” on allegedly false and misleading direct-to-consumer (“DTC”) drug advertising as an effort to ensure “radical transparency” regarding safety risks and to “break the cycle of overmedicalization that drives America’s chronic disease epidemic.” Furthermore, while the government has pursued FDCA enforcement theories related to off-label promotion more cautiously in recent years due to litigation risk from increasingly robust First Amendment jurisprudence, new enforcement initiatives aimed at curbing gender-affirming care suggest a potential revitalization of off-label promotion theories in this context.

Reducing “Overcriminalization” in Regulatory Matters

Another notable development in the FDCA enforcement landscape is reflected in Executive Order (“EO”) 14294, titled “Fighting Overcriminalization in Federal Regulations.” Issued on May 9, 2025, EO 14294 directs agencies to curb prosecutions of criminal regulatory offenses, stating that criminal enforcement of strict liability regulatory offenses is “generally disfavored.”² The EO emphasizes that criminal prosecution should be a last resort, encourages reliance on civil and administrative enforcement where feasible, calls for clear mens rea standards, and requires agencies to inventory criminal regulatory offenses under their jurisdiction within one year. The EO may have particular significance for FDA-regulated industries given the FDCA’s strict liability misdemeanor provisions that have formed the basis of significant criminal resolutions and jury verdicts in the past.

If implemented as written, EO 14294 could significantly reduce the volume of criminal FDCA enforcement, as misdemeanor cases may become less palatable, and felony cases would expose defendants to the potential for mandatory exclusion from participation in government programs.³ Implementation could also lead to greater reliance on FDA civil enforcement tools (e.g., injunctions and seizures) and on civil False Claims Act (“FCA”) theories.

Impact of DOJ Reorganization and Workforce Reductions

While new priorities are prompting new enforcement initiatives, significant workforce reductions and organizational changes at FDA and DOJ are likely to impact future enforcement activity. The administration’s focus on reducing the size and scope of the federal workforce and agency budgets, along with changes in the workplace environment, resulted in the departure of substantial numbers of experienced FDA and DOJ personnel in 2025, including attorneys and investigators with specialized FDCA expertise and institutional knowledge.

A reorganization at DOJ headquarters resulted in the dissolution of the Consumer Protection Branch (“CPB”),⁴ which historically supervised and coordinated civil and criminal FDCA enforcement matters. CPB had been authorized to oversee and conduct such matters “to ensure uniform and balanced application” of the statute and had “exclusive authority to defend in federal district courts FDA actions” challenged under the Administrative Procedure Act (“APA”) or the U.S. Constitution.⁵ Former CPB personnel and enforcement functions have been reassigned primarily to the Civil Division’s new Enforcement & Affirmative Litigation Branch and to a newly created Health & Safety Unit within the Criminal Division’s Fraud Section.⁶

The loss of CPB as a centralized civil and criminal enforcement hub may affect the consistency, pacing, and selection of enforcement theories in future FDCA matters. In its absence, greater responsibility may shift to individual U.S. Attorneys’ Offices or DOJ components that may have less experience with the complexity of the FDCA and FDA regulations and less familiarity with longstanding FDA policy and precedent. The reorganization may also undermine the effective coordination and cooperation between DOJ and FDA gained from close institutional relationships built over decades between CPB, FDA’s Office of Chief Counsel and FDA’s Office of Criminal Investigations.

At FDA, workforce reductions and internal reorganizations may affect inspection capacity, investigative timelines, and the agency’s ability to support complex criminal enforcement actions, particularly those requiring sustained coordination with DOJ. Civil FDCA enforcement tools such as injunctions and seizures also require significant FDA resources and coordination with DOJ. Accordingly, practical constraints on FDA enforcement capacity may further increase DOJ’s reliance on FCA or other non-FDCA-based enforcement theories—which could potentially lead to DOJ investigations and corporate resolutions with less substantive FDA involvement.

