FDA Seeks to Ban Some Supplements from Pharmacy Compounding*
…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.
Making the way for big Pharma: