Consumer Protection Branch Practice Areas

Consumer Health and Safety

Consumer Fraud, Deceptive Acts and Practices, and Privacy

Drugs, Devices, and Dietary Supplements

The Branch investigates and litigates a wide range of violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The Branch’s investigations include drug and medical device manufacturers selling adulterated and misbranded products, as well as fraudsters selling fake cures or counterfeit pharmaceuticals. The Branch also brings enforcement actions against manufacturers and importers of dietary supplements and ingredients that create a safety risk to consumers. The Branch uses both criminal and civil tools to tackle conduct by a range of industry players, including physicians, drug compounders, pharmaceutical companies, and manufacturers and sellers of dietary supplements.

Food Safety

The Branch plays a key role in protecting the safety of America’s food supply chain. Working closely with the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), the Branch pursues civil and criminal actions against companies and individuals for failing to maintain sanitary facilities, distributing tainted food products, and making significant misrepresentations to customers or the public.

Opioids and Counterfeit Pill Initiative

With more than 84,000 Americans dying annually from prescription drug and synthetic opioid overdoses, the Department of Justice is committed to using every available tool to prevent overdose deaths and hold accountable those responsible for the opioid crisis. The Branch is on the front lines of the Department’s fight, pursuing criminal and civil actions against entities and individuals across the prescription opioid supply chain. Additionally, the Branch is pursuing both criminal and civil actions targeting companies involved in the manufacture and distribution of chemicals and equipment used to create counterfeit pills laced with fentanyl.

The Branch is aided in its work by its expertise in enforcing the Controlled Substances Act (CSA) and the FDCA, as well as by its experience with complicated and multi-district litigation. The Branch’s strong relationships with U.S. Attorneys’ Offices, the Criminal Division, the Drug Enforcement Administration (DEA), and the FDA also position it well to coordinate actions and advise Department leadership on policies and initiatives. Through dedicated effort, the Consumer Protection Branch aims to help stem the opioid crisis by ensuring that opioids are not diverted and abused.

The Consumer Product Safety Act

The Consumer Product Safety Act (CPSA) requires manufacturers, distributors, and retailers of consumer products to report “immediately” to the Consumer Product Safety Commission (CPSC) information that reasonably supports the conclusion that a product contains a defect that could create a substantial product hazard or creates an unreasonable risk of serious injury or death. The Branch works closely with the CPSC to hold accountable manufacturers that put profits over the safety of consumers. Prompt reporting of potentially dangerous defects in or problems with products is vital to impactful and immediate consumer protection.

Clinical Trial Fraud

Clinical trials of investigational drugs are necessary for the government and pharmaceutical companies to determine whether a drug for which a company may seek FDA approval is safe and effective. The FDA relies on the truthfulness and accuracy of clinical trial data to make regulatory decisions about the approval of new drugs, with the goal of ensuring that all FDA-approved drugs are safe and effective for their approved uses. Unscrupulous clinical research personnel who fabricate or falsify clinical trial data can adversely and materially impact the FDA’s decisions concerning drug approval and thereby put patients at risk. The Branch has charged and secured convictions of numerous individuals, including licensed medical professionals and clinical support staff, in connection with clinical trial fraud schemes.

Tobacco

The Branch has long partnered with the FDA and other public health agencies to enforce laws relating to the sale and marketing of tobacco products. The Consumer Protection Branch was responsible for litigating, and enforcing the secured relief from, the United States’ racketeering case against cigarette manufacturers for deceiving the public about smoking’s addictiveness and health risks. The Branch also enforces the ban on advertising cigarettes or smokeless tobacco on television and radio, and it is active in addressing new enforcement issues posed by e-cigarettes and vaping products.

Transportation

The Branch has recently expanded its efforts to protect consumers from unlawful and unsafe products and unfair and deceptive practices in transportation. Branch attorneys and partner U.S. Attorneys’ Offices are working closely with the Department of Transportation (DOT), including its Office of the Inspector General, its Office of Aviation Consumer Protection, the National Highway Traffic Safety Administration (NHTSA), the Federal Railroad Administration, and the Federal Motor Carrier Safety Administration. The Branch uses its civil and criminal enforcement tools to hold corporations and executives in all areas of transportation accountable and to enforce transportation laws protecting consumers. The Branch’s expanding work in this area has affected all modes of transportation, including the airlines, the railroads, and cars and trucks.

Transnational Elder Fraud

The Branch devotes considerable resources to stopping scams that target or disproportionately affect older adults, especially large-scale fraud schemes that target hundreds or even thousands of potential victims. Prominent in this work is the Branch’s coordination of the Department’s Transnational Elder Fraud Strike Force, which combats foreign-based scams with resources from CPB, U.S. Attorneys’ Offices, the U.S. Postal Inspection Service, the Federal Bureau of Investigation (FBI), and other law enforcement agencies. As part of that effort, Branch personnel are building and maintaining strong partnerships with foreign law enforcement, including by co-chairing the Global Anti-Fraud Enforcement Network.

Emerging Technologies

Artificial Intelligence (AI), online advertising (AdTech), cyber-enabled crimes, and other rapidly developing technologies are increasingly being used to harm consumers. The Branch recently created an Emerging Technologies Initiative to identify and target individuals and corporations that are facilitating unlawful activity through a variety of advanced analytical tools.

Privacy and Identity Integrity

Consumers have a right to make informed decisions regarding how and when their sensitive and personal information is shared with third parties. The Branch, working alongside the Federal Trade Commission (FTC) and other law enforcement partners, brings both civil and criminal enforcement actions against individuals and businesses who unlawfully disclose consumers’ sensitive and personal information.

Illegal Telemarketing

Illegal telemarketing frustrates Americans and, at times, includes deceptive pitches or outright attempts to defraud. Working with law enforcement partners including the FTC, the Federal Communications Commission (FCC), and state attorneys general, the Branch uses both civil and criminal tools to aggressively pursue those who place and carry illegal telephone traffic.

Deceptive Acts and Practices

Unscrupulous business practices harm consumers in many ways, increasing costs, jeopardizing privacy, and preventing consumers from making informed decisions about goods and services. The Branch, working in partnership with the FTC, brings cases against such practices under the FTC Act and regulations promulgated by the FTC. These actions seek civil monetary penalties and strong injunctive relief aimed at preventing future violations of the law.

Servicemember Fraud

Through the Department’s Servicemembers and Veterans Initiative, the Branch prosecutes fraud schemes that target the men and women who defend America, bringing actions against product-marketing, debt-relief, and identity-theft scams.

Defensive Practice

The Branch is authorized to defend the Food and Drug Administration, the Federal Trade Commission, the Consumer Product Safety Commission, and other federal agencies in civil litigation in courts throughout the country. This work includes cases challenging, under the U.S. Constitution and the Administrative Procedure Act (APA), agency actions related to food, drugs, medical devices, tobacco, and other consumer products. These cases typically involve complex issues regarding the FDCA, the Tobacco Control Act, the Public Health Service Act, the Federal Trade Commission Act, and the CPSA. The Branch’s defense of these matters enables our agency partners to conduct their important work in safeguarding the health, safety, economic security, and identity integrity of American consumers.

Updated January 7, 2025

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