The FDA is likely to move against numerous natural, compounded medicines.
The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA on what supplements and drugs can be individually formulated for patients—many of whom have very specific needs that can only be met through these alternative formulations. The next meeting of the PCAC has been announced for May 8-9, and the following substances will likely face the axe: nicotinamide adenine dinucleotide (as well as the disodium-reduced version), which plays an important role in our health (see below); nettle (Urtica dioica); ubiquinol (CoOQ10); vanadyl sulfate; and artemisinin, a critical medicine used against malaria and other diseases.
Also on the agenda is the nomination of “oral solid modified release drug products that employ coated systems”—that is, coated time-release tablets—to the “Difficult to Compound” list. As the name suggests, if a product or delivery system is added to this list, it will no longer be available from compounding pharmacies.
As has been the case in past meetings, the FDA has recommended that all of these substances be rejected. Since the PCAC almost always follows the FDA’s lead, we will need a strong response from concerned consumers if we’re to save these natural medicines.
Here’s what’s at stake:
- Artemisinin is a compound found in sweet wormwood, a herb that has been used in traditional Chinese medicine for centuries. It is most notably used to treat malaria, but it may also be helpful for tuberculosis and a host of other conditions. Considering the rise of drug-resistant TB, which is virtually untreatable and is sending conventional doctors into a panic, it would be lunacy to restrict access to this herb.
- Ubiquinol is by far the most effective, bioavailable form of CoQ10. Some people may not be able to convert the ubiquinone form of CoQ10 into ubiquinol, which means access to ubiquinol products is extremely important. CoQ10 / ubiquinol has many benefits—it is used for energy production by every cell in the body. It is especially useful for patients on statins since these drugs deplete the body of CoQ10.
- Nettle has a number of salutary effects. It was used by Roman soldiers to withstand the cold by stimulating blood circulation. It helps the body detoxify itself, alleviates allergic reactions, and promotes healthy blood circulation.
- Vanadyl sulfate is an insulin mimic and a natural therapy for diabetes and insulin resistance. It is a form of a trace mineral found in mushrooms and shellfish.
- Nicotinamide adenine dinucleotide (NAD) is a vital compound involved in mitochondrial health and energy metabolism. As NAD levels decline later in life, mitochondrial function is impaired, resulting in various symptoms of aging. NAD is also an essential cofactor of certain key enzymes that are responsible for longevity. Every year we are learning more about how critical NAD is, including for cancer control.
Compounding pharmacies make customized, natural medicines for patients for whom it is difficult to swallow a pill (the elderly, children, and patients with disabilities, for example), as well as for patients with allergies, sensitivities to environmental contaminants and preservatives, or who require doses or delivery systems different than those of commercially available products. The ability of compounding pharmacies to function, thrive, and produce these crucial supplements plays a crucial role in people’s lives.
The FDA has repeatedly demonstrated that it is unconcerned with the needs of these vulnerable patients. Time and time again, the FDA has advised the PCAC to reject the medicines that come before it—medicines for which there is little to no safety concern, like curcumin, boswellia, and aloe vera.
It has long been our suspicion that the end goal is to eliminate the compounding industry altogether, and this is a devious way to do it—just whittle away at the ingredients that are allowed to be compounded, and it’s “death by a thousand cuts” for compounding pharmacies. And it’s all done to eliminate competition for major drug companies. We see this as yet another instance of the FDA putting the needs of Big Pharma over the health of the American people.
Action Alert! Send a message to the PCAC urging it 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.