# Justice Manual § 4-8.205: Litigation Involving Drugs or Medical Devices

> Federal · Agency guidance · In force

URL: https://www.frixlaw.com/law-library/statutes/JM_S4-8.205

## Section

- **Citation:** Justice Manual § 4-8.205
- **Heading:** Litigation Involving Drugs or Medical Devices
- **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 § 4-8.205

## Text

In considering whether to initiate or continue an investigation, civil complaint, or criminal prosecution involving promotion of an unapproved use of an FDA-approved drug or device, the Department will prioritize matters involving promotion that is false, misleading, or encourages unapproved new uses likely to cause consumer harm.  In any such matter, Department attorneys also should consult relevant Department resources and note that some courts have held that truthful, non-misleading commercial speech does not itself violate the FDCA.

[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)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/JM_S4-8.205. Check the current official text before relying on it. Not legal advice.