FDA's Botox Warning Targets Websites With Unapproved Products

 The FDA sent 18 warning letters to websites that illegally market unapproved and misbranded botulinum toxin (Botox) products, the agency announced.

The letters were addressed to sites with names like cosmo-korea.com, derma-solution.com, glamderma.com, and koreanfillers.com, among several others.

Unlike other warning letters, however, these weren't addressed to a specific individual, such as a company owner or CEO. Instead, each letter was addressed to the website name -- and none included address or email information.

The sites were reportedly based in South Korea, China, Panama, and the U.S., according to the letters.

FDA said it was aware of adverse events associated with the products, including botulism symptoms, but did not offer specifics. Iatrogenic botulism symptoms include headache, facial paralysis, and muscle weakness. Botulism can also result in difficulty breathing and death, FDA said.

Indeed, FDA-approved botulinum toxin products include a boxed warning about a significant risk for serious or life-threatening side effects.

The agency warned that patients should only receive FDA-approved botulinum toxin products from a licensed provider who is trained to give such injections, and they should make sure products are obtained from an authorized source, as products from unauthorized sources may be contaminated and unsafe.

There have been a number of cases of problematic botulinum toxin products in the U.S. in recent years. In 2024, the CDC warned that counterfeit botulinum toxin was spreading across the U.S., and was involved in nine hospitalizations across nine states. Earlier this year, an aesthetician in New York was arrested for injecting customers with counterfeit Botox at his medical spa after some complained that it made them sick.

The first botulinum toxin product, onabotulinumtoxinA, was approved by the FDA in 1989. Since then, FDA has approved several competing versions, including abobotulinumtoxinA (Dysport) and incobotulinumtoxinA (Xeomin).

In addition to cosmetic uses, these products are approved by FDA to treat a host of medical conditions, including migraine, bladder dysfunction, and limb spasticity, among others.

Healthcare professionals and consumers should report any adverse events with these products to FDA's MedWatch system, the agency said.

https://www.medpagetoday.com/publichealthpolicy/fdageneral/118329