For most of my life, I’ve observed the FDA belligerently suppress natural treatments and any unorthodox therapy which threatens the medical monopoly while simultaneously railroading through a variety of unsafe and ineffective drugs regardless of how much public protest the agency meets. Consider this 2004 Senate testimony by the FDA scientist who got Vioxx banned that accurately described exactly what would come to pass with the COVID vaccines two decades later.
As such, I do not hold the FDA in a positive light, especially given that during COVID-19, I (like many others) spent hundreds of hours trying to get the agency to allow the limited use of off-patent therapeutics for COVID-19—all of which ultimately went nowhere due to the unjustifiable roadblocks the agency kept putting up.
Over the past year, especially since Trump’s election, I’ve received many questions about FDA reform. To address the issue properly, I’ve carefully examined both sides.
In medicine, “sensitivity” refers to a test’s ability to correctly identify those who have a condition (e.g., detecting an infection), while “specificity” measures how well the test avoids false positives (i.e., correctly identifying those who don’t have the condition). The challenge is that improving one often reduces the other. For example, increasing the PCR cycle threshold in COVID tests made it more likely to detect infections (higher sensitivity), but also increased false positives (lower specificity). This trade-off leads to problems, like breast cancer screenings, where high sensitivity can result in false positives and unnecessary “treatments” for women who don’t actually have cancer.
The FDA faces a similar challenge: it must prevent harmful foods and drugs from reaching the market while ensuring useful products aren’t blocked. Though this seems straightforward, it’s incredibly difficult, and the FDA has often failed at both, even with leadership dedicated to public health.
Crime Against the Food Law
In the late 1800s, food producers were selling adulterated products, and pharmaceutical companies peddled medicines with secret ingredients like opium and alcohol. Public outrage grew, especially after exposés like Upton Sinclair’s The Jungle, which helped spark the 1906 Pure Food and Drug Act. This law gave the Bureau of Chemistry the power to ensure accurate labeling and prevent harmful additives in food.
The director of the Bureau of Chemistry (and thus the first head of the FDA), Harvey Wiley conducted tests on food additives, proving they made healthy volunteers sick. While the public and many scientists supported his findings, the food industry fought back with powerful lobbyists and legal tactics.
Note: the additives Wiley scrutinized were boric acid and borax, salicylic acid (aspirin) and salicylates, benzoic acid and benzoates, sulfur dioxide and sulfites, formaldehyde, sulfate of copper (used to green produce), and saltpeter (nitrates).
Gradually, the food industry hijacked the presidency, and in 1912, Wiley resigned, realizing he could achieve more for America’s health as a private citizen than within the government.
Wiley’s book “The History of A Crime Against The Food Law” details much of the same abhorrent industry tactics we see happening now. For example, a series of investigative reports recently showed that the processed food industry’s lobbyists worked fervently behind the scenes to block RFK’s nomination and had there not been widespread public protest, would have stopped us from Make America Healthy Again.
Those tactics also highlight a key point Wiley made—the only way to create change in this industry is to coax the public at large to demand it, as the moment you rely upon the members of the government to fix it, lobbyists will crush those efforts.
Generally Recognized as “Safe”
Many food additives are “generally recognized as safe” (GRAS), meaning they’re widely used without regulation. Wiley faced two major issues: food industry counterfeiting and harmful additives. The industry often faked products to cut costs, like selling grain alcohol as whiskey or using polluted waters to enlarge oysters.
Despite evidence of harm, the food industry claimed these additives were essential for production, even though competitors showed higher-quality (and ultimately more profitable) products could be made without them. Wiley also warned that chronic exposure to additives could cause long-term health issues, such as organ damage and aging.
Sadly, his concerns were ignored as industry influence grew and he was unable to ban them—rather they were eventually reclassified as “generally recognized as safe.” As a result, these “safe” additives have contributed to widespread chronic illness in society.
