FDA BOTOX® Warning: What Patients Must Know

Hello, My Dears –

With more than twenty years of medical experience, from my fellowship at the University of Alabama to extensive work in hospital acute care, I have always placed patient safety at the heart of my practice. When I established Novel U Wellness and Med Spa in Long Beach, I carried those same high standards into the field of aesthetic medicine, driven by the belief that everyone deserves to feel confident and beautiful without ever compromising their health.

But not everyone in the aesthetics industry shares that commitment. And right now, there’s a dangerous epidemic of fake BOTOX® flooding the market, putting unsuspecting patients at serious risk.

The FDA’s Wake-Up Call to the Public

The U.S. Food and Drug Administration recently issued 18 warning letters to websites illegally selling unapproved botulinum toxin products directly to consumers and unlicensed practitioners. This represents one of the largest enforcement actions against counterfeit cosmetic injectables in recent history, and it should serve as a wake-up call for anyone considering aesthetic treatments.

Between late 2023 and early 2024, at least 22 individuals across 11 states developed serious complications after receiving injections from these illegal sources. Their symptoms (blurry vision, difficulty swallowing and breathing, slurred speech, and progressive muscle weakness) indicated that the neurotoxin was spreading beyond the intended injection site, a potentially life-threatening complication.

These weren’t just adverse reactions to legitimate products. These were the consequences of unregulated, untested, and often counterfeit substances being injected into people’s faces and bodies by individuals who had no business holding a syringe.

Understanding What Makes This So Dangerous

Botulinum toxin is one of the most potent neurotoxins known to science. In fact, in its purified form used for medical purposes, this is a substance so powerful that dosing is measured in units smaller than a grain of salt. This isn’t something to take lightly or purchase from a website offering rock-bottom prices to the public.

The FDA-approved products used in legitimate medical practices such as BOTOX®, Dysport®, Xeomin®, and Daxxify® undergo rigorous manufacturing standards, extensive clinical trials, careful quality control, and specific storage and handling requirements. These safeguards exist for a reason: without them, patients are playing Russian roulette with their health.

The illegal products flooding the market bypass every single one of these protections. They’re often manufactured overseas with no regulatory oversight, stored improperly, shipped in conditions that can break down the protein structure, and sold to anyone with a credit card: no medical license required.

What could possibly go wrong? Everything.

The Anatomy of a Counterfeit Crisis

Let me paint you a picture of how this typically unfolds. You see an advertisement on social media for “luxury botox treatments at affordable prices.” The photos look professional. The person claims to be “certified” and has a few dozen followers vouching for their work. The price is about half what you would pay at a medical spa like mine.

What you don’t know is that the person behind that social media account ordered their “botox” from one of those illegal websites and purchased knock-off products with names like “Botulax,” “Nabota,” “Coretox,” or “Innotox.” None of these are FDA-approved for use in the United States. The seller has no medical training, no understanding of facial anatomy, and no idea how to handle complications if they arise. They’re operating out of a home, hotel room, or back room salon with no proper sterilization equipment, no emergency protocols, and no medical license.

The product itself? It might be contaminated with bacteria. It might be far too strong or completely inert. It might have been sitting in a non-refrigerated warehouse for months, breaking down into something unpredictable and dangerous. It may not contain any botulinum toxin, just an unknown substance packaged to appear authentic.

And if you experience complications after your treatment (such as persistent eyelid drooping or difficulty swallowing) these unqualified providers take no responsibility, leaving you without any recourse.

The Economics of Cutting Corners

In this economy, everyone is looking for ways to save money, and aesthetic treatments aren’t cheap. But there’s a reason legitimate medical practices charge what they charge for BOTOX® treatments, and it’s not greed: it’s safety, quality, and expertise.

When you come to Novel U Wellness and Med Spa for BOTOX® cosmetic treatments, here’s what you’re paying for: FDA-approved products purchased directly from authorized distributors, with full documentation and lot numbers; proper refrigerated storage from the moment the product arrives until it’s drawn into your syringe; a sterile medical environment that meets hospital-grade standards; my credentials that include more than 20 years of medical experience as a board-certified internist; comprehensive knowledge of facial anatomy, muscle function, and potential complications; emergency protocols and the ability to manage any complication that might arise; follow-up care and ongoing monitoring of your results; licensing and accountability.

The person offering “discount Botox” at a fraction of the legitimate market price isn’t providing any of these things. They’re cutting corners in ways that put you at risk, and the few hundred dollars you save aren’t worth a trip to the emergency room, or worse.

