Stop FDA's Proposed Ban on Compounded Glutathione!
FDA's Pharmacy Compounding Advisory Committee (PCAC) is meeting on June 8, 2022, to discuss outlawing the use of glutathione in compounded medications!
NAC (N-acetyl-L-cysteine) is a derivative of the amino acid L-cysteine. While L-Cysteine is found in the diet - from lean meat, NAC is not. In 1963, NAC was first FDA approved as a respiratory drug. It’s also used to prevent liver damage from acetaminophen and alcohol poisoning. NAC was available as a dietary supplement for decades – and there are only limited reports of adverse events because it is very safe. In 2021, FDA banned NAC for use in dietary supplements. Now it is going after glutathione.
NAC is a precursor of glutathione, a cellular antioxidant. Glutathione is known as the most powerful antioxidant in the world. It is believed to protect other antioxidants such as vitamins C and E, prolonging and enhancing their effectiveness. In other words, it works with your own body to heal itself.
In making its decision about the legality of compounding glutathione, PCAC is required to investigate how it is clinically used to treat patients. They will review your comments, data and presentations submitted by patients, doctors, health care providers, and pharmacists. So feel free to pass this on.
How Do I Help?
Submit your personal testimony. Advocate by telling your success story and sharing how you or your loved one has benefited from compounded glutathione. What is a compounded medication? Usually starting from a powder, it is hand-made by pharmacists, usually into a capsule. Benefits include customizing doses to your weight, as well as having an alternate supply just in the form of over-the-counter supplements that may be of lower quality. Compounding pharmacists saved America with a supply of ivermectin.
All electronic and written submissions will be added to docket number FDA-2021-N-0357. The comment period ends in 15 days from today. Submit a Comment HERE.
Join the Public Discussion on Glutathione HERE. The public and interested parties are invited to participate in a public meeting, with attendance and comments. The meeting will be held on June 8, 2022, from 9:30 a.m. to 5:15 p.m. (EST) via online teleconference meeting room. The room will be made available at least 2 days in advance of the meeting, accessed in the link below.
TIMING DEADLINES for FDA Glutathione Discussion on June 8, 2022:
May 24, 2022. Comments for committee consideration are due no later than May 24, 2022. All those received in this time frame will be reviewed at the June 8, 2022 PCAC meeting on Tuesday, June 7, 2022.
The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time, June 7, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered on time only if they are postmarked or the delivery service acceptance receipt is on or before that date. The Agency will review all comments and the committee's recommendations in its final decision.
By joining FDA's public discussion on banning glutathione , we stay together, support our right to receive supplements that make a difference in our lives, and protect our pharmacists' ability to dispense them.
And please strongly consider providing public comments to the Docket, with a deadline of May 24th for the FDA's discussion on June 8, 2022. Our compounding pharmacy's access to compounded glutathione is important because of you.
Thank you.