# Justice Manual § 4-8.200: Federal Food, Drug, and Cosmetic Act Litigation > Federal · Agency guidance · In force URL: https://www.frixlaw.com/law-library/statutes/JM_S4-8.200 ## Section - **Citation:** Justice Manual § 4-8.200 - **Heading:** Federal Food, Drug, and Cosmetic Act Litigation - **Jurisdiction:** Federal - **Kind:** Agency guidance - **Status:** In force - **Text as of:** August 14, 2026 - **Source:** Compiled text - **Location:** DOJ Justice Manual / Title 4: Civil / 4-8.000 - Consumer Protection / Justice Manual § 4-8.200 ## Text 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] ## Nearby sections - [Justice Manual § 4-8.010 Introduction](https://www.frixlaw.com/law-library/statutes/JM_S4-8.010.md) - [Justice Manual § 4-8.100 Persons to Contact at CPB](https://www.frixlaw.com/law-library/statutes/JM_S4-8.100.md) - [Justice Manual § 4-8.200 Federal Food, Drug, and Cosmetic Act Litigation](https://www.frixlaw.com/law-library/statutes/JM_S4-8.200.md) - [Justice Manual § 4-8.205 Litigation Involving Drugs or Medical Devices](https://www.frixlaw.com/law-library/statutes/JM_S4-8.205.md) - [Justice Manual § 4-8.215 Strict Misdemeanor Liability and “Park” Misdemeanor Liability Under the FDCA](https://www.frixlaw.com/law-library/statutes/JM_S4-8.215.md) - [Justice Manual § 4-8.220 FDCA Seizures](https://www.frixlaw.com/law-library/statutes/JM_S4-8.220.md) - [Justice Manual § 4-8.225 Tobacco](https://www.frixlaw.com/law-library/statutes/JM_S4-8.225.md) - [Justice Manual § 4-8.230 Defensive FDCA Litigation](https://www.frixlaw.com/law-library/statutes/JM_S4-8.230.md) - [Justice Manual § 4-8.300 The FTC Act and Other Statutes Administered by the Federal Trade Commission](https://www.frixlaw.com/law-library/statutes/JM_S4-8.300.md) - [Justice Manual § 4-8.400 Elder Fraud, Servicemember Fraud, and other Mass-Marketing Fraud Schemes](https://www.frixlaw.com/law-library/statutes/JM_S4-8.400.md) - [Justice Manual § 4-8.500 The Consumer Product Safety Act and Other Statutes Administered by the Consumer Product Safety Commission](https://www.frixlaw.com/law-library/statutes/JM_S4-8.500.md) - [Justice Manual § 4-8.600 Statutes Administered by the National Highway Traffic Safety Administration](https://www.frixlaw.com/law-library/statutes/JM_S4-8.600.md) - [Justice Manual § 4-8.700 Civil Penalty and Injunctive Actions](https://www.frixlaw.com/law-library/statutes/JM_S4-8.700.md) --- Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/JM_S4-8.200. Check the current official text before relying on it. Not legal advice.