The Global BOTOX CRISIS: It's Time to Face the Truth

Botulism outbreaks tied to Botox are no longer isolated incidents, they are happening right now, across continents, and even when regulations appear to be followed. Governments, manufacturers, and regulatory bodies have offered the same tired excuses: that these cases are only due to counterfeit products, unlicensed providers, or back-alley injections. But the evidence tells a far more disturbing story. Why? Read until the end, this issue has several layers to it.

Recent Global Outbreaks: Not Just an Isolated Occurrence

UK: The UK Health Security Agency recently issued a national alert after patients were hospitalized due to botulism-like symptoms linked to cosmetic injections. https://www.cddft.nhs.uk/about-us/news/durham-botulism-cases

BBC Coverage: Highlights the dangers of unregulated cosmetic procedures and rising concern among health professionals. BBC Article

US: In Milton, Massachusetts, a spa owner was criminally charged after botox-related botulism cases. CBS Article

Spring 2024 U.S. Outbreak: According to the CDC, nearly half of the patients affected were injected with approved botulinum toxin A products by licensed providers. CDC Summary

CDC’s Own Words: Iatrogenic Botulism

According to the CDC, iatrogenic botulism occurs when an overdose of botulinum toxin is administered for cosmetic or therapeutic reasons. CDC Definition

But here’s THE TRUTH: overdose is not necessary for botulism to occur. The FDA’s black box warning clearly states that botulinum toxin may spread beyond the injection site, causing life-threatening reactions, even at typical doses. To read the black box warning labels for each commercial product click HERE

WHY IS THIS HAPPENING? A number of reasons!

Botulism from Approved, Regulated Products

Of the 17 confirmed U.S. cases in Spring 2024, 13 were cosmetic related. These were not shady treatments, they occurred in 9 states and were administered by licensed professionals.

Lack of Regulation on Who Can Inject

In many places, non-medical providers can inject a neurotoxin that carries a black box warning. How is this allowed?

No Dose Limit Standards

Providers often exceed the product’s safety limits, treating off-label areas, or re-dosing, also called a "top off" too frequently. These appointments happen in close succession and often take a user past the recommended treatment limit (in units) for that particular muscle.

Product Sourcing Is Uncontrolled

Many providers buy from unauthorized distributors. There is no universal requirement to verify the authenticity of the product. This definitely poses a massive issue in patient safety.

Typically, reputable providers do their due diligence to purchase approved products directly from manufacturers. Many of our Botox Dysport Side Effects support group members who have suffered with systemic reactions after using botulinum toxin A treatment, have confirmed the legitimacy of the product they received. However, it is also important to highlight that illegitimate products are a potential concern. See the comment below from a provider that discusses this issue on our recent Instagram post. She stated:

"There are so many distributors that will sell 'Botox' that will actually arrive in the Botox vial but it is not coming from the direct manufacturer Allergan. They also cost much less than going through the direct manufacturer which also requires providing a license to the company to be able to purchase it. When buying from one of these distributors instead, this (license submission) is not required."

Inadequate Training on Side Effects

Some injectors don’t read the black box warning. Many do not recognize botulism symptoms after treatment. This is a terrifying gap in patient safety! Evidenced by the vast majority of our group members stating that when they reported their adverse reactions to their provider, they were met with statements that "they have never heard of that happening before," or "your side effects can't be from Botox."

Conflicting Guidance from Health Authorities

Even the CDC and FDA haven’t aligned their messaging. Public Citizen has petitioned the FDA to fix misleading labeling and strengthen the black box warning label. There is zero excuse for these agencies to not align! They have a responsibility to uphold the highest standards of safety, and yet they can't seem to collaborate with one another to get this crucial update on patient safety finished. Petition

No Regulation in Advertising

Botox is glamorized online with no warnings. Misleading content is rampant and unchallenged. You don't have to look far to see how social media platforms like Instagram, and Tiktok are doing a huge disservice to people, particularly young adults worldwide. These platforms are used as grounds to peddle and normalize the use of these products with little oversight! Something MUST be done here. Just look at the sheer number of providers doing this on social media, it's astounding. Our team was among the first people in social media spaces to blow the whistle on the new trend of self-injecting these products too. HOW is a prescription drug, that carries the risk of death ordered online, shipped, and allowed into the hands of a layperson? Hello?! DEA are you paying attention? See our video. HERE

Underreporting of Adverse Events

Very few people report reactions to FDA’s MedWatch or to their governing body in their own country. The real number of botulism cases is much higher. The FDA's database, FAERs only represents 1-10% of the total number of injuries out there. Simple math tells us that if everyone reported their adverse events to botulinum, the safety picture of all botulinum toxin products (regulated and unregulated) would look far more disturbing. Read reports HERE

Emergency Rooms Are Not Prepared

Doctors often do not recognize the warning signs of pharmaceutical botulism, they are not familiar with the patient safety warning label, and misdiagnose patients routinely. This leads to a failure to acquire, and administer the antitoxin in time. There is no standard of testing or protocols for iatrogenic botulism in ERs. Therefore, proper diagnosis relies on an ER doctor's knowledge of iatrogenic botulism poisoning after botulinum toxin A injections. Most have ZERO knowledge or training on this topic, which is a huge issue in patient safety!

No Global Labeling Standards

Botox safety labels differ by country. WHY? This is a global product with the same global risks. Warnings should be standardized. Iatrogenic botulism as a result of botulinum toxin A products, aka Botox, happens the same in the United States as it does in England, or Australia. It also happens the same for regulated and unregulated products. Why are regulators not paying attention?

How Much Is Too Much?

The FDA-approved cosmetic dose for upper half of the face is small! Yet some patients are receiving 500+ units in one sitting, in off-label, unstudied areas. The CDC confirms that large doses dramatically increase the risk of systemic botulism. (Which is why unregulated product is of significant concern.) (CDC Risk Factors)

But again, this Isn’t Just the UK or U.S.

Hong Kong: Botulism after unlicensed injections (Source)

Turkey: Outbreaks tied to intragastric botulinum injections (Study)

Similar incidents documented in global case reports. (Study)

Washington: Recent iatrogenic botulism case from unregulated product. (Source)

Recent summary of global cases over the last 7 weeks. (Source)

Of course this is a global issue! AND it pertains to BOTH regulated and unregulated botulinum toxin A products. What will it take for agencies and manufacturers to act?

CALL TO ACTION: Speak Up

If you're in the UK: Submit your story (now through July 22, 2025) to the Women and Equalities Committee Call for Evidence. Regulators can't instigate change without injury stories. (Submit HERE)

If you’re in the U.S., Turkey, Hong Kong, or beyond: Contact your local health authority. DEMAND stronger regulations. Botulinum toxin A products either regulated or unregulated belong nowhere in the hands of everyday consumers. Report adverse events to both regulated or unregulated products to MedWatch or your country’s equivalent. For a full list of regulators, join our support group. HERE

Friends, we must amplify these warnings, educate others, and pressure regulators to act. Because the truth is clear. Pharmaceutical botulism after botulinum toxin A may happen from real OR unregulated products. It can happen from botulinum toxin A when used as directed. It can happen when used not as directed. It can happen from licensed or unlicensed providers. The bottom line is, botulinum toxin A is the world's most lethal neurotoxin! ANY use, in ANY capacity may lead to the development of botulism.

Please speak up! Silence protects the broken system, not the people.

Let’s change that. TOGETHER.