Alan Dumoff’s Letter to PCAC

Filed Electronically at Regulations.gov
May 24, 2022
Pharmacy Compounding Advisory Committee
Center for Drug Evaluation and Research
US Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
Re: Comments on Docket FDA-2021-N-0357
Message to PCAC Members regarding Glutathione
Dear PCAC Committee Members:
I write on behalf of the American Association of Naturopathic Physicians (AANP), one of the
nominators of glutathione.1 While the FDA appears to have provided an in-depth analysis that supports
its rejection of this important therapy, the rubric applied is deeply faulty and sharply slanted to yield
recommendations against the inclusion of safe and effective therapies on the positive list. While many
of the details provided are subject to challenge, the less obvious but more critical point is that the
standards being applied to these reviews are contrary to statute and poor public health policy. I begin
by writing of my own experience as it perfectly encapsulates the profound flaws in the FDA’s
ingredient review process and its recommendation against the inclusion of glutathione in the positive
list.2 I highlight the salient points from my experience and then expand on each below.
1 AANP has been partnered in these efforts with the Integrative Medicine Consortium
(IMC), the American Academy of Environmental Medicine (AAEM), the American College for
Advancement in Medicine (ACAM), the International College of Integrative Medicine (ICIM) and the
Academy of Integrative Health and Medicine (AIHM). Together we filed a detailed Citizens Petition
raising this and numerous other defects in the review process which can be found
https://www.regulations.gov/document/FDA-2019-P-1351-0001,
2 I would have preferred to also present to the Committee live at the meeting, but the
federal register notice gave only 11 days to learn of it and file the request for a public speaker slot. We
and many other stakeholders have complained repeatedly about the lack of notice given at every step of
the process, which is a disservice to us and to the Committee who deserves to have the input of those
with actual clinical experience about nominated ingredients. The inadequate timing has been ongoing
and appears intentionally designed to reduce public opposition. See for e.g., my correspondence in the
June 6, 2022 Briefing Package at 105-6.
The American Association of Naturopathic Physicians
300 New Jersey Avenue, NW, Suite 900 – Washington, DC 20001
Toll Free: 202-237-8150 – Fax: 202-237-8152
www.naturopathic.orgAANP Comments on Docket FDA-2021-N-0357 Regarding Glutathione
Alan Dumoff, JD, MSW
May 24, 2022
Page 2
My Encounter with Glutathione
Due to several inhalation mishaps that damaged my lungs, I spoke with about seven of my
client functional medicine and naturopathic doctors3 who all recommended that I nebulize glutathione.
Every doctor I talked with occasionally nebulized glutathione themselves as well as recommended it
for their patients, reporting considerable success. I have been nebulizing glutathione off and for the past
several years and found it to be profoundly helpful. My experience contrasts with FDA’s requirements
in a number of critical ways:
Functional Therapies Not Allowed. Note that I am not being treated for a specific “disease,” I
am using it to heal these injuries and improve lung function. It was not suggested to me by consulting a
diagnostic decision tree with a pathway through FDA’s narrow disease lens but because of its known,
direct therapeutic effects. Glutathione has been used for decades by physicians with a functional
approach to care4 to obtain benefits as an antioxidant, anti-inflammatory and detoxification agent and
for other therapeutic functional purposes. It may not be obvious to members of the Committee that
FDA’s position is that even demonstrated therapeutic effects are insufficient to allow use, but have
imposed a disease requirement without statutory basis and which serves no public health purpose. It
does allow the Agency to require proof supporting a disease indication even where use is generally as a
functional therapy. While we believe the disease standard has been met, FDA is engaged in
misdirection by focusing on this artificially imposed threshold.
3 Naturopathic medical schools provide equivalent foundational coursework as MD and
DO schools, including pharmacology, cardiology, neurology, radiology, obstetrics, gynecology,
immunology, dermatology, and pediatrics. Degrees are awarded after extensive classroom study,
clinical training and an extensive postdoctoral exam. ND training includes the prescription of clinical
doses of vitamins and herbs and safe administration via oral, topical, IM and IV routes. Currently, 27
states and territories license NDs to practice. In 9 of those states, NDs function as primary care
physicians with prescribing rights. Naturopathic physicians have an excellent safety record with
licensing boards and a low incidence of malpractice.
4 To ensure it is clear, functional physicians are fully trained and licensed medical doctors
whose practice focus and training is in an approach that considers metabolic, immune, and other
functional vectors in an effort to seek underlying causes of disease that are often highly individualized.
Their differential decisions about use of compounded ingredients includes consideration of the
therapeutic use of nutritional ingredients for their functional effects and are well-developed. See for e.g.
Gaby A. Nutritional Medicine, Fritz Perlberg Publishing (2011) (1326 pages); Werbach M., Moss J.,
Textbook of Nutritional Medicine, Third Line (1999) (740 pages); Katz D. Nutrition in Clinical
Practice: A Comprehensive, Evidence-Based Manual for the Practitioner (2nd Ed.) LMW (2008) (592
pages); Kligler B, Lee RA, Integrative Medicine: Principles for Practice, McGraw-Hill (2004) (700
pages); Rakel, D. Integrative Medicine (4th Ed.) (2017) (1152 pages). Naturopathic medicine also has a
strong evidence base exhibited in text books for that field, including Pizzorno J. et al. The Clinician’s
Handbook of Natural Medicine, Churchill Livingstone (3rd Ed. 2015) (1008 pages).