The creation of the HSU within the Criminal Fraud Section indicates that criminal liability is a real risk for companies that operate in the food, drug and consumer goods spaces.
On December 2, 2025, the Department of Justice (DOJ) announced the launch of a new unit within the Criminal Division’s Fraud Section, called the Health & Safety Unit (HSU). The creation of this unit comes on the heels of the DOJ disbanding the Civil Division’s Consumer Protection Branch in September of this year, a group that utilized both civil and criminal enforcement in the consumer protection area. The new unit coincides with the DOJ’s restructuring efforts in this space. According to the DOJ, the HSU will serve two main purposes: (i) protecting the food and drug supply for consumers and (ii) enforcing consumer product safety laws.
First, the HSU will function as the criminal enforcement arm of the federal Food, Drug and Cosmetic Act. In that vein, the HSU will partner closely with the Food and Drug Administration and other similar federal agencies. According to the DOJ, the HSU will focus its cases on adulterated, misbranded or counterfeit food, drugs and devices; transportation safety; dangerous consumer product defects; and other threats related to consumer goods.
Second, the HSU will bring criminal enforcement actions under the Consumer Product Safety Act, the Federal Hazardous Substances Act and related statutes. These cases will involve companies and individuals who fail to report known defects in hazardous products. The HSU will also partner with the Department of Transportation and the National Highway Transportation Safety Administration to bring criminal actions against companies and individuals who conceal dangerous vehicle defects.
Organizationally, the HSU falls within the larger DOJ Criminal Fraud Section. The Criminal Fraud Section targets its investigations into sophisticated economic crimes and complex misconduct that puts public health and safety at risk. The creation of the HSU within the Criminal Fraud Section indicates that criminal liability is a real risk for companies that operate in the food, drug and consumer goods spaces. With that in mind, companies that operate in these areas should assess their internal fraud and compliance frameworks consistent with applicable federal laws and regulations.
For More Information
If you have any questions about this Alert, please contact Michael J. Rinaldi, Mary P. Hansen, William M. McSwain, Katie Kovalsky, any of the attorneys in our White-Collar Criminal Defense, Corporate Investigations and Regulatory Compliance Group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.