Americans trust the food and medicines they consume daily, thanks to the Food and Drug Administration (FDA). However, in recent times, the reliability of this federal agency has been questioned due to a series of complaints related to the food and medicines consumed by the American public. During the 2024 United States presidential campaign, the Republican Party, through its nominee for HHS Secretary, Robert Francis Kennedy Jr. (JFRK Jr.), denounced that the healthcare system is captured by Big Pharmaceutical Companies, Big Food Companies, and federal agencies regulating health and nutrition, including the FDA. Some say the FDA is a reliable federal agency because it regulates medicines and foods consumed to benefit American public health and nutrition.
Others say the FDA is not a reliable federal agency because it has become politicized and corrupted in favor of the interests of Big Pharmaceutical Companies, the Big Food Industry, and the federal health agencies it is supposed to regulate, to the detriment of American public health and nutrition. I agree with the latter; the FDA is not a reliable federal agency because it has become politicized and corrupted in favor of the interests of Big Pharmaceutical Companies, the Big Food Industry, and the federal health agencies it is supposed to regulate, to the detriment of American public health and nutrition.
One reason I believe the FDA is not a reliable federal agency is due to its politicization in recent decades. The FDA is led by the Commissioner of Food and Drugs, a position appointed by the President with Senate approval and typically held by a Doctor.
However, the FDA is not entirely independent of politics and operates as part of the federal government in Washington, D.C. According to Alex Gordon of Harvard University, in his publication “The Delicate Dance of Immersion and Isolation: The Politicization of the FDA Commissioner,” the FDA Commission had become more political since 1988 when Congress made the position subject to Senate confirmation. Whether beneficial or adverse, this politicization of the agency has raised numerous questions about its independence (Gordon). Political considerations, such as conflicting interests and government decisions, heavily influence FDA decisions.
Both Congress and the executive branch exert significant influence over the FDA. Critics are concerned that FDA scientific decisions may be too susceptible to political interference, such as political pressure affecting the approval of drugs, dietary supplements, and medical devices. Examples of political interference include the approval of mifepristone (the first abortion pill regimen) in 2019 by the FDA, which was influenced by the executive branch. The FDA’s ability to regulate dietary supplements was hindered by political interference, and the FDA’s ability to regulate Menaflex (knee patch) was affected by congressional interference.
In 2009, the FDA admitted it mistakenly approved the Menaflex patch for injured knees due to pressure from Congress members and the manufacturer. Holly Fernandez Lynch, Steven Joffe, and Matthew S. McCoy of the Department of Medical Ethics and Health Policy at the Perelman School of Medicine at the University of Pennsylvania, in their article “The Limits of Acceptable Political Influence on the FDA,” argue that White House involvement in decision-making during the COVID-19 pandemic has renewed attention to the independence of the U.S. Food and Drug Administration. They argue that the FDA cannot make decisions based solely on science, and political considerations play a significant role (Fernandez, Joffe, and McCoy). Therefore, the politicization of the FDA is inevitable, given its organizational structure as part of the federal government. Congress sets the FDA’s budget and legal parameters, and the President appoints the FDA Commissioner. The FDA is supposed to make decisions based on scientific evidence and expert judgment. However, political pressure can affect its decision-making.
Another reason I believe the FDA is not a reliable federal agency is because it has been corrupted in favor of the interests of the Big Pharmaceutical Industry, the Big Food Industry, and the federal health agencies it is supposed to regulate. The agency regulates a wide range of food and health products, including medicines, medical devices, tobacco products, cosmetics, animal foods, and dietary supplements. Its primary function is to ensure these products meet specific quality standards before entering the U.S. market.
Currently, approximately 20% of consumer purchases are regulated by the agency. The agency’s fiscal budget 2024 amounted to $6.9 billion, most of which came from the federal government and industry tax rates. Since 1992, the agency has relied on tax revenues from regulated manufacturers, raising doubts about its independence (Ferragano and Klobucista). During the COVID-19 pandemic, the FDA ordered mandatory use of the COVID-19 vaccine despite accusations of undue influence by the pharmaceutical industry. Pfizer, Johnson & Johnson, and Moderna were among the first companies to develop the vaccine, which drew criticism that its development could take 10 years and was developed in just 10 months, after which the FDA confirmed its effectiveness. There have been allegations of conflicts of interest regarding the approval of aspartame, including interactions between the FDA and sweetener companies. In the 1970s and 1980s, there were allegations of a revolving door between regulators and the industry.
