FDA Law Enforcement: Critical to Product Safety

By Rados, Carol | FDA Consumer, January-February 2006 | Go to article overview

FDA Law Enforcement: Critical to Product Safety


Rados, Carol, FDA Consumer


Sometimes, the strategy proved simple--sampling chocolates and jelly beans to detect substandard ingredients. Other times, the plan was more complicated--paying youngsters to cause a disturbance in front of a store to draw everyone outside long enough for investigators to secretly locate and copy company records. Even more unconventional means sometimes were employed. At one time, a can with a rat in it was used to train investigators to detect, by taste, cream that might have been contaminated by the rodents.

Health officials involved in enforcing Food and Drug Administration rules and regulations during the early 20th century generally used a variety of tactics--ranging from the ingenious to the heroic--to ensure that companies making products under the jurisdiction of the then Bureau of Chemistry complied with the laws.

"It required great determination on the part of some to push the rat to one side with a grading rod and then taste the cream," said Walter S. Greene, head of the FDA's Microanalytical Laboratory, in 1934. "But probably a dozen or more seizures were made on rat cream in 10 days because of this training."

Today, a law enforcement team operates within a science-based framework that includes rules and traditional methods for ensuring that companies producing FDA-regulated products don't put the public at risk. This team of more than 3,000--made up of investigators, compliance officers, scientists, laboratory analysts, public affairs specialists, and criminal investigators--is directed by the Office of Regulatory Affairs (ORA), the FDA's primary regulatory component.

"We're the eyes and ears of the agency," says Deborah D. Ralston, director of the ORA's Office of Regional Operations. "The idea is that we follow up on anything that needs investigating."

The ORA and its components are responsible for inspecting the full range of FDA-regulated products--both before they are marketed and afterwards. From outside ports of entry to inside manufacturing facilities, on any given day FDA investigators can be found conducting inspections, collecting and analyzing samples, and implementing the FDA's many policies, which impact the regulation of food, cosmetics, drugs, biologics, and medical devices in this country.

Stationed in more than 190 offices, resident posts, and laboratories around the United States and in Puerto Rico, ORA employees work cooperatively with other federal, state, local, and foreign agencies to safeguard the public health and to ensure honesty and fair dealing between regulated industries and consumers.

While some offices within the ORA pursue administrative and civil remedies against violations of public health laws, the Office of Criminal Investigations (OCI) is the organization responsible for conducting and coordinating all criminal investigations related to serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and related acts, as well as the Federal Anti-Tampering Act (FATA). The OCI's special agents present their investigative findings to U.S. Attorneys' Offices around the country, which have the responsibility for prosecuting those who deliberately produce defective products (adulterate), or misbrand, counterfeit, or tamper with FDA-regulated goods.

Established in 1992, the OCI has a small but highly qualified staff capable of providing the FDA with a vital criminal enforcement component to enhance the agency's inspection, compliance, and regulatory mission. The OCI interacts with the Department of Homeland Security (DHS), the Central Intelligence Agency (CIA), the Federal Bureau of Investigation (FBI), the National Counter-Terrorism Center (NCTC), and others, to assist with terrorism-related threats or acts of terrorism involving FDA-regulated products.

Prior Enforcement Without Boundaries

The crusade against those who do not comply with the laws actually began when the 1906 Pure Food and Drugs Act was passed by Congress after 25 years of debate, and as a result of both industry and consumer complaints about the poor quality and misleading labeling of many food and drug products sold in interstate commerce. …

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