FDA seeks to ban compounded glutathione, AANP responds with call-to-action

Access to compounded glutathione is under review by the U.S. Food and Drug Administration (FDA) and the committee that advises the agency on this matter will meet on June 8 to discuss whether to continue to allow glutathione to be compounded.

The Pharmacy Compounding Advisory Committee (PCAC) will be reviewing only the compounded forms of glutathione, not just the ingredient as a dietary supplement, according to an email alert sent out by the American Association of Naturopathic Physicians (AANP) on Monday May 23. According to the AANP, PCAC will listen to testimonies, review comments, and consider the FDA staff’s recommendations before voting on whether glutathione can or cannot be compounded.

In event materials for the June 8 meeting, the FDA recommended weighing against glutathione being placed on the 503A Bulks List, which includes bulk drug substances that can be used in compounding. The PCAC will take this into account in their discussion.

“A ban on compounded glutathione would be disastrous," said Laura Farr, executive director of the American Association of Naturopathic Physicians, in an email to Integrative Practitioner. "FDA's recommendations are a gross intrusion on the practice of medicine and a provider's clinical expertise to tailor compounded glutathione specifically for a patient's needs and will put the health of millions of patients at risk."

According to Farr, the PCAC committee usually votes to support FDA staff recommendations. As a result, the AANP is currently working in a coalition to help prepare testimony, submit research, and mobilize comments to defend compounded glutathione. The organization is urging comments from practitioners who prescribe compounded glutathione and their patients who are impacted.

Compounded glutathione is used by patients who don't respond well to FDA approved drugs, when prescribed by providers in individualized treatment plans for dozens of diseases and conditions, ranging from Parkinson's to lung disease, and mitigating adverse effects of chemotherapy in cancer treatments (among many others), Farr said.

According to the PCAC meeting announcement, glutathione was reviewed for the following uses: skin lightening, cystic fibrosis, asthma, chronic obstructive pulmonary disease, chronic lung disease, oxidative stress, reduction of the side effects of chemotherapy, inhibition of chemical induced carcinogenesis, prevention of radiation injury, treatment of heavy metal poisoning (cadmium and mercury), acetaminophen toxicity, autism spectrum disorder, Alzheimer’s disease, Parkinson’s disease, major depressive disorder, schizophrenia, helicobacter pylori infection, human immunodeficiency virus infection, tuberculosis, otitis media, peripheral obstructive arterial disease, anemia, diabetes, and septic shock.

Practitioners can provide feedback and submit comments regarding their clinical experiences and the impact of this compounded ingredient on patient care through the AANP’s website or through the FDA website by June 7, 2022.