Plug into the FDA

Conspiracy theories, distrust, and gossip often run rampant among the American people, with one of the most notable instances happening during the COVID-19 pandemic. Those difficult social-distancing days forced the public to take a closer look at how the government and their agencies were run, with the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) coming under intense scrutiny as they played pivotal roles in managing the global crisis. After 2020, everyone knew about the CDC’s crucial role that they played in the pandemic, but what about the FDA? They made headlines as they were scrutinized by approving the much-awaited Pfizer COVID vaccine, but the FDA does much more than hand out stamps of approval. Today, we at The Plug would like to shed some light about the FDA and help you learn more about it, from how it came about to where it stands today.

How the FDA Came to Be

You might not have guessed this, but the U.S. Department of Agriculture (USDA) actually played an important role in the birth of the FDA. President Abraham Lincoln signed the department into existence in 1862, believing that it was important to invest in America’s agriculture, especially after seeing that 90% of the population were farmers (1). Commonly known as “The People’s Department”, USDA helped rural America thrive through innovative technology and improved strategies, with one of its greatest achievements being how it educated farmers and facilitated the recovery of crop yields after the devastating Dust Bowl disaster of the 1930s (1). Nowadays, the USDA and its sub-agencies cover a wide range of issues through public policy on food, agriculture, natural resources, rural development, nutrition, and more (2). 

The early 1900s were a tough time for the working class of America, and there were many unsafe practices around food production. Harvey Wiley was appointed chief chemist in 1883 for USDA’s Bureau of Chemistry, and he spent his career trying to improve the common issues of tampered food and poor food processing (3, 4). It wasn’t until Upton Sinclair published his book, The Jungle, that people were exposed to the horrors of how food actually got to the table (4). The vocal discontent of the public helped Wiley push the Pure Food and Drug Act of 1906, which prohibited the sale of misbranded or adulterated food and drugs (4). This act gave the Bureau of Chemistry responsibilities that went outside just a scientific research role, and in 1927, the bureau was reorganized as the Food, Drug, and Insecticide Administration (4). It wasn’t until four years later when it was renamed the Food and Drug Administration (4).

The FDA Today

The FDA currently holds many responsibilities for American health and safety. They supervise “most food products, human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumer, medical, and occupational use, cosmetics, and animal feed” that are regulated in the United States (3). All this responsibility calls for a pretty intense workplace structure! The FDA has since moved from the USDA to the Department of Health and Human Services (HHS), with the reason being that it is an agency that concerns itself with the public's health versus just food. The FDA is then divided into different categories with offices that are in charge of everything under that jurisdiction; there are nine main centers along with 13 headquarters, which then break down even more to run like a well-oiled government machine. In 2021, the FDA had over 18,000 employees with a budget of $6.1 billion (5). 

User Fees

With a multitude of categories and areas to supervise, the FDA has a widespread budget to help. Since it is a government agency that works for the interest of the American people, the government provides a majority of its funding. However, there are other ways the FDA receives funds; in 2021, $3.3 billion came from the federal budget, whereas $2.8 billion came from user fees (5).

And what are user fees? In 1992, Congress passed the Prescription Drug User Fee Act, allowing the FDA to collect fees from people who submit applications for approval of a new drug (6). This opened the gates for other laws to be passed that allowed the FDA to collect fees under other categories. The FDA has claimed that user fees do not influence their decisions under any circumstances, stating these fees are solely used to help fund the review and approval process (6). 

Source: U.S. Food and Drug Administration

Labels & Statements

Now to the good stuff: The Plug’s journey in navigating the bureaucracy of the FDA! There are actually a few products such as tobacco, cosmetics, baby formula, and dietary supplements where the FDA doesn’t give an official stamp of approval but instead monitors and inspects (7). Since The Plug is a dietary supplement, 75 days before blessing the public with our product back in 2019, a premarket safety notification was sent to the FDA for review. This is done to show that products are safe and are manufactured in a facility that follows the FDA’s guidelines (7, 8). The next step is to ensure that all the wording on our packaging follows the specific labeling elements and nutritional information that FDA regulation requires (7). This is an important step that goes all the way back to that first FDA act of 1906, which stopped people from misbranding products such as food, drugs, and medicines (4). Continuing the work of 1906, the Dietary Supplement Health and Education Act of 1994 requires a disclaimer on all products deemed as dietary supplements: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease" (8). This explains that, legally, the FDA does not approve this type of product and that only prescription drugs can cure diseases. 

In The Plug We Trust

The FDA is a bureaucratic nesting doll of administrations, centers, and offices. Every role plays a part in keeping the public’s health under constant vigilance. Just like the FDA, The Plug’s main concern is YOUR health. This is why we’re always working hard to make sure that we are FDA compliant and that our products are of top quality for your consumption. There’s nothing we love more than supporting your wellness journey!

For Further Reading

If you’d like to learn more about the FDA, check out:

https://www.fda.gov/ 

Bibliography 

1. Farming in the U.S. [Internet]. PBS: Public Broadcasting Service. Available from: https://www.pbs.org/wgbh/americanexperience/features/troublesome-farming-us/  

2. USDA Celebrates 150 Years [Internet]. USDA: U.S. Department of Agriculture. Available from: https://www.usda.gov/our-agency/about-usda/history  

3. Swann JP. FDA's Origin [Internet]. FDA: U.S. Food and Drug Administration. Updated 2018 Feb 1. Available from: https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/fdas-origin

4. Our History [Internet]. USDA: U.S. Department of Agriculture. Available from: https://www.fsis.usda.gov/about-fsis/history.  

5. FDA at a Glance [Internet]. FDA: U.S. Food and Drug Administration. Updated 2024 Oct 16. Available from: https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance

6. Prescription Drug User Fee Amendments [Internet]. FDA: U.S. Food and Drug Administration. Updated 2025 Mar 21. Available from: https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments

7. Is It Really 'FDA Approved'? [Internet]. FDA: U.S. Food and Drug Administration. Updated 2022 May 10. Available from: https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved.  

8. Questions and Answers on Dietary Supplements [Internet]. FDA: U.S. Food and Drug Administration. Updated 2024 Feb 21. Available from: https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements