———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: afiore@cdc.gov
Cc: dpd1@cdc.gov, Matthew_Kuehnert@mtf.org, ebelay@cdc.gov, richard.bradbury@jcu.edu.au
Date: 11/19/2025 9:06 AM EST
Subject: Progress Toward Understanding Infection-Associated Chronic Conditions and Illnesses
Emerging Infectious Diseases Volume 31, Supplement—October 2025 Progress Toward Understanding Infection-Associated Chronic Conditions and Illnesses Anthony E. Fiore https://wwwnc.cdc.gov/eid/article/31/14/25-1187_article
Excerpt:
“Complicating the frustrated patient’s predicament, clinicians attempting unproven treatments (e.g., repeated antibiotic courses) might exacerbate illness by introducing additional risks or temporarily masking potentially treatable causes.”
To: Anthony Fiore, MD, MPH,
In 2016 Dr. Paul Auwaerter, past president of the Infectious Diseases Society of America coauthored a study revealing the persister form of Borrelia burgdorferi resistant to antibiotics.
-What has tuberculosis and Borrelia burgdorferi in common? In the late stage of the disease occurs persistent (tolerant) bacteria, which essentially means that the bacteria lasts and lasts and lasts. They protect themselves against antibiotics and are difficult to treat.
– Both Borrelia burgdorferi and tuberculosis is relatively easy to cure in the early stages, even with the use of one antibiotic. In the late stage it is impossible to cure the disease with the same type of treatment in the acute phase, said Dr. Ying Zhang when he visited the year NorVect conference.
-Dr. Ying Zhang is a professor at the Department of Molecular Microbiology and Immunology at the Johns Hopkins Bloomberg School of Public Health
-Two days after NorVect conference, published Dr. Ying Zhang’s latest research Identification of new compounds with high activity against stationary phase Borrelia burgdorferi from the NCI compound collection.
2016
A Drug Combination Screen Identifies Drugs Active against Amoxicillin-Induced Round Bodies of In Vitro Borrelia burgdorferi Persisters from an FDA Drug Library Jie Feng 1, Wanliang Shi 1, Shuo Zhang 1, David Sullivan 1, Paul G Auwaerter 2, Ying Zhang 1 https://pubmed.ncbi.nlm.nih.gov/27242757/
Abstract
Under experimental stress conditions such as starvation or antibiotic exposure, Borrelia burgdorferi can develop round body forms, which are a type of persister bacteria that appear resistant in vitro to customary first-line antibiotics for Lyme disease. To identify more effective drugs with activity against the round body form of B. burgdorferi, we established a round body persister model induced by exposure to amoxicillin (50 μg/ml) and then screened the Food and Drug Administration drug library consisting of 1581 drug compounds and also 22 drug combinations using the SYBR Green I/propidium iodide viability assay. We identified 23 drug candidates that have higher activity against the round bodies of B. burgdorferi than either amoxicillin or doxycycline.
Lyme disease (LD), caused by Borrelia burgdorferi, is the most common vector-borne disease in the United States and Europe. Despite the standard 2–4 weeks’ antibiotic treatment, approximately 10%–20% of patients will develop posttreatment LD syndrome, a condition that is poorly understood. One of the probable causes is thought to be the presence of B. burgdorferi persister forms that are not effectively killed by the current LD antibiotics. In this study, we evaluated nitroxoline, an antibiotic used to treat urinary tract infections, for its activity against a stationary-phase culture enriched with persister forms of B. burgdorferi. Nitroxoline was found to be more active than doxycycline and equally active as cefuroxime (standard LD antibiotics) against B. burgdorferi. Importantly, the nitroxoline two-drug combinations nitroxoline + cefuroxime and nitroxoline + clarithromycin, as well as the nitroxoline three-drug combination nitroxoline + cefuroxime + clarithromycin, were as effective as the persister drug daptomycin-based positive control three-drug combination cefuroxime + doxycycline + daptomycin, completely eradicating stationary-phase B. burgdorferi in the drug-exposure experiments and preventing regrowth in the subculture study. Future studies should evaluate these promising drug combinations in a persistent LD mouse model.