Looking Back: Notable FDCA and Related Enforcement in 2025

This section highlights notable enforcement activity in 2025, beginning with FDCA criminal and civil actions involving medical devices, prescription drugs, and food, before discussing recent FCA settlements related to alleged FDA regulatory violations. These matters provide insight into the enforcement approaches and risk areas likely to shape enforcement activity in 2026.

Medical Devices

Several individual device-related criminal prosecutions in 2025 have underscored potential personal liability for criminal FDCA violations. The government also entered several deferred prosecution agreements (“DPAs”) and non-prosecution agreements (“NPAs”) to resolve corporate criminal investigations involving medical devices. Each of these matters was resolved without requiring the medical device company to plead guilty to FDCA or other violations.

Individual Prosecution of Former Magellan Executives

In March 2025, three former executives for Magellan Diagnostics, Inc. (“Magellan”) entered guilty pleas in the U.S. District Court for the District of Massachusetts in connection with an alleged scheme to conceal a malfunction in lead testing devices that produced inaccurately low lead test results. As noted in Ropes & Gray’s 2024 Enforcement Review, Magellan previously pleaded guilty to related misdemeanor FDCA charges, entered into a DPA with respect to related felony charges, and was ordered to pay $42 million.

• The former Magellan CEO and COO each pleaded guilty to one count of causing, with the intent to defraud and mislead, the introduction of devices into interstate commerce that were misbranded because the company had not submitted to FDA (1) a 510(k) submission alerting the agency to device changes and (2) reports of corrections initiated with respect to the devices. The former CEO was sentenced to one year of home detention and ordered to pay a $10,000 fine. The former COO also pleaded guilty to an additional felony misbranding count related to the failure to file medical device reports and was sentenced to nine months of home detention and ordered to pay a $20,000 fine.
• Magellan’s former Director of Quality Assurance and Regulatory Affairs pleaded guilty to one count of making false statements to FDA and was sentenced to one year of probation (with the first six months to be served in home detention) and ordered to pay a $600 fine.

Individual Prosecution of Provider Who Distributed Recalled Respiratory Devices

In December 2025, a physician and owner/operator of a Washington sleep clinic pleaded guilty in the U.S. District Court for the Eastern District of Washington to adulterating and misbranding medical devices while they were held for sale, with the intent to defraud or mislead. The action relates to a series of Class I recalls that Philips Respironics (“Philips”) initiated in June 2021 for several of its continuous positive airway pressure (“CPAP”) machines, bi-level positive airway pressure (“BiPAP”) machines, and certain mechanical ventilators due to problems arising from allegedly toxic foam used in the devices.⁷

According to the plea agreement, the defendant allegedly purchased at least 500 used and recalled Philips CPAP and BiPAP machines from an online reseller and directed staff to remove the foam using screwdrivers, hooks, and other tools before distributing them to patients. DOJ alleged the altered products were misbranded due to lack of 510(k) clearance and adulterated due to lack of PMA approval and because of other quality-related violations. The clinic allegedly billed these misbranded and adulterated devices to Medicaid using false representations that the devices were new and in good working order. Sentencing is scheduled for March 2026. The defendant faces up to three years’ imprisonment, a fine of up to $250,000, and restitution.

Corporate Medical Device Resolutions

DOJ announced three notable device-related FDCA corporate resolutions in 2025, none of which involved corporate guilty pleas.

