FDA Issues Warnings to Websites Selling Unapproved Botox

As reported by Dermatology Times, the US Food and Drug Administration (FDA) has issued 18 warning letters to the operators of websites illegally marketing unapproved and misbranded botulinum toxin products, often sold under the guise of popular cosmetic injectables such as Botox. The FDA declared that these unapproved formulations pose serious health risks, including botulism symptoms, and have already been linked to adverse events.

The FDA issued warning letters to:

• acecosm.com
• aesthetic-essentials.com
• celestapro.com
• cosmenic.net
• cosmo-korea.com
• derma-solution.com
• dermaxshop.com
• ellepharm.com
• estaderma.com
• filleroutlet.com
• glamderma.com
• glowface.store
• glownestbeauty.com
• koreafillerexperts.com
• koreanfillers.com
• maypharm.net
• meamoshop.com
• mjsmedicals.com

In the FDA’s announcement, Commissioner Marty Makary, MD, MPH, emphasized the agency’s commitment to consumer protection, 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.”

The FDA warned that counterfeit or unapproved botulinum toxin products obtained from unauthorized sources may be adulterated, contaminated, improperly stored or ineffective. Beyond reduced efficacy, improper handling or dosing increases the risk of severe neurologic adverse events. Clinicians are urged to remain vigilant and confirm that all injectable neurotoxins are procured through verified supply chains.

The agency advises both health care professionals and consumers to report any suspected adverse events associated with botulinum toxin products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Botulinum toxin is a potent neurotoxin used therapeutically and cosmetically to block nerve signals in muscles, reducing muscle contraction. FDA-approved formulations, such as onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), and daxibotulinumtoxinA-lanm (Daxxify), are indicated for a range of uses, including dynamic facial wrinkles, chronic migraine, cervical dystonia and spasticity. These agents are prescription-only and must be administered by trained, licensed clinicians using products sourced from authorized distributors.

“Botulinum toxin products are drugs that have serious side effects like muscle weakness, paralysis or respiratory failure. Using misbranded products that are not FDA-approved could lead to severe complications. The FDA’s recent action emphasizes the necessity of going to a licensed healthcare professional for botulinum toxin injections,” Philadelphia dermatologist Kachiu Lee, MD told Dermatology Times.