by Dr. Joseph Mercola, Mercola:
Story at-a-glance
- The U.S. Food and Drug Administration was originally created in 1906 to protect public safety, but food industry lobbyists gradually gained influence and forced out its first leader Harvey Wiley, who had fought against harmful food additives
- Under the FDA’s “Generally Recognized as Safe” (GRAS) designation, many potentially harmful food additives have been allowed into the food supply, with nearly 99% of new food chemicals since 2000 exploiting this loophole
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- The FDA has consistently opposed natural therapies like DMSO (a chemical shown to help with pain, neurological conditions, and injuries), raw milk, and certain stem cell treatments, while pushing potentially dangerous pharmaceutical alternatives
- Historical FDA vaccine scandals include the 1955 polio vaccine contaminated with SV40 virus, the 1976 swine flu vaccine that caused Guillain-Barré syndrome, and Gulf War Syndrome linked to mandated experimental vaccines. Recent controversial FDA approvals include SSRI antidepressants despite known suicide risks, Alzheimer’s drugs with dangerous side effects, and Ozempic for weight loss without sufficient long-term safety data
- Proposed reforms include separating approval tracks for conventional and alternative medicines, implementing stronger conflict of interest laws, making trial data public, and creating better mechanisms to revoke approvals of harmful drugs
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:
In 2004, the FDA official who got Vioxx pulled perfectly described the gross regulatory failure with the COVID vaccines. His must-see testimony exposes the FDA’s pay-to-play environment that let’s dangerous drugs sail through and never be withdrawn. A🧵 pic.twitter.com/GgDhIiqoTV
— A Midwestern Doctor (@MidwesternDoc) October 22, 2024
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 unnecessary “treatments” for women who don’t actually have cancer.1
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.2
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,3 which helped spark the 1906 Pure Food and Drug Act.4 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 Wiley5 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).