Dr. Fiore…This is the missing research that should have been conducted early in the discovery phase of the disease but as we now know, all the eggs were put into the vaccine basket while a campaign was orchestrated to discredit the sick and disabled patient population along with the courageous clinicians attempting to help these patients. https://pubmed.ncbi.nlm.nih.gov/21867956/
When many people see a big, beautiful pile of colorful autumn leaves, it feels like an open invitation to dive in. The scene evokes joy, nostalgia, and the simple thrill of childhood.
But for Isabel Rose, it brings up something very different. It reminds her of a moment that marked the beginning of her lifelong struggle with Lyme disease.
What others see as innocent fun, she now views with alarm.
Ticks thrive in damp, shaded environments close to the ground. Leaf piles, tall grass, and wooded edges are prime habitats for them. Children playing in these areas are at increased risk, often unaware that a single tick bite can lead to years of misery.
For Isabel, what began as a carefree childhood leap into a leaf pile became the start of a medical nightmare.
Isabel is now a writer, Lyme disease advocate, and founder of Mothers Against Lyme, a support network for families affected by congenital and pediatric Lyme. She also serves on the board of Project Lyme, a national nonprofit.
In a recent essay published on her Substack, Isabel shares the story of how a tick bite at age 8 led to decades of misdiagnosed symptoms, chronic illness, and eventually, the discovery that both she and her children had Lyme disease and co-infections.
Her experience is a powerful reminder of the importance of tick awareness. Ignoring the risks can be hazardous to yourself–and future generations.
While ticks can’t fly on their own, I’ve seen them be blown in wind. I’ve also heard a story of a person walking through the forest out east where tick populations are high. They heard what sounded like rain drops falling, but it wasn’t rain. It was ticks dropping from trees!
This year marks a major milestone for the MyLymeData patient registry—our 10th anniversary. MyLymeData is a project of LymeDisease.org. Over the past decade, MyLymeData has transformed the landscape of Lyme disease research by putting patients at the center.
Click on image to view larger image
Download Your 32 page full color
2025 MyLymeData Chart Book
Capturing information about patients with chronic Lyme disease that was previously unknown.
To celebrate, we’re publishing the MyLymeData 2025 Research Chartbook—a visual summary of a decade of groundbreaking research, collaboration, and progress. The chartbook transforms the individual experiences of over 19,000 patients into actionable insights. It highlights the extraordinary power of patient-driven research to impact science and promote public policy change.
Since its launch, MyLymeData has:
Enrolled over 19,000 participants
Collected tens of millions of data points on symptoms, treatments, and outcomes
Contributed to multiple National Science Foundation awards, working with artificial intelligence and academic researchers
Published eight peer-reviewed big-data studies that have been cited over 100 times by other scientific publications and in reports to Congress
Recognition and Collaboration
The importance of MyLymeData was recognized by the National Academies of Science, Engineering, and Medicine in its report on the future direction of Lyme disease research. Most recently, we received a Congressionally Directed Medical Research Program grant to use artificial intelligence and data from the registry to better define and understand persistent neurological Lyme disease.
The MyLymeData 2025 Research Chartbook is a celebration of what we’ve accomplished together—and a springboard for what comes next.
Our work is deeply collaborative. We partner with the Lyme Disease Biobank (a Bay Area Lyme Foundation project), academic researchers from institutions including the University of California, Los Angeles, the University of Washington, Johns Hopkins University, the College of New Jersey, and industry scientists. We’ve also served on panels and advisory boards for the National Academies of Sciences, Engineering, and Medicine; the Tick-Borne Disease Working Group; the International Lyme and Associated Diseases Society; and the Columbia Clinical Trials Research Network.
None of this would be possible without the patients who power this registry. Your willingness to share your experiences has fueled a decade of progress and helped shape the future of Lyme disease research. We are deeply grateful for your trust, your data, and your voice.
