The History of the Food and Drug Administration (FDA)

This brings us to the first question regarding what led to the inception of the FDA? And well, The US Food and Drug Administration is a scientific, regulatory, and public health agency that oversees items accounting for 20 cents of every dollar spent by consumers. Its jurisdiction encompasses most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumer, medical, and occupational use, cosmetics, and animal feed. The agency grew from a single chemist in the U.S. Department of Agriculture in 1862 to a staff of approximately 15,000 employees and a budget of $4.4 billion in 2014, comprising chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers, and many others. About one-third of the agency’s employees are stationed outside of the Washington, D. C. area, staffing over 150 field offices and laboratories, including five regional offices and 20 district offices. Agency scientists evaluate applications for new human drugs and biologics, complex medical devices, food and color additives, infant formulas, and animal drugs. Also, the FDA monitors the manufacture, import, transport, storage, and sale of about $1 trillion worth of products annually at a cost to taxpayers of about $3 per person. Investigators and inspectors visit more than 16,000 facilities a year, and arrange with state governments to help increase the number of facilities checked.
Beginning as the Division of Chemistry and then (after July 1901) the Bureau of Chemistry, the modern era of the FDA dates to 1906 with the passage of the Federal Food and Drugs Act; this added regulatory functions to the agency’s scientific mission. The Bureau of Chemistry’s name changed to the Food, Drug, and Insecticide Administration in July 1927, when the non-regulatory research functions of the bureau were transferred elsewhere in the department. In July 1930 the name was shortened to the present version. FDA remained under the Department of Agriculture until June 1940, when the agency was moved to the new Federal Security Agency. In April 1953 the agency again was transferred, to the Department of Health, Education, and Welfare (HEW). Fifteen years later FDA became part of the Public Health Service within HEW, and in May 1980 the education function was removed from HEW to create the Department of Health and Human Services, FDA’s current home. To understand the development of this agency is to understand the laws it regulates, how the FDA has administered these laws, how the courts have interpreted the legislation, and how major events have driven all three.
During this time, states exercised the principal control over domestically produced and distributed foods and drugs in the 19th century, control that was markedly inconsistent from state to state. Then, the Vaccine Act of 1813, though short-lived, was the first federal law dealing with consumer protection and therapeutic substances. Federal authority was limited mostly to imported foods and drugs. Adulteration and misbranding of foods and drugs had long been a fixture in the American cultural landscape, though the egregiousness of the problems seemed to have increased by the late 19th century (or at least they became more identifiable). By this time science had advanced significantly in its ability to detect this sort of fraud. Also, legitimate manufacturers were becoming more concerned that their trade would be undermined by purveyors of deceitful goods. For instance, quinine-containing cinchona bark powder could be made less therapeutically effective–and much more profitable–by cutting it with just about anything, alum and clay masked poor wheat flour and thus netted a heftier return for the unethical company, and sufferers of any number of serious or self-limited diseases were relieved only of their finances by vendors of worthless nostrums. Even the so-called ethical drug firms were guilty of this practice.
Following this, the Division of Chemistry began investigating the adulteration of agricultural commodities as early as 1867. When Harvey Washington Wiley arrived as chief chemist in 1883, the government’s handling of the adulteration and misbranding of food and drugs took a decidedly different course, which eventually helped spur public indignation at the problem. Wiley expanded the division’s research in this area, exemplified by Foods and Food Adulterants, a ten-part study published from 1887 to 1902. He demonstrated his concern about chemical preservatives as adulterants in the highly publicized “poison squad” experiments, in which able-bodied volunteers consumed varying amounts of questionable food additives to determine their impact on health. And Wiley unified a variety of groups behind a federal law to prohibit the adulteration and misbranding of food and drugs, including state chemists and food and drug inspectors, the General Federation of Women’s Clubs, and national associations of physicians and pharmacists.
THE CONTROVERSIAL HISTORY OF ASPARTAME, AND THE FDA’S ROLE 
And now onto the second question regarding what is the role of the FDA in the history and controversy of aspartame? To begin with, the history of aspartame dates back to 1965 when the low-calorie sweetener was accidentally discovered by chemist James Schlatter. After the evaluation of data from required studies, the US Food and Drug Administration approved aspartame for use in certain foods in 1981, soft drinks in 1983, and authorized aspartame as a general-purpose sweetener for foods and beverages in 1996. The European Union approved aspartame in 1994 as a food additive. It is currently approved for use in more than 100 countries.