What Every Patient Needs to Know Right Now

If you’re currently receiving BOTOX® treatments or considering them, here’s what I want you to understand with absolute clarity: legitimate BOTOX® administered by qualified medical professionals remains incredibly safe. Over 8.7 million botulinum toxin procedures were performed in the United States last year, making it the most popular minimally invasive cosmetic treatment available. When done correctly, complications are rare and usually minor.

The FDA’s enforcement action isn’t targeting medical spas like mine. We’re not the problem. The problem is the underground network of illegal sellers and unlicensed injectors who are exploiting patients’ desire for beauty and taking advantage of their trust.

So how do you protect yourself? Start by only receiving treatments in proper medical settings and never at homes, hotel rooms, or non-medical salons. Always verify your provider’s credentials before they touch your face. I’m a board-certified internist, and I’m proud to show patients my credentials, my medical license, and documentation of my training.

Ask to see the vial before the injection. A legitimate provider will gladly show you the packaging, which should have clear English language labeling with the manufacturer’s name, lot number, and expiration date. At Novel U Wellness and Med Spa, transparency is standard practice, not something you have to request.

If the price seems dramatically lower than what established medical practices in your area charge, ask yourself: What corners are being cut? Is this a risk you’re willing to accept? Your face and your health are worth more than a discount.

Trust your instincts. If something feels “off” – if the provider is secretive about their products, defensive about questions, or pressuring you to decide quickly – walk away. A reputable medical professional will welcome your questions and take time to ensure you feel comfortable and informed.

If anyone asks you to buy products online to take to someone for your cosmetic injections, decline to do so. This is a major red flag. Legitimate medical practices source their own products through proper channels. If someone asks you to provide the product, they’re likely unlicensed and unable to purchase through legal means.

The Symptoms You Should Never Ignore

Even with legitimate treatments, it’s important to know what normal looks like versus what requires immediate medical attention. After a proper BOTOX® treatment, you might experience mild temporary redness at injection sites, slight bruising, or a mild headache. These are normal and resolve quickly.

What’s not normal, and what requires emergency medical care, includes difficulty swallowing or breathing, trouble speaking or slurred speech, excessive or spreading muscle weakness, progressive vision changes or drooping eyelids that worsen over hours or days, weakness spreading to other parts of your body, flu-like symptoms combined with muscle weakness, or severe headache with signs of infection.

These symptoms can indicate that the toxin is spreading systemically, a rare but serious condition. With legitimate, FDA-approved products administered correctly, this is extraordinarily uncommon. But with counterfeit or improperly stored products, the risk increases significantly. If you experience any of these symptoms after any injection, seek immediate medical care and be completely honest with healthcare providers about what was injected and by whom.

A Personal Commitment to Your Safety

When I transitioned from hospital medicine to founding Novel U Wellness and Med Spa, people sometimes asked if I missed the intensity of acute care. The truth is, I brought that intensity with me. Every patient I treat receives the same level of careful attention, the same rigorous safety standards, and the same medical expertise I provided in hospital settings.

My artistic eye for aesthetic beauty is informed by decades of medical training and a deep understanding of anatomy, physiology, and patient care. I don’t just see you as a face to inject: I see you as a whole person deserving of respect, honesty, and the highest standard of care.

That’s why I’ll always show you the vial. That’s why I’ll always answer your questions without making you feel like you’re being a nuisance. That’s why I maintain hospital-grade standards in my practice. And that’s why I’ll never compromise your safety for convenience or profit.

The recent FDA warnings have shaken many people’s confidence in aesthetic treatments, and I understand that reaction. But I hope this message reaches you with clarity: the danger isn’t in BOTOX® itself. The danger is in the unregulated, illegal market that’s exploiting patients’ trust and desire for beauty.

You have the power to protect yourself by making informed choices, asking the right questions, and choosing providers who prioritize your safety above all else. Your confidence and beauty shouldn’t come at the cost of your health, and in the hands of a qualified, licensed medical professional using legitimate products, they don’t have to.

Moving Forward with Confidence and Wisdom

The aesthetic medicine industry faces a pivotal moment: while technology and expertise are advancing, the rise of counterfeit products and unlicensed providers threatens patient safety. By choosing licensed professionals, verifying credentials, and avoiding deals that seem too good to be true, patients help uphold higher standards and protect themselves and others. Though these treatments may feel like luxuries, your health and safety are essential – and always my top priority at Novel U Wellness.

Wishing You Light and Love,

Dr. Shahnoos

Board-Certified Internal Medicine
Director, Novel U Wellness & Med Spa
Long Beach, California