If you are a patient who is not enrolled in MyLymeData, please enroll today. If you are a researcher who wants to collaborate with us, please contact me directly.
MyLymeData is one of the largest patient-driven registries in the nation, with over 19,000 patients enrolled. It was created by patients, is run by patients and will address the issues that Lyme disease patients care about. MyLymeData Viz provides the community with results from MyLymeData. If you are enrolled in MyLymeData, we thank you for providing the data that will accelerate the pace of research in Lyme disease. If you are not enrolled, please enroll today.
I found the following table most interesting which can be found in top link:
This table shows side effects from the clot shot in both the general population as well as those with Lyme/MSIDS. In short, nearly everyone in both groups had pain at the injection site. Most frightening is that anywhere from 60-70% experienced fatigue, anywhere from 40-63% headache,30-60% muscle pain, and 23-45% joint pain.
The article aptly states:
It is possible that patients reporting Lyme flare-ups misattributed COVID vaccination side effects to Lyme disease since many of the symptoms overlap.
Sadly, the article regurgitates false statistics – namely that 32 million people in the US have been infected with the COVID, and more than 500,000 have died.
The CDC combined test results that diagnose current COVID infections with test results that measure someone has ever had the virus. Those that once had the virus but are well aren’t sick!
“TechImmune, LLC has been awarded a business (SBIR) grant from the U.S. National Institute of Allergy and Infectious Diseases (NIH) to develop a Universal Vaccine Against Multiple Coronavirus Variants of Concern. Additional grants are pending.” Scientific Advisor
Dr. Redfield is the former Director of the Centers for Disease Control and Prevention and a distinguished public health leader with decades of experience in medicine and research. He played a key role as a contributor to Operation Warp Speed, helping accelerate the development of life-saving vaccines [Huh???] during the COVID-19 pandemic. Today, he continues to advance the field through his active involvement in Long COVID clinical research.
Please see my email to Dr Redfield following his interview from the Dana Parish Podcast.
———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: “rrredfieldmd@gmail.com” <rrredfieldmd@gmail.com>
Cc: dana@danaparish.com, sephillips18@gmail.com, skottilil@ihv.umaryland.edu
Date: 11/06/2025 10:39 AM EST
Subject: The Dana Parish Podcast; Dr. Redfield Breaks His Silence — Long COVID, Cancer & Vaccines [And Chronic Lyme]
The Dana Parish Podcast
Dr. Redfield Breaks His Silence — Long COVID, Cancer & Vaccines [And Chronic Lyme] http://
Excerpt:
Dana Parish: “Why are we still suffering like this… it is known at the upper echelons of Public Health that Lyme is chronic.”
Dr. Redfield: “Cause people can’t get a simple diagnostic test to prove it.”
Institute of Human Virology, University of Maryland
725 West Lombard St, Room N560
Baltimore, MD 21201
Dr. Redfield,
You are mistaken. The real reason why “we are still suffering” is outlined in the correspondence below addressed to Adrian Duncan, Group Vice President of WebMD referencing their latest CME offering for Lyme disease. Google’s Gemini AI describes it as: intent to deceive for financial gain.
Carl Tuttle
Independent Researcher
Hudson, NH USA
Cc: Shyamasundaran Kottilil, MBBS, PhD
Institute of Human Virology, Director, Clinical Care & Research; Chief, Infectious Diseases; Professor of Medicine
Email sent to Adrian Duncan, Group Vice President WebMD:
#1 ——— Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: aduncan@webmd.net
Cc: cme@medscape.net, caitlin@medlitera.com, naseem@medlitera.com, michelle@medlitera.com
Date: 10/24/2025 12:42 PM EDT
Subject: Medscape Now! Understanding the Latest Evidence and Best Practices for Interprofessional Care of Post-Treatment Lyme Disease Syndrome
“To date, our understanding of the pathophysiology of Lyme IACI remains limited,[4] with little to no evidence supporting chronic Borrelia infection as the underlying cause.”