1981 President Ronald Reagan appointed Dr. Arthur Hull Hayes Jr. as the new FDA Commissioner. Donald Rumsfeld presented a reassessment of aspartame, allowing Hayes to approve it for human consumption. Some argue that the political power of sweetener companies contributed to maintaining its legality, even when studies showed it was harmful. Dr. John Olney, a neuroscientist at the Washington University School of Medicine, investigated the potential consequences of brain damage and other harmful effects of aspartame use in carbonated beverages. In 1996, he published his findings in the Journal of Neuropathology and Experimental Neurology. These studies documented a disturbing increase in brain tumors and brain cancer since the approval of aspartame use in carbonated beverages in 1983. Olney was convinced of the relationship between the two (Sikes). For this reason, I believe the FDA is unreliable because it is dominated by the Pharmaceutical and Food Industries, as evidenced by its revolving door policy with the industry and its anti-scientific rulings, despite evidence that such rulings are contrary to safety and public health.
The reliability of the FDA has been questioned due to a series of complaints related to the medicines and foods it regulates. The FDA regulates alcohol and tobacco, which have caused deaths and destruction for a long time. There is no known medical use for either, while tobacco has caused cancer and other heart diseases. The FDA collaborates with industry and states to issue public communications and alerts about market withdrawals that pose significant or serious risks to consumers or users of the product. The FDA also issues warning letters to companies selling potentially dangerous supplements, ensuring they are aware of potential risks and can take action instead of arresting them. A 2006 report from the Institute of Medicine found significant deficiencies in the FDA’s system for ensuring drug safety in the U.S. market. Critics argue that the FDA is not rigorous enough in regulating certain products, allowing unsafe drugs to be marketed due to pressure from pharmaceutical companies, not ensuring safety in storage and labeling, and allowing agrochemicals, nutritional additives, and dangerous food processing techniques. Some critics believe the FDA has been too concerned with safety in approving new drugs and has been slow to withdraw approved drugs when evidence shows their insecurity. Examples include Rezulin (rofecoxib), which is an anti-inflammatory for arthritis, pain, and migraine, and Vioxx (rofecoxib), which is an anti-inflammatory for pain and inflammation, which were later withdrawn from the market due to unacceptable risks to patients. (Baciu, Stratton, and Burke). For this reason, the reliability of the FDA is strongly questioned for its bias toward pharmaceutical and food industries when it comes to unsafe products and its failure to sanction these industries instead of notifying them.
Some people say the FDA is a reliable federal agency because it regulates medicines and foods consumed to benefit public health and nutrition in the United States. This may be true, but if it were only about regulating medicines and foods consumed to benefit public health and nutrition. However, at this point, the problem goes beyond the benefit of health and nutrition. The FDA is a federal agency politicized by its organizational structure as part of the federal government; moreover, it is controlled and corrupted by the Pharmaceutical and Food Industry in favor of its interests and whose reliability is questioned in regulating certain products.
For these reasons, I believe the FDA is not a reliable federal agency because it is inevitably politicized as part of the federal government and dominated by the Big Pharmaceutical and Food Industry in favor of its interests, as evidenced by the complaints. In addition, there is a lack of rigor in sanctioning these industries regarding unsafe products for the consuming public. I believe that if we want to be a healthy and prosperous country, we must begin to reform the institutions that control our health and nutrition to avoid undue influence from mighty politicians and lobbying groups from the pharmaceutical and food industries.
ABOUT THE AUTHOR
Luis Henry Contreras Del Aguila
Food Industries Engineer Universidad Nacional Agraria de la Selva- Tingo Maria- Peru
Master in Agribusiness Administration ESAN University – Lima-Peru
CEO, Country Agribusiness
REFERENCES
Ferragamo, Mariel & Klobucista, Claire. “What Is the FDA’s Role in Public Health?”. www.cfr.org, January 27, 2025, https://www.cfr.org/backgrounder/what-fdas-role-public-health
Fernandez, Holly, et al. “The limits of acceptable political influence over the FDA”. www.nature.com, January 18, 2021, https://www.nature.com/articles/s41591-020-01200-w
Gordon, Alex. “The Delicate Dance of Immersion and Insulation: The Politicization of the FDA Commissioner”. www.dash.harvard.edu, April 29, 2003, https://dash.harvard.edu/server/api/core/bitstreams/7312037c-a65d-6bd4-e053-0100007fdf3b/content
Sikes, Morgan. “The aspartame controversy of 1981: The Hidden Truth Behind the Not-So-Sweet Artificial Sweetener”. www.vtechworks.lib.vt.edu, https://vtechworks.lib.vt.edu/server/api/core/bitstreams/a814bc16-5c18-4e53-82eb-6472e092e7af/content