OII: FDA’s “Stalwart” Protectors of Public Health

By Michael C. Rogers, Associate Commissioner for Inspections and Investigations

In case you’re not familiar with OII, we’re the FDA’s Office of Inspections and Investigations.

Our on-the-ground teams conduct inspections, investigations, imports screening, emergency response, and law enforcement—across the country and around the world—so that the foods, drugs, and other medical products you rely on will be safe.

Critically, our teams also intervene when those everyday items are not safe, so that fraudulent drugs, for instance, or bacterially contaminated produce, don’t reach or harm your family.

We serve the American consumer proudly through our robust commitment to regulatory oversight in the name of public health and safety.

In a modern world, AI and other data-combing technologies are necessary to helping us achieve this. In addition, our vast partnerships help us expand our reach and deliver our gold standard of safety—not only to small towns across this nation, but to countries around the globe where many of our prescription drugs are made and foods sourced.

Our People

But it’s the people of OII, working on site and in person, who act daily on our promise of exceptional food and drug safety—and who ensure that industry does the same.

We’re the proverbial eyes and ears inside food, drug, and medical product facilities, making sure a company’s manufacturing and sanitation practices are consistent with U.S. food and drug safety laws and regulations. The samples and other evidence our investigators collect during their inspections form the basis of the public safety actions (including recalls and import alerts) that are designed to shield you, your family, and even your pets, from harm.

Safe Foods

Consider our food investigators who responded last year to an urgent Salmonella outbreak in eggs that caused dozens of Americans to be hospitalized.

As you can read about in this story, our teams acted quickly, flying in from around the country to conduct a flurry of critical inspections and sample collections at several Midwestern poultry houses. Their on-site assessments helped confirm the source of the Salmonella outbreak, helping lead to the removal of tens of thousands of contaminated eggs from grocery store shelves.

Fighting Fraud and Illicit Drugs

OII also targets criminals, here and abroad, who dare to commit health fraud and other harms against innocent Americans. Our law enforcement teams have made significant inroads combating the opioid crisis and sale of illicit drugs in this country. Our agents’ behind-the-scenes efforts recently ensured that three men caught selling illegal drugs, including medications prescribed for diabetes, will be brought to justice.

OII import teams, frontline defenders at our nation’s borders, work around the clock reviewing import entries, and screening food, drugs, medical devices, and other FDA-regulated products coming into this country. Every day our teams block contaminated, counterfeit, and other potentially harmful products from reaching U.S. stores.

Our import teams, for instance, in close collaboration with our U.S. Customs and Border Protection partners, recently helped seize 76 million dollars’ worth of unauthorized vaping products that could have otherwise reached our youth.

Passion for Mission

Frontline public health work often entails long hours, frequent travel, and time spent away from home for weeks at a time. Yet, it also offers the chance to glimpse our impact: through direct engagement with the consumers, patients, and families we’re charged to protect. One thing we all share in OII: an unyielding commitment to mission.

I know this well, as a former investigator who got hooked on serving public health over 30 years ago.

Early Fighters Against Chemicals in Our Foods

One of our very first inspectors, Wendell Vincent, was a tenacious defender of the American consumer.

When U.S. fruit growers in the 1930s refused to stop using lead arsenate as a pesticide—even after it was declared toxic by the agency, Vincent and other field inspectors continued to show up at farms and insist that the chemical be abandoned.

Even under threats of violence, including an episode when an FDA inspector was warned he should be “hung from the closest telephone pole” for intervening on behalf of public health, Vincent and his teams persisted, helping oversee the eventual removal of lead arsenate from the nation’s fruit spraying operations.

Their championing saved lives—with Vincent going down in FDA history, according to an early agency commissioner, as a “stalwart protector” of public health.

Fierce Dedication, to Make America Healthy

At OII, this fierce dedication to food and medical product safety, and our country’s health, has not wavered.

Continuing in the tradition of the determined public health defenders who came before us, we are committed—with deepened resolve under our new leadership—to use all tools at our disposal, including trusted science, the legal authorities granted to us, and the power of human engagement, to keep Americans safe and improve the health of this nation.