• In February 2025, DOJ announced a $1 million settlement with Advanced Inventory Management, Inc. (“AIM”) to resolve an investigation into the company’s alleged sale of medical devices imported from foreign suppliers that were not authorized by their manufacturers for sale in the United States. AIM and its sole owner and CEO entered DPAs filed in the U.S. District Court for the Northern District of Illinois in connection with a one-count felony information charging each defendant with misbranding of a medical device while held for sale. Since the government did not allege that the products lacked required regulatory clearance or approval in the United States, this case appears to be primarily a fraud case based on FDCA enforcement theories. Under the terms of the three-year DPA, AIM agreed to pay $1 million, implement a compliance and ethics program, and provide the government with annual reports on remediation efforts and implementation of the program. The CEO’s DPA required that he assist AIM in abiding by the terms of its DPA, complete 100 hours of community service, and fulfill other obligations.
• In August 2025, Kimberly-Clark Corporation agreed to pay approximately $40.4 million in connection with a one-year felony DPA resolving a long-running criminal investigation into the alleged misleading marketing and distribution of surgical gowns. In a criminal information filed in the U.S. District Court for the Northern District of Texas, DOJ alleged that a company employee conducted fraudulent testing on MicroCool gowns to avoid having to submit a premarket notification to FDA after making a change to the gowns. The resolution involved the deferral of felony adulteration charges. Under the DPA, Kimberly-Clark agreed to pay the $40.4 million noted above, provide ongoing cooperation with DOJ, implement compliance and ethics measures, and report to DOJ regarding remediation and implementation of those measures. 
• In November 2025, DOJ announced that Aesculap Implant Systems (“Aesculap”) entered an NPA in connection with its alleged introduction of adulterated medical devices into interstate commerce. The NPA is not publicly available, but DOJ’s press release suggests it relates to Aesculap’s alleged distribution of an uncleared high-speed surgical drill and an uncleared reusable sterilization container for medical instruments. As part of a global resolution, Aesculap also agreed to pay $38.5 million to resolve FCA allegations related to the sale of the VEGA Knee System from 2010 to 2023 despite allegedly knowing it failed at an unacceptably high rate and was not reasonable or necessary for use in knee replacement surgeries. The FCA complaint also alleged Anti-Kickback Statute (“AKS”) violations.
  • In a related matter, former Aesculap regulatory affairs specialist Peter Stoll III was sentenced to one year in prison in January 2024 and ordered to pay more than $122,000 in restitution to Aesculap after pleading guilty to one felony count of introducing adulterated and misbranded devices into interstate commerce.⁸ Allegations included that he forged FDA clearance letters for the adulterated devices at issue in the corporate NPA.

The compliance program elements in the DPAs noted above generally track provisions used in several prior medical device DPAs, including the Magellan DPA entered into in May 2024.⁹ In recent years, CPB’s Corporate Compliance and Policy Unit played a significant role in standardizing and “templatizing” compliance provisions in DPAs and NPAs.¹⁰ It remains to be seen whether the government will continue to use templates developed by CPB in future resolutions, in the aftermath of the DOJ’s restructuring.

Drugs

Investigations Related to the Provision of Gender-Affirming Care

Perhaps the most significant FDCA drug-related enforcement development this year was the issuance of EO 14187 in January 2025, directing federal agencies to significantly limit nationwide access to gender-affirming care for individuals under age 19, and U.S. Attorney General Pamela Bondi’s April 2025 follow-on memorandum outlining planned efforts to use the FDCA and FCA “to investigate and hold accountable medical providers and pharmaceutical companies that mislead the public about the long-term side effects of chemical and surgical mutilations.” Notwithstanding the Justice Manual’s recognition of court holdings that truthful, non-misleading commercial speech does not itself violate the FDCA,¹¹ the Bondi memorandum asserts that “even if otherwise truthful, the promotion of off-label uses of hormones . . . run[s] afoul of the FDA’s prohibitions on misbranding and mislabeling.”

In June 2025, Assistant U.S. Attorney General Brett Shumate announced DOJ civil enforcement priorities consistent with the above-described directives. Shortly thereafter, in July 2025, DOJ took the unusual step of publicly announcing that it had issued more than 20 subpoenas to hospitals, physicians, and clinics involved in gender-affirming care. Certain of these subpoenas have been challenged in whole or in part, and several have subsequently been quashed by federal district courts,¹² although proceedings remain ongoing in various district and appellate courts. Also in July 2025, in remarks at an FTC workshop, DOJ’s then Chief of Staff disclosed that the government had “issued subpoenas to major manufacturers of the drugs used in trans-related medical interventions for possible violations of drug marketing laws and the [FDCA].”

Life sciences companies should closely monitor ongoing litigation and further developments from these investigations, given implications of potential federal court rulings regarding intended use under the FDCA and the scope of permissible scientific exchange between medical product manufacturers and providers.