Adrian Duncan, Group Vice President
Global Head of Education & Medical Affairs
Dear Mr. Duncan,
In reference to the Medscape article written by Naseem Bazargan, I asked Google’s Gemini AI the following questions:
The latest Medscape CME education claiming to be developed with AI assistance, appears to have omitted the following references:
2018 Middelveen study; “Persistent Borrelia Infection in Patients with Ongoing Symptoms of Lyme Disease” identifying twelve patients who were culture positive after antibiotic treatment. Some of these patients had taken as many as eleven different types of antibiotics. Also missing is the NIH funded Embers studies of persistent Bb infection in monkeys and mice. And the Sapi study: “The Long-Term Persistence of Borrelia burgdorferi Antigens and DNA in the Tissues of a Patient with Lyme Disease” Here is the positive culture report from the CDC at Fort Collins Colorado and the chronic Lyme autopsy results from the patient in the Sapi study: Page 1, 2, 3, 4, 5, 6, 7. The destructive nature of Borrelia is evident in the patient’s liver (nutmeg liver), kidneys, heart, lungs and brain. The patient died after the insurer refused additional IV antibiotic therapy.
In fact, there appears to be 700 references identifying persistent infection. Question: So, is AI participating in the collusion to suppress evidence of antibiotic resistance or chronic Lyme disease? And what about the other 700 references identifying persistent infection?
Mr. Duncan… I will spare you the lengthy discourse and get right to the point.
Questions to AI:
1. Does a chronic relapsing seronegative disease fit the vaccine model?
AI Response:
A chronic, relapsing, seronegative disease does not fit the traditional vaccine model, which is primarily designed to prevent initial infections. The characteristics you describe present significant scientific and commercial challenges for vaccine developers.
2. Since you agreed that a chronic, relapsing, seronegative disease does not fit the traditional vaccine model this in and of itself would be the motivation to conceal any and all evidence of persistent infection wouldn’t you agree? This so-called debate is not a debate at all and deserves a criminal investigation. Who would be a suitable candidate to approach for a legal case?
AI Response: Allegations of medical fraud are typically handled as civil matters, but they can become criminal if there is evidence of gross negligence, recklessness, or intent to deceive, especially for financial gain.
Mr. Duncan,
Thirty-four years agoDr. Allen Steere identified chronic Lyme disease which should have set off a red flag prompting an immediate search for better antimicrobials but then did a 180° as he became principal investigator (PI) of the Phase 3 clinical trial for the first Lyme disease vaccine. So all the eggs were put into the vaccine basket while a campaign was orchestrated to discredit the sick and disabled patient population along with the courageous clinicians attempting to help these patients. Apparently, a chronic relapsing seronegative disease did not fit the business model of patent royalties, vaccine development and pharmaceutical profits. This set the stage for long-term treatment denial and unimaginable pain and suffering around the world. It has been ongoing for over three decades now and the latest CME from Medscape is propagating this travesty.
Lyme disease has been grossly mishandled by our public health officials for the sake of a vaccine. A false public health narrative was enforced and any clinician who did not follow that narrative risked losing their license to practice medicine as seen in the documentary: Under our Skin. (please watch the 5min trailer)
I want to make this crystal clear; suppressing evidence of antibiotic resistance is not collaboration, it is collusion. Will you turn a blind eye to the facts/evidence I have presented?
A response to this inquiry is requested.
Respectfully submitted,
#2 ———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>To: aduncan@webmd.netCc: cme@medscape.net, caitlin@medlitera.com, naseem@medlitera.com, michelle@medlitera.comDate: 10/28/2025 9:28 AM EDT
Subject: Re: Medscape Now! Understanding the Latest Evidence and Best Practices for Interprofessional Care of Post-Treatment Lyme Disease Syndrome
Dear Mr. Duncan,
In 2016 Dr. Paul Auwaerter, past president of the Infectious Diseases Society of America coauthored a study revealing the persister form of Borrelia burgdorferi resistant to antibiotics.