BUT, the artificial sweetener aspartame has been the subject of several controversies since its initial approval by the US Food and Drug Administration in 1974. The FDA approval of aspartame was highly contested, beginning with suspicions of its involvement in brain cancer, alleging that the quality of the initial research supporting its safety was inadequate and flawed, and that conflicts of interest marred the 1981 approval of aspartame, previously evaluated by two FDA panels that concluded to keep the approval on hold before further investigation. In 1987, the US Government Accountability Office concluded that the food additive approval process had been followed properly for aspartame. The irregularities fueled concerns among people in society, which – based on how the FDA operates, we now understand to be quite legitimate.
THE FDA’S FAILURES AS A REGULATOR IN THE STATUS QUO
And now on the final question regarding how has the FDA failed in its responsibilities as a regulator in the status quo? In what they say was an effort to encourage the discovery of more treatment and diagnostic options in the medical field, the US Food and Drug Administration finalised a new rule allowing certain clinical trials to operate without obtaining informed consent from participants. They say that the mitigatory factor is that the study cannot pose more than minimal risk to humans and must include appropriate safeguards to protect the rights, safety, and welfare of those involved. The rule was issued in late December 2023 and went into effect on Jan. 22, 2024. Now, the FDA initially proposed the rule in November 2018, permitting an institutional review board to waive the requirement for informed consent under certain conditions. The agency received comment letters on the proposed rule from academia, institutional review boards (or IRBs), public advocacy groups, industry, trade organisations, public health organisations, and citizens. It appears that many see this measure as an improvement to safety of clinical trials (which is concerning, but also exposes how low the bar must be for the FDA if this is considered an improvement from them).
Of course, some (correctly) warned that “a waiver of consent [is necessary and ethically justifiable for, especially] for certain types of clinical investigations that are critical for medical advancement, patient care, and safety.” Other commenters believed the rule simply goes “against the spirit” of protecting humans in medicine. But, much of the pushback against this new rule from the FDA is that this new rule suggested the changes would allow Institutional Review Boards to compromise on standards more and more, adding that the term “minimal risk” is too vague and could be misinterpreted or abused. The result would be decreased public trust in research and health care providers. However, this new rule from the FDA ought to be considered against a long history of the medical and pharmaceutical industry knowling harming patients, and normalising that behaviour through fine print and bureaucracy.
Now, despite this very apt criticism, the FDA says that how they define minimal risk is a mitigator of this. Minimal risk, as defined by the FDA, means the likelihood of experiencing harm or discomfort is not greater for a subject during a study than for them during everyday tasks. In other words, there’s minimal risk in nearly every activity, from walking to putting away the dishes to picking the kids up from school; the study’s risk cannot exceed the risk one experiences daily.
BUT, this definition of minimal risk is not enough to guarantee safety – in fact, limits and definitions of minimal risk that have been used by medical and food companies in the past or even in status quo reveal a concern. For instance, we’ve discussed once, here on The War Room, a study conducted by the Healthy Babies, Bright Futures Association which found that 94% of baby foods and homemade purees made from raw ingredients contained detectable amounts of heavy metals. Lead was found in 90% of baby foods, arsenic in 68%, and cadmium in 65% of baby products. And yet in most cases, these levels of heavy metals fell within the legal limits! In fact, for the longest time, the FDA’s standards for minimal risk were not made with the intent to protect your health and wellbeing – instead, they were heavily politicised and filled with legal loopholes for the manufacturers of the products. Just have a listen to Attorney Cal Warriner, as he discussed, 7 years ago, the practice in the drug and medical device legal field and how the FDA reviews products presented to them.
Well, this really tells us that, with their track record, no one can afford to take the FDA on its word when it claims that this new rule on minimal risk actually ensures safety. Because it has made that promise over and over. In any case, this new ruling on clinical trials comes at a time when the FDA has been attempting to rebuild its reputation after the COVID plandemic, during which it was heavily swayed by political influence. In fact, the agency has been called upon by industry leaders to tighten its prescription drug and medical device approval process—and to make it more transparent. But, have a listen to the following cases because they really shine light at how deeply entrenched the problems in the FDA are: not only the sloppy approval processes but ESPECIALLY the harms that people suffered as a result of the products that the FDA approved.
The FDA might have been created for a noble purpose, but it is abundantly clear that the organisation has metamorphosed into an enabler of the bad and harmful conduct that it was supposed to prevent in the first place. No wonder a number of the commissioners go on to work for the pharmaceutical companies they were supposed regulate shortly after – this is a problem of corruption that ought ot be addressed, especially in the new Trump administration, that has adopted a more fundamental and proactive approach to healthcare, through the Make America Healthy Again project.
Written by Lindokuhle Mabaso