The Food and Drug Administration (FDA) has issued stern warnings to 18 companies for the illegal sale of counterfeit or misbranded botulinum toxin products online, which are marketed as alternatives to Botox. According to the FDA, these companies operated websites that claimed to sell products containing the active ingredient in Botox, posing significant health risks to consumers.
The warning letters follow an investigation by the Centers for Disease Control and Prevention (CDC) last summer, which examined 17 cases across nine states where individuals experienced severe reactions after receiving counterfeit Botox injections. These adverse effects included blurry vision, difficulty swallowing, breathing challenges, and slurred speech.
Dr. Marty Makary, FDA Commissioner, emphasized the urgency of the situation, stating, “Unapproved and misbranded Botox products carry serious health risks. Today we’re taking action to protect American consumers and prevent online entities from selling these dangerous products.”
Risks of Counterfeit Products
Botox and similar neurotoxin products are available only through licensed medical professionals. These treatments work by blocking the release of specific neurotransmitters, leading to temporary muscle paralysis. While they are commonly used for cosmetic purposes, such as reducing wrinkles, they also serve therapeutic roles, including migraine management.
However, the FDA warns that products purchased online may be counterfeit or mislabeled, exposing consumers to serious health dangers. Some items claim to contain botulinum toxin types approved in other countries but not in the United States. For instance, two firms received warnings related to the sale of Innotox, often referred to as “Korean Botox” on social media.
Reports earlier this year highlighted a troubling trend of individuals self-injecting Innotox without any medical supervision after purchasing it online. These products are typically cheaper than traditional Botox, and misleading social media portrayals suggest they can be safely injected by untrained individuals.
Expert Opinions on Self-Administration Risks
Board-certified dermatologists caution that self-injecting these products carries considerable risks. Dr. Evan Rieder, who is certified in dermatology and psychiatry, explained the potential consequences: “If there is actual botulinum toxin in the product and you’re injecting it into the wrong places, you could experience facial muscle weakness or paralysis. Sometimes, these effects take several injections to manifest and can persist for months.”
Molly O’Rourke, a registered nurse and injector at 207 Laser in Portland, Maine, added to the discussion, stating, “You could think that you’re in the clear and then suddenly find you can’t open one of your eyes.” Dr. Michelle Henry, another board-certified dermatologist, warned of the most severe outcomes, noting that excessive botulinum toxin can lead to flaccid paralysis, affecting essential muscles, including those required for breathing.
When administered by qualified medical professionals, appropriate measures can be taken to mitigate adverse effects. In contrast, consumers injecting unverified products may find themselves unprepared for potential complications, a situation that health experts find alarming.
As the FDA continues to address the issue of counterfeit Botox products, it urges consumers to seek treatments only from licensed healthcare providers to avoid the dangers associated with unregulated and potentially harmful alternatives.
