The clock is ticking for us to demonstrate massive grassroots opposition to a ban on compounded glutathione. Act now! Action Alert!
On Wednesday, June 8th, an FDA advisory committee is meeting to discuss whether glutathione can continue to be made at compounding pharmacies. The FDA has already suggested that the committee recommend a ban. The deck is stacked against glutathione and other natural medicines; we have to mount a substantial grassroots response to protect this critical antioxidant.
Our previous articles over the last few weeks detail the tremendous health benefits of glutathione. It helps with cancer treatment, Parkinson’s and Alzheimer’s, pulmonary disease, immune enhancement, autism spectrum disorder, COVID-19, headaches, detoxification, and more. The main reason glutathione can have help with such a diverse array of conditions is its role in reducing oxidative stress—an imbalance between free radicals and antioxidants.
Compounded glutathione is especially critical. Glutathione is not absorbed well when taken in oral supplement form; that’s why many integrative doctors opt for compounded forms which can be delivered through intravenous, intranasal, or sublingual administration. There are no commercial versions of glutathione in these forms, so an FDA ban would mean loss of access to all of these forms.
In detailing its reasoning for backing a ban on glutathione, the FDA cites safety issues. The FDA cites safety issues with glutathione, including hepatoxicity, or damage to the liver. Is the FDA aware that n-acetylcysteine (NAC), which tells the body to make glutathione, is the standard treatment for acetaminophen poisoning—which causes liver injury? What is the FDA thinking?
Further, the FDA’s adverse event reporting system lists 114 total adverse events from glutathione between 1991 and 2022. That’s an average of just under 4 adverse events per year. As with any medicine, there is always the possibility of side effects, particularly when that medicine is used irresponsibly. But 4 adverse events a year? What FDA-approved drug can boast such a safety profile? Tecfidera is considered a safer drug for multiple sclerosis; it averages 11,789 adverse events per year. Tylenol, for which there is adverse event data all the way back to 1970, averages 462 adverse events per year.
We cannot let this happen. If the FDA’s advisory committee votes to ban glutathione, it is a certainty that the FDA will issue a proposed rule to ban glutathione along with other natural medicines it doesn’t like. As we’ve argued elsewhere, we believe the FDA is doing all of this to protect drug industry profits. Glutathione is a threat to the drugs that treat the disease conditions mentioned above. In fact, there are several clinical trials that are looking, or have already looked at, glutathione to treat Parkinson’s, Alzheimer’s, type 2 diabetes, cystic fibrosis, HIV infection, COVID-19, and more.
Action Alert! Use the form below to post a message to regulations.gov defending glutathione; you will also send a message to the FDA, PCAC, and Congress. Please send your message immediately.