-What has tuberculosis and Borrelia burgdorferi in common? In the late stage of the disease occurs persistent (tolerant) bacteria, which essentially means that the bacteria lasts and lasts and lasts. They protect themselves against antibiotics and are difficult to treat.
– Both Borrelia burgdorferi and tuberculosis is relatively easy to cure in the early stages, even with the use of one antibiotic. In the late stage it is impossible to cure the disease with the same type of treatment in the acute phase, said Dr. Ying Zhang when he visited the year NorVect conference.
-Dr. Ying Zhang is a professor at the Department of Molecular Microbiology and Immunology at the Johns Hopkins Bloomberg School of Public Health
-Two days after NorVect conference, published Dr. Ying Zhang’s latest research Identification of new compounds with high activity against stationary phase Borrelia burgdorferi from the NCI compound collection.
2016
A Drug Combination Screen Identifies Drugs Active against Amoxicillin-Induced Round Bodies of In Vitro Borrelia burgdorferi Persisters from an FDA Drug Library Jie Feng 1, Wanliang Shi 1, Shuo Zhang 1, David Sullivan 1, Paul G Auwaerter 2, Ying Zhang 1 https://pubmed.ncbi.nlm.nih.gov/27242757/
Abstract
Under experimental stress conditions such as starvation or antibiotic exposure, Borrelia burgdorferi can develop round body forms, which are a type of persister bacteria that appear resistant in vitro to customary first-line antibiotics for Lyme disease. To identify more effective drugs with activity against the round body form of B. burgdorferi, we established a round body persister model induced by exposure to amoxicillin (50 μg/ml) and then screened the Food and Drug Administration drug library consisting of 1581 drug compounds and also 22 drug combinations using the SYBR Green I/propidium iodide viability assay. We identified 23 drug candidates that have higher activity against the round bodies of B. burgdorferi than either amoxicillin or doxycycline.
Lyme disease (LD), caused by Borrelia burgdorferi, is the most common vector-borne disease in the United States and Europe. Despite the standard 2–4 weeks’ antibiotic treatment, approximately 10%–20% of patients will develop posttreatment LD syndrome, a condition that is poorly understood. One of the probable causes is thought to be the presence of B. burgdorferi persister forms that are not effectively killed by the current LD antibiotics. In this study, we evaluated nitroxoline, an antibiotic used to treat urinary tract infections, for its activity against a stationary-phase culture enriched with persister forms of B. burgdorferi. Nitroxoline was found to be more active than doxycycline and equally active as cefuroxime (standard LD antibiotics) against B. burgdorferi. Importantly, the nitroxoline two-drug combinations nitroxoline + cefuroxime and nitroxoline + clarithromycin, as well as the nitroxoline three-drug combination nitroxoline + cefuroxime + clarithromycin, were as effective as the persister drug daptomycin-based positive control three-drug combination cefuroxime + doxycycline + daptomycin, completely eradicating stationary-phase B. burgdorferi in the drug-exposure experiments and preventing regrowth in the subculture study. Future studies should evaluate these promising drug combinations in a persistent LD mouse model.
Dr. Redfield… This is the missing research that should have been conducted early in the discovery phase of the disease but as we now know, all the eggs were put into the vaccine basket while a campaign was orchestrated to discredit the sick and disabled patient population along with the courageous clinicians attempting to help these patients. What has been deceitfully established here in the US is wreaking havoc globally. Example: Lyme disease: Australians ‘being treated worse than a dog riddled with mange’, Senator John Madigan says https://www.abc.net.au/news/2016-01-11/lyme-disease-treatment-in-australia-criticised-by-john-madigan/7080708
This research is being suppressed as the disabled Lyme patient population around the globe remain sick indefinitely. (Three decades and counting)
Guideline signatory Dr. Raymond Dattwyler owns 24 patents for Lyme disease that include diagnostic testing and vaccines both live bacteria and oral and endorses the categorical assertion that chronic Lyme disease does not exist yet his patent for novel chimeric nucleic acids and protein antigens which could serve as a basis for a vaccine or for improved immunodiagnostic reagents for Lyme disease, issuing almost contemporaneously with the 2006 IDSA Lyme Disease Guidelines seems to say exactly the opposite:
“Currently, Lyme Disease is treated with a range of antibiotics, e.g. tetracycline, penicillin and cephalosporins. However, such treatment is not always successful in clearing the infection. Treatment is often delayed due to improper diagnosis with the deleterious effect that the infection proceeds to a chronic condition, where treatment with antibiotics is often not useful. One of the factors contributing to delayed treatment is the lack of effective diagnostic tools.” (Dattwyler, et.al. United States Patent 7,179,448)
Please take a moment if you will to review the following inquiry addressed to doctor Dattwyler who has set the stage for long-term treatment denial. It should be noted that there was no response.
