FDA Court Cases – Overview

• FDA court cases arise from enforcement actions taken against violations of U.S. federal laws, primarily the Federal Food, Drug, and Cosmetic (FD&C) Act.

• These cases may involve civil violations—resulting in warning letters or monetary penalties—or criminal prosecutions that can lead to fines and imprisonment.

• Recent actions include convictions for selling unapproved drug products and legal rulings holding clinics accountable for distributing adulterated or misbranded stem cell treatments.

Types of FDA Court Cases

1. Criminal Investigations

• Conducted by the FDA’s Office of Criminal Investigations (OCI).

• Focus on serious violations that may lead to criminal charges, court trials, and potential imprisonment.

2. Civil Penalties

• The FDA may issue warning letters for regulatory violations.

• If corrective actions are not taken within 30 days of a Notice of Noncompliance, the FDA can impose civil monetary penalties.

3. Regulatory Enforcement Actions

These cases often relate to:

• Adulterated or Misbranded Products

  • Items found to be contaminated, impure, unsafe, or falsely labeled.

• Unapproved New Drugs

  • Products marketed or sold without FDA approval for safety and effectiveness.

• Misinformation & Unlawful Sales

  • Promotion or distribution of unauthorized products, often marketed with misleading or unverified claims.