The FDA Just Flagged Ozempic. Your Body Already Has a Better Answer.
- Dr. Mindy Pelz
- 15 hours ago
- 8 min read
Note: This article discusses a developing regulatory and legal situation. It does not constitute medical advice. If you are using a GLP-1 medication, speak with your prescribing physician before making any changes.
A significant story broke recently about the blockbuster weight-loss drugs Ozempic and Wegovy — and if you or someone you love has taken these medications, or if you have been watching the GLP-1 conversation unfold, this one deserves your attention.
The FDA issued a formal warning letter to Novo Nordisk, the maker of Ozempic and Wegovy, citing serious violations related to how the company reported patient side effects. The letter, dated March 5, 2026, was the result of a federal inspection at Novo Nordisk’s New Jersey headquarters. [1]
This is not a minor compliance issue. When the FDA says a pharmaceutical company failed to properly report adverse events — including deaths — connected to one of the most widely prescribed drugs in modern history, it raises a question every woman should be asking:
What do we actually know about these medications? And what are we still learning?
I recorded a full breakdown of this story. Watch it below, then keep reading for the complete picture.
What the FDA Actually Found
The FDA’s warning letter identified specific failures in how Novo Nordisk tracked and submitted safety information after Ozempic and Wegovy reached the market. According to the letter and subsequent reporting, the violations included:
Three patient deaths linked to semaglutide — the active ingredient in Ozempic and Wegovy — that were not properly investigated or reported within the required 15-day timeframe. [1]
One of those deaths was a suicide that Novo Nordisk failed to investigate or report at all. [2]
A separate case of suicidal ideation submitted to the FDA late. [2]
A stroke in a patient taking liraglutide, another GLP-1, that was rejected and never reported. [3]
Failure to develop written procedures ensuring all serious adverse events were properly flagged. [2]
It is important to be precise here. The FDA did not conclude that semaglutide caused these deaths. The agency’s concern was specifically about the failure to report and investigate them as required. But here is why that distinction matters less than it might seem.
The entire post-market safety system depends on complete, accurate, timely data. When that data is missing or delayed, regulators cannot make fully informed decisions about a drug’s safety profile. With GLP-1 drugs now being taken by millions of people, many not for diabetes but for weight loss, that system needs to work correctly.
Novo Nordisk responded saying it had been working to address the FDA’s concerns and that the letter made no conclusions about the quality or safety of its medicines. [3]
The Growing Legal Picture
The FDA warning does not exist in isolation. At the same time this story broke, thousands of lawsuits were already moving through U.S. federal courts involving GLP-1 medications including Ozempic, Wegovy, and Mounjaro, consolidated into multidistrict litigation. [4]
Many lawsuits center on two serious complications patients say they experienced:
Gastroparesis
Sometimes called stomach paralysis, this is a condition where the stomach slows down or stops emptying properly. Because GLP-1 drugs work partly by slowing gastric emptying which creates feelings of fullness — there is a plausible biological mechanism. A 2023 study in JAMA found significantly increased risk of gastrointestinal complications including gastroparesis in patients using GLP-1 drugs for weight loss. [5]
Vision problems
Some lawsuits involve nonarteritic anterior ischemic optic neuropathy, or NAION — sometimes called an eye stroke where patients experienced sudden vision loss. A 2025 study in JAMA Ophthalmology examined the association between semaglutide use and this condition. [6]
A lawsuit is not proof that a drug caused a harm. These cases are still being argued and investigated. What they represent is the reality that when millions of people start using a new medication quickly, additional side effects often emerge over time. That is exactly why post-marketing safety reporting exists and why the FDA’s warning to Novo Nordisk matters.
How GLP-1 Drugs Actually Work
GLP-1 medications mimic a hormone your body naturally produces called glucagon-like peptide-1, which plays a role in blood sugar regulation and appetite control. When the drug activates GLP-1 pathways:
Stomach emptying slows down
Appetite decreases
Insulin release increases
Blood sugar drops
People feel full faster, eat less, and many lose weight. [7] But here is the critical distinction I want you to sit with:
These drugs are pharmacologically suppressing appetite. They are not fixing the underlying metabolic dysfunction that caused weight gain in the first place.
When the drug stops, the biology driving the weight gain is often still there.
What Your Body Is Already Designed to Do
Here is the part of this conversation almost nobody is talking about — and the part I find most important.
Your body already has a natural system for producing GLP-1. And a large part of that system lives in your gut microbiome.
Certain microbes in your gut take fiber from food and convert it into molecules called short-chain fatty acids. Those molecules then signal specialized cells in your intestinal lining to release GLP-1 naturally. When your gut microbiome is diverse and well-fed, your body is producing its own appetite-regulating hormones without any pharmaceutical assistance. [8]
But when the microbiome becomes damaged — through diets high in ultra-processed foods, repeated antibiotic use, the birth control pill, or chronic stress — the microbes that help produce these natural signals begin to disappear. [9] When that happens, GLP-1 signaling drops, insulin resistance increases, and metabolic dysfunction sets in.
So instead of only asking how we can stimulate GLP-1 with a drug, we should also be asking: how do we protect and rebuild the microbes that help us produce it naturally?
This is exactly what I teach in the Reset Academy. We do not just talk about fasting — we go deep on rebuilding the gut microbiome, restoring natural GLP-1 signaling, and creating a lifestyle that supports your metabolism from the inside out. Women in the Academy run urinary hormone tests, track their metabolic markers, and learn to read what their body is actually telling them.
