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The Fraud Section of the U.S. Department of Justice ("DOJ") recently announced the creation of a fourth unit within the Section, the Health & Safety Unit ("HSU"). The stated goal of the new unit is to investigate and prosecute violations of laws designed to protect public health and safety. Per the Fraud Section's website, the new unit will "focus on 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."
HSU is charged with criminal enforcement of the Food, Drug, and Cosmetic Act ("FDCA"). The FDCA was initially passed in 1938 after a toxic drug killed over 100 people and currently regulates the safety and labeling of most foods, food additives, color additives, dietary supplements, prescription and non-prescription drugs, medical devices, cosmetics, and tobacco products. The FDCA gives the Food and Drug Administration ("FDA") civil authority over the same subject matter and DOJ anticipates that HSU will work closely with the FDA and other federal partners to bring actions "against companies and individuals who fail to maintain sanitary facilities, distribute adulterated or misbranded food or drug products, conceal safety-related information from FDA, or make significant misrepresentations to the public."
HSU will also bring criminal enforcement actions under other federal statutes, such as the Consumer Product Safety Act and the Federal Hazardous Substances Act. Interestingly, HSU will work with the Department of Transportation and the National Highway Transportation Safety Administration to investigate and prosecute individuals and companies that conceal dangerous vehicle defects that could cause serious injuries.
Analysis
The creation of the HSU follows the disbanding of DOJ's Consumer Protection Branch earlier this year and presents very new territory for the Fraud Section. We anticipate that this transition will take some time to mature and play out, especially given that attorneys from the Consumer Protection Branch don't necessarily have any background in criminal prosecution. There has been a lot of change within the DOJ as a whole in the last year, and in the Fraud Section in particular. The formation of the HSU further indicates that the Fraud Section is moving away from its traditional areas of emphasis and towards the priorities of the new administration.
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