The History of the FDA and Why It Was Created

The Food and Drug Administration (FDA) can be traced back to the Pure Food and Drug Act of 1906. It was during this time that the government aimed to prevent the sale of adulterated and misbranded food and drugs as consumers began to voice concerns about unsafe and potentially deceptive products.

In 1930, the FDA’s predecessor was created. It was known as the Food, Drug, and Insecticide Administration which shortly thereafter was reorganized and renamed the Food and Drug Administration. The name change was due to the agency’s expanded scope of responsibilities and oversight.

It wasn’t until the 1960s and the Thalidomide Tragedy that the FDA received significant attention. It became known that the drug Thalidomide, which was widely used in other countries to alleviate morning sickness in pregnant women, caused several birth defects. It triggered the strengthening of drug safety regulations and the requirement by the U.S. Government for drugs to be thoroughly tested before entering the market.  

In 1962, the U.S. Congress passed the Kefauver-Harris Amendments which required drug and pharmaceutical companies to prove not just the safety of their drugs but also their effectiveness before they were allowed to be marketed.

Since then, the FDA’s responsibilities have expanded beyond drugs and food to other commodities such as medical devices, cosmetics, and tobacco products including e-cigarettes.

In the 1980s, the FDA played a pivotal role in responding to the HIV/AIDS epidemic and today is heavily involved in the opioid crisis as well as the COVID-19 pandemic. 

As times have changed and technology has become more advanced, the FDA strives to continuously modernize its regulatory processes to keep pace with the science. They are doing this by implementing various risk-based approaches to prioritize its resources and streamline the approval process for new, innovative products such as new drugs and medical devices, balancing the need for innovation with consumer protection.

Our experts at FDA Specialist offer a variety of consulting services for helping you meet FDA’s rigorous regulatory requirements for bringing your food, drug, cosmetic, or medical device product to market.