Food and Drug Administration Report
By: Carlos Escobar
The Food and Drug Administration (FDA), officially founded in 1906, was created as a
federal agency with the purpose of consumer protection. Before the FDA there were serious
long-standing abuses in the consumer product marketplace. Today, the FDA stands as a
cornerstone of public health and safety in the United States. Since its foundation, the
organization has evolved and transformed into a powerful agency responsible for regulating and
overseeing millions of products that impact the daily lives of Americans. Within this report, we
will dive into the root of the FDA and its creation, discuss how the organization has evolved, and
examine the guidelines the FDA enforces today to maintain product safety. However, we will
also discuss the shortcomings of the FDA and what changes should be made to ensure that the
public health of the people it set out to protect remains at the forefront.
Since the creation of the United States up until the twentieth century few laws regulated
the sales of domestically produced food and medicine. One of the only exceptions was the
Vaccine Act of 1813. This law encouraged the public to vaccinate against smallpox. During that
time smallpox accounted for thirteen percent of American deaths but the public was hesitant
about the drugs used in the vaccine which was discovered in 1798. The law was passed to ensure
to the public that federal agents were preserving the genuine vaccine and provided against
unethical sales practices. Since then, it was not until Harvey Washington Wiley was appointed
chief chemist of the US Department of Agriculture's Division of Chemistry in 1883 that there
would be any emphasis or research on the adulteration and misbranding of food products and
drugs in the United States. From 1887 to 1902 Wiley published his findings and lobbied to create
a federal standard for food and drugs distributed in the country. As the country was transitioning
to a heavily industrialized setting it was clear that regulations needed to be set. The public began
to pay attention to the issues but it all erupted when famous reporter Upton Sinclair released
"The Jungle" in 1906 which detailed the horrific working conditions in a Chicago meatpacking
facility. He explained the disgusting conditions in the facility which filled the public with
outrage. The government knew that it could not wait any longer and needed to make a change
(Singla 1998).
Until then, hundreds of bills had been presented but none of them would get passed into
law. However, the pressure from the public became too large and these efforts paid off when
then-President Theodore Roosevelt passed the Pure Food and Drug Act of 1906. The landmark
legislation sought to eradicate the widespread mislabeling and adulteration of products that posed
serious health risks to the public. The act required manufacturers to provide accurate ingredient
labels and adhere to the new standards set by the new law. The act gave oversight to the Bureau
of Chemistry within the USDA to enforce these regulations. The Bureau was allowed to inspect
facilities and had the authority to take action against companies that violated the law. They were
also within their right to seek injunctions and seize products that were deemed unsafe. It was not
until 1930 that the agency was eventually branched off and renamed to the Food and Drug
Administration (Powers 2022).
In 1911, the case US v. Johnson revealed some of the first flaws in the law which was
exploited by some individuals. Johnson argued that the misbranding provisions did not include
false curative or therapeutic statements but instead only pertained to the identity of the drug. The
Supreme Court ruled in favor of Johnson meaning that Congress had to pass an amendment. It
did so in 1912 with the Sherley Amendments. Congressman John Shirley of Kentucky
introduced the bill to broaden the regulatory powers of the government in safeguarding the
quality and safety of food and drugs. The amendments provided a clearer definition of
"misbranding" and now prevented false and misleading curative or therapeutic statements. The
amendments also increased labeling requirements to include the quantity of certain ingredients in
products such as alcohol and narcotics. Penalties were also increased making non-compliance
more costly to companies. Since the original law was passed, many companies felt that it would
be more beneficial for them to keep breaking regulations since the fines were not too aggressive.
With the amendment, many of those companies corrected their practices (Davies 2014).
In 1914, Congress passed the Harrison Narcotic Act with the intent to curb narcotic use in
America, specifically the use of opium. The law was aimed to address the growing addiction
concerns associated with drugs. Pharmacists and physicians had to keep records of transactions
and patients could only obtain these drugs with prescriptions. The hope was to provide these
drugs only for medical use and prevent them from being illegally distributed. The next big
change would not come until 1937 when Harold Watkins created the Elixir of Sulfanilamide.
