Compounded medication and natural healing substances are under attack by the FDA.
The FDA and the pharmaceutical industry are orchestrating a silent takeover against compounding pharmacies, one of the last bastions of natural medicine, hence rapidly lowering your chances of getting any type of individualized medication. It’s a page-turner in an already shady chronology of medical takeovers.
Compounded medication is vital for those who opt for a specialized natural-based medication or a modification to accommodate an allergy. It may come in a dropper, pill, or ointment; it could support your digestion, sleep, energy or libido; or counter allergy, pain, inflammation, or infection. But if it contains Boswellia, Curcumin, Melatonin, CoEnzyme Q10, Aloe Vera, Tea Tree Oil or any other 236 natural healing substances, it may soon be illegal.
No this is not a joke.
Compounded Medication: A Silent Heist
In the early 1900s, most medications were done by pharmaceutical compounding. It made perfect sense. People want, need, and prefer individualized preparations for their unique conditions. After mass-produced generic drugs flooded the market in the 1930s, compound trained pharmacies began to make more money as drug dispensers.
By the end of the twentieth century, as chronic disease and desperation hits a historic high, compounded medicine represents up to three percent of the prescription market today (see below table).
According to the International Academy of Compounding Pharmacists (IACP), the trade group representing the compounding industry, there are 56,000 community-based pharmacies in the U.S. About half of them directly serve local patients and doctors. Some 7,500 compounding pharmacies specialize in what the IACP calls “advanced compounding services.”
The FDA traditionally regulates drug manufacturers and states regulate pharmacies.
Three government agencies regulate compounding pharmacies:
- State boards of pharmacy ensure that pharmacies follow state regulations for pharmacy practice.
- The FDA regulates “the integrity of the drugs” and the active pharmaceutical ingredients from which they are made.
- The Drug Enforcement Administration regulates compounding pharmacies’ handling of controlled substances.
The FDA is now using its particular jurisdiction to hinder the use of natural substances in compounded medication.
The hearings have already begun.
In an interview* published on Journal Of Restorative Medicine on January 4, 2019, Dr. Paul Anderson, who is testifying at the FDA hearings, says that the process began a few years back when the FDA invited compounding pharmacies and natural medicine practitioners to “submit substances for a hearing.”
After practitioners complied, the FDA told them that only some of the substances — 68 out of 310 to be exact — “warranted a hearing.”
“The rest will automatically become illegal to compound without even having had a hearing,” says Dr. Anderson.
The range of endangered natural substances is mind-boggling.
Substances that the FDA says should be illegal to compound include many substances that are inside our bodies, such as acetylcarnitine, certain forms of glutamine, chondroitin, D-ribose, and a number of other things that we actually can’t live without. The list also includes commonly used natural substances such as artemisinin, Boswellia, MSM (methylsulfonylmethane), glycyrrhizin, and certain B vitamins such as nicotinamide.
If a natural substance can’t be proven by a doctor, clinic, or pharmacy to be the only treatment for a particular condition, it will automatically become illegal.
“The way the FDA hearings are set up, if these substances do not have some very clear medical indication for which they are the only treatments, the FDA essentially tells the committee that they should not approve it.”
In other words: if there is a pharmaceutical alternative to natural medicine, the latter may become history.
It sounds bad and it is bad. It’s the kind of bad that affects everything in a very bad way.
Dr. Anderson cites an example. Curcumin, the messy orange powder in your kitchen cabinet that happens to be a powerful antioxidant.
In my clinical practice, informed by a growing evidence base, we were compounding curcumin, which is now on the FDA ‘no’ list, to use in very high doses with patients who had advanced cancer for which nothing else was working. The results were that the progression of metastases stopped in a number of patients and metastases actually regressed in a few. So, this worked as a proof of concept without a single high-grade adverse event. In about 2015, we nominated curcumin to be reviewed by the FDA because it was not an approved drug, and we were trying to ensure it would remain available to patients. Nobody on the FDA panel seemed interested in our findings, though. Then, a couple of years later, I saw that a patentable synthetic form of curcumin, called Lipocurc™, was in development.
So here we are, looking at a silent takeover of natural medicine.
The FDA ruling is not in place yet but it could be enforced anytime. We have no idea how far-reaching the implications we’re dealing with are. But even in their mildest form, the rulings represent an unprecedented attack on the right of individuals to count on natural substances for their healing.
We invite you to raise your own voice in this matter. Even if you never cry out because you think it’s useless, do it this time. Outrageous or tyrannical public rulings, laws or legislators that go against common human rights have never been stopped without a public outcry. And in this case, the rulings are about to be put into place amidst total media silence.
Share the news and let the federal judge who will rule on this case hear from you. If you’re a patient or practitioner who believes in your right to use natural medicine over synthetic drugs, let them know your stance.
- Go to www.regulations.gov
- Enter the text: FDA-2015-N-3534-0001 in the Search box
- Click on “Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket”
- Click on the Comment Now! Button on the top right of the screen
- Donate to the GoFund Me campaign