FDA Voices
The FDA at 120: A Long, Distinguished History Protecting Americans
By: Kyle A. Diamantas, J.D., Acting Commissioner of Food and Drugs
There may be no better illustration of the critical and integral role the U.S. Food and Drug Administration has played in the history of our nation’s health than the timely juxtaposition of two anniversaries occurring this year – our nation’s 250th and the FDA’s 120th. That’s because this confluence underscores how, for nearly half of our nation’s existence, Americans have relied on, and benefited from, the FDA’s oversight of our food, medical products, veterinary products, cosmetics, and so much more.
The FDA’s regulatory role began in 1906 with the passage of the Pure Food and Drugs Act, which authorized the Bureau of Chemistry—the FDA’s immediate predecessor—to regulate contaminated, misbranded, and dangerous foods and medicines. The agency did not receive its present name, the Food and Drug Administration, until 1930. Over time, the FDA’s basic law has been repeatedly amended, augmented, and strengthened in response to gaps or shortcomings, further enhancing the FDA’s essential role as the nation’s guardian of public health.
While the 1906 law laid the cornerstone for the agency and sought to resolve dangers caused by the widespread use of unsafe and fraudulent so-called “patent medicines” by prohibiting “false or misleading statements” on product labels, it did not stop the makers of a product called Dr. Johnson’s Cancer Cure, who circulated advertisements claiming they could “cure any cancer.” This led to a 1912 amendment of the law clarifying that the “false and misleading” clause applied to both product ingredients and therapeutic claims. This milestone empowered the FDA to take action against a broad range of fraudulent products, establishing a rigorous standard for protecting consumers from wrongful drug advertising that has continued to grow stronger through the years.
Another example of this evolution occurred following the development in the 1930s of a traveling FDA exhibit dubbed the “American Chamber of Horrors,” which highlighted 100 dangerous, deceptive, or worthless products that the FDA still lacked authority to remove from the market. Among these were several dangerous cosmetics that had caused significant injuries like hair loss, loss of sight, and permanent neurological damage. Because the 1906 law did not apply to cosmetics, the FDA could not take action against those manufacturers. This exhibit’s vivid documentation of the injuries helped build the public and political support necessary for the passage of the seminal 1938 Food, Drug, and Cosmetics Act.
Over the ensuing decades, the FDA responded to a growing number of dangerous products and public health emergencies. In 1919-20, for example, the FDA tracked a series of botulism outbreaks that killed 18 people in New York, Michigan, and Ohio, linking it to canned California olives. Collaboration with state and local food and drug officials led to the swift identification and removal of the product from grocery store shelves. This not only saved many lives, but also led to what is sometimes described as the first national food recall, many decades before a 2011 law gave FDA mandatory recall authority.
During the 1929 holiday season, the FDA investigated reports of illness among members of a Virginia family who had eaten a Christmas fruitcake. The FDA’s analysis revealed that the flour used contained arsenic residue, likely due to being stored in close proximity to arsenic pesticide spray. The mother of the family had used the same flour to bake a number of fruitcakes that were sold and shipped across the Washington, D.C.-area, and even as far north as Canada. Thanks to FDA inspectors and the assistance of a talented FDA canine named Scotty, who helped sniff out the arsenic, the FDA was able to recover all of the loaves before they caused additional illness.
One of the most infamous episodes in modern drug history involved thalidomide. In the early 1960s, FDA medical officer Dr. Frances Oldham Kelsey refused to give FDA approval to the drug thalidomide, even though many other countries at the time had allowed its use. Thalidomide exposure during pregnancy caused severe limb and organ deformities in thousands of babies worldwide, while thousands of exposed pregnancies tragically ended in miscarriage and stillbirth. Dr. Kelsey’s decisive action spared Americans a similar tragedy and serves as a powerful reminder of the why the FDA works to make sure that a manufacturer’s claims about a treatment or a product are backed up by the best evidence possible.
These are just a few of the countless examples of the diligence, commitment, and even heroism demonstrated by FDA staff in service to the American public. As the agency’s responsibilities have grown, many new products such as medical devices and radiation-emitting electronics have come under our remit. The FDA has added other types of oversight as well, including standards of identity for foods, enhanced drug and medical device labeling, and the foundational requirement that companies provide empirical evidence of a new drug’s safety before marketing.
Today, the FDA’s work touches virtually every American, every day. We ensure the food that people eat is safe and properly labeled and we provide important information on the nutritional value of those foods. We oversee the safety and effectiveness of the medicines and medical devices on which people rely. We regulate tobacco products, veterinary products, cosmetics, and radiation-emitting electronics. By disseminating authoritative, fact-based scientific and medical information, we empower the public to make informed choices about their health.
Perhaps the most significant aspect of the FDA’s work—and the reason the agency remains so important—is its commitment to making decisions through objective, rigorous evaluation of scientific evidence, data, and the risks and benefits of the products Americans use. This unwavering scientific integrity enables the FDA to provide reliable, fact-based information so people can make informed decisions about their health. After 120 years, the agency continues to adapt as science, technology, and public health needs evolve: we study outcomes, listen to patients about what works and what does not, and adjust our approach when the evidence calls for change. We also bring together leading scientific expertise to respond to advances in gene therapy, immunotherapy, nutrition, food safety, and emerging technologies, while strengthening our ability to address public health crises and communicate with the public in a timely, targeted, and responsible way. In all of this work, the FDA remains patient-centered, evidence-driven, and prepared to move at the speed of science.
As we move into the next era of the FDA, our priorities and our responsibilities will continue to grow in many important ways, including: supporting increased American innovation in medicine, food, and technology, and helping position our nation to lead globally; advancing our nation’s health security in the face of public health emergencies, biological and cybersecurity threats, and supply chain vulnerabilities; removing barriers that delay or limit American’s access to safe, effective and affordable medical products; and protecting American health by addressing the root causes of chronic disease and poor health outcomes, including the safety and quality of the food supply.
In other words, after 120 years, the FDA will be even more vital, essential, and relevant to our nation and public health, than ever before. We will continue to do everything we can to support innovation in treatments and cures for patients and safer foods and other products for Americans. We’re just getting started.