DOJ Consumer Branch's End Leaves FDA Litigation Questions

This article was originally published in Law360 on August 11, 2025, and is republished here with permission.

With the dissolution of the U.S. Department of Justice’s Consumer Protection Branch set to occur by Sept. 30, a vital question that remains to be fully answered is who will be responsible for litigation matters typically handled by the CPB — such as civil and criminal enforcement cases related to products regulated by the U.S. Food and Drug Administration

Companies must remain vigilant and adaptable in order to mitigate any risks associated with this evolving regulatory framework, and any upcoming turmoil associated with the end of the CPB era.

It will be important to review quality management systems and procedures, enhance employee training as needed, and investigate consumer complaints promptly, while continuing to track enforcement efforts at both the federal and state levels. 

CPB Background

For years, the CPB has been part of a consolidated approach in focusing the federal government’s enforcement efforts to protect consumers through civil and criminal enforcement.¹

Established in 1971, the CPB has focused its work on statutes administered by the FDA, the Federal Trade Commission, the U.S. Consumer Product Safety Commission and the National Highway Traffic Safety Administration. 

The CPB, charged with enforcing the Federal Food, Drug, and Cosmetic Act, or FDCA, includes highly specialized prosecutors that work closely with the FDA to investigate and litigate civil and criminal matters involving food and drug safety, deceptive business practices, and other fraudulent activity that negatively affects consumers.

The CPB has also led efforts in conjunction with U.S. attorney’s offices around the country and federal law enforcement agencies to combat the nation’s opioid crisis.

Notable and recent cases litigated by the CPB have included:

• U.S. v. Valley Processing Inc., in the U.S. District Court for the Western District of Washington: In 2024, the former president and owner of now-closed juice manufacturer Valley Processing Inc. in Sunnyside, Washington, pled guilty to a multiyear conspiracy to distribute tainted and potentially unsafe apple and grape juice to customers, including some who provided grape juice for the National School Lunch Program;²
• U.S. v. Johannes Vulto and Vulto Creamery LLC, in the U.S. District Court for the Northern District of New York: In 2024, a former raw milk cheese manufacturer pled guilty to the introduction of adulterated food into interstate commerce that was linked to a 2016-2017 outbreak of listeriosis, the disease caused by the pathogen Listeria monocytogenes;³ and
• U.S. v. Drogueria Betances LLC, in the U.S. District Court for the District of Puerto Rico: In 2023, one of Puerto Rico’s largest distributors of pharmaceutical drugs entered a consent decree requiring it to pay $12 million and make extensive improvements to its compliance program, resolving allegations that from 2016 to 2019, the company failed to report to the U.S.Drug Enforcement Administration hundreds of suspicious orders for opioids and other controlled substances distributed to the company’s customers.⁴ 

In handling a wide range of investigations and cases such as these, the CPB shouldered a large portfolio that will now have to be reprioritized and reallocated.

CPB Dissolution

The DOJ’s decision to disband the CPB was reported by news outlets as early as April, with a target dissolution date of Sept. 30, which coincides with the end of the current fiscal year.⁵ According to reporting, the over 100 attorneys who currently work in the unit will be relocated to the DOJ’s Criminal Division, Civil Division and the Federal Programs Branch.⁶ 

The reported move comes in the wake of the DOJ announcing the decriminalization of regulatory offenses in the digital assets industry in an April 7 memorandum from the deputy attorney general titled “Ending Regulation By Prosecution.”⁷ This was followed by decriminalization as a general policy matter as well, under Executive Order No. 14294, issued on May 9.⁸

This executive order asserts that it is intended to “ease the burden on everyday Americans and ensure no American is transformed into a criminal for violating a regulation they have no reason to know exists,” by disfavoring criminal enforcement of criminal regulatory offenses and strict liability offenses.⁹

This change will have a direct impact on FDA-related litigation, as the misdemeanor provision of the FDCA creates a form of strict criminal liability, which may no longer be enforced.¹⁰

In light of the disbanding of the CPB and the deprioritizing of criminal enforcement of regulations as a policy, it remains to be seen exactly how the consumer protection landscape will take shape over the course of the next few years.