Clinical Trial Fraud

Although DOJ initiated fewer clinical trial fraud prosecutions in 2025 than in prior years, it continued to pursue actions against contract research organizations (“CROs”) and investigators who allegedly falsified clinical data or misrepresented trial activities.

• In March 2025, the co-owners of Florida-based CRO A&R Research Group (“A&R”) pleaded guilty in the U.S. District Court for the Southern District of Florida to conspiracy to commit wire fraud, admitting to falsifying subject eligibility and clinical data in the trial of an asthma drug. In addition to owning the CRO, the defendants held key roles at the site, with one serving as A&R’s Clinical Research Director and the other its Regulatory and Contract Affairs Manager. Defendants were each sentenced to three years of supervised release.
• In a related case, a former investigator for A&R pleaded guilty to making false statements to FDA, admitting to falsely representing that he was present at every subject visit during two asthma clinical trials.¹³ In June 2025, the U.S. District Court for the Southern District of Florida sentenced him to three years of supervised release and ordered him to pay a $10,000 fine and nearly $8,000 in restitution to victims.

Unlawful Distribution of Animal Drugs

The government continued to take action against the unlawful manufacture, marketing, and distribution of animal drugs.

• In June 2025, following the corporate criminal plea resolving felony FDCA allegations against FDA-registered outsourcing facility U.S. Compounding (“USC”) that was highlighted in Ropes & Gray’s 2024 Enforcement Review, a jury in the U.S. District Court for the Southern District of New York convicted USC’s former Vice President of Sales of one count of conspiracy to distribute adulterated and misbranded prescription animal drugs with the intent to defraud and mislead.¹⁴ Shortly after entry of this jury verdict, USC’s former CFO and East Coast Sales Manager were each charged with and pleaded guilty to the same charge.¹⁵ USC’s former CFO also pleaded guilty to making false and misleading statements regarding the company’s financial results, the adequacy of internal controls, and the absence of fraud in filings with the Securities and Exchange Commission. All three defendants are scheduled to be sentenced by April 2026.
• In December 2025, the U.S. Attorney’s Office for the Northern District of Florida announced the indictment of an individual allegedly involved in the manufacturing, marketing, and sale of adulterated animal drugs directly to consumers over the internet.¹⁶
• In April 2025, in one of the year’s only drug-related FDCA injunctions, the U.S. District Court for the District of Arizona enjoined AniCell Biotech LLC and its CEO from manufacturing and distributing unapproved new animal drugs deemed to be unsafe and thus adulterated. According to the complaint, defendants manufactured and distributed animal cell- and tissue-based products derived from equine amniotic tissue for use in animals and continued to market those products despite receiving multiple FDA warnings that the products were unapproved new animal drugs.

Crackdown on DTC Drug Advertising

HHS and FDA signaled a significantly more aggressive posture toward drug advertising and promotion in 2025, with a particular focus on DTC advertising and online and social media promotion. As described in a Ropes & Gray Alert and Podcast, on September 9, 2025, the agencies announced plans to pursue “aggressive enforcement” of DTC drug advertising. In connection with this announcement, FDA has to date issued more than 125 warning and untitled letters to drug and biologics manufacturers, compounding pharmacies, outsourcing facilities, and telehealth companies alleging false or misleading promotional claims.

Food

As discussed in a prior Enforcement Review, the infant formula industry has faced sustained federal scrutiny since disruptions to the nation’s infant formula supply in 2022. That scrutiny continued in 2025.