During these times antibiotics were brand new to the public and scientists were still making
discoveries on a relatively frequent basis. Watkins was tasked by the head of S.E. Massengill
Company to make an antibiotic that was easier to digest by putting it in a syrup form. Watkins
used diethylene glycol which unbeknownst to him was poisonous to humans. 107 people died,
most of them children. Congress quickly introduced The Federal Food, Drug, and Cosmetic Act
of 1938 (FFDCA) and it was signed into law by President Roosevelt. The law mandated that new
drugs must be deemed safe before selling and advertising could begin, it also demanded safe
tolerances had to be set to prevent poisoning, and further increased the oversight of the FDA in
prosecuting manufacturers (West 2018).
Throughout the next several decades, Congress continued to enact amendments like the
Durham-Humphrey Amendment of 1951 which deemed certain medications unsafe unless with
medical supervision and mandated that they were made available only with prescriptions.
Another significant change came in 1962 with the Kefauver-Harris Drug Amendment which now
required drug manufacturers to prove to the FDA the effectiveness of their products. In 1997, the
FDA Modernization Act was enacted and showed to be a major reform in the regulation of food,
medical products, and cosmetics. The act increased patient access to new experimental drugs and
medical devices. It increased the speed at which the agency reviewed new medications. Another
modernization act was passed in 2011 labeled the FDA Food Safety and Modernization Act
(FSMA). FSMA provided the FDA with new enforcement authorities related to food safety
standards and provided tools to hold imported foods to the same standards as domestic foods.
Today, the FDA is much bigger than what it originally was when it was first created in 1938. As
technology advanced changes needed to be made. Many however feel that the changes have not
been enough and that perhaps one agency is no longer enough to keep up with the growing
demand of the country (FDA 2023).
In March 2019, the FDA went through a reorganization to modernize its structure and be
able to keep up with the growing health concerns in the country. As of 2023, the FDA employs
over 18,000 individuals nationwide. These numbers include a wide variety of professionals such
as scientists, doctors, regulatory specialists, inspectors, and administrators. At its head is the
Office of the Commissioner and below are four directorates that oversee the core functions of the
agency. The four offices are Medical Products and Tobacco, Food and Veterinary Medicine,
Global Regulatory Operations and Policy, and Operations. These offices further branch down
into different centers such as the Center for Drug Evaluation and Research (CDER), Center for
Biologics Evaluation and Research (CBER), Office of Vitro Diagnostics and Radiological Health
(CDRH), and Center for Veterinary Medicine (CVM). There are plenty of other centers that fall
under the FDA umbrella and when analyzing it with an objective perspective one can see how it
could be difficult for the organization to stay on top of all the branches it oversees.
The Office of the Commissioner within the FDA holds significant responsibilities in
ensuring the safety of food, drugs, and products. The Commissioner, as the head of the FDA,
oversees several crucial obligations. One primary responsibility involves setting and
implementing the agency's goals and regulatory policies. This involves decision-making on new
product approvals, developing and enforcing regulations, and assessing the safety and
effectiveness of various products. They lead and direct the work of thousands of employees,
ensuring that the FDA fulfills its mission to protect and promote public health. The
Commissioner also manages crises and emergencies related to public health. They engage in
public outreach, providing guidance and information to healthcare professionals, industries, and
the public. Additionally, the Commissioner acts as the FDA's representative in interacting with
the US government, international organizations, and industry stakeholders.
The FDA employs a thorough process to inspect new products before they can be
introduced to the market. The inspection process is tailored to the specific category of the
product. For drugs, the FDA measures the product through a rigorous review of preclinical
studies and the manufacturing processes. This includes evaluating the safety, effectiveness, and
quality of the product. The FDA also inspects the facilities where the drug is manufactured to
ensure they meet the required standards for production, storage, and handling. In the case of
medical devices, the FDA examines various aspects such as design, manufacturing, performance,
and potential risks. The evaluation might involve pre-market testing, clinical trials, and an
assessment of the manufacturing facilities. For food and cosmetics, the FDA examines labeling,
ingredients, and potential health risks associated with consumption or use. Inspections might
focus on facilities, the manufacturing process, and the ingredients to ensure compliance with
safety and quality standards. The inspection process involves both pre-market assessment and
post-market surveillance. Before approval or clearance for market entry, the FDA evaluates data
provided by manufacturers. After products are on the market, the FDA continues following
through various means such as sampling and monitoring safety concerns reported by consumers
or healthcare professionals (Llamas 2023).
