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OCI Frequently Asked Questions

Office of Criminal Investigations

Who We Are

As the U.S. Food and Drug Administration’s (FDA) criminal law enforcement arm, the Office of Criminal Investigations (OCI) protects the American public by conducting criminal investigations of illegal activities involving FDA-regulated products, arresting those responsible, and bringing them before the Department of Justice for prosecution.

OCI is part of the Office of Inspections and Investigations (OII) within the U.S. Food and Drug Administration, an agency of the U.S. Department of Health and Human Services (HHS).

Our Mission

As a component of FDA, OCI protects public health by investigating suspected criminal violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other related laws. 

OCI has the primary responsibility for criminal investigations conducted by the FDA and for all law enforcement and intelligence issues pertaining to threats against FDA-regulated products and entities. OCI concentrates its resources on investigations of significant criminal violations that pose a danger to the public health.

In 1991, in the wake of a generic drug scandal, the FDA Commissioner announced the establishment of OCI within FDA. This newly-created law enforcement office was formed with the support and urging of the House Committee on Oversight and Government Reform.

Statutes under which OCI conducts investigations include:

  • Food, Drug, and Cosmetic Act (Title 21),
  • Public Health Services Act (Titles 42),
  • Federal Anti-Tampering Act (Title 18 USC § 1365), and
  • Other related acts (e.g. Title 18)

Our Work

OCI Special Agents are dedicated to protecting the health of the public by investigating criminal allegations falling within FDA’s jurisdiction. They have the authority to obtain and execute arrest and search warrants, carry firearms, and gather evidence to enforce U.S. criminal law. And, while serving as OCI special agents, they receive continuing advanced instruction into laws enforced by the FDA, interviewing techniques, financial crimes, computer forensics, asset forfeiture, legal education, and Internet investigations.

Yes. OCI Special Agents have the authority to obtain and execute arrest and search warrants, carry firearms, and gather evidence to enforce U.S. criminal law. As criminal investigators, they collect and provide information to the Assistant United States Attorneys in the respective district. Depending on the specific facts of the case, the first step may actually be an arrest. There are several steps in the federal criminal process. Please refer to DOJ’s Steps in the Federal Criminal Process (https://www.justice.gov/usao/justice-101/steps-federal-criminal-process).

OCI is responsible for investigating serious violations involving the array of products regulated by FDA from drugs, medical devices, biologics, to dietary supplements, food, tobacco, and cosmetics. OCI concentrates its resources on investigations of significant criminal violations that pose a danger to the public health.

OCI priorities include:

  • Breaches in the legitimate medical supply chain by individuals and organizations dealing in unapproved, counterfeit, and substandard medical products.
  • Criminal violations in situations where the normal regulatory process has been unable to remedy the problem.
  • Criminal violations where the risk of harm to the public health is particularly significant and the only remedy appears to be through the criminal process.
  • Criminal conduct that prevents the FDA from being able to properly regulate. This includes false statements to the FDA during the regulatory process and obstruction of justice.

Cases can come to OCI in a variety of ways, including through:

  • Other Federal Agencies (FBI, HHS-OIG, HSI, DEA, etc.)
  • Private Industry (Pharmaceutical, Medical Device, Food, etc.)
  • FDA Centers (CDER, CDRH, CFSAN, CBER, CVM, CTP)
  • FDA District Offices (Consumer Complaint Coordinators)
  • State Agencies (Law Enforcement agencies, Medical, Pharmacy Boards)
  • Citizen Complaints (e.g., via the OCI online reporting portal)

OCI conducts investigations on the following threats to public health:

  • Supply chain violations (drug diversion, foreign medical products)
  • Cybercrime (websites selling illicit / false products)
  • Manufacturing violations (contaminated food (salmonella) compounded drugs (sterility))
  • Clinical Trial / New Drug Application Fraud
  • Dietary Supplements (undeclared ingredients)
  • Medical Devices (unapproved marketing)
  • Fraudulent health treatments (miracle cures)
  • Counterfeit products (counterfeit drugs, personal protective equipment)
  • Tampering (medication tampering at hospital)
  • Veterinary Drugs (diversion of veterinary products)

Past OCI cases include:

Criminal wrongdoing involving FDA-regulated products is increasingly a global one. As a result, OCI has in recent years augmented its domestic work by cultivating strategic relationships with its global law enforcement partners. For example, since 2017, OCI together with several United Kingdom (U.K.) agencies has carried out a series of initiatives called “Operation Ancord” (previously called Operation Lascar). This effort has helped the participating agencies seize violative shipments of illicit prescription drugs destined for the United States, develop leads for criminal investigations, and identify current trends and trade routes. OCI also participates each year in “Operation Pangea”— a global effort led by Interpol to combat the sale of illegal, counterfeit, or unapproved pharmaceutical drugs. This effort has led to the seizure of illegal prescription drugs.

OCI works closely with jurisdictional and regulatory partners, including local and state police, the Department of Homeland Security Customs and Border Protection and Homeland Security Investigations, the Drug Enforcement Agency, the Department of Justice, the U.S. Postal Inspection Service, international governments, and others, to investigate crimes and protect public health.

For example, state police might refer a case to OCI that falls under the jurisdiction of FDA, such as a supply chain or drug tampering cases in their state. As another example, CBP identifies potential violative shipments being imported into the United States and refers relevant information to OCI when appropriate.

Working for OCI

Many jobs at OCI are special agent positions. Additionally, OCI has several positions to support its mission, including intelligence research specialists, investigative analysts, and administrative support staff.

OCI agents are highly trained professionals with a wide range of skills and qualifications. To become an OCI agent, candidates must undergo a rigorous selection process that includes a background check, physical fitness test, and extensive training in investigative techniques and FDA regulations. OCI agents must also have excellent communication and teamwork skills, as they often work closely with other law enforcement agencies on complex cases. Additionally, agents must be able to adapt quickly to changing situations and make sound decisions under pressure. 

FDA/OII/OCI strives to have a workforce that builds and maintains a diverse and inclusive workplace that promotes collaboration, innovation, high-performance, and respect while ensuring a safe working environment. To achieve this objective, OCI utilizes a range of hiring processes, programs, and authorities to recruit a diverse workforce. Information pertaining to jobs at FDA can be found at this link: Jobs and Training at FDA

Other Resources 

Additionally, below are several links pertaining to a variety of hiring programs and authorities utilized by FDA/OCI for
recruitment.

 

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