# DOJ Increases FDA Fraud Scrutiny

The U.S. Department of Justice issued Directive 26-12 on October 1, 2026, identifying fraud related to the Federal Food, Drug, and Cosmetic Act as a factor in corporate enforcement. The directive may lead to more joint DOJ–FDA investigations of companies in FDA-regulated industries, including healthcare and life-sciences contractors and suppliers. It creates no new procurement or contract opportunity, but signals heightened enforcement exposure across contractor and supplier relationships.

- Healthcare and life-sciences contractors and suppliers should review their compliance controls, required reporting, and potential exposure throughout their supply chains.
- Procurement and compliance teams can use the directive to assess how supplier oversight and reporting processes address FDCA-related fraud risks; the signal describes an enforcement factor, not a new mandatory procurement requirement.

**Jurisdictions:** federal
**Industries:** Healthcare
**Topics:** Regulatory Compliance
**Published:** October 12, 2026

### Government Entities
- U.S. Department of Justice (DOJ)
- U.S. Food and Drug Administration (FDA)
- National Fraud Enforcement Division (NFED)

### Sources
- [DOJ Directive Signals FDA-Regulated Industries May Be Subject to Enhanced Scrutiny | Holland & Knight LLP - JDSupra](https://www.jdsupra.com/legalnews/doj-directive-signals-fda-regulated-3400687) - JD Supra