Note: those additives included sodium benzoate, sulfur dioxide, alum (potassium aluminum sulfate), sulfur dioxide, saccharin, modified corn sugars, saccharin, and nitrogen bleached flour—many of which were linked to cancer. Sadly, since 2000, nearly 99 percent of new food chemicals added to the food supply chain have exploited the GRAS loophole. I believe the widespread use of aluminum in processed foods is particularly detrimental (due to it greatly impairing the physiologic zeta potential and causing micro-clotting throughout the body), and provides a key explanation for why you often see certain rapid improvements in individuals once they stop eating processed foods and their additives.
The Kefauver–Harris Amendment
In the years that followed Wiley’s departure, the handicapping of the FDA continued. As such, the FDA agent assigned to the morning sickness drug thalidomide could only stall but not reject it—a tactic that prevented catastrophic birth defects across America. A 1962 amendment was then passed, giving the FDA the power to block unsafe drugs.
This law gave the FDA excessive power, slowing drug approval and causing mismanagement. It also required “well-controlled” trials for drug approval, which the FDA defined as expensive double-blind randomized controlled trials (RCTs). This:
- Elevated RCTs, making drug approval a “pay-to-play” system, with approval costs soaring to 0.98-4.54 billion.1,2
- Created bias, as RCTs cost so much they inevitably produce results in favor of their sponsor (which often outweigh any benefit of their expensive “controlled” design).
- Sidelined smaller, effective observational trials, which, being affordable, are feasible for investigators to conduct without pharmaceutical sponsorship and can yield the same results as large RCTs (proven by a 2014 Cochrane Review).
- Stifled innovative therapies, as unorthodox treatments lacking costly RCTs were dismissed. As a result, medical innovation in the U.S. slowed, with scientists financially pressured to avoid challenging existing paradigms, leading to fewer groundbreaking discoveries despite advancing technology.
Because the FDA had rapidly expanded in numerous directions it was not prepared for, it subsequently frequently failed to fulfill its primary responsibilities (e.g., taking something harmful off the market), and it simultaneously took things away Americans actually wanted. This in turn led to numerous committees investigating the FDA (e.g., Commissioner Lay’s Kinslow report of his agency’s serious shortcomings) and key officials with integrity like Lay being kicked out, all of which were encapsulated a series of scathing articles that were published by the New York Times in 1977.
In my eyes, the most important thing about this period of FDA reforms was that the FDA was the most complained about agency in the government. Congress made numerous attempts to fix it (as did ethical FDA officials)—but nothing was ever solved.
The DMSO Saga
Over the last seven months, I’ve begun exploring a remarkable forgotten side of medicine—DMSO. This simple and freely available natural chemical is incredibly effective at treating a variety of (often “incurable”) conditions, including many that are otherwise impossible to treat including:
•Strokes, paralysis, a wide range of neurological disorders and circulatory disorders.
•Chronic pain and a wide range of tissue injuries.
•Many autoimmune, protein and contractile disorders.
•Head conditions, such as tinnitus, vision loss, dental problems, and sinusitis.
•A wide range of internal organ diseases.
•Acute and chronic infections including shingles and herpes.
•Many skin conditions including acne, herpes, hair loss and varicose veins.
•Many aspects of cancer, and when used in combination with other therapies, directly treating challenging cancers.
Likewise, since publicizing this research, I’ve received over two thousand reports from readers who then took it and had almost unbelievable results that precisely match what many reported in the 1960s and 1970s.
This all raises a simple question. How is it that no one knows about DMSO or that an agent that could dramatically reduce the need for opioids or prevent millions with stroke and spinal cord injury from having a life of disability never saw the light of day?
That’s because as DMSO rapidly spread across America in the 1960s, the FDA reversed its initial positive stance, declaring DMSO dangerous without evidence. This pivot was initially prompted by the FDA not wanting to have to process a flood of new drug applications, and then evolved into being done to protect the status quo and to justify the FDA’s newfound police powers. Despite extensive safety studies showing DMSO posed no risk to humans and numerous Congressional hearing being held to legalize DMSO, for decades, the FDA continued to demonize it, claiming a lack of evidence for efficacy (as DMSO’s characteristic effects make blinded trials with it impossible). Because of this, DMSO only became available decades later after the public got fed up with the FDA targeting natural medicines and the 1994 Dietary Supplement Health and Education Act was enacted (which removed the FDA’s ability to regulate natural medicines).
