The DOJ’s Crackdown on Health and Safety Violations

Today we’re tackling a development from the U.S. Department of Justice that could reshape compliance strategies across multiple industries. The DOJ has launched a new Health & Safety Unit within its Criminal Division’s Fraud Section, and this could signal a sizeable shift for companies in health, safety, and consumer product sectors.

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• DOJ Unleashes New Health & Safety Unit: Anticipate Augmented Criminal Enforcement for Certain Regulated Industries

About the authors

• Luke Cass
• Michael E. Clark
• Kristina M. Moore
• Ting-Yu Huang*

Transcript

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Host 1

Welcome to another episode of Womble Perspectives! Today we’re tackling a development from the U.S. Department of Justice that could reshape compliance strategies across multiple industries. The DOJ has launched a new Health & Safety Unit within its Criminal Division’s Fraud Section, and this could signal a sizeable shift for companies in health, safety, and consumer product sectors.

Host 2

Absolutely. The HSU officially came online December 2nd, and its mission is clear: investigate and prosecute violations of federal laws designed to protect public health and consumer safety. We’re talking about criminal enforcement here, which means companies need to start thinking differently about risk.

Host 1

That’s exactly right., The DOJ has consolidated civil enforcement capabilities and moved the Consumer Protection Branch into the Fraud Section. That signals a move toward centralized, aggressive enforcement. If you’re in pharmaceuticals, medical devices, food, or consumer products, you could be squarely in the spotlight.

Host 2

More than just more paperwork or compliance checklists, these violations can lead to criminal charges. The HSU will enforce the Food, Drug, and Cosmetic Act, including misbranding offenses. That covers everything from counterfeit pills to dietary supplements and even tobacco products.

Host 1

The DOJ is targeting companies that fail to maintain sanitary facilities, distribute adulterated or misbranded products, or conceal safety-related information from the FDA. Even making significant misrepresentations to the public can land you in hot water.

Host 2

Not only that, the HSU will also enforce the Consumer Product Safety Act and the Federal Hazardous Substances Act. If a company deliberately fails to report defects or hazards that pose serious injury or death risks, that’s a criminal issue now. Plus, they’re teaming up with the Department of Transportation and the National Highway Traffic and Safety Administration to go after concealed vehicle defects.

Host 1
Now, layer on President Trump’s December 6th Executive Order. It directs DOJ and FTC to create task forces to combat anti-competitive behavior in the food supply chain. So, businesses face a dual threat: pricing scrutiny and intensified health and safety enforcement.

If you’re in food or agriculture, you need to anticipate investigations into both pricing practices and safety compliance. That’s a lot of pressure on compliance teams.

Host 2

So in light of these changes, what steps should businesses take to prepare? First, recognize the heightened criminal risk. Second, strengthen compliance programs, especially safety reporting and escalation procedures. And don’t forget DOJ’s voluntary self-disclosure programs; they can be a lifeline.

And one more thing: it never hurts to be prepared for congressional investigations. If you get a subpoena or inquiry, treat it with the highest level of seriousness. Respond deliberately, document everything, and coordinate internally. 

Host 1

The DOJ’s message is clear: health and safety violations are no longer just regulatory hurdles, they’re potential criminal liabilities. Companies need to act now.

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