Federal Food, Drug, and Cosmetic Act Litigation

To ensure uniform and balanced application of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301,

et seq

., the Consumer Protection Branch (CPB) is authorized to oversee and conduct all civil and criminal matters arising under the FDCA.

See

28 C.F.R. § 0.45(j);

JM 4-1.313

.

CPB personally handles all civil matters arising under the FDCA, except as provided in

JM 4-8.220

as to routine seizure actions.  Information relating to a possible civil violation of the FDCA should be brought immediately to CPB’s attention.

CPB personally handles, jointly handles, or monitors all criminal matters involving possible violations of the FDCA.  Upon opening any criminal investigation involving a possible violation of the FDCA, USAOs must notify and consult with CPB.  A USAO conducting such an investigation must also consult with CPB as to what role CPB will play in the investigation.  CPB will confirm receipt of and respond to a notification within 15 business days.

CPB generally will personally or jointly handle investigations and cases involving possible criminal violations of the FDCA that it deems to have nationwide implications.  Investigations and cases that have nationwide implications may include, but are not limited to, instances in which:

a publicly traded corporation is a criminal target or criminal defendant;

a non-frivolous First Amendment defense may be available;

a subject’s or target’s individual liability, criminal or civil, is based on the “responsible corporate officer” doctrine (the so-called

Park

doctrine);

the conduct at issue led to death or other serious bodily injury;

the amount of any criminal fine, forfeiture, disgorgement, and/or restitution or of any related civil damages or penalties may exceed $100 million; or

the conduct at issue involves fraud on or misleading the FDA.

ual liability, criminal or civil, is based on the “responsible corporate officer” doctrine (the so-called

Park

doctrine);

the conduct at issue led to death or other serious bodily injury;

the amount of any criminal fine, forfeiture, disgorgement, and/or restitution or of any related civil damages or penalties may exceed $100 million; or

the conduct at issue involves fraud on or misleading the FDA.

For a monitored criminal investigation or case, CPB may request status updates on the matter’s progress and legal and factual theories.  At least 15 business days before filing criminal charges in a monitored matter, a USAO must notify and consult with CPB regarding the factual and legal basis for the charges.

Throughout the course of any criminal or civil litigation action concerning alleged FDCA violations or involving the FDA, USAOs are required to report to CPB significant litigation developments involving FDCA policy and interpretation, questions of first impression concerning the FDCA, and any adverse court decisions construing the FDCA or its implementing regulations.

Attorneys from the FDA may not be appointed as Special Assistant U.S. Attorneys without the approval of CPB’s Director.

Notice to CPB is provided through the Director, Deputy Directors, or Assistant Directors (see the directory “Expertise in the Civil Division”).

[updated January 2021]