• In March 2025, FDA announced Project Stork, a set of actions and initiatives focused on ensuring the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply. In July 2025, FDA sent a letter to firms involved in the manufacturing and distribution of infant formula, baby foods, and foods intended for children, describing FDA actions to streamline the collection, analysis, and dissemination of crucial recall information.
• In August 2025, DOJ announced that infant formula company Able Groupe, Inc. pleaded guilty in the U.S. District Court for the Northern District of Texas to importing food without providing prior notice to FDA, with intent to defraud or mislead, and to smuggling goods into the United States.¹⁷ According to court documents, Able Groupe sold European infant formula into the United States beginning in 2019 despite FDA import alerts related to nutrient and labeling deficiencies. In its plea agreement, Able Groupe admitted to attempting to avoid FDA detection by using false commodity descriptions. The criminal case followed an FDA inspection that led to a recall of approximately 76,000 units of formula and the cessation of the company’s operations in August 2021. In its press release, DOJ noted that the case marked the first time a defendant pleaded guilty to a felony prior notice violation and highlighted that the matter would result in a total government recovery of approximately $2.3 million. Sentencing for the Able Groupe is scheduled for February 2026.
• In December 2025, FDA issued warning letters to four major retailers for their alleged failure to adequately remove recalled infant formula from their store shelves. The affected products had been recalled by the manufacturer in November 2025 due to a potential connection to a multistate outbreak of infant botulism. FDA reported that the retailers continued to offer recalled product for purchase in locations across several states after receiving written notice of the recall. FDA described these warning letters as underscoring a “concerning problem” with recall effectiveness at the retail level. In conjunction with these December 2025 warning letters, FDA also issued a letter reminding food manufacturers, packers, distributors, exporters, importers, and retailers of their legal responsibilities with respect to food recalls.

Last year also included one notable food-related enforcement action outside the infant formula context. In March 2025, DOJ announced that the U.S. District Court for the District of Maryland entered a consent decree against ice cream manufacturer Totally Cool, Inc. and its CEO in connection with alleged current good manufacturing practice violations. Prior to the settlement, FDA inspections identified Listeria monocytogenes contamination and multiple food safety violations at a Totally Cool facility, prompting FDA to suspend the facility’s registration and the company to recall more than 60 of its products in June 2024.

Life Sciences FCA Resolutions

DOJ appears increasingly willing to rely on the FCA alone to address conduct implicating FDA regulatory requirements. Several device matters were resolved solely under the FCA in 2025, including cases involving issues bearing on compliance with FDA quality system requirements.

• In July 2025, DOJ announced that a maker of genomic sequencing technology agreed to pay $9.8 million to resolve FCA allegations connected to genomic sequencing systems. According to the settlement agreement, the government contends that between 2016 and 2023, the company marketed and sold genomic sequencing systems to government agencies with software that had cybersecurity vulnerabilities and lacked an adequate security program and sufficient quality systems to identify and address those vulnerabilities. This matter is notable given priorities under DOJ’s Civil Cyber-Fraud Initiative as well as the Food and Drug Omnibus Reform Act (“FDORA”) amendments making failure to comply with FDA cybersecurity requirements a prohibited act under the FDCA.¹⁸ While we have not yet seen an FDCA case that directly alleges failure to comply with FDA cybersecurity requirements, this settlement underscores the importance of considering cybersecurity controls in relation to quality systems processes.
• In September 2025, DOJ announced an $8 million settlement with an orthopedic device manufacturer. The settlement resolves allegations that the company marketed and sold knee replacement systems for several years despite knowledge that two of its components failed prematurely at higher-than-acceptable rates, rendering the systems not reasonable or necessary for use during total-knee replacement surgeries.

At least four FCA cases resolved in 2025 relied on allegations connected with the marketing of FDA-cleared or -approved medical products for unapproved intended uses.

