FDA Issues Warnings to 18 Companies for Selling Counterfeit Botox

The Food and Drug Administration (FDA) has issued warnings to 18 companies for illegally selling counterfeit or misbranded Botox products online. These companies were found to operate websites that advertised products claiming to contain botulinum toxin, the active ingredient in Botox. The warnings follow an investigation conducted by the Centers for Disease Control and Prevention (CDC), which examined 17 incidents across nine states where individuals suffered severe adverse reactions after receiving counterfeit Botox injections.

Health officials reported complications including blurry vision, difficulty swallowing, breathing challenges, and slurred speech. FDA Commissioner Dr. Marty Makary emphasized the serious health risks associated with unapproved Botox products, stating, “Today we’re taking action to protect American consumers and prevent online entities from selling these dangerous products.”

Health Risks of Counterfeit Botox

Botox and similar neurotoxins are only available through a prescription from licensed medical professionals. These injections work by blocking the release of a specific neurotransmitter, temporarily paralyzing muscles. While Botox is primarily used for cosmetic purposes, such as reducing wrinkles, it also serves medical functions, including migraine management.

The FDA warns that products purchased online may be counterfeit or mislabeled, exposing consumers to significant health dangers. Some of these products may contain botulinum toxin forms approved in other countries but not in the United States. For instance, two companies received warnings for selling Innotox, often referred to as “Korean Botox” on social media.

Earlier in 2023, reports highlighted the growing trend of individuals self-injecting Innotox purchased online without professional supervision. These products are typically less expensive than genuine Botox and are often portrayed in social media videos as safe for self-administration.

Expert Opinions on Self-Administration Risks

The medical community has raised alarms about the dangers of self-injection. Dr. Evan Rieder, a board-certified dermatologist, warned that improper injection of even legitimate botulinum toxin can lead to severe complications. “If you’re just injecting it into the wrong places, you could have facial muscle weakness or facial muscle paralysis,” he explained.

The effects of incorrect injections may not be immediately apparent, potentially taking multiple treatments to manifest. Molly O’Rourke, a registered nurse and nurse injector, noted that complications could arise unexpectedly, saying, “You could think that you’re in the clear and then all of a sudden, you can’t open one of your eyes and you don’t know what to do.”

At the most severe end, excessive botulinum toxin can result in flaccid paralysis, affecting essential muscles, including those required for breathing. Dr. Michelle Henry, another board-certified dermatologist, highlighted the grave outcomes associated with such complications, indicating that patients could face life-threatening situations.

When administered by licensed professionals, these injections can be safely managed, allowing for immediate intervention if adverse effects occur. In contrast, consumers purchasing these products online may find themselves without support in critical situations, increasing the potential for severe health risks.

This series of warnings from the FDA serves as a crucial reminder of the importance of obtaining medical treatments from verified sources. As the trend of purchasing cosmetic procedures online continues to rise, consumers are urged to prioritize safety and consult healthcare professionals to mitigate the risks associated with counterfeit products.