FDA Law Enforcers Protect Consumers’ Health

When it comes to fighting crime, most Americans think of the FBI, state troopers, sheriffs’ agencies, and police departments. Much less known is a battle waged against certain kinds of criminals by law officers whose badges identify them as “FDA-Special Agent.”

The men and women of FDA’s Office of Criminal Investigations (OCI) represent the consumers’ front line against companies and individuals who endanger the public’s health. These criminals carry out unlawful actions involving pharmaceuticals, foods, and other products regulated by FDA. OCI focuses on violations of two laws—the Federal Food, Drug, and Cosmetic Act and the Federal Anti-Tampering Act.

The Role of Special Agents

FDA’s Special Agents are stationed in multiple cities throughout the continental United States and Puerto Rico. “We operate much like every other federal law enforcement organization,” says Terry Vermillion, founding Director of OCI.

“We gather facts and present them to the local U.S. Attorney’s Office,” he says. “The U.S. Attorney’s Office determines if and who will be prosecuted and OCI does the investigative work to support the effort.”

Special Agents:

  • come to FDA mostly from other federal law enforcement agencies, such as the U.S. Secret Service, Immigration and Customs Enforcement, Postal Inspection Service, and Drug Enforcement Administration
  • bring years of prior federal criminal investigative experience using traditional law enforcement methods, professional contacts, and investigative techniques
  • investigate FDA-related crimes typically involving counterfeit, unapproved or illegally diverted drugs, product tampering and substitution, fraudulent health treatments, and allegations of fraud in new drug applications and clinical trials
  • have all the legal powers and capabilities of a well-equipped federal law enforcement organization
  • have federal statutory authority to obtain and execute arrest and search warrants, carry firearms, and gather evidence to enforce United States criminal law
  • obtain specialized training as polygraph examiners, computer forensics examiners, firearms instructors, and technical surveillance specialists (if selected to do so)

A Collaborative Approach

FDA’s Special Agents frequently investigate criminal wrongdoing by large companies. If these investigations lead to prosecution, the guilty officers and employees often receive federal prison sentences, while the company can expect to receive multimillion-dollar fines and restitution payments.

Many times when OCI initiates an investigation, other federal law enforcement agencies that have a jurisdictional interest will join the investigation. Many OCI cases have an international aspect. Since being founded in 1992, OCI has developed good working relationships with many foreign law enforcement counterparts, which aid in bringing criminals outside the United States to justice.

Field investigations are enhanced by OCI’s skilled investigative analysts and technical specialists. In addition, the FDA’s Forensic Chemistry Center in Cincinnati, Ohio, provides valuable forensic laboratory support by performing many different laboratory tests related to suspect products involved in OCI investigations.

How to Report Suspected Crime

OCI has six field offices and six resident offices located throughout the United States and Puerto Rico. Field offices are located in New York; Washington, D.C.; Miami; Kansas City, Kan.; Chicago; and Los Angeles. Resident offices are located in San Francisco; Austin, Texas; New Orleans; San Juan, Puerto Rico; Atlanta; and Boston.

Consumers can alert OCI to suspected criminal activity involving FDA-regulated products by contacting the OCI office located in their region:

OCI headquarters: 240-276-9500

  • · New York: 201-547-3851
  • · Washington, D.C.: 240-276-9400
  • · Miami: 954-476-5400
  • · Los Angeles: 949-366-4600
  • · Kansas City, Kan.: 913-384-7400
  • · Chicago: 630-769-5520
  • · San Francisco: 510-637-3480
  • · Austin, Texas: 512-349-2599
  • · New Orleans: 985-871-5152
  • · San Juan, Puerto Rico: 787-281-4863
  • · Atlanta: 404-253-2317
  • · Boston: 978-531-5850

This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

For More Information

FDA’s Office of Regulatory Affairs
www.fda.gov/ora/

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