• In March 2025, Diopsys, Inc. agreed to pay up to $14.25 million to resolve allegations that it caused the submission of false claims by promoting its NOVA device for uncleared uses between 2015 and 2021. The complaint alleged that Diopsys made substantial changes to its NOVA device requiring new clearance and marketed the device in ways that induced medically unnecessary testing claims. Under the settlement, Diopsys will make up to $1.225 million in guaranteed payments and up to $13.025 million in contingent payments.
• In May 2025, DOJ announced that Assertio Therapeutics, Inc. (“Assertio”) agreed to pay $3.6 million to resolve allegations that it caused the submission of false claims for its fentanyl nasal spray Lazanda. Assertio allegedly targeted high-volume pain specialists, thereby inducing prescriptions for individuals without breakthrough cancer pain and causing claims submitted to Medicare and TRICARE for prescriptions that were not medically necessary.
• In September 2025, Semler Scientific, Inc. (“Semler”) and a former distributor agreed to pay a total of nearly $37 million to resolve allegations related to the marketing of their FloChec and QuantaFlo devices. The settlement agreements alleged that Semler and the distributor marketed and distributed these devices as digital ankle-brachial index (“ABI”) products without FDA clearance for this intended use. Semler agreed to pay $29.75 million and enter into a five-year Corporate Integrity Agreement with HHS-OIG, and its former distributor agreed to pay $7.2 million.
• In December 2025, DOJ announced that RST-Sanexas, Inc., its owners, and certain related entities (collectively, “Sanexas”) agreed to pay $1.5 million to resolve FCA allegations related to marketing the company’s electrical stimulation devices. Between 2017 and 2022, defendants allegedly marketed the RST Sanexas neoGEN-Series device for uses outside its FDA clearance, including for the treatment of acute pain, improved nerve health, nerve regrowth, epidermal nerve fiber density (“ENFD”) testing, and as a combination product with vitamin injections. DOJ further alleged AKS violations by Sanexas. The settlement relates to a broader national investigation that resulted in recent settlements with health care providers and clinics as well.¹⁹

The FCA has been an oft-used enforcement tool against life sciences companies and healthcare providers for many years. However, federal courts appear increasingly more open to the argument that the qui tam provisions of the FCA are unconstitutional. On December 12, 2025, the U.S. Court of Appeals for the Eleventh Circuit heard argument in U.S. ex rel. Zafirov v. Florida Medical Associates, considering whether these provisions violate Article II of the U.S. Constitution. As described in our recent Alert, appellants argue that relators exercise core executive power without appointment or adequate presidential control. The relator and the government counter that historical practice and statutory safeguards, such as government intervention, dismissal and settlement authority, and court-supervised limits on relator participation, preserve sufficient executive oversight. Given the FCA’s centrality to health care enforcement, the court’s resolution could materially affect whistleblower-driven cases in FDA-regulated sectors and potentially set up U.S. Supreme Court review.

See our recent Ropes & Gray Alert for a broader cross-industry discussion of FCA resolutions in 2025 and key takeaways.

Looking Ahead to 2026

Recognizing the limitations of prediction in an uncertain climate, industry should nonetheless be prepared for continued, aggressive enforcement related to the administration’s policy priorities, such as addressing allegedly false and misleading advertising and promotion and the provision of gender-affirming care for minors. It also remains critical for companies to continue investing in quality and compliance programs. While organizational changes at FDA and DOJ are likely to affect enforcement capacity and processes for pursuing matters involving FDA-regulated products, and the potential impact of EO 14294 regarding “fighting the overcriminalization of regulatory violations” remains to be seen, industry should not assume that the government will overlook violations of FDA regulatory requirements related to the quality and safety of medical products and foods. Further, prosecutors have historically relied on non-FDCA enforcement theories in criminal cases involving FDA-regulated products which often allow for higher sentences and may permit the consideration of additional evidence that would not otherwise be permitted. Reliance on statutes outside the FDCA may increase in light of EO 14294 and the current administration’s emphasis on limiting criminal enforcement of misdemeanor regulatory offenses.

While this review summarizes significant resolutions from 2025, ongoing matters may not yet have resulted in public announcements, as cases can take time to develop before information about them is public. Further, serious enforcement tends to accompany serious threats to public health and safety, regardless of an administration’s stated priorities. Companies and their executive teams should continue to emphasize the importance of compliance and maintain robust compliance and quality systems focused on early detection, corrective action, and prevention.

Ropes & Gray will continue to monitor enforcement actions and trends related to FDA-regulated products in 2026. If you have any questions, please contact any member of our Life Sciences Regulatory and Compliance practice or your usual Ropes & Gray advisor.