Future FDA-Related Enforcement Priorities and Responsibilities

While deregulation may be the new normal for the foreseeable future, the Trump administration has provided some guidance as to policy goals surrounding FDA responsibilities and authorities, which may inform both civil and criminal enforcement priorities.

Reducing Regulatory Barriers to Domestic Pharmaceutical Manufacturing

On May 5, President Donald Trump signed an executive order with the stated purpose of improving domestic production capabilities for pharmaceuticals.¹¹

Among other things, the order directed the FDA to increase fees and inspections of foreign manufacturing plants, and also directed the FDA to improve enforcement of active pharmaceutical ingredient source reporting by foreign drug producers.¹²

Available enforcement actions in this context might include court-ordered seizures of products that enter the marketplace, or injunctive relief sought to prevent foreign-based pharmaceutical products that do not meet source reporting requirements from entering interstate commerce.

Make America Healthy Again

Another initiative introduced through executive order has been the Make America Healthy Again Commission, established on Feb. 13.¹³ The executive order’s stated purpose was to address health problems in the U.S. by working to lower chronic disease rates through nutritional choices, physical activity, and improving food and drug quality and safety, among other efforts.¹⁴

Pursuant to the Make America Healthy Again initiative, the FDA has been actively involved in seeking to eliminate certain common food dyes; exploring how to roll back the Generally Recognized As Safe rule, a policy that allows food companies to decide whether food additives are safe; and collecting research relating to exercise and contaminants in school meals. 

But in order to fully enforce such policies, the FDA will likely still need some form of litigation support from the DOJ.

Opioid Crisis

Combating the nationwide opioid crisis has been prominently featured in the Trump administration’s agenda. Efforts to halt the influx of illicit drugs to the U.S. have been referenced in multiple memoranda and executive orders, including:

• The presidential memorandum of Jan. 20, asserting an “America First” trade policy; 
• Proclamation 10886 of Jan. 20, declaring a national emergency at the southern border;
• Executive Order No. 14157 of Jan. 20, designating cartels and other organizations as foreign terrorist organizations; and
• Executive Order No. 14195 of Feb. 1, imposing duties to address the synthetic opioid supply chain in China.

The CPB has recently spearheaded the pursuit of criminal and civil matters targeting companies involved in the manufacture and distribution of fentanyl laced products, working in tandem with the FDA and other agencies to enforce the Controlled Substances Act and the FDCA. The elimination of the CPB will certainly leave a void in this area that will need to be filled by other experienced branches and agencies.

Any investigations into illicit drug trafficking tied to cartels may now be shifted to the DOJ’s National Security Division, which typically handles violations of the International Emergency Economic PowersAct and allegations surrounding the provision of material support or resources to designated foreign terrorist organizations.

While approval requirements for terrorism and International Emergency Economic Powers Act charges related to cartels and administered by the National Security Division were suspended by the attorney general on Feb. 5, this suspension was only for 90 days, so such authority may now be reasserted by the National Security Division.¹⁵

Various U.S. attorney’s offices responsible for border districts may also see an uptick in cases, as the DOJ has indicated its intention to shift resources to such offices to deal with immigration-related issues.

Regardless of the offices within the DOJ that oversee such matters, companies should anticipate an increase in enforcement tied to opioids that will include the utilization of new tools and authorities.

Practical Impacts and Guidance

As is the case with the reallocation of resources within any large organization, growing pains should be expected.

Various U.S. attorney’s offices throughout the country will likely be tasked with shouldering the weight of enforcement responsibilities. This may lead to inconsistent or fragmented approaches regarding the FDCA and other consumer protection laws.

State attorneys general may also step up to ensure consumers in their jurisdictions are adequately protected.

