FDA will hold a drug compounding annual listening session, virtually, from 9-11 a.m. ET on June 17. This listening session is an opportunity for stakeholders to voice their views on compounding to the FDA. Dr. Mary Ann Block met with IMC members this week for guidance in using her 5 minute opportunity. Alan Dumoff also plans to testify.
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).
26 May 2022 APC amicus brief addresses ambiguity in FDA insanitary conditions guidance “Insanitary conditions” are whatever FDA says they are. This is neither legal nor fair. That’s the gist of APC’s argument in a “friend of the court” brief filed in U.S. District Court in New Jersey on May 13. Funded by member contributions to the APC’s Legal Action Fund, the amicus brief was authorized in response to an urgent request from Wedgewood Pharmacy that APC support its filing for a temporary restraining order against FDA. Wedgewood filed its papers seeking a TRO on May 5, 2022, only after FDA demanded that Wedgewood immediately recall all nonsterile products within their expiry period, gave the pharmacy only 24 hours to respond, and failed to provide the pharmacy any information supporting the need for such an extraordinary, broad recall. Wedgewood told the court it suspected that, without the TRO, FDA would move quickly to publish a news release impugning Wedgewood based on FDA’s unsubstantiated findings of “insanitary conditions” at the pharmacy. In the TRO filing, Wedgewood and its lawyers argued that FDA had inspected the pharmacy and issued eight observations in a Form 483 related to vague notions of insanitary conditions, which focused on areas well outside the pharmacy’s compounding areas. Wedgewood further stated that none of the observations listed on the Form 483 FDA violated applicable USP standards. APC’s amicus brief, approved by the Executive Committee*, focused solely on the lack of standards in FDA’s Insanitary Conditions GFI and FDA’s failure to promulgate any enforceable rules concerning the same. APC engaged in the matter because we were—and remain—concerned about the significant implications on other APC-member compounding pharmacies if FDA continues to impose what appears to be the vague, subjective disciplinary standard suffered by Wedgewood. In particular, FDA derives its enforcement authority from a non-binding guidance document that contains not any objective standards, but instead relies on what appears to be a bunch of examples and the nebulous statement that “other conditions not described in the guidance may also be considered unsanitary.” How is a compounder to know what is in fact violative conduct? In that vein, we argue in the amicus that a pharmacy “would have no basis to know under the plain meaning of the term ‘insanitary conditions’ or under the explanation set forth in the Insanitary Conditions Guidance that ‘observed personnel who moved rapidly in a sterile compounding area’ or who ‘was noted to have their safety glasses down on their nose’ would meet the standard for insanitary conditions.” Both of those were among FDA’s Form 483 observations against Wedgewood. Last week the District Court denied Wedgewood’s request for a TRO. The judge said she could not issue a restraining order on an action that had not yet occurred—in this case, FDA’s publishing of a damning press release. But during oral argument, she also made clear that she expected FDA to work with Wedgewood to settle their difference and seemed to suggest she wanted that to occur without FDA publishing a news release that could unnecessarily damage Wedgewood’s reputation based on unsubstantiated or exaggerated claims of “insanitary conditions.” While APC strongly supports the maintenance of sanitary workspaces where compounded drugs are prepared—it’s simply essential for assuring patient safety—there must be standards for what constitute “insanitary conditions,” and those standards need to be rooted in science and the law. Our amicus brief in this matter is the clearest elucidation of the flaws in FDA’s Insanitary Condition Guidance I’ve seen. I do urge you to read it. APC is proud of our involvement in this matter. Just another way we’re looking out for you. Best,  |
