The Department of Health and Human Services (HHS) reviewed all criminal regulatory offenses under its authority, as required by Executive Order 14294. This work helps improve transparency and ensures that enforcement is clear, fair, and consistent.
Clear and consistent rules help:
- The public better understand the law
- Regulated entities know what is expected of them
- Agencies focus enforcement on serious or intentional wrongdoing
To see the complete list of offenses, penalties, and legal standards, read the full report.
For further details, see the response data.
Summary of the Findings
HHS identified 26 criminal regulatory offenses across 8 Divisions and subcomponents, including the CDC, FDA, and ASPR. These offenses cover a wide range of areas, such as:
- Public health and safety
- Food and drug regulation
- Biomedical research
- Controlled substances
- Health programs
Criminal enforcement remains an important tool for protecting the public and maintaining trust in these programs.
Areas of Improvement
The review found that the rules are not always clear or consistent—especially when it comes to the level of intent required to prove a violation (known as “mens rea”).
- Some offenses do not require proof of intent (strict liability)
- Others require proof that someone acted knowingly or willfully
- In some cases, the required intent is not clearly defined at all
This variation can make it harder for individuals and organizations to understand their responsibilities and for agencies to enforce the rules consistently.