Something Simple You Can Start Today
There is also a remarkably simple tool that supports your body’s natural GLP-1 production and requires no prescription: the order in which you eat your food.
Research has shown that when you eat fiber or vegetables first, then protein and fat, and leave carbohydrates for last, your body produces more GLP-1 naturally. [10] Here is why:
Fiber feeds the gut microbes that produce short-chain fatty acids
Those molecules signal your intestinal cells to release GLP-1
Protein entering the gut further stimulates GLP-1 release
By the time carbohydrates arrive, your body already has hormonal signals in place to manage the glucose spike
Something as simple as rearranging what you eat first can meaningfully shift how your metabolism responds to a meal. Your body has incredibly intelligent systems built in. Sometimes we just need to work with them instead of overriding them.
Why This Particularly Matters for Women
Women’s bodies are especially sensitive to metabolic changes because our hormones interact with metabolism constantly — through our menstrual cycle, stress hormones, thyroid function, perimenopause, and menopause. [11]
So when a drug blunts appetite and slows digestion, we need to ask a bigger question: what does this mean for a woman’s long-term hormonal balance? What I am hearing from women includes concerns about fatigue, hair loss, muscle loss, and nutrient deficiencies from reduced food intake.
These do not happen to everyone. But they are the kinds of questions we should be asking as more women — particularly perimenopausal and menopausal women start using these medications. Hormonal health and metabolic health are deeply intertwined, and a drug that changes your relationship with food does not operate in isolation from your hormonal system.
The Deeper Issue We Need to Name
The reason GLP-1 drugs have exploded is because we are in the middle of a genuine metabolic health crisis. Research has shown that over 90% of Americans have some degree of metabolic dysfunction, including insulin resistance, blood sugar instability, and chronic inflammation. [12]
What we have done is take a lifestyle-driven metabolic problem and tried to solve it with a pharmaceutical appetite suppressant. For some people these medications are genuinely helpful tools. But it is worth naming clearly:
Medications should never replace metabolic education.
What Your Body Can Do When You Give It the Right Tools
Your body already has a built-in system designed to restore metabolic balance. It is called fasting.
When you fast, your body naturally increases GLP-1 signaling, improves insulin sensitivity, activates fat burning, and initiates cellular repair through autophagy. [13] These are not side effects — they are your biology working exactly as designed.
That is why I have spent years teaching women how to fast in a way that works with their hormones. Not to suppress appetite artificially, but to help the body remember how to regulate itself. The foundational principles are in Fast Like a Girl — and the deeper, guided implementation is inside the Reset Academy.
What I Want You to Take From This
This story is not about fear. It is not a reason to panic if you are currently taking a GLP-1 medication. It is a reason to stay informed, ask good questions, and make sure your prescribing physician is part of any decisions you make.
What the FDA warning tells us is that the science on these medications is still evolving. The lawsuits tell us the same thing. And what the biology of the gut microbiome, meal sequencing, and fasting tells us is something I have believed for a long time:
Your body is not broken. It has systems designed to regulate appetite, metabolism, and hormones. The goal is to support those systems — not replace them.
Watch the full video above for my complete breakdown. And if you are ready to learn how to build your own natural GLP-1, support your microbiome, and create a lifestyle that works with your hormones rather than against them, that is exactly what we do inside the Reset Academy.
Ready to make your own GLP-1 naturally?
Inside the Reset Academy, I teach you the exact lifestyle tools — fasting protocols, gut microbiome repair, meal sequencing, and hormone testing — that help your body produce its own GLP-1 without a prescription. This is metabolic education done right.
References
[1] NBC News. FDA warns Novo Nordisk of potential unreported GLP-1 side effects. March 2026.
[2] BioSpace. Novo Hit With FDA Warning Letter for Unreported Ozempic Safety Signals. March 2026.
[3] CBS News. FDA warns Novo Nordisk over unreported potential Ozempic side effects. March 2026.
[4] U.S. Judicial Panel on Multidistrict Litigation. In Re: GLP-1 Receptor Agonists MDL-3163. December 2025.
[5] Sodhi M. et al. Risk of Gastrointestinal Adverse Events Associated With GLP-1 Receptor Agonists for Weight Loss. JAMA. 2023.
[6] Hathaway J.T. et al. Semaglutide and Nonarteritic Anterior Ischemic Optic Neuropathy. JAMA Ophthalmology. 2025.
[7] Müller T.D. et al. Mechanisms of GLP-1 Receptor Agonist-Induced Weight Loss. The American Journal of Medicine. 2025.
[8] Zhao L. et al. Crosstalk between GLP-1 and gut microbiota in metabolic diseases. PMC. 2023.
[9] Zinöcker M.K. & Lindseth I.A. The Detrimental Impact of Ultra-Processed Foods on the Human Gut Microbiome and Gut Barrier. PMC. 2025.
[10] Imai S. et al. Effects of Vegetables Consumption Before Carbohydrates on Blood Glucose and GLP-1 Levels. PMC. 2022.
[11] Mauvais-Jarvis F. et al. Gender differences in glucose homeostasis and diabetes. Physiology & Behavior. 2018.
[12] Araújo J. et al. Trends and Disparities in Cardiometabolic Health Among U.S. Adults, 1999-2018. JACC. 2022.
[13] de Cabo R. & Mattson M.P. Effects of Intermittent Fasting on Health, Aging, and Disease. NEJM. 2019.