———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: Raymond_Dattwyler@nymc.edu
Cc: npjvaccines@nature.com, abarrett@utmb.edu, R.W.Titball@exeter.ac.uk, mgomesso@uthsc.eduDate: 01/06/2023 2:46 PM EST
Subject: The year that shaped the outcome of the OspA vaccine for human Lyme disease
Department of Microbiology and Immunology
New York Medical College
Valhalla, NY
Raymond J. Dattwyler, Corresponding Author
Dear Dr. Dattwyler,
I read your manuscript with great interest as you call attention to a treatment-resistant Lyme arthritis with “no evidence of DNA” found in the joints of patients after antibiotic treatment.
For some strange reason however, I could not find the following 1995 publication within your paper identifying treatment-resistant neuroborreliosis:
We report an unusual patient with evidence of Borrelia burgdorferi infection who experienced repeated neurologic relapses despite aggressive antibiotic therapy. Each course of therapy was associated with a Jarisch-Herxheimer-like reaction. Although the patient never had detectable free antibodies to B. burgdorferi in serum or spinal fluid, the CSF was positive on multiple occasions for complexed anti-B. burgdorferi antibodies, B. burgdorferi nucleic acids and free antigen.
In fact, Dr. Dattwyler there seems to be a great deal of “treatment-resistant” evidence published in multiple journals over the past three decades:
Does a chronic relapsing seronegative disease fit the vaccine model? If not, would that, in and of itself, be the hidden reason for denying chronic (treatment-resistant) Lyme disease for almost three decades? In other words, patent royalties and pharmaceutical profits over lifesaving care?
A response to this inquiry is requested.
Carl Tuttle
Hudson, NH
Cc: Alan D.T. Barrett, PhD Editor-in-Chief
Rick Titball, PhD, DSc, Deputy Editor
Dr. Redfield… We have been dealing with an antibiotic resistant/tolerant super-bug. Post Treatment Lyme Disease Syndrome (PTLDS) is simply a fabricated medical condition disguising treatment failure. A chronic relapsing seronegative disease DOES NOT fit the vaccine model because you cannot prove vaccine efficacy in a disease where we don’t know who has or does not have the infection! So, deny the chronically infected by suppressing all evidence of antibiotic resistance, claim that the infection is easily treated because newer curative treatment for all stages of disease would give the public an excuse not to take the vaccine, reject all direct-detection methods that prove chronic infection and voila! move forward with patent royalties, vaccine development and pharmaceutical profits. The federal watchdog is no more. People suffering and dying and for what? Lyme for Profit.
The CDC has propagated this false Lyme disease narrative for decades and to this day refuses to recognize the disabling stage of the disease exposed in the documentaries Under our Skin and The Quiet Epidemic.
You may want to read the following Newsweek article published April 2024 by Lindsay Keys Co-Director of The Quiet Epidemic as it describes precisely what affect suppressing/concealing antibiotic resistance has had on the patient population…
ANH-USA has released a ground-breaking Strategic Roadmap and Action Plan exposing how outdated FDA rules are blocking access to medical foods—science-based nutrition therapies that could help millions of Americans prevent, manage, and even reverse chronic disease. Our Action Plan shows how we’re going to fix it. It’s time to educate Congress: sign our Action Alert now!