Coordination efforts between agencies within the federal government may suffer, as the CPB played a key role in fostering communication between agencies such as the DEA, the FDA and the FTC.

Companies should consider taking the following steps to prepare for such uncertainty on the horizon, so that they are in the best position to navigate this evolving regulatory environment:

• Review and strengthen quality management systems and compliance programs to ensure internal policies and procedures are in line with the FDCA and relevant consumer protection laws.
• Track enforcement efforts by various U.S. attorney’s offices and state attorneys general, and maintain open lines of communication and relationships with such offices when possible.
• Enhance training efforts, particularly for employees involved in product development, manufacturing, marketing and sales.
• Stay informed about administration priorities, and actions undertaken by agencies such as the FDA and the FTC.
• Conduct internal investigations in response to consumer complaints or internal red flags, and implement corrective actions before they escalate. Consider self-disclosure, if applicable.

Taking these steps will help adequately prepare companies and persons subject to FDA jurisdiction and consumer protection laws for the inevitable uncertainty that will come with the closure of the CPB.

[1] Aside from proactive enforcement, the CPB is also authorized to defend the FDA, the FTC, the CPSC and other federal agencies in civil litigation to include challenges to agency actions related to food, drugs, medical devices, tobacco and other consumer products.
[2] U.S. v. Valley Processing Inc., 1:22-CR-02097-SAB-2. See https://www.justice.gov/usao-edwa/pr/fruit-juice-manufacturing-companyand-its-former-president-plead-guilty-food-safety.
[3] U.S. v. Johannes Vulto and Vulto Creamery LLC, 3:24-CR-0061-TWD. See
https://www.justice.gov/usao-ndny/pr/former-new-york-cheese-producer-sentenced-selling-raw-milk-cheese-products-linked.
[4]U.S. v. Drogueria Betances LLC , 3:23-CV-01538-RAM. See
https://www.justice.gov/usao-pr/pr/federal-court-orders-puerto-rico-pharmaceutical-distributor-pay-12-million-connection.
[5] See Dayen, David, Justice Department Shutting Branch That Prosecutes Consumer Fraud Cases, The American Prospect (April 24, 2025), https://prospect.org/justice/2025-04-24-justice-department-shuts-branch-that-prosecutes-consumer-fraud-cases/; see also Lynch, Sara N., US Justice Department unit for drug and food safety cases being disbanded, Reuters (April 25, 2025), https://www.reuters.com/business/healthcare-pharmaceuticals/us-justice-department-unit-drug-food-safety-cases-being-disbanded-2025-04-25/.
[6] Id.
[7] Deputy Attorney General Memorandum, “Ending Regulation By Prosecution” (April 7, 2025), https://www.justice.gov/dag/media/1395781/dl?inline.
[8] Executive Order No. 14292 (May 9, 2025), https://www.presidency.ucsb.edu/documents/executive-order-14294-fighting-overcriminalization-federal-regulations.
[9] Id.
[10] U.S. v. Watkins, 278 F.3d 961, 964 (9th Cir. 2002).
[11] Executive Order No. 14293 (May 5, 2025), https://www.whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines/.
[12] The White House “Fact Sheet: President Donald J. Trump Announces Actions to ReduceRegulatory Barriers to Domestic Pharmaceutical Manufacturing” (May 5, 2025), https://www.whitehouse.gov/fact-sheets/2025/05/fact-sheet-president-donald-j-trump-announces-actions-to-reduce-regulatory-barriers-to-domestic-pharmaceutical-manufacturing/.
[13] Executive Order No. 14212 (Feb. 13, 2025), https://www.whitehouse.gov/presidential-actions/2025/02/establishing-the-presidents-make-america-healthy-again-commission/.
[14] Id.
[15] Office of the Attorney General, “Total Elimination of Cartels and Transnational Criminal Organizations” (Feb. 5, 2025), https://www.justice.gov/ag/media/1388546/dl.