…At the next meeting of the FDA’s Pharmacy Compounding Advisory Committee. If recent history is any indication, the outlook is not good—unless we push back. Action Alert!
The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA in writing new rules regarding what supplements and drugs can be made individually for patients with specific needs by compounding pharmacies. It will meet for the fourth time, on March 8 and 9, to discuss whether to continue to allow a new group of supplements and drugs from being made for individuals. Here are some of the substances being considered:
- Boswellia (Indian frankincense) is a tree resin that has been used for thousands of years to treat a variety of conditions, and recently has been shown to have anti-inflammatory properties. It also can be used to treat arthritis and osteoarthritis. Drug companies no doubt see this potent herb as a major threat to current or future drugs.
- Aloe vera, 200:1 freeze dried. Aloe vera leaves have been used medicinally as far back as the 16th century BCE. It is widely used in natural and traditional medicine for a variety of conditions, treating everything from burns to constipation, psoriasis, and herpes simplex virus.
- D-ribose is a natural ingredient for increasing energy (ATP) production. Evidence indicates that d-ribose can rejuvenate heart muscles after a heart attack or other cardiac events.
- Chondroitin sulfate is a structural component of the cartilage in joints. It stimulates the production of cartilage, improves blood circulation to the joints, and is used to treat osteoarthritis, among other things.
- Acetyl-L-carnitine is naturally produced by the body, functions as an antioxidant, and promotes the production of glutathione in cells. It is used for Alzheimer’s disease, age-related memory problems, and a wide range of other conditions.
These are, of course, supplements. As such they are commonly available. Yet the committee seems to think that everyday supplements should be banned from compounding. This is completely illogical. You can buy them in stores! Yet your doctor cannot include them in personalized medicine he prescribes?
Despite this crazy illogic, we doubt that any of these supplements will get a fair hearing. Last year, remember, PCAC voted to ban curcumin, which is widely used for its well-documented anti-inflammatory properties, among many other health benefits.
The elimination of supplements from compounding has far-reaching implications for natural medicine. Sometimes patients don’t even have the option of using any form other than the compounded one. Supplements are compounded for all types of patients—such as those with environmental sensitivities who cannot have supplements with preservatives, autistic children and other patients for whom swallowing pills is extremely difficult, or patients suffering from depression who rely on compounded amino acid solutions to manage their mood. All of these types of patients, and many more, will suffer if the PCAC continues to ban supplements from compounding.
The PCAC only makes recommendations to the FDA, but the committee has almost always followed the agency’s lead, or else the agency has arranged the verdict in advance—it is often hard to tell. We noted early last year that the PCAC seems to be a stacked deck, and developments have proved this observation correct. It has long been our suspicion that the end goal is to eliminate the compounding industry altogether, and this is a clever way to do it—whittle away what ingredients are allowed to be compounded, and it’s “death by a thousands cuts” for compounding pharmacies.
We must send a clear message to the PCAC to maintain patient access to compounded supplements—some of our most vulnerable patients rely on them!
Action Alert! Send a message to the PCAC urging them to approve the ingredients that have been nominated to the Bulk Ingredient List—and send a copy to Congress as well. Your legislators need to see what is happening to their compounding law! Please send your message immediately.
Other articles in this week’s Pulse of Natural Health:
Bad Trade Deal Gets Worse
Crony FDA Chief Approved by Senate
the F-orced D-eath A-uthority needs to be abolished
AND WELL THEY SHOULD (face the ax)!!!
Shame on you for agreeing to write the crap your boss told you to.
You and your bosses are traitors to consumers and their well being.
You are either a paid troll for the pharmaceutical industry or woefully ignorant of the true facts of the inner workings of our corrupt government. There is nothing in the list of ingredients that would be harmful to consumers unlike MANY of the concoctions put out by Big Pharma which have so many side effects they kill hundreds of people a year who are taking their medications exactly as prescribed. The Board and the FDA are the traitors to consumers.
Ya! I’m a doctor of chiropractic for over 25 years and have seen 4 of the 5 products mentioned here safely giving my patients relief and healthier function in the ways described WITHOUT THE FIRST SIDE-EFFECT. I call TROLL!!!!
It’s good to have trolls like you, it just makes us more resolved to fight for our basic human right to use natural supplements. Thank you towercam!
There should not be any controversy regarding any of these ingredients. Aloe Vera leaves a threat to mankind? Come on. A tbs. a day of the gel will do wonders for your liver and digestion. Cleansing, mild, soothing – a gentle gift from God. Big Pharma hates healthy, natural ingredients that truly heal. I guess the awful side effects and devastating health problems brought on by so many of the offerings of Big Pharma are a source of endless income for the Medical Industrial Complex. All those ingredients that were listed are wonderfully useful.
This may be a false fact in the story. The aloe vera leaf skin has shown to cause cancer in mice in high doses. There are a few chemicals in the skin that are toxins. The gel itself, the pulp of the leaf, to my knowledge, is safe.
Thank you for correcting me. The other ingredients listed are at least somewhat familiar to me. I have used all but one of them. But I just use the gel or aloe leaf carrier oil, not the leaf.
If our government was worried about us getting cancer they would not be creating all this Roundup Ready frankenfood, or spraying the skies almost daily with aluminum, barium, lithium, strontium, etc.
I think we should have freedom of health care, more than freedom of religion. Freedom of health care is our right to life, and liberty. These restrictions on supplements are an infringement on our basic rights as persons..
Here in Canada we can now get euthanized, but we’re not allowed to treat ourselves with supplements that keep us young, healthy, strong, and vibrant.
Let us all fight for our basic rights to live and liberty..
You are right. It is about freedom. Many years ago we had a Governor in my state who was an ophthalmologist. He believed everyone should have an eye exam every year, and had a law passed to that effect. It sounds very healthy and progressive. But if you scratch an eyeglass lens so badly you won’t to replace the lens, and your prescription is one year and one day old, you have to spend 100.00 on an eye exam even if your old prescription is still good. I think this whole nanny state business just makes people stupider.
Is it the case the aloe vera is being banned from compounding, or only the leaf with the skin? I have seen a study that shows that the skin of the leaf in high doses appears to cause cancer in mice. This is why California caused whole-leaf aloe vera to be labeled carcinogenic. Not the pulp of the leaf, which is very healthy to my knowledge.
Can we get Ben Carson on this problem?
The corporate string pullers of the FDA love to gloat about the free market whenever it works in their favor. However, when We the People exercise our right to vote with our wallets, they in turn respond by trying to game the system and thus attempt to limit our options to only their products and services. They’d sell out their own Fairy Godmothers for a buck.
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