Branching off: The restructuring of the DOJ’s Consumer Protection Branch and what it means for companies

Historically, the now-shuttered CPB was responsible for investigating violations of the Federal Food, Drug, and Cosmetics Act (FDCA); the Controlled Substances Act; the Consumer Product Safety Act (CPSA); and other statutes related to consumer health and safety and consumer fraud. The CPB also worked closely with regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC). As such, the CPB was an extraordinarily important unit to companies and individuals in regulated sectors like life sciences and food. The CPB grew rapidly over the years, especially in the 2010s, and its docket of criminal and civil cases grew commensurate with that uptick in attorneys.

The organizational structure of CPB was unique: housed within the DOJ’s Civil Division, the branch handled both civil and criminal investigations and prosecutions. The recent reorganization addresses this anomaly – and likely seeks to sharpen areas of expertise of DOJ attorneys – by dividing the civil and criminal functions of the CPB. Civil functions will now effectively reside in the newly-constituted Enforcement & Affirmative Litigation Branch of the Civil Division, while criminal investigations and prosecutions will now fall under the Health & Safety Unit of the Fraud Section of the Criminal Division.

Within the Civil Division, the Enforcement & Affirmative Litigation Branch is composed of two sections, reflected by its title. While the Affirmative Litigation Branch is responsible for litigating against “states, municipalities, and private entities that interfere with or obstruct federal policies,” the Enforcement Section is responsible for pursuing impact litigation under statutes such as the FDCA and the CPSA.

Within the Criminal Division, the Health & Safety Unit is now housed within the Fraud Section of the DOJ, per updates that were made to the DOJ website late last year. The Health & Safety Unit will be responsible for investigating and criminally prosecuting violations of statutes like the FDCA and CPSA, as well as other federal public health and safety laws. In practice, the attorneys in this section will likely focus on many of the same criminal matters that were previously handled by the CPB. 

Although the branch itself has been dissolved, its mission seems primed to continue across the Civil and Criminal Divisions. Both explicitly in press releases and implicitly through resource allocation, the DOJ has indicated its intent to prioritize civil and criminal enforcement of consumer fraud laws:

• According to its updated website, the Health & Safety Unit has signaled that it will prioritize enforcement actions regarding “adulterated, misbranded, or counterfeit food, drugs, and devices; transportation safety; dangerous consumer product defects;” and “other threats that arise when companies and individuals ignore legal obligations meant to help ensure the safety of the products they distribute to consumers.” It will also pursue actions for failing to “maintain sanitary facilities,” hiding safety information, and making significant public misrepresentations. Additionally, like the CPB, the Health & Safety Unit will work closely with regulatory agencies like the FDA and U.S. Department of Transportation.
• In announcing the establishment of the Enforcement & Affirmative Litigation Branch within the Civil Division in September 2025, Civil Division Assistant Attorney General Brett A. Shumate stated that “[t]his restructuring reflects the Department’s commitment to aggressively protecting consumers and advancing the interests of the United States.”  The description of the Health & Safety Unit reflects a similar priority: “to protect public health and safety” from a criminal enforcement perspective.
• After reports in April 2025 that the CPB prosecutors who handled criminal cases would be relocated to the Criminal Division, it took some time for the DOJ to officially communicate the office to which these attorneys would be transferred. The DOJ announced the creation of the Enforcement & Affirmative Litigation Branch on September 25, 2025, but the Health & Safety Unit was established without an official corresponding announcement. Its webpage was created on December 2, 2025. It is not presently known how many criminal prosecutors are assigned to this new unit.
• The creation of the Health & Safety Unit stands in contrast to other DOJ units that have been substantially cut; for example, the number of attorneys in the DOJ’s Public Integrity Unit has been significantly decreased this year, according to AP News, and Reuters reported that the number of FCPA Unit prosecutors focusing on FCPA and Foreign Extortion Prevention Act (FEPA) enforcement have also been reduced as of this summer. 
• This unit appears to be focused first and foremost on investigating knowing, intentional, and fraudulent conduct. As announced in a May 12, 2025 memorandum by Matthew Galeotti, one of the DOJ’s white-collar crime priorities was to investigate and prosecute “fraud that threatens the health and safety of consumers.” The new Health & Safety Unit will have jurisdiction over statutes that contain strict liability offenses, and by Executive Order 14294 (May 9, 2025), the Administration directed the Department that “[s]trict liability offenses are ‘generally disfavored’” and “[p]rosecutions of criminal regulatory offenses should focus on matters where a putative defendant is alleged to have known his conduct was unlawful.”

The DOJ’s reorganization of the CPB into separate units within the Criminal and Civil Divisions amplifies the expertise of the branch’s former attorneys and makes clear that consumer fraud enforcement remains a top priority for the current Administration. Companies in consumer products industries should keep their foot on the gas when it comes to compliance and be mindful of both civil and criminal enforcement risks.

Hogan Lovells has extensive experience navigating clients through prosecutions in areas now handled by these new units. We are ready and able to assist clients, both in connection with DOJ investigations and with internal investigations that identify activities that may give rise to potential legal exposure.

Please do not hesitate to contact any of the undersigned or your regular Hogan Lovells contacts if you would like to further discuss this development.

Authored by David Sharfstein, Douglas Fellman, Evans Rice, Michele Sartori, and Paget Barranco.