THE TOPLINE
America is facing a chronic disease crisis, yet FDA rules restrict access to medical foods—nutrition-based therapies designed to meet the special dietary needs of people with diagnosed health conditions.
By treating these foods like drugs, FDA policy has stifled innovation, discouraged research, and cut off patients from affordable, safe, and effective nutrition-based care.
ANH-USA’s roadmap lays out how to modernize medical food policy, broaden access, and bring the “food is medicine” vision to life.
How can a nation that spends so much on health be so sick? Because we’ve built a healthcare system that waits for people to get sick—and then treats them with drugs that are expensive, dangerous, and do not address the root cause of illness in the first place.
Medical foods (MFs) are specially formulated products that provide targeted nutrition for people whose dietary needs cannot be met by regular foods alone. They’re used in hospitals every day, often in the form of shakes, powders, or enteral (feeding tube) formulas for patients recovering from surgery, living with metabolic disorders, or managing chronic disease.
Medical foods can help underserved populations reduce age-related disease and chronic conditions like diabetes, cardiovascular disease, and arthritis, improving health while reducing healthcare costs. They’re safe, effective, and far less expensive than many branded drugs.
So why don’t more Americans have access to them?
The Problem: A System Rigged Against Nutrition
Medical foods are trapped inside an outdated legal framework. In 1988, Congress created the medical food category in the Orphan Drug Act—a law meant to encourage the development of drugs for rare diseases.
Current rules say medical foods can only be used under a doctor’s supervision—even though most physicians receive very little training in nutrition. Meanwhile, qualified nutrition professionals like Certified Nutrition Specialists and Registered Dietitians are shut out from helping patients access these lifesaving foods.
The FDA’s interpretation of the law is so narrow that medical foods are completely shut out from addressing common chronic conditions like diabetes, heart disease, and metabolic syndrome, even though nutrition is central to their management. In its guidance document, for example, the FDA states, “There are no distinctive nutritional requirements associated with the management of [diabetes],” so medical foods cannot target diabetes.
Making matters worse, medical foods are often denied insurance reimbursement because FDA policy has left their prescription status in limbo. This is critical: our healthcare system mostly runs on insurance reimbursement. But because of the FDA’s restrictive rules, medical foods are left out of that system. As a result, most doctors and patients don’t even know these products exist—and when they do ask for them, insurance almost always refuses to cover the cost. By effectively hiding a whole category of safe, affordable nutrition-based treatments, the system blocks competition and discourages companies from investing in this promising area of medical science.
In short: the FDA has put medical foods in handcuffs for decades while we’ve been seeing increasing rates of chronic disease that are nutrition and lifestyle related. This is crony medicine at its finest: shut out natural, nutrition-based interventions in favor of pharmaceutical monopolies over disease treatment.
Our Solution: A Roadmap for Reform
ANH-USA’s Strategic Roadmap and Action Plan offers a clear, actionable plan to fix this broken system. We’re calling for a modern framework that empowers innovation and restores nutrition to its rightful place in medicine.
Key recommendations include:
Modernize the definition. Update the statutory language so medical foods can address common chronic diseases, not just rare ones.
Expand access and supervision. Allow qualified nutrition professionals—not just doctors—to oversee medical food use.
Clarify prescription status and enable reimbursement. Give medical foods a clear path to coverage through Medicare, Medicaid, the Veterans Administration, and private insurers.
Replace regulatory intimidation with guidance. End the warning-letter culture and provide transparent, science-based rules for innovation.
Educate healthcare professionals. Integrate medical nutrition training into medical, nursing, dietetic, and pharmacy schools nationwide.
These changes would unleash innovation, bring competition and lower prices, and expand patient access to safe, proven, food-based therapies.
Why It Matters
Medical foods won’t replace drugs—but they can reduce the need for them. By addressing the nutritional roots of disease, medical foods can help people stay healthier, longer, while saving billions in healthcare costs.
It’s time to bring “food as medicine” from rhetoric to reality.
Madison Area Lyme Support Group 