As our FDA Death Meter demonstrates, the FDA approves dangerous drugs with horrific side effects that are given to tens of millions of Americans, while simultaneously waging a multi-pronged war on natural medicine in what is in all likelihood a deliberate effort to eliminate the competition for their Big Pharma clients.
The harm caused by this prolonged war is incalculable, since it is impossible to know how many lives would have been saved or substantially improved if more patients had knowledge of (and access to) important natural products and modalities.
Dietary and nutritional supplements have a remarkable record of both safety and effectiveness. There are over 487 times more adverse event reports for FDA-approved prescription drugs than there are for supplements, and 409 times more serious events for drugs than supplements. The following graph makes the difference obvious:
Supplement quality is maintained through strict adherence to Current Good Manufacturing Practices (CGMPs), which the FDA already has in place, and which are extremely stringent.
Unfortunately, the FDA has a strong allegiance to the pharmaceutical industry, stemming from their huge financial ties—Big Pharma essentially pays FDA’s bills. Because of this, the FDA approves and promotes pharmaceutical drugs (which may not be very effective, and which may be extremely dangerous, even mind-altering) while attacking dietary supplements, trying to regulate safe and effective supplements as if they were dangerous drugs, and seeking to get them taken off the market. This ensures big sales for Big Pharma, and continued income for the FDA.
The New Dietary Ingredient draft guidance
The Dietary Supplement Health and Education Act of 1994, which governs dietary supplements, required the FDA to create a notification system for new dietary ingredients (NDIs)—supplements introduced or substantially modified after 1994. But for the next seventeen years, supplement manufacturers had very little guidance on what constitutes an NDI and when or how to send an NDI notification.
In 2011 the FDA issued a draft guidance on NDIs. It contained provisions that threaten to sweep up to 41,700 dietary supplements off the market and would cost the industry as much as $14.7 billion. It was intended to be a notification system only, but—in an astounding perversion of congressional intent—the guidance attempted to establish a draconian pre-approval system for supplements, which placed an intolerable financial and logistical burden that most supplement manufacturers could never meet.
The war on natural medicines
Compounding is a method of preparing medications that are customized for a patient’s specific needs. Compounding allows prescribers (such as doctors and other medical professionals) and pharmacists to create medications that are the exact strength, dosage, and ingredient mix best suited to treat a particular patient.
In November 2013, the Drug Quality and Security Act was signed in to law, which tightened federal control over compounding pharmacies. It threatens many natural medicines, including bioavailable estriol, intravenous vitamin and mineral treatments, and individualized chelation treatments. Supplements and natural substances must be pre-approved by the FDA to be legal to compound, and the FDA is senselessly rejecting almost all natural substances—curcumin, boswellia, and aloe vera to name just a few.
Laboratory-developed tests (LDTs) are diagnostic tests developed and performed by local labs. They are widely used—thousands of different LDTs are available—and include genetic tests, tests for rare conditions, and companion diagnostics. LDTs are vital tools for personalized medicine because labs can even create custom diagnostic tests, but the FDA is working to stop this important technology.
The FDA has been attempting to throttle innovators in the medical testing field for some time. The agency is doing this to protect the monopoly of testing giants Quest Diagnostics and LabCorp, and of course hospitals.
LDTs are under the jurisdiction of the Centers for Medicare and Medicaid Services, yet the FDA is looking to expand its regulatory power over the field by regulating tests as medical devices—a move that members of Congress have vehemently denounced.
Medical foods in danger
“Medical foods” are foods specifically formulated and processed for a sick patient to meet specific nutritional requirements for the management of a disease or condition, and are used under medical supervision. Because the FDA wants as little competition as possible for Big Pharma, the agency is attempting to severely restrict the market for medical foods.
In 2013 the FDA issued an updated draft guidance on medical foods which drastically limits the number of medical conditions that medical foods can be used to manage. Outrageously, the guidance specifically excludes diabetes—both type 1 and type 2, as well as gestational diabetes—because, according to the FDA, diabetes can be controlled by simply managing or tweaking one’s normal diet (along with taking FDA-approved drugs, of course).
Under the new guidance, producers of medical foods will either have to reformulate their products to go through the drug approval process or else market them as dietary supplements (which would severely limit the claims their products could make, depriving practitioners and consumers of valuable health information).
The FDA is attacking homeopathy.
In 2015, the FDA held a public hearing to evaluate its enforcement policies for homeopathic drug products, indicating that an attack against homeopathy may be imminent. In the eyes of the FDA, it seems that the besetting sin of homeopathic preparations, as with supplements, is that they can under certain circumstances compete with FDA-approved Big Pharma drugs—the very drugs that pay the FDA’s bills, including staff salaries.