Despite the restructuring, there is still a growing concern from the public that the FDA
cannot keep up with the growing demand and has been called to split up. Many argue that the
agency's dual responsibilities create conflicts of interest and hinder its ability to focus effectively
on either. With the changing landscape of pharmaceuticals and the food industry, there's a
growing belief that a split in the FDA would lead to more specialized attention, streamlined
regulations, and a stronger focus on the distinct challenges of each sector. It would allow for a
deeper focus on emerging technologies, scientific advancements, and evolving health concerns
specific to either faction. The recent pandemic was further proof that the agency is not properly
equipped to deal with issues of that magnitude. Drug manufacturers like Pfizer and Moderna
were able to produce a vaccine in record time but the public was hesitant in being inoculated
because they had not been approved by the FDA. The FDA approved the drugs faster than it had
done any vaccine in the past and some ways hurt the public perception because many felt that
they rushed their decision and had not been thorough enough with their investigation of the
approval process (Taylor 2022).
There are those, however, who believe that the FDA should not be split up and their
argument deserves some consideration. One key point is the relationship between food and drug
safety. The current structure of the FDA allows for a holistic approach to public health. The
crossover between food and drug safety often involves shared resources, knowledge, and
expertise. Combining these efforts allows for a more comprehensive understanding of healthrelated issues and potential interactions between food and drug products. Additionally, a singular
FDA maintains uniform standards and consistency in regulatory processes, which can be more
efficient and cost-effective. Separating the FDA might present challenges, such as potential
duplication of efforts, increased administrative costs, and the difficulty of establishing separate
regulatory outlines. Instead of splitting the FDA, they argue that it instead needs to be expanded.
Congress should be increasing their budget allowing them to properly staff their offices and be
given the ability to delegate in a more focused manner.
In conclusion, while there are compelling arguments on both sides of whether splitting
the FDA is a good idea or not. Changes within the agency are essential to meet the evolving
demands of the public. Whether it involves expanding its capacity, restructuring its divisions, or
maintaining the status quo with certain improvements, a critical assessment of the FDA's current
structure is necessary. It's crucial to frequently evaluate the FDA's effectiveness in ensuring
public health and safety, aiming for a responsive, efficient, and adaptable regulatory system that
can effectively navigate the difficulties of the changing landscape of food and drug products. The
debate highlights the need for ongoing dialogue and potential reforms to ensure the FDA remains
capable of addressing the challenges of the 21st-century food and drug industries.
Works Cited
Davies. “FDA Focus: The Sherley Amendment.” TPL, TPL, 10 Nov. 2014,
www.thepharmaletter.com/article/fda-focus-the-sherley-amendment.
“FDA History Milestones.” U.S. Food and Drug Administration, FDA, 30 Jan. 2023,
www.fda.gov/about-fda/fda-history/milestones-us-food-and-drug-law.
Llamas, Michelle. “Food and Drug Administration (FDA) - Safety Guidelines.” Drugwatch, 5
Sept. 2023, www.drugwatch.com/fda/.
Powers, Kristin. “A History of Research: 1906 Pure Food & Drug Act-The Birth of the FDA.”
Obstetrics & Gynecology, 14 Nov. 2022, obgyn.wustl.edu/a-history-of-research-1906pure-food-drug-act-the-birth-of-the-fda/.
Singla, Rohit K. Missed Opportunities: The Vaccine Act of 1813, Harvard University, 1 May
1998, dash.harvard.edu/bitstream/handle/1/10015266/rsingla.html?sequence=2.
Taylor, Michael. “Opinion: It’s Time to Fix FDA by Breaking It Up.” POLITICO, 11 Apr. 2022,
www.politico.com/news/magazine/2022/04/11/fix-fda-break-it-up-00024423.
West, Julian G. “The Accidental Poison That Founded the Modern FDA.” The Atlantic, Atlantic
Media Company, 16 Jan. 2018, www.theatlantic.com/technology/archive/2018/01/theaccidental-poison-that-founded-the-modern-fda/550574/.